FM DECEMBER 2018 ISSUE - digital edition

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December has brought us yet another World Aids Day. Even after three 

decades Dear Doctor of raising awareness about the HIV infection pandemic since 1988, 

the world hasn’t still moved forward much in countering this deadly disease. 

For We India, know the you prevalence are busy. It rate is always in fact reassuring shot up to the that third the trust highest and in faith the of 

world hundreds over of the patients period. in The your country healing has touch about keeps 2.14 million you busy people in this infected noble 

with 

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the virus. 

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Of this, 

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while 

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on some of 

The 

the 

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latest 

part 

developments 

is that many 

in 

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emerging 

the patients, 

medicine. 

who are 

In 

under 

this era 

antiretroviral treatment, are developing multi-drug resistance due to poor 

of innovation, medical science is getting redefined almost by the day. Old 

compliance. Therefore, India faces manifold problems on this front. We need to 

technologies are being replaced by the new in the blink of an eye. Robots 

tackle the untreated, as well as the more crucial, drug-resistant patients, along 

and artificial intelligence are taking over a good part of the procedures, 

with an estimated 88,000 newly infected every year. 

while genomics and molecular science unveil the mysteries of life further. 

It’s time to put our act together to handle this enormous task and you have 

We are fortunate to have such breakthroughs as they help specialists like 

the most crucial role in it. For this, a critical update on the world scenario 

you rise above the expectations of today’s informed patient. 

is vitally important. As the scientific world is exploring newer options of 

treatment to overcome drug resistance and more efficient pathways to prevent 

infection, 

Similarly, it 

we 

is 

bring 

also a 

you 

time 

up-to-date 

when India 

on 

is 

the 

witnessing 

latest on this 

revolutionary 

front, such 

growth 

as the use 

in 

of 

healthcare 

broadly neutralising 

industry, especially 

antibodies 

in the 

(bNAbs), 

private 

pre-exposure 

sector, wherein 

prophylaxis 

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(PrEP), 

NextGeneration number of doctors Sequencing are taking (NGS) up multiple technology roles to of diagnose clinician, HIV researcher drug resistance and 

and entrepreneur. gene therapy This using requires CCRS expansion edited T cells of your in this focus issue to on a wider HIV/AIDS. canvas. In 

this Another context, major it becomes focus in important this issue is how on the a busy much-awaited professional revamp like you of can the 

country’s keep pace medical with these curriculum latest developments by Medical Council in a of quick India and (MCI) easy last way. week. We 

had, in our September edition, highlighted India’s dated medical curriculum as 

a At serious Future concern. Medicine, This which is a welcome is conceived change, and crafted after 21 by years. a team We are of senior discussing 

the journalists, critical aspects scientists of and this revamp doctors, in our this aim issue, to along help with you many do just other that. We 

interesting are equipped developments. to bring you the latest from the science of care from across 

the In world this issue, in an we interesting are also starting and convenient a new series way, on supplemented India’s First & by Most the Unique best 

institutions, of views and facilities, analyses technologies from the masters and products in each in field. the medical We present and healthcare you this 

space specialised to keep knowledge the fraternity vehicle updated that plugs on the you amazing into the headway emerging made world by of the 

industry. care seamlessly. Come, let’s join hands in this information journey. 

Happy reading, 


editor@futuremedicineindia.com 

C H Unnikrishnan 

editor@futuremedicineindia.com 

www.futuremedicineindia.com futuremedicineindia FutureMedIndia 

© 2018 NextGen Science Media Pvt. Ltd, RNI Number KERENG/2012/44529 

AUGUST 2018/ FUTURE MEDICINE / 3

EDUCATION CASE REPORT HEALTH INSURANCE POLICY 

Vol 5 Issue 8 

December 2018 

₹ 250.00 

VOL 5 | ISSUE 8 

PAGES 100 

DECEMBER 2018 

FUTUREMEDICINEINDIA.COM 

MBBS CURRICULUM 

REVAMPED 

NON-FUNCTIONAL 

PLATELETS 

ENCOUNTERING 

AN ELUSIVE 

VIRUS 

INNOVATIVE THERAPEUTIC STRATEGIES 

TO REIN IN THE HIV CONTAGION 

EXCLUDING 

EXCLUSIONS 

BEHIND HIGH 

DRUG PRICES 

30 

DRUG RESISTANCE 

THREAT OF 

RESISTANT HIV 

REGULAR FEATURES 

06 Letters 

08 News updates 

34 Drug approvals 

52 Research snippets 

56 Hospital news 

60 Policy 

66 Clinical practice 

68 Technology 

70 Public health 

72 Guidelines 

78 Devices&gadgets 

88 Events 

94 Essay 

96 Calendar 

97 Book review 

98 Holy grail 

Columns 

16 THE CATALYST 

Muralidharan Nair 

54 Dr Rajani Kanth Vangala 

12 

EDUCATION 

MBBS 

CURRICULUM 

BEING 

REVAMPED 

The “outcome-driven” syllabus 

aims to expose students to the 

actual clinical significance of 

what they are taught 

40 

STRAIGHT TALK 

“INDIA IS WAY 

BEHIND IN 

ACHIEVING ITS 

2020 TARGET” 

Dr Ishwar Gilada, 

President, AIDS Society of India

58 

HEALTH INSURANCE 

FEWER 

EXCLUSIONS 

All health 

conditions 

acquired after 

policy inception 

should be 

covered by 

insurers, moots 

IRDIA working 

group 

44 

CASE REPORT 

METABOLIC 

DEFECTS 

LEADING TO 

BEHAVIOUR 

DISORDER 

A type of mucopolysaccharidosis 

can be easily misdiagnosed 

as ADHD or autism 

84 

CENTRE FOR 

SPORTS SCIENCE, 

CHENNAI 

We are moving 

towards 

medicines with 

new mechanisms 

of action and 

long-acting 

formulations, as 

we think about 

more options 

for patients and 

making HIV a 

smaller part of 

their lives. 

Dr John Pottage 

Chief Medical Officer, 

ViiV Healthcare. 

18 

COVER STORY 

ENCOUNTERING AN 

ELUSIVE VIRUS 

Drug makers are developing innovative 

approaches to rein in HIV as the 

prospect of a vaccine against the virus 

looks distant

CASE REPORT DRUG RESISTANCE REGULATORY COPD 

letters to the editor 

IMMUNOTHERAPY FOR 

LUNG 

CANCER 

WILL CHECKPOINT BLOCKERS ALTER 

WELL-ENTRENCHED TREATMENT ALGORITHMS? 

ABERNETHY - 

AN UNUSUAL 

SUSPECT 

TACKLING 

EMERGING 

PATHOGENS 

MCI IN DIRE 

STRAITS 

Refreshing reading 

₹ 250.00 

VOL 5 | ISSUE 7 

PAGES 100 

NOVEMBER 2018 

FUTUREMEDICINEINDIA.COM 

EBV INTERVENTION 

IN EMPHYSEMA 

Hello, 

I would like to mention 

about the cover story 

on immunotherapy of 

November edition. It was very 

informative. Including the 

suggestions of various expert 

specialists really gave a good 

awareness on the status of 

immunotherapy in the current 

scenario. The contents of the 

magazine keep up well with 

the latest developments in 

the field. Both interesting and 

refreshing. 

Dr Natu Seth, 

Pondicherry 

Reality of a therapy 

Sir, 

The cover story on 

immunotherapy gives a 

good idea on the reality of 

the therapy unlike simply 

glorifying it as in most 

journals. We know that 

immunotherapy is not the 

way to a complete cure in all 

types of cancers and also the 

cost implications are never 

really mentioned anywhere. 

Opinions of the clinicians 

are well documented in 

the article. I would suggest 

that perhaps a story based 

on the cost implications of 

immunotherapy and the 

percentage of the population 

who can really afford and 

benefit them, including details 

on the average cycles of the 

therapy given to a different 

patient by various clinicians 

could be a new approach. 

Overall it is a good work 

well committed to connecting 

the medicine and research 

field. 

Best Regards. 

Dr Alok Saxena 

Patna 

EBV instructive 

Dear sir, 

Found the article on EBV 

intervention in emphysema 

written by Dr. George really 

instructive. The contents 

including news and research 

works are all helpful in 

keeping the readers up-todate 

in the medical field. All 

the best! 

Dr Mythily Sawant, 

Pune 

Unbiased initiative 

Sir, 

Unbiased and a unique 

initiative. The approach really 

enables readers including 

medical students to get 

a good awareness of the 

various areas of our discipline. 

Includes instructive articles 

and latest news such as 

published policies and new 

drugs and devices approvals. 

Dr Raju Vernekar, 

Belgaum 

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news updates 

ICMR releases new 

antimicrobial stewardship 

guidelines 

The Indian Council of Medical 

Research (ICMR) has released 

Antimicrobial Stewardship Guidelines 

documents for hospital administrators 

and clinicians, recently. 

The guideline is intended to provide 

directions to Indian hospitals to set up 

structure and processes of antimicrobial 

stewardship programmes (AMSP). 

There is an urgent need to improve 

antibiotic use in hospitals, which can 

be achieved through implementation 

of good AMS programmes. AMS 

programmes have been found helpful 

in improving the quality of patient 

care and safety through increasing 

the frequency of correct therapy and 

prophylaxis, reducing treatment failures 

and increased infection cure rates, 

according to an ICMR statement. 

Implementation of an effective 

AMSP requires a multidisciplinary 

approach involving a variety of experts. 

Most of the hospitals in India lack 

structure and process of AMSP. 

Recognizing the importance to 

create AMSP structures in healthcare 

institutions in the country, ICMR has 

initiated AMSP activities by developing 

AMSP curriculum, conducting workshops 

and developing AMSP research projects. 

The ‘National Health Policy’ (2017), 

addresses antimicrobial resistance as 

one of the key issues and prioritises 

development of guidelines regarding 

antibiotic use, limiting the over-thecounter 

use of antibiotics, restricting the 

use of antibiotics as growth promoters 

in livestock, and pharmaco-vigilance 

including prescription audit inclusive 

of antibiotic usage in the hospital and 

community. 

Nephroplus 

acquires 

DaVita Care 

NephroPlus, a dialysis care 

network, has acquired 

DaVita Care India, part of 

DaVita Inc., a Fortune 500 

company. 

Under the terms of the 

agreement, NephroPlus will 

acquire DaVita Care India’s 

network of 22 centres which 

serve more than 1,700 dialysis 

patients nationwide. 

The acquisition will boost 

Nephroplus’ servicing 

capacity as a dialysis centre 

network and will have a 

presence in 18 states of India 

with 176 centers across 97 

cities. 

DaVita Care (India) Pvt. 

Ltd. owns and operates a 

network of dialysis and 

kidney care centers that 

provide care for acute and 

end-stage renal disease 

patients in India. The company 

offers dialysis services, 

including in-center and 

home hemodialysis, 

peritoneal dialysis, and 

AV fistula and AV graft 

procedures and allied services 

that include psychological 

counselling and diet and 

nutrition advice. 

TCS backs 

research on 

SIDS 

Tata Consultancy Services 

(TCS) has donated 5,000 

8 / FUTURE MEDICINE / DECEMBER 2018

pro bono technical and 

scientific research hours to 

Seattle Children’s Center for 

Integrative Brain Research 

to discover the causes of 

sudden unexpected infant 

deaths (SUID), including 

sudden infant death 

syndrome (SIDS). 

Seattle Children’s is one 

of the top five paediatric 

research centres in the 

United States. A portion 

of the pro bono hours 

committed by TCS has already 

been used for building a 

digital fundraising platform. 

Additional projects will be 

announced in the coming 

months. 

TCS officials said that 

the power of digital 

technologies, particularly 

analytics and cloud 

computing, would help 

researchers get closer to 

the answers they have been 

seeking for so long, and to 

save precious little lives. 

According to the 

Organisation for Economic Cooperation 

and Development, 

in the US, roughly 6 out of 

1,000 children die before 

their first birthday. Of these, 

about 4,000 infants, or 1 in 6, 

die each year of unexpected 

causes. Within this larger 

umbrella, SIDS remains the 

leading cause of death among 

children from one month 

to one year of age, with 

90 percent of SIDS deaths 

occurring within the first six 

months of life. 

Translumina 

presents 10-year 

data of Yukon 

Choice DES 

Translumina Therapeutics 

LLP has presented a 

10-year patient safety and 

efficacy data of its drugeluting 

stent (DES) Yukon 

Choice PC, recently. 

The research findings of a 

randomized control trial called 

ISAR-TEST 4 were presented 

by leading cardiac expert from 

Germany, Dr. Sebastian Kufner 

at the 2018 American Heart 

Association Scientific Sessions 

at Chicago, Illinois, United 

States. 

The trial compared Yukon 

Choice PC against Xience 

(manufactured by Abbott 

Vascular, USA) in 2603 

patients in Germany for a 

follow-up period of 10 years. 

The data demonstrated that 

at 10 years, both Indian made 

Yukon Choice PC and much 

used USFDA approved Xience 

stents showed significantly 

better results than the 

Cypher stent regarding major 

adverse cardiac events, with a 

risk reduction of 18% and 21% 

and mortality risk reduction 

of 18% and 22%, respectively. 

There were no significant 

differences between Yukon 

Choice PC and Xience stents 

regarding these outcomes. 

However, Yukon Choice 

PC showed the lowest rate 

of definite or probable stent 

thrombosis with a significant 

risk reduction than the Cypher 

stent (50% reduction) and 

even a numerically lower rate 

than the Xience stent (29% 

reduction). 

Yukon Choice PC uses a 

technology combining special 

surface modification and low 

polymeric load for controlled 

and optimal release kinetics of 

an anti-proliferative drug. 

Yukon Choice PC 

stents are manufactured 

at the Dehradun facility of 

Translumina Therapeutics. 

Sydney varsity 

announces MPH 

programme 

T 

he University of New 

South Wales, Sydney has 

announced admissions to a 

Masters in Public Health (MPH) 

for students from India in 

partnership with India’s leading 

healthcare organization, Apollo 

Hospitals and its education arm 

- MedVarsity. 

The MPH programme 

will provide students with 

advanced disciplinary 

knowledge and skills to 

undertake population 

health roles in government, 

community and health service 

agencies in any international 

ASBT ties up with TIGS to probe antibiotic resistance 

Amrita Vishwa 

Vidyapeetham’s School 

of Biotechnology has tied up 

with Tata Institute of Genetics 

and Society (TIGS) to conduct 

research in antimicrobial 

resistance (AMR). 

TIGS is a partnership 

between the University of 

California San Diego (UCSD), 

Tata Trusts and the Institute 

for Stem Cell Biology and 

Regenerative Medicine. 

The collaboration 

between Amrita School of 

Biotechnology (ASBT) and 

TIGS will focus on developing 

new tools to reverse antibiotic 

resistance. 

Earlier, ASBT and UCSD 

tied up in establishing the 

mechanism of action of natural 

products like clove bud oil 

to inhibit quorum sensing in 

Pseudomonas aeruginosa and 

attenuate virulence. 

Funding from the Bill & 

Melinda Gates Foundation 

and the Department of 

Biotechnology, Govt. of India 

as well as Biotechnology 

Industry Research 

Assistance Council 

(BIRAC) to ASBT has 

also resulted in 

new strategies 

deploying 

bacteriophages 

to counter the 

virulence of 

MDR bacterial 

pathogens. 

DECEMBER 2018 / FUTURE MEDICINE / 9

setting including the Indian 

sub-continent. 

The programme can be 

undertaken either full-time 

or part-time through online 

mode to encourage students 

to continue working while they 

study and comprises a total 

of 8 courses of 48 units of 

credit (UOC) with 168 hours of 

internship. 

For programme beginning 

term starting mid- September 

2019 the closing dates for 

applications is 31 July, 2019 

The programme fosters 

sophisticated understanding 

and application across 

the complex body of 

multidisciplinary knowledge 

of public health including 

epidemiology, biostatistics, 

social determinants of 

health, health promotion, 

population-targeted health 

research methods, and 

health programme design, 

implementation and 

evaluation. 

Pilot study using 

new MDR TB 

drug in 7 states 

India will be rolling out 400 

doses of the new anti-TB 

medication delamanid in 

seven states in a pilot study 

using the drug. 

Delamanid is the first 

in a new class of TB drugs 

called nitroimidazoles being 

developed to treat multi-drug 

resistant TB (MDR TB). 

The drug will be provided 

to MDR TB patients from the 

states of Punjab, Rajasthan, 

Karnataka, Odisha, Kerala, 

Lakshadweep, according to 

reports. 

All the patients will 

receive 100 mg delamanid 

tablets orally twice a day for 

24 weeks in combination with 

a regimen of second-line TB 

drugs. 

India received delamanid 

doses with the aid of the 

United States Agency for 

International Development 

(USAID). 

Shubhra Singh 

is new chief 

of NPPA 

The Union government 

has appointed Shubhra 

Singh as Chairman the 

National Pharmaceutical 

Pricing Authority (NPPA) with 

immediate effect. 

NPPA regulates drug 

pricing in India. 

Shubhra Singh, a 

Rajasthan cadre 1989 batch 

IAS officer, was posted in 

Delhi as the principal chief 

resident commissioner of 

Rajasthan government. 

The incumbent chairman 

of the apex drug pricing 

authority, RK Rakesh Kumar 

Vats, 1986 batch West Bengal 

cadre IAS officer, will take 

charge as additional secretary 

and financial advisor in the 

ministry of health and family 

welfare. 

New AIIMS centres to have 

ayurveda departments 

New All India Institute 

of Medical Sciences 

(AIIMS) and 100 ESIC 

hospitals will soon have 

ayurveda departments. 

Dedicated 

departments of ayurveda 

will be opened in the 

new 19 AIIMS and 100 

ESIC hospitals across the 

country, according to 

Minister of State for Ayush 

Shripad Yesso Naik. 

The work has started 

to set up ayurveda 

departments in hundred 

ESIC hospitals under 

Ministry of Labour. 

Approval has also been 

received from Home 

Ministry to open ayurveda 

departments in seven 

hospitals of BSF and other 

paramilitary forces, Naik 

said inaugurating the 

3rd Ayurveda Day in New 

Delhi, recently. 

The Ayush Ministry has 

taken many steps to fulfill 

the theme `Ayurveda for 

public health’ and decided 

to further expand the 

coverage of the national 

programme of ‘Prevention 

of Non-Communicable 

Disease’ from existing six 

states. 

The Ayush-Health 

Management Information 

System (A-HMIS), a 

dedicated software 

application for Electronic 

Health Record (EHR) 

for the Ayush systems 

of Healthcare, has also 

been launched as part 

of the function.A-HMIS is 

expected to revolutionise 

the way ayurveda, 

yoga, unani, siddha 

and homoeopathy are 

practised in the country, 

by inducting modern 

IT-solutions into these 

systems. 


EU, US experts reach a consensus on 

supine hypertension 

The European and American medical 

associations have come to a 

consensus agreement on the definition 

and diagnosis of neurogenic supine 

hypertension, recently. 

Until now, it was difficult to outline 

a generally accepted set of symptoms – 

and therefore to diagnose – for this type 

of high blood pressure. 

With the publication of a consensus 

statement, experts from the European 

Federation of Autonomic Societies (EFAS) 

and the American Autonomic Society 

(AAS) have now reached an agreement 

on the subject. 

Supine hypertension refers to high 

blood pressure that occurs when the 

sufferer is in a recumbent position. This 

is often caused by neurodegenerative 

conditions such as Parkinson’s, which 

attack the autonomic nervous system 

and in turn the mechanism controlling 

the cardiac muscle. 

Supine hypertension can lead to 

strokes, brain haemorrhages and heart 

attacks. In view of these potentially 

fatal consequences, a clear definition 

of the symptoms and timely diagnosis 

of the condition is essential. But until 

recently, no international standard was 

in place. 

"The consensus between the EU and 

US medical experts provides clear criteria 

for diagnosing supine hypertension. 

There were no clear-cut criteria before," 

said EFAS President Prof. Walter Struhal. 

The criteria apply to patients 

suffering from orthostatic hypotension 

– a form of low blood pressure that can 

lead to high pressure when the patient 

lies down, due to the condition’s impact 

on the autonomic nervous system. The 

consensus defines systolic blood pressure 

of more than 140mm Hg and/or diastolic 

blood pressure of more than 90mm Hg 

as an indication of supine hypertension, 

measured after at least five minutes of 

rest in a recumbent position. Criteria 

have also been defined which allow 

for distinctions to be made between 

mild, moderate and severe forms of the 

disease. 

This consensus was urgently needed 

because large numbers of patients 

suffering from neurodegenerative 

conditions are also affected by circulatory 

dysregulation, said Prof Struhal. 

Diagnosing such dysfunctions, 

which include supine hypertension, is 

simple, but there is little awareness of 

them. And of course, recognising the 

conditions is a prerequisite for effective 

treatment. 

Autonomic nervous system disorders, 

some of which are extremely rare 

“orphan diseases”, pose particular 

challenges for neurologists, and 

represent a pioneering research topic. 

According to Prof Struhal, a paper 

describing the recommendations on how 

to manage supine hypertension is in 

preparation. 


education 

MBBS CURRICULUM 

BEING REVAMPED 

The “outcome-driven” syllabus aims to expose students to the actual clinical 

significance of what they are taught 


DR SUMIT GHOSHAL 

Students joining the MBBS course 

in medical colleges throughout 

the country from August 

2019 onwards would be educated 

and trained according to a new 

Competency-Based curriculum recently 

approved by the Board of Governors of 

the Medical Council of India. Those who 

are already in their senior years would 

continue with the old curriculum, which 

was set up in 1997. 

In addition to the usual medical 

subjects such as Anatomy, Physiology, 

Pathology, Pharmacology, etc, the new 

curriculum will have a few additional 

subjects like Attitude, Ethics and 

Communication, which are expected 

to equip the students with the skills 

needed to deal with patients. This was 

a long felt need among senior clinical 

practitioners all over India. 

THIS IS A MAJOR 

DEPARTURE FROM THE 

PREVIOUS SYSTEM 

WHERE EXPOSURE TO THE 

CLINICAL ASPECTS OF ANY 

ANATOMICAL STRUCTURE 

WOULD BE VERY MINIMAL 

The new syllabus is also being 

described as “Outcome-driven”, 

which means that students are 

being exposed to the actual clinical 

significance of what they are taught, 

right from the start of their training. 

Thus, along with the lectures and 

practical lessons given in the Anatomy 

Department on “the various joints and 

subtypes and examples”, they are also 

exposed to their clinical importance in 

orthopaedics. Likewise, the segment 

on skin and deep fascia would be 

“vertically integrated” with the basic 

features of dermatology, venereology 

and leprosy. 


This is a major departure from 

the previous system, under which 

exposure to the clinical aspects of any 

anatomical structure or physiological 

function would be very minimal until 

training in pre-clinical subjects -- 

Anatomy, Physiology and Biochemistry 

-- was completed. It was only from 

the second stage of the MBBS course, 

when subjects like Pathology and 

Pharmacology were introduced, that 

the students were given rotational 

postings in the clinical departments. 

But since the new curriculum has to 

run simultaneously with the old syllabus 

(for the senior students), the scheme 

poses a special challenge to the 

teaching faculty. Dr Avinash Supe points 

out that the reorientation of teaching 

staff had begun as far back as 2014. 

However, Dr Ravindra Deokar of 

the Department of Forensic Medicine 

and Toxicology (FmT) at Seth G S 

Medical College, Mumbai has a different 

view.“It is being said that the Casualty 

Department in the Medical College 

Hospitals would be placed under FmT, 

but this could result in a staff shortage. 

Besides, there will be some new 

THE NEXT STEPS IN 

IMPLEMENTING THE 

CURRICULUM WOULD BE 

THROUGH A SERIES OF 10 

NODAL CENTRES AND 10 

REGIONAL CENTRES 

topics like Sports Medicine, along with 

Physiology [in the new syllabus]. How 

would they be handled,” Dr Deokar 

observed. He also felt people (students 

and staff) were not clear about what 

was happening at the top. 

The next steps in implementing the 

curriculum would be through 10 nodal 

centres and 10 regional centres, but the 

precise division of responsibility among 

these centers has not been worked out 

as yet. 

Clearly the new MBBS curriculum is 

very much a work in progress; and how 

well it is implemented and integrated 

with existing arrangements, only time 

will tell. 

MEMBERS OF 

RECONCILIATION BOARD 

1. Dr Avinash Supe: Chairman: 

Former Director Medical 

Education, Municipal Medical 

Colleges of Greater Mumbai 

2. Dr Krishna G Seshadri: 

Member, Board of 

Management, Visiting 

Professor, Department of 

Endocrinology, Diabetes and 

Medical Education, Sri Balaji, 

Vidyapeeth, Puducherry 

3. Dr Praveen Singh: Head of 

Departments of Anatomy 

and Medical Education, 

Convenor MCI Nodal Centre, 

Pramukhswami Medical 

College, Karamsad, Gujarat 

4. Dr R Sajith Kumar: Head of 

Deparments of Infectious 

Disease and Medical 

Education, Convenor MCI 

Nodal Centre, Government 

Medical College, Kottayam, 

Kerala 

5. Dr P V Chalam: Principal and 

HOD, Department of Surgery, 

Bhaskar Medical College, R R 

District, Telangana 

6. Dr Subir K Maulik: Professor, 

Department of Pharmacology, 

All India Institute of Medical 

Sciences, New Delhi 

7. Dr Dinesh Kumar Badyal: 

Head of Department of 

Pharmacology, and Professor, 

Department of Medical 

Education, Co-Convenor, 

MCI Nodal Centre, Christian 

Medical College, Ludhiana 

8. Dr Alka Rawekar: Head of 

Department of Physiology, 

Professor of Medical 

Education, Co-Convenor, MCI 

Nodal Centre, Jawaharlal 

Nehru Medical College, 

Sawani (Meghe), Wardha, 

Maharashtra 

9. Dr Sunita Y Patil: Professor, 

Departments of Pathology 

and Medical Education, 

Resource Faculty, MCI Nodal 

Centre, Jawaharlal Nehru 

Medical College, KLE Academy 

of Higher Education and 

Research, Belagavi, Karnataka 

10. Dr M Rajalakshmi: Chief 

Consultant, Academic Cell, 

Medical Council of India, New 

Delhi 


“CONCEPT FOR NEW CURRICULUM WAS 

DEVELOPED SOMEWHERE IN 2011” 

Dr Avinash Supe, a well-known 

expert in medical education, 

served as Chairman of the Board 

during the long-drawn process of 

formulating the new MBBS curriculum. 

A few years ago, he was conferred the 

B C Roy Award for being an Eminent 

Medical Teacher. In this interview, he 

talks about the new MBBS course, the 

process by which it was developed and 

that a lot of work still remains to be 

done in this regard. Excerpts from his 

conversation with FM: 

There are a lot of questions in the 

minds of both teachers and students 

with regard to the new curriculum. 

What is being done about them? 

At the moment, only the AETCOM 

document has been made public. 

The rest are under process and would 

follow in due course. 

Would further work also be done 

by the Reconciliation Board, of which 

you are chairman? 

The Reconciliation Board has 

finished its work. The remaining part 

would be handled by a separate 

Expert Committee. In case our help and 

opinion is sought by the committee, we 

shall provide it. 

How long did you and your 

colleagues need for completing this 

document? 

The concept for this was 

developed somewhere in 2011. It 

resulted in a Vision Document that 

was completed in 2015. This was sent 

to various government groups for 

evaluation and validation. That much 

time is needed for the various wings of 

government to make their assessment. 

Even the previous version, that is the 

Regulations on Graduate Medical 

Education of 1997, was completed in 

1994, but brought into force three 

years later. 


column 

the catalyst 

Ayushman Bharat: 

A two-month scorecard 

Initial analysis shows the national health insurance 

programme needs an urgent ramp up 

MURALIDHARAN NAIR 

I 

had written about the Ayushman Bharat 

(AB) scheme just around the time when 

it was being launched nationally by the 

Prime Minister in September. The article had 

attempted to analyse and comment on the 

preparedness of the centre and the states, 

and what would matter for the success of 

the programme. 

At the time, much of the analysis was 

based on conjectures, in the absence of any 

tangible data points to assess our readiness 

to launch a scheme of such magnitude. 

While it was my conviction then, and now, 

that the timing of the launch had less to 

do with preparedness and more to do with 

political exigencies, a certain degree of 

performance must be ensured even if the 

eye is primarily on reaping political benefits 

from the launch. 

Now, we have the first set of data points 

on the actual performance of the scheme 

after two months of launch. These are as 

follows: 

1) Total number of beneficiaries - 2,32,592 

2) Share of care provided through public 

health facilities - 32% 

3) Top five specialities by claim -- oral and 

maxillofacial surgery, general surgery, general 

medicine, ophthalmology, obstetrics and 

gynaecology. 

4) Top five states by usage: Gujarat, Tamil 

Nadu, Maharashtra, Chhattisgarh and West 

Bengal. 

Before offering a critical analysis of this 

data, I must clarify that I am acutely aware 

that two months are too short a period for 

any definitive evaluation of a scheme of 

this magnitude. It is also very heartening 

to see that the programme has been set 

in motion, unlike many other well-meaning 

schemes of this kind that get mired in 

endless intellectual/bureaucratic muddle, 

either to die a quiet death or be subjected 

to significant delays. Having said that, it is 

important to highlight what needs to be 

corrected with an utmost sense of urgency 

to ensure that the scale-up happens in the 

most efficient manner for a scheme that has 

life-changing implications for its beneficiaries. 

With the aforesaid background, my views 

on the aspects of Ayushman Bharat that 

need correction are as follows: 

1. Improve communication and 

outreach: An analysis of the number of 

beneficiaries reveals that only 20% of the 

actual hospitalisation cases occurring in 

the target population is currently under 

the scheme. That is to say, out of every 10 

people actually getting hospitalised in the 

target group eligible for AB, only 2 or fewer 

are availing the benefits of the scheme. This 

can be derived by comparing the actual 

hospitalisation rate of the target population 

group before the launch of the scheme in 

the 18 states where the scheme is being 

piloted and the number of beneficiaries 

hospitalized under AB in the first two months 

of the scheme. It should be noted that the 

actual number of states where the pilots are 

running is reported to be 22, but only 18 

have been mentioned on the AB website. 

Hence, this is a conservative estimate. Even if 

it’s just a two-month-old scheme, a figure of 

less than 20% is too low. Given that it is an 


entitlement based scheme, the propensity to 

avail by the beneficiary is extremely high and 

typically such schemes are expected to result 

in a rise in hospitalisation rates in the first 

year. This is also corroborated, anecdotally, 

in my conversations with the target group 

population in multiple states where the pilots 

are on. In fact, the states that have emerged 

as leaders had a history of well-entrenched 

state-sponsored schemes targeting at 

least 50% of the target group which got 

subsumed under AB. The beneficiary 

numbers under AB would have been much 

lower without the cannibalisation. 

2. Focus on improving the share of 

public health facilities: What is surprising 

are comments from senior authorities 

managing the programme, highlighting the 

68% share of private healthcare providers as 

a positive aspect, indicative of their adoption 

THE PLANNED ECONOMICS OF 

THIS SCHEME NECESSITATES 

SIGNIFICANTLY IMPROVING 

THE SHARE OF PUBLIC HEALTH 

FACILITIES TO AT LEAST TO 50% 

TO MAKE IT SUSTAINABLE 

HOSPITALISATION RATES IN 18 PILOT STATES 

State 

AB Eligible 

Population 

Hospitalization 

rate* 

Arunachal Pradesh 381896.1 2.361182% 9,017 

Chhattisgarh 17,495,693 3.8% 658,350 

Goa 191,181 6.1% 11,735 

Haryana 6,473,679 4.7% 302,288 

Himachal Pradesh 1,972,401 3.5% 69,961 

Jammu & Kashmir 4,079,255 2.8% 112,654 

Madhya Pradesh 37,894,393 2.1% 778,202 

Number of 

hospitalizations 

per annum 

Maharashtra 41,552,599 4.5% 1,868,024 

Manipur 1,434,866 1.0% 13,761 

Meghalaya 1,538,761 1.9% 29,334 

Mizoram 365,923 2.2% 8,176 

Nagaland 869,815 0.5% 4,264 

Uttar Pradesh 67,440,610 2.9% 1,930,534 

Uttarakhand 3,190,169 1.3% 42,023 

West Bengal 57,819,767 2.0% 1,146,539 

Chandigarh 142,437 3.7% 5,287 

Dadra & Nagar Haveli 145,065 1.6% 2,298 

Daman & Diu 58,784 5.3% 3,113 

Actual hospitalisation 

of the target population 

Hospitalisation claims under AB 

(annualised based on 2 month data) 

AB claims as a % of 

actual hospitalisation 

243,047,291 2.9% 6,995,559 

1,458,000 

20.8% 

*As per NSSO or RSBY whichever is higher 

of scheme. Indeed, support of private 

healthcare is crucial for the programme, 

but the planned economics of this scheme 

necessitates significantly improving the 

share of public health facilities to at least 

to 50% to make it sustainable. Hence, the 

deterioration in the public share to 32% from 

34%, which is the current national average, 

is not good news. 

3. Speed up empanelment of the 

tertiary care players: The specialities that 

have come up on top are not typically found 

to be so in a normal situation, particularly 

ophthalmology and obstetrics/gynaecology. 

At the same time, cardiac ailments, that 

account for 10% of hospitalisations in India, 

does not find a mention. This is possibly 

owing to insufficient empanelment of highend 

tertiary care private hospitals (given 

the paucity of sufficient capability in public 

health) which needs to be ramped up. The 

good news is that oral and maxillofacial 

surgery coming on top is perhaps indicative 

of accident/trauma care getting the benefit. 

In conclusion, it must be emphasized 

that what have been commented upon as 

areas of improvement are based on the 

very limited data that has come into public 

view. A more comprehensive view can be 

taken after six months of implementation 

and when more details are available, but 

the government may not have the luxury of 

time in this case. With the elections coming 

up in six months, it is imperative for the 

government to do everything it can to ramp 

up effective usage of the scheme as soon as 

possible. 

The author has long-standing association with 

EY India but the views are strictly personal. 


cover story 

ENCOUNTERING AN 

ELUSIVE 

VIRUS 

Drug makers are developing 

innovative approaches to 

rein in HIV as the prospect 

of a vaccine against the virus 

looks distant 

S HARACHAND 

The human immunodeficiency virus continues to evade a 

cure even after several decades of its discovery. Around 

36.9 million people worldwide were living with HIV/AIDS 

at the end of the year 2017, according to UNAIDS figures. 

Global efforts have helped to bring down the mortality 

rates of the HIV-infected significantly. Cocktails of highly 

active antiretrovirals help manage the HIV infection — whose 

diagnosis was once considered a death sentence — like any 

other chronic ailment today. 

Nevertheless, there has been no marked abating of the 

rate of new infections for over a decade now. An estimated 1.8 

million individuals worldwide became newly infected with HIV 


in 2017, nearly 5,000 new infections per day. 

Efforts to develop an effective vaccine against HIV are 

getting longer than expected as the tricky virus hoodwink 

every attempt by researchers to pin it down. Meanwhile, the 

emergence of drug-resistant strains of HIV appears to be 

casting a shadow over the UNAID’s stated goals of getting rid 

of the virus in the next 10-12 years. 

Innovators in the field are now looking at alternate 

therapeutic strategies to tame the virus as a definitive solution 

that can totally eliminate the microbe is nowhere in sight. 

5,000 

people are newly infected 

with HIV each day. 

Antibody prophylaxis 

Priming the immune system to combat the virus using broadly 

neutralizing antibodies (bNAbs) is one such an approach. 

Rockefeller University researchers have come out with data 

from Phase 1b clinical trials showing that a combination of 

two bNAbs is capable of suppressing HIV for months at a 

time. Experimental antibodies 3BNC117 and 10-1074 fight 

HIV from two different pathways, significantly reducing 

chances of resistance if both drugs are administered 

together. 

The researchers report that a six-week course of 

three injections of the two bNABs suppressed HIV for 

an average of 21 weeks, and for over 30 weeks in some 

patients. In a second study in viremic patients, published 


in Nature Medicine, the bNAb combo 

therapy reduced virus levels for up to three 

months. 

Like immunotherapy which uses anticancer 

antibodies, bNAbs interact with the 

host immune system thereby prompting 

the body to produce HIV-fighting 

antibodies on its own by boosting natural 

immunity. 

This way, bNAbs can probably address 

one of the major setbacks with the current 

antiretroviral therapy (ART). Even though 

ART can bring down the viral load to 

undetectable levels, these drugs cannot 

eliminate the latent virus. The lingering 

virus poses the threat of rising again in the 

form of more dangerous, resistant strains 

as soon as the patient discontinues the 

strict antiretroviral regimen. 

bNAbs are currently being evaluated as 

an alternative to ART. Since bNAbs are long 

acting, they can obviate daily dosing. In 

terms of efficacy, bNAbs are also safe and 

better than any previously tested antibody 

therapy, indicate the results published in 

Nature. 

"Due to their ability to suppress and 

prevent viral rebound, studies are also 

ongoing to evaluate their use as a passive 

immunotherapeutic agent. They are also 

being evaluated for treatment when 

administered alone or concomitantly with 

ART,” says Adar Poonawalla, CEO, Serum 

Institute of India (SII), Pune, India. 

bNAbs have demonstrated their ability 

to neutralise several strains of HIV. In 

recent years, researchers have identified 

hundreds of bNAbs that are both potent 

and broadly cross-reactive against the 

majority of HIV variants circulating globally. 

Some of these bNAbs are now being 

explored for their potential ability to 

prevent, treat and cure HIV infection. The 

results of the first study of the efficacy of 

a bNAb for prevention of HIV infection 

are expected within the next two years, 

and additional bNAb combinations are 

advancing toward efficacy testing. 

If turns out to be successful, bNAbs 

could change the way HIV infection is 

treated. 

Antibody prophylaxis, however, can be 

costly, unlike conventional small molecule 

antiretrovirals that come for less than a 

Due to bNAbs’ 

ability to suppress 

and prevent viral 

rebound, studies 

are also ongoing 

to evaluate their 

use as a passive 

immunotherapeutic 

agent. They are 

also being 

evaluated for 

treatment when 

administered alone 

or concomitantly 

with ART. 

Adar Poonawalla, 

CEO, Serum Institute 

of India, Pune. 

90-90-90 

GOAL 

TOWARDS 

ENDING AIDS 

EPIDEMIC 

UNAIDS, the joint United Nations 

programme on HIV and AIDS, set the 

target that by the year 2020, 90% of all 

people living with HIV will know their HIV 

status, 90% of all people with diagnosed 

HIV infection will receive sustained 

antiretroviral therapy and 90% of all 

people receiving antiretroviral therapy will 

have viral suppression. 

A UNAIDS advisory panel of global 

treatment experts conceptualized the 

90-90-90 targets based on documented 

achievements of regional and national 

programmes in diverse regions of the 

world. 

At a national level, a growing number 

of countries are either on track to 

achieve the 90-90-90 target or have 

approached, met or exceeded one or 

more of the elements of the target. 

India is only at about 75% of the 

first 90 and the figures are far below for 

the second and the third 90s, according 

to AIDS Society of India, a non-profit 

organization of doctors and researchers 

in HIV/AIDS. 

Closing treatment gap 

The world needs a new, evidencebased 

HIV treatment narrative that 

effectively captures the extraordinary 

expansion of treatment-related 

knowledge. Rather than focus on a 

single number (i.e., those receiving HIV 

treatment), the new target recognises 

the need to focus on the quality and 

outcomes of antiretroviral therapy as 

treatment services are scaled up. These 

new targets address progress along 

the HIV cascade of engagement in 

care, measuring the degree to which 

programmes are meeting their ultimate 

goal of viral suppression. It captures both 


the therapeutic and preventive benefits 

of HIV treatment. 

The new targets prioritise equity. The 

world will not end the AIDS epidemic 

unless all communities affected by HIV 

have full and equitable access to lifesaving 

treatment and other prevention 

services. The ambitious 90-90-90 

target demands dramatic progress in 

closing the treatment gap for children, 

adolescents and key populations using 

rights-based approaches. 

When complemented by a scaleup 

of other prevention tools, the target 

would reduce the annual number of 

new HIV infections by nearly 90% by 

2030. The number of AIDS-related 

deaths would fall by 80% by 2030 

with the achievement of these new 

post-2015 targets based on available 

diagnostic and treatment technologies, 

with the expectation that the likely 

emergence and uptake of additional 

medical innovations (such as improved 

diagnostic tools and longer-acting 

antiretrovirals) will ensure at 

least a 90% reduction in AIDS-related 

deaths by 2030. 

Meeting those targets should result in 

the achievement of the following impactlevel 

interim milestones: by 2020, a 

reduction of new HIV infections to fewer 

than 500,000 globally and a reduction in 

deaths from AIDS-related illness to fewer 

than 500,000 globally -- approximately 

a 75% reduction in both measures since 

2010. 

For both HIV incidence and AIDSrelated 

deaths, the envisaged rapid 

scale-up would result in the 

sharpest declines between now 

and 2020, with continued 

reductions occurring in the 

following decade as the 

epidemic’s momentum 

is progressively 

depleted, says the UNAIDS 

document. 

TARGET 1 

90% 

DIAGNOSED 

TARGET 2 

90% 

ON HIV 

TREATMENT 

TARGET 3 

90% 

SUPPRESSED 

Several African countries are either 

approaching, or within striking distance 

of, having at least 90% of people living 

with HIV tested at least once, according 

to UNAIDS. Although these figures 

represent a substantial improvement 

over earlier years, it is estimated that 

only about 45% of people living with 

HIV in sub-Saharan Africa know their 

status. 

High treatment coverage levels have 

been achieved regionally and nationally 

in multiple settings, putting them on 

pace to reach the second prong of the 

90-90-90 target if progress continues, 

UNAIDS says. In countries as diverse 

as Botswana and Colombia, more 

than 70% of people diagnosed with 

HIV infection are currently receiving 

antiretroviral therapy. In Brazil, more 

than 60% of people diagnosed 

with HIV infection were receiving 

antiretroviral therapy in 2013. 

Countries and programmes have also 

succeeded in achieving high levels 

of viral suppression, demonstrating 

the feasibility of a target of 90% viral 

suppression among all people receiving 

antiretroviral therapy by 2020. 

Nationally in Rwanda, for example, 

83% of people receiving antiretroviral 

therapy were found to be virally 

suppressed after 18 months of therapy 

in 2008-2009 

According to data from 17 countries 

in Latin America and the Caribbean, the 

median rate of viral suppression among 

recipients of HIV treatment is 66%, 

with more than 80% of individuals 

receiving antiretroviral therapy having 

achieved viral suppression in at least 

five countries (Barbados, Brazil, 

Honduras, Mexico and Uruguay) 


slug 

“We hope to start manufacturing 

bNAb combos early next year” 

Adar Poonawalla is the chief executive 

officer of Serum Institute of India (SII). 

Headquartered in Pune, western India, 

SII is currently the world's largest vaccine 

manufacturer by the number of 

doses produced. In October, the 

International AIDS Vaccine Initiative (IAVI) 

and SII announced a partnership to 

develop and manufacture affordable 

and accessible monoclonal antibody 

products for HIV. Mr Poonawalla shared 

his views on the collaboration with FM. 

Excerpts: 

Serum Institute has joined hands 

with IAVI to produce bNAbs against HIV. 

Can you elaborate on the nature and 

scope of the agreement? 

Through this partnership, SIL and 

IAVI are committed to the development 

of accessible, low-cost, antibodybased 

therapeutics for HIV and other 

global health challenges (e.g., snake 

bite and anti-microbial resistance) and 

to enable global access to the same. 

Leveraging the joint ability of discovery, 

development and manufacturing with 

IAVI and SIL through their individual or 

joint investments and complementary 

roles and responsibilities will ensure 

appropriate selection, development and 

low-cost manufacturing, while delivering 

a formulation that meets end-user needs 

via Serum Institute’s established coldchain 

mechanisms that currently deliver 

vaccines to over 160 countries, including 

LMICs. 

In what way are bNAbs going to help 

in bringing down the HIV numbers visa-vis 

ART? Have SII and IAVI identified 

any potential bNAbs for development? 

bNAbs have demonstrated a significant 

potential in neutralizing several strains of 

HIV. They are currently being evaluated 

as potent tools for disease prevention 

and vaccine design. Due to their ability 

to suppress and prevent viral rebound, 

studies are ongoing to evaluate their 

use as a passive immunotherapeutic 

agent. They are also being evaluated for 

treatment when administered alone or 

concomitantly with ART. 

Researchers at IAVI have identified 

a few bNAbs that are both potent and 

broadly neutralizing against a majority 

of the HIV strains circulating globally. 

Through these antibodies of IAVI and 

others, that we as partners will identify, 

we shall be looking at creating an 

innovative combination that would have 

the most potent response against HIV. It 

is our hope to initiate the manufacturing 

of these combinations of antibodies 

through a platform approach by early 

next year. 

The production of monoclonals is 

highly resource-intensive. And the 

prevalence rate of HIV infection is 

rather high in the regions of the world 

where the accessibility and affordability 

are poor. How will the agreement IAVI 

help to address this? 

In addition to investments in 

discovery, development and production 

technologies, SIL and IAVI shall implement 

an integrated business approach mapped 

to regional needs and preferences, 

through this agreement. We shall engage 

with other relevant agencies in the 

country and globally for facilitating policy, 

financial, and implementation support to 

promote the effort of making the product 

widely available and affordable for HIV 

disease management. 

What other programmes/initiatives 

does SII have to deal with HIV? 

SIIPL is in advanced clinical 

development of r-BCG, which will play a 

key role in [controlling] TB in HIV-exposed 

population. 

dollar for a day's pills pack. Significantly, the majority of people 

suffering from the HIV disease are located in the regions of the 

world where affordability and accessibility are abysmally low. 

Hence, the success of the therapy hinges on how promptly it 

can be made available across the globe, particularly in places 

where HIV infection rates remain unacceptably high. 

In October, International AIDS Vaccine Initiative (IAVI) 

announced collaboration with SII to develop large-scale, lowcost 

manufacturing of antibody-based HIV products. Currently, 

the world’s largest vaccine producer, SII supplies vaccines to 

over 160 countries in the world. 

The goal is to enable the most promising antibodies to be 

developed in the most promising combinations to maximize 

chances of success, according to IAVI. The collaboration 

between IAVI and SII brings together partners with 

complementary expertise to expedite the introduction of the 

drugs to regions with the highest disease burden. 

The efficacy of antibody prophylaxis in blocking HIV 

infection, however, is yet to be ascertained. The bNAb 

researchers believe that these antibodies have the potential 

to not only treat HIV but also prevent the infection. Presently, 

pre-emptive antiretroviral medication is available for high-risk 

groups. Compliance is a big issue with this kind of prophylaxis, 

which requires daily dosing. Long-acting HIV bNAbs could 


probably allow people to achieve the desired outcome while 

obviating the need for daily pills. 

PHOTO: UMESH GOSWAMI 

GENE THERAPY 

USING CCRS EDITED 

T CELLS 

clinical study using gene-edited 

A T cells designed to eradicate 

persistent HIV infection in patients 

receiving antiretroviral therapy is 

expected to start in 2018. 

These clinical trials will test the 

hypothesis that treating patients 

with their own gene-edited T cells 

may lead to a sustained increase 

in T cell counts and eradication of 

latent HIV reservoirs. 

The new study is designed in 

such a way that T cells from the 

blood of 20 subjects will have the 

CCR5 gene “knocked out” via zinc 

finger nuclease (ZFN) gene editing. 

The CCR5 gene allows HIV to enter 

host cells. In this process, ZFN, 

which are engineered proteins akin 

to genetic “scissors” is designed to 

enable targeted editing of genes 

by creating double-strand breaks in 

DNA at precise locations identified 

by researchers. 

The newly-edited, “repaired” 

cell population would be expanded 

and infused back into the patients. 

A second set of ten patients will 

receive an infusion of unmodified 

T cells. 

The study is to be conducted 

by Case Western Reserve University 

and Sangamo Therapeutics, Inc with 

a grant from National Institutes of 

Health, USA. 

Sangamo has completed several 

earlier phase 1/2 studies evaluating 

CCR5 edited T cells (known as SB- 

728-T) in patients. These single-arm 

studies demonstrated an ability to 

efficiently knock out the CCR5 gene 

in T cells by ZFN-driven gene editing 

and grow the cells ex vivo. 

Injectable ARVs as PrEP 

Another promising approach which is being investigated as a 

possible alternative to the current daily-dosing ART regimen is 

long-acting injectable antiretrovirals. 

In October, ViiV Healthcare, a global specialist HIV company 

established by GlaxoSmithKline and Pfizer, announced 

results from a 3-year study from LATTE-2, a phase IIb study 

investigating a long-acting, two-drug, injectable regimen of 

cabotegravir and rilpivirine. 


Cabotegravir is an investigational integrase 

inhibitor (INI), whereas rilpivirine is a once-daily 

non-nucleoside reverse transcriptase inhibitor 

(NNRTI). The NNRTI is currently used for the 

treatment of HIV-1 infection in combination with 

other antiretroviral agents in ART-naïve adult 

patients with a viral load = 100,000 HIV RNA 

copies/mL. 

At 160 weeks, the data showed, 90% and 

83% of the patients receiving the long-acting 

injectable regimen of cabotegravir and rilpivirine 

every eight and four weeks, respectively, 

remained virally suppressed. Some of the 

patients on the oral comparator arm elected 

to switch to the injectable regimen at week 96. 

Among them, 97% of those on the eight-week 

dosing schedule and 100% of those on the 

four-week remained virally suppressed at week 

160. 

Apart from improving individual outcomes, 

adherence to ARV-therapy among people 

living with HIV is essential to curb ongoing 

transmission. Making the high-risk population 

comply with the strict daily oral medication is 

one of the major challenges faced by caregivers. 

A long-acting prevention method may improve 

treatment compliance and effectiveness, 

helping individuals who have difficulty taking 

daily antiretroviral prevention medicine, or 

ViiV Healthcare 

believes 

cabotegravir 

long-acting 

injection, 

administered as a 

single agent, may 

become an effective 

option for HIV 

prevention (PrEP). 

Dr John Pottage, 

Chief Medical Officer, 

ViiV Healthcare. 

complying with other prevention measures. 

”ViiV Healthcare believes cabotegravir 

long-acting injection, administered as a single 

agent, may become an effective option for HIV 

prevention (pre-exposure prophylaxis, PrEP),'' 

says Dr John Pottage, Chief Medical Officer, ViiV 

Healthcare. 

ViiV is currently conducting 2 multinational 

Phase 3 clinical trials for PrEP in collaboration 

with the HIV Prevention Trials Network (HPTN). 

The first, HPTN 083, is being conducted in men 

who have sex with men (MSM) and transgender 

women, while protocol HPTN 084 is being 

conducted among women in sub-Saharan 

Africa. 

The WHO has recommended PrEP for all 

groups at risk of infection. A study conducted 

by Kirby Institute at the University of New South 

Wales, Sydney on 3,700 men with high levels 

of adherence found that the incidence of HIV 

infection was less than 1 in 2,000 per year, 

compared with an expected incidence of 

2 per 100 per year or higher in the absence of 

PrEP. 

Recently, ViiV has also reported positive 

data on fostemsavir for treatment-resistant 

HIV infection. Treatment failure and antiviral 

resistance remain a concern for heavily 

treatment-experienced patients. Fostemsavir, an 


investigational prodrug of temsavir, is an attachment inhibitor 

of HIV-1. 

Results from the 48-week data showed that 54% 

of patients in the randomised cohort achieved virologic 

suppression on treatment with fostemsavir plus optimised 

background therapy. Additionally, patients in the randomised 

cohort showed immunologic improvement through week 48 as 

demonstrated by an increase in CD4+ T-cell counts. 

"We are moving towards medicines with new mechanisms 

of action and long-acting formulations, as we think about more 

options for patients and making HIV a smaller part of their 

lives," says Dr Pottage. 

In addition to fostemsavir, ViiV is pursuing maturation 

inhibitors and biologics and is partnering with University of 

North Carolina HIV Cure Center. 

Towards a functional cure? 

Abivax, a clinical-stage company headquartered in Paris, is 

currently working on an approach that seeks to block the viral 

RNA's ability to multiply. 

Experimental drug candidate ABX464 is an oral small 

molecule that inhibits HIV replication through an entirely new 

mechanism of action. In two Phase 2a clinical trials, ABX464 

demonstrated up to 50% reduction of HIV-DNA in peripheral 

blood mononuclear cells after 28 days of combination 

treatment with ART. 

Pre-clinical data suggest that ABX464 has the potential 

to reduce or eliminate the viral reservoirs in patients with 

HIV, thus delivering long-term control of the viral load and 

preventing the emergence of HIV mutants that are resistant to 

treatment after six months of treatment in vitro. It also offers 

the advantages of less frequent dosing. 

``The biggest problem with current therapies in HIV is 

that they are unable to reduce the viral reservoir of HIV that 

lies latent in human immune cells. The viral reservoir is the 

integrated viral DNA within infected cells that perpetuates the 

production of viruses,'' says an Abivax spokesperson. 

Though ART can keep active viruses out of the 

bloodstream, existing reservoirs, or HIV “factories”, cannot be 

affected by ART. Therefore, if ART is terminated even for a short 

time, a viral rebound can occur. 

ABX464 has a particular mechanism of action in HIV that 

is two-fold. Viral DNA integrated into infected cells codes for 

viral proteins that the cell is “tricked” into producing during 

translation. ABX464 is believed to inhibit a protein that is 

necessary for the shuttling of certain viral proteins out of 

the nucleus, thus preventing viruses from being reproduced 

within infected cells. ABX464 also induces splicing of certain 

sequences of viral RNA, the molecular products of which signal 

the immune system to attack the cells which are infected, 

according to the spokesperson. 

Abivax believes the drug can offer a functional cure 

for HIV by way of this mechanism. That means the virus 

can be controlled without the need for ART, and not a 

PREP: A DAILY PILL 

TO PREVENT HIV 

P 

re-exposure prophylaxis (PrEP) is 

a combination of tenofovir and 

emtricitabine. It is approved for daily 

use to help prevent an HIV-negative 

person from getting HIV from a sexual 

or injection-drug-using partner who is 

positive. USFDA has approved the pill 

for HIV-negative adults and adolescents 

weighing at least 35 kg. 

Daily PrEP use can lower the risk of 

getting HIV from sex by more than 90% 

and from injection drug use by more 

than 70%. 

The WHO has recommended 

PrEP for all groups at risk of infection. 

Randomised controlled trials have 

shown that rapid, targeted, and highcoverage 

roll-out of PrEP can have a 

large and fast impact on people at risk. 

PrEP was approved in 2012 in the 

US. The uptake, however, was slow at 

the beginning. By late 2016, as many 

as 83,672 men in the US had started on 

PrEP, according to estimates. 

The NHS announced it would 

provide PrEP to 10,000 patients 

in selected clinics in England from 

September 2017. There was a marked 

decline in HIV diagnoses in the same 

year, following the introduction of PrEP. 

In France, roughly 97% of men 

who have sex with men (MSM) (2,805 

people) were commenced on PrEP in 

the first 12 months of roll-out in 2016. 

Only four new HIV infections in this 

cohort were reported. 


HIV and AIDS (Prevention & Control) Act 2017 

India’s Human Immunodeficiency Virus and Acquired Immune 

Deficiency Syndrome (Prevention and Control) Act, 2017, 

came into force on September 10, 2018, the health ministry 

announced. 

The new Act seeks to prevent and control the spread of HIV 

and AIDS along with protecting the human rights of affected 

people and criminalises discrimination against patients suffering 

AIDS. 

India makes discrimination against HIV/AIDS a punishable 

offence. 

• The Act empowers a 

person living with HIV to 

report discrimination meted 

out against them in fields 

of employment, health care 

services, educational services, 

public facilities, property rights, 

holding public office, and 

insurance. 

• The Act penalises 

“propagation of hatred” 

against the protected person 

where a violator could be 

punished with a minimum 

jail term of three months to 

a maximum of two years and 

can be fined up to one lakh 

rupees. 

• It prohibits isolation of 

segregation of an HIV-positive 

person. Every HIV-positive 

person has the right to 

reside in a shared household 

and use facilities in a nondiscriminatory 

manner. 

• The Act reads: “No person 

shall, by words, either spoken 

or written, publish, propagate, 

advocate or communicate 

by signs or by visible 

representation or otherwise 

the feelings of hatred against 

any protected persons or 

group of protected person.” 

• Under the law, no HIVaffected 

person can be subject 

to medical treatment, medical 

interventions or research 

without informed consent. 

Further, no HIV positive 

woman, who is pregnant, can 

be subjected to sterilisation or 

abortion without her consent. 

• No person is compelled to 

disclose his HIV status except 

by an order of the court. A 

breach of violation attracts 

a jail sentence of up to two 

years or a fine of up to Rs 1 

lakh, or both. 

• Every establishment is 

obligated to keep HIV-related 

information protected. 

Every HIV-positive person is 

compelled to take reasonable 

precautions to prevent the 

transmission of HIV to other 

persons. 

• The Act makes Anti- 

Retroviral Treatment (ART) 

a legal right for all HIV/AIDS 

patients. It has also adopted 

“test and treat” policy which 

means any person testing 

positive will be entitled to free 

treatment by the state and 

central government. Earlier, 

this was restricted by a CD4 

count rate. 

• It also provides for 

confidentiality of HIV-related 

information and makes it 

necessary to get informed 

consent for undertaking HIV 

tests, medical treatment and 

research. 

• The law makes it mandatory 

for state governments to 

appoint an Ombudsman to 

inquire into complaints related 

to the violation of the Act and 

the provision of health care 

services. 

• The new legislation has 

provisions to safeguard 

the property rights of HIV 

positive people. Every HIV 

infected person below the age 

of 18 years has the right to 

reside in a shared household 

and enjoy the facilities of the 

household. 

complete eradication. 

Abivax is now preparing for Phase 2b trials of ABX464 in 

HIV. 

Latency reversal agents 

Clearly, a cure for the infection can be possible only by fully 

eliminating the virus from its reservoirs. Latent proviruses, 

which are competent to replicate, continue to persist in 

virally suppressed individuals on ART. Researchers are 

working on strategies to target these latently infected cells and 

allow immune recognition and the clearance of this reservoir. 

Vorinostat is one such pharmacologic agent being 

evaluated in different studies to reactivate the latent reservoir 

so that infected cells can be recognized and targeted. A 

histone deacetylase inhibitor, vorinostat is currently approved 

by USFDA for the treatment of cutaneous T cell lymphoma. The 

efficacy of vorinostat is being tested in various clinical settings, 

including in conjunction with ART agents as well as with 

immunotherapy. 

The ongoing RIVER trial explores whether a combination 

of a four-drug ART regimen that includes raltegravir, two 

anti-HIV vaccines and ten doses of vorinostat can effectively 

reduce latent HIV in resting CD4 cells in participants with newly 

diagnosed HIV. 

VORVAX, a Phase I/IIa study, is looking at the effect of a 

combination of vorinostat and AGS-004 on latent HIV. 

AGS-004 is an investigational HIV immunotherapy designed to 

boost the immune system's response to reactivated latent HIV. 

Another Phase I study is evaluating vorinostat in 

combination with an HIV-1 antigen- expanded specific T-cell 

therapy on reactivated latent HIV in adults whose HIV is well 

controlled by ART. 


GLOBAL 

BURDEN OF HIV 

The new Political Declaration adopted 

by United Nations Member States 

charts a course to end AIDS as a 

public health threat by 2030 

WOMEN AND HIV 

Every week, around 

7000 

young women 

aged 15–24 years 

become infected 

with HIV. 

In sub-Saharan 

Africa, three 

in four new 

infections are 

among girls aged 

15–19 years and 

young women 

aged 15–24 years 

are twice as likely 

to be living with 

HIV than men. 

310,000 

Latin America 

1,800,000 

100,000 

Caribbean 

15,000 

Western & Central Europe 

and North America 

2,200,000 

61% 

57% 

70,000 

West and 

Central Africa 

6,100,000 

370,000 

78% 

Middle East and 

North Africa 

220,000 

East and 

Southern Africa 

19,600,000 

800,000 

18,000 

40% 

66% 

29%

36,900,000 

people were living with HIV worldover in 2017 

DECLINING MORTALITY 

AIDS-related deaths have been 

reduced by more than 51% since 

the peak in 2004-05. 

Displaying values in units of 000s. 

INDIA 

has THIRD largest number of 

people living with HIV 

2.5M 

2M 

1.5M 

1M 

290 

0.5M 

1990 

36% 

53% 

820 

1,500 

1,900 

1,400 

1,000 

1995 2000 2005 2010 2015 ’17 

Eastern Europe and 

Central Asia 

1,400,000 

130,000 

Asia and the Pacific 

5,200,000 

280,000 

940 

DISTRIBUTION OF HIV 

New HIV infections have doubled 

in Eastern Europe and Central 

Asia and increased by more than 

a quarter in the Middle East and 

North Africa over the past 20 years. 

908,600 

10 

7% 

2,140,000 

people are infected 

with the virus. It 

shows 6.9% decline 

in numbers over a 

decade. 

6% 

7% 

10% 

Women living 

with HIV 

states account for 82% of 

the total estimated people 

living with HIV in the country. 

5% 

4% 

Uttar Pradesh 

West Bengal 

Tamil Nadu 

Bihar 

Telengana 

3% 

Gujarat 

Rajasthan 

Karnataka 

18% 

Andhra 

Pradesh 

40% 

of new HIV infections 

among women 

Other 

states 

Maharashtra 

13% 

15% 

ART 

1,181,129 

or 56% of PLHIV 

are under ART 

scheme. The rest 

of the people 

are either not 

reached out or yet 

to get ART. 

Coverage of people 

receiving ART 

Newly infected 

12% 

SOURCE: http://aidsinfo.unaids.org/ & naco.gov.in 

INFOGRAPHICS: GOPAKUMAR K

drug resistance 

THREAT OF 

RESISTANT HIV 

Clinical management of HIV using the knowledge of known mutations 

can improve care 

DR RAJANI KANTH VANGALA 

Global and large-scale use of 

anti-retroviral therapy (ART) is 

helping reduce relative rates of 

morbidity and mortality from acquired 

immunodeficiency syndrome. However, 

clinical benefits are soon becoming 

outweighed by the emergence of 

drug-resistant HIV-1 strains. At present, 

ART is directed against virus-specific 

enzymes as well as the processes of 

attachment and entry into cells. These 

therapies are neither curative nor 

eradicative, as latent HIV infection 

is established through the 

integration of double-stranded 

proviral DNA into the host cell. In 

India and elsewhere, the use of ARTs 

is leading to a rapid evolution of the 

virus and an increase in individuals 

presenting with HIV drug resistance 

(HIVDR) mutations. Monitoring of 


HIVDR mutations are needed for proper 

management and ensuring optimal 

therapy to patients. As patients with 

acquired drug resistance are increasing, 

so are newly infected patients with 

transmitted drug resistance. 

This clearly suggests that the 21 

million people receiving ART are at 

risk as also the target of eliminating 

HIV as a public health threat by 

2030. More than 1 patient in 10 are 

becoming ART-resistant in low and 

middle income countries with respect 

to non-nucleoside reverse transcriptase 

inhibitors (NNRTIs). Pretreatment 

drug resistance is associated with 

an increased risk of virological 

failure, impaired immune recovery, 

accumulation of drug resistance, 

increased risk of treatment switches 

and death. WHO recommends a shift to 

alternative, non-NNRTI-based first-line 

ART (i.e., based on integrase inhibitors 

or protease inhibitors) or individualised 

pretreatment drug resistance testing to 

guide the choice of an appropriate 

first-line treatment. Additionally, 

continuous resistance surveillance 

is recommended as a part of the 

WHO Global Action Plan on HIV 

drug resistance. One technological 

breakthrough has led to the 

development of highly robust next 

generation sequencing (NGS) 

technologies with the ability to detect 

low-frequency, minority HIV variants at 

increasingly affordable prices. 

Importance of HIV-1 genotyping 

A recent case-control study nested 

within a prospective multicountry 

cohort by Seth C Inzaule et al (The 

Lancet HIV, http://dx.doi.org/10.1016/ 

S2352-3018(18)30177-2), studied the 

International Antiviral Society (IAS)- 

USA mutation list or the Stanford HIV 

Drug Resistance Database (HIVDB) 

using Illumina MiSeq next-generation 

sequencing technology. They compared 

the conventional pretreatment drug 

resistance detection threshold of 20% 

or more for Sanger-based sequencing 

to diagnostic accuracy measurements 

and the odds of virological failure using 

PRETREATMENT DRUG 

RESISTANCE IS ASSOCIATED 

WITH AN INCREASED 

RISK OF VIROLOGICAL 

FAILURE, IMPAIRED IMMUNE 

RECOVERY, ACCUMULATION 

OF DRUG RESISTANCE 

conditional logistic regression for 1%, 

5% and 10%. A 12-month follow-up 

of 1896 participants suggested that 

virological failure had an odds ratio (OR) 

of 9.2 (95% CI 4·2–20·1) at a detection 

threshold of 20% or more, for patients 

with pretreatment resistance compared 

to without pretreatment drug resistance. 

Lowering the threshold to 10% resulted 

in an odds ratio of 6.8 (95% CI 3·3–13·9), 

5% to 7·6 (3·4–17·1) and 1% to 4·5 

(2·0–10·2). This suggests that lowering 

the threshold does improve the ability to 

identify at-risk participants, but a slight 

reduction of specificity from 98% to 

96% was observed. This suggests that 

in the era of ARTs, HIV-1 genotyping 

is very important for both clinical 

management and public health 

surveillance for anyone living with HIV-1 

anywhere in world. 

Detecting low-frequency mutations 

Ultrasensitive genotyping tests can 

improve the clinical evaluation and 

identification of low-frequency drug 

resistance mutations (LFDRM). LFDRMs, if 

detected robustly, can impact the efficacy 

of treatment protocols of ART and the 

outcomes. Furthermore, the level at 

which each drug resistance mutation is 

present in the virus population can play 

an important role. Several studies (Simen 

et al., 2009b, Li et al., 2011 and Cozzi- 

Lepri et al., 2015) evaluated the dosedependent 

association between LFDRMs 

and the risk of virological failure of 

first-line NMRTI therapy. The mutational 

load (ie., the mutant frequency multiplied 

by the total HIV-1 RNA levels) may be 

a better predictor of virological failure 

(Gupta et al 2014, Goodaman et al 2011). 


It is well known that 1% of viruses have 

K103N mutation and patients carrying 

these mutant viruses respond to firstline 

Efavirenz (EFV)-based therapy if 

they have 100,000 copies/mL versus 

1,000 copies/mL. A review (Barth et 

al 2010) analyzing 89 studies with 

12,288 patients suggested that the most 

common mutations are M184V (65%) 

and K103N (52%). Thymidine-analog 

mutations (TAMs: M41L, D67N, K70R, 

L210W, T215Y/F, and K219Q/E) were 

less common, ranging from 5%–20% 

of patients, whereas K65R was found 

in 5% patients. A larger cohort study, 

PharmAccess African Studies to Evaluate 

Resistance (PASER), where 37% of the 

cohort received ZDV, 27% received 

d4T and 33.5% received TDF. Majority 

of patients (96%) acquired resistance 

during the therapy was also carried 

out. The most common mutations were 

M184V (53.5%) and K103N (28.9%). 

TAMs occurred in 12.7% of subjects 

receiving ZDV, 5% in d4T and 4.3% in 

TDF. 

Viral tropism 

Viral tropism is another factor 

AN NGS BASED 

PRETREATMENT AND 

CLINICAL MANAGEMENT OF 

HIV USING THE KNOWLEDGE 

OF KNOWN MUTATIONS CAN 

LEAD TO IMPROVEMENTS IN 

CLINICAL CARE 

to be considered, as it has been 

demonstrated (Raymond et al., 2011; 

Archer et al., 2010, 2009; Tsibris et al., 

2009; Westby et al., 2006) that in case 

of maraviroc prescription, which is a 

selective CCR5 co-receptor antagonist, 

approximately 10-15% of treatmentnaïve 

subjects and 50% of experienced 

subjects have viruses that can also use 

a CXCR4 co-receptor. It was also shown 

that V3-loop 454 sequencing was a 

better predictor than the first version of 

Monogram’s phenotypic Trofile Assay in 

a retrospective analysis of two clinical 

trials of maraviroc (Swenson et al., 

2011a). Deep sequencing by NGS was 

shown to also have better results from 

MERIT trial reanalysis and to be cost 

effective too. 

In India, it was feared that the lack 

of resources, coupled with tuberculosis, 

would lead to very high HIV 

transmission. However, with ART rollout, 

transmission has been reduced by 54%. 

With increased levels of first-line ART 

comes the challenge of drug resistance. 

It has been reported that (Hosseinipour 

et al. 2013) there are predictable 

mutation patterns at 12 month ART in 

resource-limited settings. Till date, the 

majority of Indian national programmes 

have relied on clinic-immunological 

monitoring for the diagnosis of 

treatment failure, especially CD4 cell 

count every 6 months. An NGS based 

pretreatment and clinical management 

of HIV using the knowledge of known 

mutations can lead to improvements in 

clinical care. Meanwhile, more studies 

can help in better understanding 

acquired disease mutations for better 

outcomes in the future. 

The author is medical scientist and former 

director of SGRF, Bangalore 


drug approvals 

Sublingual tablet 

to treat grass 

pollen allergy 

Stallergenes Greer, a 

biopharmaceutical 

company specialising in 

treatments for respiratory 

allergies, said it received 

approval from the USFDA for 

the extension of the indication 

for Oralair, a sublingual tablet, 

to treat patients ages five 

to nine with grass polleninduced 

allergic rhinitis. 

Oralair is the only allergy 

immunotherapy tablet that 

contains grass pollens from 

five of the most common 

grasses (Sweet Vernal, 

Orchard, Perennial Rye, 

Timothy, and Kentucky Blue 

Grass) in the United States. 

The mixed pollen extract 

received FDA approval in 

patients ages ten to 65 in 

2014. 

Oralair is indicated as 

immunotherapy for the 

treatment of grass polleninduced 

allergic rhinitis for 

any of the five grass species 

contained in the product. 

It has been approved 

based on results from doubleblind, 

placebo-controlled trials 

in Europe and the United 

States in over 2,500 adults 

and children. The results of 

these trials demonstrated that 

pre-seasonal and co-seasonal 

treatment reduces patients’ 

allergy symptoms and their 

need for symptom-relieving 

medication. 

Once-daily 

revefenacin for 

COPD in US 

Revefenacin (Yupelri) 

has been granted 

approval as a oncedaily, 

nebulized 

bronchodilator for 

the maintenance 

treatment of 

Cabozantinib for 

HCC in adults 

Ipsen received approval 

from the European 

Commission (EC) for 

cabozantinib (Cabometyx) 

tablets as a monotherapy 

for hepatocellular 

carcinoma (HCC) in adults 

who have previously been 

treated with sorafenib. 

The EC approval is 

based on results from 

the CELESTIAL trial of 

cabozantinib in patients 

with advanced HCC who 

received prior sorafenib. 

In this phase 3 pivotal 

trial, cabozantinib 

demonstrated a statistically 

significant and clinically 

meaningful improvement 

in overall survival (OS) 

versus placebo. 

The drug is also 

approved in the EU for the 

treatment of advanced 

renal cell carcinoma 

(RCC) in adults who have 

received prior VEGFtargeted 

therapy and 

for previously untreated 

intermediate- or poor-risk 

advanced RCC. 

Ipsen is a partner of 

Exelixis, Inc. 

patients with chronic 

obstructive pulmonary disease 

(COPD) in the US. 

Revefenacin is a longacting 

muscarinic antagonist 

(LAMA). 

In two replicate pivotal 

Phase 3 efficacy studies, 

revefenacin demonstrated 

statistically significant 

improvements as compared 

to placebo in trough forced 

expiratory volume in one 

second (FEV1) and an 

overall treatment effect on 

trough FEV1 (OTE FEV1) after 

12 weeks of dosing, said 

Theravance Biopharma, Inc 

and Mylan N.V. 

Additionally, the 

companies completed a 

12-month Phase 3 open-label 

safety study versus tiotropium 

in which no new safety issues 

were identified. Rates of 

AEs and SAEs in the study 

were low and comparable to 

those seen in the tiotropium 

treatment arm. 

Elotuzumab 

for multiple 

myeloma 

Bristol-Myers Squibb 

and AbbVie said US 

FDA approved elotuzumab 

(Empliciti) for the treatment 

of multiple myeloma as 

a combination therapy 

with lenalidomide and 

dexamethasone (ERd) in 

patients who have received 

one to three prior therapies. 

Elotuzumab is an 

immunostimulatory antibody 

that specifically targets 

Signaling Lymphocyte 

Activation Molecule Family 

member 7 (SLAMF7), a cellsurface 

glycoprotein. SLAMF7 

is expressed on myeloma cells 

independent of cytogenetic 

abnormalities. SLAMF7 is 

also expressed on natural 

killer cells, plasma cells, and 

at lower levels on specific 

immune cell subsets of 

differentiated cells within the 

hematopoietic lineage. 

The drug has a dual 


mechanism-of-action. It 

directly activates the immune 

system through natural killer 

cells via the SLAMF7 pathway. 

Elotuzumab also targets 

SLAMF7 on myeloma cells, 

tagging these malignant cells 

for natural killer cell-mediated 

destruction via antibodydependent 

cellular toxicity. 

The approval for multiple 

myeloma is based on data 

from the randomized, openlabel, 

Phase 3, ELOQUENT-2 

study, which demonstrated 

that the ERd regimen resulted 

in a 30% reduction in the 

risk of disease progression or 

death compared to Rd alone. 

Elotuzumab is available for 

injection for intravenous use in 

300 mg and 400 mg vials. 

Bijuva to 

treat hot 

flashes in US 

women 

The US FDA has approved 

estradiol and progesterone 

(Bijuva) oral capsules, 1 

mg/100 mg, for the treatment 

of vasomotor symptoms due 

to menopause in women with 

a uterus. 

The approval is based 

on the clinical development 

programme that included the 

pivotal Phase III Replenish 

Trial. The results of the trial 

were published in the journal 

Obstetrics & Gynecology. 

The pill is a novel 

combination of bio-identical 

estradiol and progesterone 

approved for the treatment 

of vasomotor symptoms 

associated with menopause 

in women with a uterus in a 

once-daily soft gel capsule 

taken orally. 

TherapeuticsMD, a 

women’s healthcare company 

which makes the drug, expects 

Bijuva to be available in the 

US. 

Sodium oxybate 

for paediatric 

cataplexy 

Sodium oxybate (Xyrem) 

has been approved to 

treat cataplexy or excessive 

daytime sleepiness (EDS) 

in patients with narcolepsy 

aged seven and older by 

USFDA, announced Jazz 

Pharmaceuticals. 

Sodium oxybate, a central 

nervous system depressant, 

was previously only indicated 

for use in adults. 

The drug won the 

approval for the treatment of 

cataplexy or EDS in paediatric 

patients with narcolepsy after 

the findings of multisite Phase 

2/3 EXPRESS study, which 

enrolled patients seven to 17 

years of age with narcolepsy 

with cataplexy. 

Study patients who were 

sodium oxybate-naive at 

entry underwent open-label 

titration to reach a tolerable 

and effective dose. All patients 

then underwent a 2-week, 

double-blind, randomisedwithdrawal 

period and were 

randomised to either remain 

on sodium oxybate or receive 

placebo. 

The primary efficacy 

endpoint was the change in a 

weekly number of cataplexy 

attacks from baseline to the 

end of the double-blind 

period. After this period, 

patients entered an openlabel 

safety period for up to 

47 additional weeks. 

The study found that 

compared with sodium 

oxybate-treated patients, 

those who received the 

placebo experienced a 

statistically significant increase 

in weekly cataplexy attacks. 

In addition, patients in the 

placebo group, during the 

double blind treatment period, 

experienced a statistically 

significant worsening of EDS 

vs patients who continued to 

receive sodium oxybate. 

EMA validates 

quizartinib 

for AML 

D 

aiichi Sankyo said the 

European Medicines 

Agency (EMA) granted 

accelerated assessment for 

quizartinib for the treatment 

of adults with relapsed or 

refractory acute myeloid 

leukemia (AML) which is FLT3- 

ITD positive. 

Quizartinib is an oral 


selective FLT3 inhibitor 

currently in phase 3 

development. 

The EU approval was 

based on results of the pivotal 

phase 3 QuANTUM-R study of 

quizartinib, which was the first 

randomized phase 3 study to 

show that an FLT3 inhibitor 

prolonged overall survival 

as an oral, single agent 

compared to chemotherapy 

in patients with relapsed/ 

refractory FLT3-ITD AML. 

The median treatment 

duration with quizartinib was 

4 cycles of 28 days each 

versus 1 cycle in the salvage 

chemotherapy arm. 

Quizartinib is currently 

under regulatory review 

with the Japan Ministry of 

Health, Labour and Welfare 

(MHLW) for the treatment of 

adult patients with relapsed/ 

refractory FLT3-ITD AML. 

Submission in the US remains 

on track for the second half of 

the fiscal year 2018. 

Lorlatinib for 

ALK-positive 

NSCLC 

Lorlatinib (Lorbrena) has 

been granted US FDA 

approval to treat patients with 

ALK-positive metastatic nonsmall 

cell lung cancer (NSCLC), 

Pfizer Inc announced. 

Lorlatinib, a thirdgeneration 

anaplastic 

lymphoma kinase (ALK) 

tyrosine kinase inhibitor 

(TKI), is indicated for patients 

whose disease has progressed 

on crizotinib and at least 

one other ALK inhibitor for 

metastatic disease; or whose 

disease has progressed on 

alectinib or ceritinib as the 

first ALK inhibitor therapy for 

metastatic disease. 

This indication is approved 

under accelerated approval 

based on tumour response 

rate and duration of response. 

The approval was based 

on a non-randomized, 

dose-ranging and activityestimating, 

multi-cohort, 

multicentre phase 1/2 study, 

B7461001, evaluating Lorbrena 

CHMP gives positive 

opinion for dengue vac 

The European Medicines 

Agency’s Committee 

for Medicinal Products 

for Human Use (CHMP) 

recommended Dengvaxia, 

Sanofi’s dengue vaccine 

candidate, for approval in 

Europe. 

The indication for 

the dengue vaccine 

recommended by the CHMP 

is for use in the prevention 

of dengue disease caused 

by dengue virus serotypes 

1, 2, 3 and 4 in individuals 

9 to 45 years of age with 

prior dengue virus infection 

and living in endemic areas. 

European Commission 

approval of the vaccine 

is expected in December 

2018. 

A person can get 

dengue more than once 

as there are four distinct 

virus serotypes circulating 

worldwide. Dengue 

infection is unique in that 

a secondary infection 

tends to be worse than the 

first infection. Therefore, 

preventing dengue in 

individuals with a prior 

dengue infection has the 

potential to reduce the high 

human and economic costs 

of severe dengue. 

The dengue vaccine has 

been evaluated in studies 

involving more than 40,000 

people from 15 countries 

with up to six years of 

follow-up data from largescale 

clinical safety and 

efficacy investigations. 

The vaccine is currently 

licensed in 20 countries for 

the prevention of dengue. 

for the treatment of patients 

with ALK-positive metastatic 

NSCLC, who were previously 

treated with one or more ALK 

TKIs. A total of 215 patients 

with ALK-positive metastatic 

NSCLC were enrolled across 

various subgroups based on 

prior treatment. Among these 

patients, overall response rate 

(ORR) was 48 percent and 

importantly, 57 percent had 

previous treatment with more 

than one ALK TKI. 

Combo drug for 

brochodilation 

in EU 

The European Commission 

has authorised an 

expanded label for oncedaily 

fluticasone furoate/ 

umeclidinium/vilanterol ‘FF/ 

UMEC/VI’ (Trelegy Ellipta) for 

patients with moderate to 

severe chronic obstructive 

pulmonary disease (COPD) 

not adequately treated with 

dual bronchodilation or with 

an inhaled corticosteroid (ICS) 

and a long-acting ß2-agonist 

(LABA). 

Bronchodilation is 

recognised as the foundation 

of COPD therapy. However, 

many patients may continue 

to struggle with symptoms 

and exacerbations over time. 

The expanded indication 

for the triple-drug regimen 

reflects the evidence 

supporting its potential 

benefits in a broader group 

of patients than originally 

indicated, giving them the 

option of taking a once-daily 


Brexanolone safe for postpartum depression: US FDA 

US FDA advisory 

panel recommended 

brexanolone (Zulresso) for 

postpartum depression. 

The Psychopharmacologic 

Drugs Advisory Committee 

(PDAC) and Drug Safety and 

Risk Management Advisory 

Committee (DSaRM) jointly 

voted 17-1 in favour of 

the injectable treatment, 

brexanolone, which aims 

to treat major episodes of 

depression during pregnancy 

or within four weeks of 

delivery. 

Brexanolone is an 

allosteric modulator of both 

synaptic and extrasynaptic 

GABAA receptors. 

Allosteric modulation of 

neurotransmitter receptor 

activity results in varying 

degrees of desired activity 

rather than complete 

activation or inhibition of the 

receptor. 

The decision came after 

FDA staff reviewers raising 

safety concerns over the loss 

of consciousness in certain 

patients who were on the 

treatment.They, however, 

recommended implementing 

a risk evaluation and 

mitigation strategy (REMS) 

programme to improve the 

safety of the product. 

Brexanolone is 

administered as a 60-hour 

intravenous infusion. The 

drug targets hormonal 

changes in new mothers, 

differentiating it as a drug 

for postpartum depression 

rather than “regular” 

depression. 

Brexanolone injection has 

completed Phase 3 clinical 

development for postpartum 

depression and a New Drug 

Application is currently under 

review with the USFDA. 

Brexanolone for the 

treatment of PPD has been 

granted Breakthrough 

Therapy Designation by the 

FDA and PRIority MEdicines 

(PRIME) designation 

from the European 

Medicines Agency 

(EMA). 

single inhaler triple therapy for 

the first time. 

The label update is 

based on data from the 

InforMing the PAthway of 

COPD Treatment (IMPACT) 

study which showed Trelegy 

Ellipta was superior to both 

the ICS/LABA Relvar/Breo 

Ellipta (FF/VI) and long-acting 

muscarinic receptor antagonist 

(LAMA)/LABA Anoro Ellipta 

(UMEC/VI) in patients with 

moderate to severe COPD on 

multiple clinically important 

endpoints, including reducing 

exacerbations and improving 

lung function and healthrelated 

quality of life. 

EMA recommends 

apalutamide for 

nmCRPC 

The Committee for Medicinal 

Products for Human Use 

(CHMP) of the European 

Medicines Agency (EMA) has 

issued a positive opinion for 

apalutamide for the treatment 

of adult patients with 

non-metastatic castrationresistant 

prostate cancer 

(nmCRPC). 

Apalutamide is an 

investigational, nextgeneration 

oral androgen 

receptor inhibitor that blocks 

the androgen signalling 

pathway in prostate cancer 

cells. 

Janssen Pharma 

submitted the data from the 

pivotal SPARTAN phase 3 

clinical study which assessed 

the safety and efficacy of 

apalutamide versus placebo 

in patients with nmCRPC who 

have a rapidly rising prostatespecific 

antigen (PSA) level 

despite receiving continuous 

androgen deprivation therapy 

(ADT). 

The SPARTAN clinical 

study showed that 

apalutamide, when added 

to ADT, significantly reduced 

the risk of developing 

distant metastasis or death 

(metastasis-free survival 

[MFS]) by 72% compared to 

placebo in combination with 

ADT. 

Eltrombopag 

to treat 

aplastic anaemia 

USFDA has expanded the 

label for eltrombopag 

(Promacta) for firstline 

treatment of severe 

aplastic anaemia (SAA) in 

combination with standard 

immunosuppressive therapy 

(IST). 

Eltrombopag is an oral 

thrombopoietin receptor 

agonist (TPO-RA) that is 

already approved for SAA for 

patients who have had an 

insufficient response to IST. 

It is also approved for adults 

and children with chronic 

immune thrombocytopenia 

(ITP) who are refractory 

to other treatments, 

and for the treatment of 

thrombocytopenia in patients 

with chronic hepatitis C virus 

infection. 

The FDA’s approval is 

based on a study showing 

that 44% of definitive ISTnaive 

SAA patients achieved 

a complete response at 6 

months when treated with 

eltrombopag concurrently 

with standard IST, which was 

27% higher than the complete 

response rate historically 

observed with the standard 

IST alone. The overall response 

rate was 79%. 


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straight talk 

“INDIA IS WAY BEHIND IN 

ACHIEVING ITS 2020 TARGET” 

DR ISHWAR GILADA, president of 

AIDS Society of India since 2015, is 

among the most prominent names 

associated with AIDS prevention 

and control in India. During the 

past 30 years, he has served on 

several national and multi-country 

platforms such as the National AIDS 

Committee, the governing board 

of AIDS Society in Asia and Pacific 

(ASAP), AIDS Advisory Board for 

Goa and Uttar Pradesh and boards 

of Global AIDS Policy Coalition and 

AIDS and Reproductive Health 

Network under Dr Jonathan Mann. 

He was recently elected to the 

Governing Council of International 

AIDS Society for a four-year term to 

represent Asia and Oceania regions. 

He discusses the progress made in 

AIDS control in the country, and the 

gaps where the system has fallen 

short. Edited excerpts from his 

conversation with 

DR SUMIT GHOSHAL. 

There is still some disagreement about the number 

of people living with HIV infection in India. The official 

government data says it is about 2.1 million, while other 

sources put the figure at 1.4 to 1.6 million. Why this 

difference? Why do we not have an accurate figure for the 

whole country? 

It will always be a guestimate, because the entire 

population has not been tested for HIV, and that will never 

be possible. Besides, HIV surveillance is now carried out 

only by the government of India. Surveillance by private 

organisations has almost stopped now. Hence, whatever 

figure the government puts out has to be taken as authentic. 

More importantly, HIV used to be most prevalent in the five 

southern states: Maharashtra, Karnataka, Tamil Nadu, Andhra 

Pradesh and Telangana, along with two northeastern states, 

Manipur and Nagaland. However, HIV is becoming more 

common in other states like Madhya Pradesh, Rajasthan and 

Gujarat because people from these places travel for work. 

This is more worrying. 

What is the government doing about it? 

Perhaps, not enough. Only an estimated 1.6 million people 

are aware that they have got the infection, which means 

five lakh people are spreading the infection unintentionally. 

The international standard is 90:90:90. That is: 90 percent 

of people who have the infection should be aware; of these, 

90 percent should be on ART; and of the people on HIV 

treatment, 90 percent should have viral load suppression. This 

is the target for 2020, but India is falling short on all counts. 

The ‘third 90’, or the testing for viral load suppression, is 

definitely very weak. Until 2017, the government of India was 

doing viral load estimation for just 16,000 people each year, 

which is one percent of the requirement! This year, they have 

expanded this to 1.6 lakh through a Private-Public Partnership 

with Metropolis Health Services, but the requirement is 1.6 

million. 

In the global scenario, the Sustainable Development 

Goals of the UN have a target to end the AIDS epidemic by 

2030. What exactly does that mean? 

It means that there should be no new HIV infections. That 

is possible to achieve, but very difficult. It will happen when 

all 2.1 million HIV positive people in India are aware of their 

status and they are put on treatment. Then, HIV positive men 

will not pass on the infection to their spouses and pregnant 


women to their newborn infants. Besides, people who cannot 

avoid being exposed to HIV infection should take preexposure 

or post-exposure prophylaxis. 

We have made a lot of changes in HIV treatment now. 

A person who knows he is going to get exposed to the 

infection can take treatment in advance and then go and 

get exposed. Or if the person has been already exposed; if 

he comes to us within 48 hours, we can treat that person by 

which he doesn’t get HIV infection. 

Now you mentioned pre-exposure prophylaxis. One 

drug is being discussed from Gilead Life Sciences, known 

as Truvada. How effective is it? And does it serve the same 

purpose as an HIV vaccine? 

Truvada is marketed in India as emtricitabine-tenofovir 

combination by Cipla under license from Gilead, to be used 

for post-exposure prophylaxis. For pre-exposure prophylaxis, 

it is not licensed to anyone, and is not part of the government 

of India’s programme. Elsewhere in the world, it is available 

PHOTO: UMESH GOSWAMI 

and being used. It is 95 percent safe; 

no medicine is 100 percent safe (only 

abstinence from sex is 100 percent safe). 

The person needs to take four tablets for 

each sexual exposure – one tablet 8-10 

hours before the act, two tablets at the 

time of sex and one tablet within 12 hours 

after the act. But if the person is going 

to be exposed again and again, like sex 

workers, or someone with multiple male 

sex partners, then they need to take the 

tablet every day. That is known as Daily 

PrEP, which offers protection of more than 

95 percent. In episodic PrEP, it is about 90 

percent. 

HIV-AIDS today is closely linked with 

TB and malaria. In fact, The Global Fund 

covers all three diseases. But in India, 

there are separate programmes for HIV, 

TB and malaria. Is that appropriate? 

First of all, the idea of clubbing the three 

diseases together is misleading. There are 

studies to show that HIV predisposes the 

patient to malaria, or even that malaria 

is more frequent in HIV positive people 

than in the general population. But TB and 

HIV are twin brothers, closely associated 

with each other. Hence, under the Revised 

National Tuberculosis Control Programme 

(RNTCP), the two programmes of HIV 

control and TB control have been merged. 

They are now managed by a single office, 

instead of two separate ones. Also, HIV 

testing is done at the TB clinics while 

TB medicines are supplied through HIV 

treatment centres. 

Health insurance for HIV positive 

people is another issue of contention. 

What is your view on that? Most health 

insurance companies have got HIV under 

their exclusion criteria, although IRDA 

(Insurance Regulatory and Development 

Authority) has given clear directives 

that such discrimination is not 

permitted anymore. Now, a 

new law has been enacted 

under which such exclusion 

will attract a jail term. This is 

because HIV infection today 

is a chronic, manageable 

disease like diabetes or 

hypertension. It is no longer 

a death sentence. 


case reports 

NON-FUNCTIONAL 

PLATELETS 

Glanzmann thrombasthenia, a very rare bleeding syndrome, is quite often 

a diagnostic challenge 

Ramana (name changed), a 14-year-old boy, was brought 

to Dr. Kiran Kartheek Veeranki, a leading paediatrician 

practising at Sravani Hospital in Guntur, Andhra 

Pradesh with a bleeding nose and bleeding gums. The boy 

complained of spontaneous bleeding in the gums and from 

the nose, on and off, without any external trauma for the past 

2 years. In addition, he also had a history of hematoma-like 

swellings at the site of intramuscular injections. In the past, 

he had been treated with fresh frozen plasma infusions at 

each bleeding instance, with temporary recovery. A thorough 

family history revealed that two of the boy’s siblings had 

died a few years ago; one sibling had died due to a bleeding 

manifestation which was not diagnosed, and the other had 

died of an infection. Since the family came from a small 

village, exhaustive testing was limited, and a detailed history 

was unavailable. 

Several routine tests were carried out - Ramana showed 

no iron deficiency, platelet counts were normal, and 

interestingly, prothrombin time test was also within normal 

limits. Bone marrow biopsy was also performed and found to 

be normal. In spite of the lack of positive laboratory findings, 

Dr. Kiran still suspected the boy to be suffering from a 

platelet function disorder based on the symptoms and clinical 

presentation. To confirm this, he convinced Ramana’s family 

to opt for genetic testing. Even though the genetic testing 

costs were high for this family, it was the only 

available option for a confirmatory diagnosis. 

Ramana’s family were looking forward to 

finally reaching a diagnosis, especially since 

they had already lost two children. 

Since Ramana had been routinely given 

fresh frozen plasma transfusions, Dr. Kiran 

first requested that the child should not be 

given any transfusions for at least 1 month 

before sending the boy’s blood sample 

for genetic testing for a platelet adhesion 

disorder panel. This was done to ensure 

that there was no contamination from 

donor plasma cells during genetic testing. 

The results of the genetic testing revealed a 

mutation in the ITGB3 gene, which encodes 

for the beta3 subunit of a protein, integrin 

alpha IIb/beta3 (αIIbβ3). This protein is 

present on the surface of platelets and key 

for platelet aggregation and formation of blot 

clots that promote wound healing. Mutations 

in either ITGB3 or ITGA2B, which codes 

for the alpha subunit of αIIbβ3, result in a 

platelet function disorder called Glanzmann 

thrombasthenia. 

Glanzmann thrombasthenia is a rare 

autosomal recessive bleeding disorder 

associated with prolonged or spontaneous 

bleeding and or bruising. The severity of 

clinical symptoms can be extremely variable. 

Some incur only minimal bruising, while 

others have severe frequent hemorrhages. 

The site of bleeding is distinct. Purpura, 

epistaxis, gingival hemorrhage and 

menorrhagia, rather than gastrointestinal 

bleeding and hematuria. 

While Glanzmann thrombasthenia is 

very rare -- affecting only one in a million 

individuals worldwide -- it is often found 

clustered amongst ethnic groups in which 


intermarriages are common. Ramana came 

from a family where intermarriages are 

rampant, and both his parents had a single 

copy of the ITGB3 mutation and are carriers 

for the disorder. Unfortunately for Ramana, 

he received two copies of the mutant gene, 

one from his father and the other from 

his mother, and consequently suffers from 

Glanzmann thrombasthenia. 

There are no known cures for such 

platelet formation disorders. However, 

Glanzmann thrombasthenia has a good 

prognosis if the patient is provided with 

careful supportive care. Local hemostatic 

procedures, such as compression and 

gelatin sponges, followed by anti-fibrinolytic 

drugs or platelet transfusions work well for 

management of minor to moderate bleeding, 

as in this case. Recently, recombinant factor 

VIIa (rFVIIa) has been shown to be effective 

in treating and preventing hemorrhages 

THE BOY’S PARENTS HAD A 

SINGLE COPY OF THE 

ITGB3 MUTATION AND 

ARE CARRIERS FOR 

GLANZMANN 

THROMBASTHENIA 

in Glanzmann thrombasthenia patients. 

However, considering the economic status of 

the family, platelet transfusion was adjudged 

the most cost-effective treatment in this 

case. Ramana is currently undergoing platelet 

transfusions as and when needed and has 

been coping well with his condition for the 

past few months. He has been advised 

against contact sports and the use of aspirin 

and non-steroidal anti-inflammatory drugs 

as these affect platelet function. He has also 

been told to maintain good oral hygiene to 

avoid bleeding gums. These management 

concepts, while critical to avoid bleeding 

episodes, are not a cure for the disorder, 

which will continue to impact Ramana’s 

lifestyle until a suitable cure is found. 

DR SHIVANEE SHAH 


case reports 

METABOLIC DEFECTS LEADING 

TO BEHAVIOUR DISORDER 

A type of mucopolysaccharidosis can be easily misdiagnosed as ADHD or autism 

Lysosomal storage diseases are a group of inherited 

metabolic disorders that occur as a consequence of a 

deficiency in a single key enzyme required for either lipid, 

glycoprotein or mucopolysaccharide metabolism, affecting 

several organs. The key symptoms of lysosomal storage disease 

include developmental delays, movement disorders, seizures 

and/or even dementia, deafness or blindness. Some patients 

have hepatomegaly or splenomegaly as well as pulmonary or 

cardiac problems or bones that grow abnormally. The severity 

and type of symptoms depend on the precise enzyme that is 

deficient. 

Dr. Kiran Kartheek Veeranki, a leading paediatrician 

practising at Sravani Hospital at Guntur in Andhra Pradesh, was 

presented with five-year-old Ravi (name changed), who was 

showing behaviour abnormalities and delayed milestones. The 

boy’s gross motor skills were limited to walking and climbing 

stairs and his fine motor skills limited to drawing straight 

lines. He was also delayed in speech and continued to have 

stranger anxiety. His parents also complained of loose stools 

and abdominal distention since the child was one year old. 

On examination, Dr. Kiran observed that the child had coarse 

facies, short stature, and hepatomegaly. Based on these clinical 

observations, he suspected the child to have a lysosomal 

storage disorder. Several primary tests were performed to 

rule out liver problems and infections. Liver function tests like 

total bilirubin, aspartate aminotransferase 

and alanine aminotransferase were normal, 

as were blood counts and stool culture. To 

confirm the diagnosis and identify the type of 

lysosomal storage disease, the child’s blood 

sample was sent for genetic testing. Genetic 

testing is critical in confirming the diagnosis, 

which, in turn, dictates the treatment regimen. 

The results showed that the patient had a 

SANFILIPPO SYNDROME B IS 

A TYPE OF RARE, AUTOSOMAL 

RECESSIVE LYSOSOMAL 

STORAGE DISEASE CAUSED 

DUE TO A DEFICIENCY OF 

GLYCOSAMINOGLYCAN 

HEPARAN SULFATE 

mutation in the NAGLU gene, which causes 

mucopolysaccharidosis type IIIB, also known 

as Sanfilippo syndrome B. 

Sanfilippo syndrome B is a type of 

rare, autosomal recessive lysosomal 

storage disease caused due to a deficiency 

in enzymes required to metabolise 

glycosaminoglycan heparan sulfate. 

Glycosaminoglycans are unbranched 

polysaccharides that are attached 

to proteoglycans in the extracellular 

matrix and the cell membrane. Several 

enzymes are important for metabolism 

of glycosaminoglycan heparan sulfate 

– heparin N-sulfatase, N-acetyl-alpha- 

D-glucosaminidase, acetyl-CoA:alphaglucosaminide 

N-acetyltransferase, and 

N-acetylglucosamine-6-sulfatase. The NAGLU 

gene encodes alpha-N-acetylglucosaminidase, 


which is required for breaking the glycosaminoglycans. 

A deficiency in this enzyme results in an accumulation of 

glycosaminoglycan molecules, which produces progressive 

cellular damage and multisystemic disease. 

Clinically, children are initially symptom-free, and usually 

present with a slowing of development as seen for Ravi. 

Sanfilippo syndrome is a progressive disorder, presenting 

first with mild developmental and behavioural problems 

and a progressive intellectual decline followed by increasing 

behavioural disturbances, hyperactivity and destructiveness. 

It is easily misdiagnosed as attention-deficit/hyperactivity 

disorder and/or autism spectrum disorders. Doctors must 

take a step back and view the entire presentation in case of 

a progressive decline in behavioural and cognitive function 

associated with skeletal abnormalities. These symptoms may 

later progress to seizures and/or dementia. 

Currently, there is no cure for this disease. Bone marrow 

transplantation has been shown to be beneficial if the 

diagnosis is made early on but does not prevent neurological 

deterioration. Intravenous injections of a recombinant enzyme 

can be administered; however, the enzyme is unable to cross 

the blood-brain barrier and consequently cannot treat the 

neurological manifestations. Substrate reduction therapy using 

small molecules that can inhibit glycosaminoglycan synthesis 

is a potential therapy option that is being explored, having 

shown promising results in animal studies and in preliminary 

human studies. Gene therapy is another 

promising option; clinical trials are currently in 

progress and may offer a suitable treatment 

option in the near future. 

Ideally, patients’ families should be 

screened for carrier status and pre-natal 

testing should be counselled in case the 

parents are planning another child. However, 

in this case, the family was unable to afford 

genetic testing and Dr. Kiran had to convince 

them that it was absolutely necessary at least 

for Ravi. 

Unfortunately for Ravi, there is no current 

treatment other than supportive care and 

conservative management. He was given 

loperamide to decrease bowel movement 

along with zinc supplements for recovering 

epithelial damage caused due to diarrhea. 

This treatment has not resolved Ravi’s 

symptoms. In spite of this, Ravi’s parents are 

happy that their son’s condition has been 

accurately diagnosed and they are mentally 

prepared for what awaits Ravi in the future. 



case reports 

DILEMMA OF DIARRHOEA 

Celiac disease can present in different ways with or without any of the myriad 

symptoms associated with the condition 

A 

14-year-old male child from Rajasthan 

presented with chronic diarrhoea 

to Dr. Shaivali Joshi, a paediatrician 

in Mumbai. The child complained of 

loose stools 4-5 times a day and also 

had a history of anaemia since infancy. 

Examination revealed that he had severe 

platonychia and koilonychia, suggestive 

of iron-deficiency anaemia. There was 

no enlargement of the liver, spleen or 

lymph nodes. Also, failure to thrive or FTT 

was not severe. While his liver and renal 

profiles and thyroid function tests were 

normal, his haemoglobin levels were indeed 

very low at 3.5-4. 5 g/dl with microcytic 

hypochromic anaemia, indicative of iron 

deficiency anaemia. Haemoglobinopathies 

were ruled out by performing haemoglobin 

electrophoresis to identify abnormal 

haemoglobin. Folic acid and B12 levels were 

also within normal range. Dr. Joshi was really 

concerned regarding the anaemia for which 

there seemed to be no obvious cause. She 

therefore referred the patient to Dr. Swati 

Kanakia, a paediatric hemato-oncologist 

at Lilawati Hospital. After reviewing case 

history and based on tests conducted, Dr. 

Kanakia suspected the diagnosis to be celiac 

disease based on the chronic diarrhoea and 

anaemia. 

Celiac disease is an autoimmune disorder 

that primarily affects the small intestine upon 

intake of gluten in genetically predisposed 

individuals. HLA-DQ2 haplotype gene 

(DQA1 0501/DQB1 0201) has been shown 

to be present in 90% of patients with 

celiac disease, while HLA-DQ8 haplotype 

(DQA1 0301/DQB1 0302) is present in 5% 

of patients. Individuals with the HLA-DQ8 

haplotype may not develop celiac disease 

and additional factors such as gluten intake 

and environmental factors such as alterations 

in the intestinal microbiota, antibiotic use and 

infections can play a role. 


or even refractory or non-responsive, and 

can be associated with other autoimmune 

disease or other conditions, including 

diabetes, thyroid disorders, liver disease, 

psoriasis, systemic lupus erythematosus and 

rheumatoid arthritis. 

There is no cure for celiac disease and 

management involves a diet that 

is completely gluten-free. Gluten is 

THE INCIDENCE OF HLA- 

DQ 2/8 IS THE SAME IN THE 

NORTH INDIAN AND SOUTH 

INDIAN POPULATION, BUT THE 

INCIDENCE OF CELIAC DISEASE IS 

MUCH HIGHER IN NORTH INDIA 

A series of tests were done to confirm whether the 

child was suffering from celiac disease. Immunoglobulin 

studies showed normal total IgG, IgA, IgM and IgE. Tissue 

Transglutaminase (tTG) IgA was negative, and tTG IgG was 

positive. Gastric fundus biopsy showed mild chronic gastritis. 

Duodenum biopsy showed moderate inflammation with 

infiltrating lymphocytes, plasma cells and few eosinophils 

in the lamina propria, and the majority of the villi were flat 

with elongated crypts. These findings are diagnostic of celiac 

disease. 

The damage to the intestinal villi results in 

malabsorption, affecting growth and development in the 

child. Consequently, some of the hallmarks of celiac disease 

are stunted growth and pot-belly, which this child did not 

present with. Other common clinical signs include diarrhoea, 

abdominal pain, osteoporosis, neurologic abnormalities, 

increased liver enzyme levels, as well as skin disorders. The 

haematological manifestations 

of celiac disease are iron-deficiency anaemia, folate 

and vitamin B12 deficiency, micronutrient deficiencies, 

thrombocytopenia, thrombocytosis, leukopenia, neutropenia, 

splenic dysfunction and IgA deficiency. In fact, the child 

did not present several common clinical signs associated 

with celiac disease. Dr. Kanakia stresses that ‘celiac disease 

can present in different ways, and it is important to think 

of it in cases of chronic anaemia, with or without chronic 

diarrhoea or any of the myriad symptoms associated with 

celiac disease’. Celiac disease can be atypical, silent, latent 

present in wheat, rye and barley, and 

these must be completely avoided. The 

child was immediately started on a 

gluten-free diet and has been doing 

well over the past 6 months. His current 

haemoglobin levels have increased to 11 g/ 

dl and he is not troubled with diarrhoea 

anymore. 

Gluten is present in one of North India’s 

key dietary ingredients -- wheat. A recent 

study has shown that while the incidence of 

HLA-DQ 2/8 is the same in the North Indian 

and South Indian population, the incidence 

of celiac disease is much higher in North 

India (close to 1% of the population) than 

in South India (about 0.01%). This is likely 

to be due to the predominantly high daily 

wheat intake in the North Indian population. 

Breads also have a very high gluten 

content, and with the advent of fast food 

joints, bread intake has considerably 

increased, and this is likely to affect the 

incidence of celiac disease as well. It will be 

important to consider how our lifestyles may 

impact the incidence of celiac disease in 

the near future. Our lifestyles are changing, 

and it remains to be seen if or when celiac 

disease joins the infamous club of lifestyle 

diseases. 



case reports 

FALLING NEUTROPHILS 

A case of severe congenital neutropenia leading to recurrent infections 

Severe congenital neutropenia is a chronic blood 

disorder due to an accumulation of granulocyte 

precursors in the bone marrow, resulting in recurrent 

fever and recurrent infections, including respiratory, skin and 

oropharyngeal infections, most often due to staphylococci 

and streptococci. Neutropenia is apparent soon after birth 

and can lead to osteoporosis or even leukaemia, affecting 

about 1 in a million worldwide. While the cause of severe 

congenital neutropenia is unknown for about one-third 

of the people with the disorder, mutations in different 

genes are known to be responsible for the rest; about 

50% of the cases are due to mutations in the neutrophils 

elastase (ELANE)gene while 10% are due to mutations in 

the HS-1-associated protein X-1 (HAX1) gene. Mutations in 

other genes such as the Wiskott-Aldrich syndrome (WAS) 

gene, that encodes for the WAS protein (WASP), may also 

result in severe congenital neutropenia. Mutations in the 

ELANEgene cause misfolding in the 3D structure of the 

protein. This results in the accumulation of the neutrophil 

elastase protein within the neutrophils, eventually leading 

to the death of the neutrophils. HAX1 is a protein required 

for regulating apoptosis. Mutations in the 

HAX1 gene results in premature death 

of the neutrophils. These mutations are 

often isolated, sporadic cases. However, 

mutations in the ELANEgene are inherited 

in an autosomal dominant manner, while 

mutations in the HAX1gene are autosomal 

recessive. 

Here is a case of three-year-old Shama 

(name changed), who presented to the 

ICU at Lilawati Hospital at Mumbai with 

fever, vomiting and rashes on the thighs 

and around the mouth. Dr. K. N. Shah, the 

consulting paediatrician, observed that 

the child had tachycardia and tachypnea 

with a palpable liver that was soft and 

non-tender, but no palpable spleen and 

lymph nodes. Laboratory tests revealed 

that her white blood counts, CRP, PCT and 

ESR were high. However, her neutrophil 

count was low, and the monocyte count 


was high. Previous history of the child showed that she had 

frequent hospitalizations in which all the reports showed 

low neutrophil counts. The patient was then referred to Dr. 

Swati Kanakia, the paediatric hemato-oncologist at Lilawati 

Hospital. She performed a bone marrow aspiration and 

biopsy to understand the cause of the neutropenia. Bone 

marrow biopsy showed a reactive marrow with a mild 

maturation arrest in myeloid series and mild 

erythroid hyperplasia. This observation, along with the 

history of neutropenia, suggested a diagnosis of severe 

congenital neutropenia. Genetic analysis revealed the 

child to have a homozygous HAX1mutation. The family 

was also tested. Both parents were heterozygous for the 

mutation and one sibling tested heterozygous for the same 

mutation. 

Severe congenital neutropenia is typically treated 

symptomatically with antibiotic treatment during each 

recurring infection and recombinant granulocyte colony 

stimulating factor (G-CSF) which can promote granulopoiesis 

and release neutrophil reservoirs from the bone marrow. 

Recombinant G-CSF treatment can increase the circulating 

neutrophil count by 10-12 folds. 

In accordance with international guidelines, Shama 

was given antibiotics and G-CSF. She requires higher than 

normal doses of G-CSF (10 mcg/kg) to document a small 

rise in neutrophil counts. Shama did well with the treatment. 

However, she continues to suffer from fever 

and respiratory infections every 2-3 months. A G-CSF 

injection has to be given to her as treatment each time. A 

definitive treatment option for severe congenital neutropenia 

BONE MARROW BIOPSY 

SHOWED A REACTIVE MARROW 

WITH A MILD MATURATION 

ARREST IN MYELOID SERIES AND 

MILD ERYTHROID HYPERPLASIA 

is bone marrow transplantation. In 

recent years, bone marrow transplants 

have become available in many bigger cities 

of India. The challenges are the availability 

of a matched donor, the cost of the 

procedure, and the availability of suitable 

expertise. Often siblings are 

suitable matched donors. While Shama’s 

brother also carries a copy of the mutation, 

it may be possible to use him as a donor. 

Shama’s parents are currently considering 

bone marrow transplantation, and one of 

the key deciding factors would be whether 

Shama’s brother could be a potential donor. 

This is the only known curative treatment for 

this potentially life-threatening disease. 



esearch snippets 

Epidural stimulators help 

restore walking ability in 

paralyzed individuals 

F 

.B. Wagner et al demonstrated a 

technological framework called 

epidural electrical stimulation (EES) 

to help restore walking ability in 

individuals with spinal cord injury. EES 

uses wireless electrical stimulators 

implanted onto the spinal cord to 

improve the neurological recovery in 

paralyzed people. The study enrolled 

three individuals who had sustained 

a spinal cord injury with permanent 

motor deficits or complete paralysis. 

The researchers mapped out the 

areas of spinal cord involved in each 

movement required for walking and 

programmed them into a sequence 

of electrical pulses that would 

stimulate the spinal cord at the 

correct time and location to facilitate 

these movements. The current study 

employed a patterned EES which, 

unlike continuous stimulation, helped 

the individuals in regaining control 

over previously paralyzed muscles 

even when electrical stimulation 

was turned off. The research 

provided more than five months of 

rehabilitation, alongside stimulation, 

which helped the participants 

improve further. Though the study 

shows a remarkable development in 

treating individuals with spinal cord 

injury, more research needs to be 

done in order to understand who will 

benefit from this technology since 

spinal injuries vary enormously in their 

location, severity and outcome. 

Nature Neuroscience 563, 6 (2018) doi: 

10.1038/d41586-018-07237-9 

Early appendix removal 

may delay Parkinson’s 

Killinger et al reported that the 

removal of the appendix at an early 

age may delay or reduce the occurrence 

risk of Parkinson’s disease (PD) in those 

individuals. The scientists observed a 

remarkably abundant presence of a 

misfolded protein α-synuclein in the 

appendix of both normal individuals and 

PD patients which was analogous to 

that found in post-mortem brain tissues 

of patients with PD. The study included 

two large-scale epidemiological datasets 

which involved more than 1.6 million 

individuals and over 91 million personyears 

which revealed that the removal of 

appendix decades before PD onset was 

associated with a lowered risk for PD 

by about 19% which was seen distinctly 

among individuals in rural areas, and 

delayed the age of PD onset. The finding 

of the presence of pathogenic forms of 

α-synuclein in human appendix provides 

insight which may help explore new 

preventive and treatment strategies 

against PD. 

Science Translational Medicine, 31 Oct 2018 Vol. 

10, Issue 465, eaar5280DOI: 10.1126/scitranslmed. 

aar5280 

Polyphenols inhibit 

amyloid-beta 

aggregation 

Ross S. Mancini et al found evidence 

revealing the neuroprotective role of 

coffee against developing Alzheimer's 

and Parkinson's disease by reducing 

the aggregation of misfolded proteins 

involved in it. The study showed a 

remarkable effect of various polyphenolic 


Transcranial stimulation to treat low back pain 

Sangtae Ahn et al reported that 

targeting a specific part of the brain 

with a weak alternating current of 

electricity significantly decreased chronic 

lower back pain (CLBP) in all participants 

of a small clinical trial. This treatment, 

known as Transcranial Alternating Current 

Stimulation (tACS), was used in a group 

of 20 patients based on the hypothesis 

that naturally occurring alpha oscillations 

associated with the thalamo-cortical 

activity pattern in the human brain are 

impaired in chronic pain and can be 

modulated. All patients were suffering 

from CLBP and were subjected to 

tACS and sham stimulation in different 

sessions. In one session the researchers 

targeted the somatosensory region using 

tACS to enhance the naturally occurring 

alpha-waves. The other session provided 

a weak untargeted electrical current 

for a placebo effect. The patients could 

not differentiate both the sessions. The 

findings revealed significantly 

enhanced alpha oscillations in 

the somatosensory regionon 

stimulation withalpha-tACS 

compared to placebo 

stimulation. The results, as 

recorded with EEG, were 

correlated with pain 

relief, giving successful 

target identification. 

Researchers plan 

on conducting 

a larger study 

to discover the 

effects of multiple 

tACS sessions, 

suggesting that it may 

provide a non-invasive 

therapeutic benefit for 

other brain associated 

disorders as well. 

The Journal of Pain DOI: https://doi. 

org/10.1016/j.jpain.2018.09.004 

compounds found in brewed coffee to 

alter the aggregation profile of amyloidbeta, 

tau and alpha-synuclein found 

associated with dementia. Three different 

types of coffee including light roast, 

dark roast, and decaffeinated dark roast 

and six different coffee components 

were analysed in the study. Of the 

various coffee components investigated, 

phenylindane was the only compound 

found to be a potent inhibitor of both 

amyloid-beta and tau aggregation, unlike 

other components. The study is the first 

to report on the aggregation inhibition 

activity of phenylindane for Ab, tau and 

a-synuclein. The researchers are currently 

involved in a further investigation on the 

cell and animal models for AD and PD 

based on the promising observations of 

the study. 

Frontiers in Neuroscience, 2018; 12 October 

2018DOI: 10.3389/fnins.2018.00735 

Neck scan detects 

early chances of 

dementia 

Researchers from University College 

London (UCL) have found that a 

five-minute scan of blood vessels in 

the neck could predict the potential 

onset of dementia a decade before the 

appearance of any apparent symptoms. 

Led by Professor John Deanfield, the 

team of international researchers 

studied a group of 3,191 middle-aged 

volunteers who were given an ultrasound 

to measure the intensity of the pulse 

reaching their brain from the heart via 

the neck. Over the next 15 years, the 

participants were monitored for their 

memory and problem-solving ability. 

Participants whose blood reached 

their brain with the highest intensity 

(25%) at the beginning of the study 

showed 50% higher risk of developing 

cognitive decline over next decade 

compared to the rest of the participants. 

The research claims to reveal the first 

direct link between the heart's pulse 

transmitted towards the brain and 

future impairments in cognitive function. 

The research suggests that adopting a 

healthy lifestyle controlling the blood 

pressure and cholesterol levels is the way 

to help stave off vascular dementia. The 

researchers proclaim that the scan could 

become a routine screening programme 

for people at risk of developing dementia 

once it is confirmed in larger studies. 

University College London https://www.ucl.ac.uk/ 

news/news-articles/1118/121118-neck-scan- 

Alzheimers 

—Compiled by Divya Choyikutty 


column 

Can NextGeneration 

Sequencing help tackle HIV? 

No routine testing for ART-related drug resistance 

in low-income settings 

DR RAJANI KANTH 

VENGALA 

Writer is medical scientist 

and former director of 

SGRF, Bangalore 

Advances in nucleic acid sequencing 

have been taking place at a great 

pace since 2005, resulting in several 

novel Next Generation Sequencing (NGS) 

systems. Current NGS technology has a 

three-step approach, in which a DNA library 

is prepared, enriched and sequenced or 

identified. Adding bioinformatics tools to this 

data gives an immense power to detect and 

identify microbiomes which are hitherto not 

known. This enables identification of new 

viruses or mutations using metagenomics 

approaches. Continuous and dynamic 

development of NGS technology, coupled 

with metagenomics, will change the scope of 

the application of this technology, and enable 

identifying intraspecies changes within a 

given biospecimen. Present day diagnostics 

use a Sanger sequencing-based method 

for molecular detection, which is not very 

sensitive. 

For example, in case of Transmitted 

drug-resistance mutations (TDRM) of HIV-1 

infection, a comparative study of NGS and 

Sanger sequencing (Roy Moscona et al., 

2017) was performed. It is well known that 

TDRM frequency may vary in the viral pool. 

It was noted that one could observe more 

non-synonymous amino acid substitutions 

and TDRM using NGS compared to the 

Sanger method. In the study, an overall 

TDRM prevalence of 8.8% was identified via 

Sanger method out of a reported prevalence 

of 10.1% in treatment-naïve individuals 

with NRTI as the most affected drug class. 

However, NGS was able to identify 31.3% 

of the patients, including those with very 

low HIV-1 viral load -- even below 5%. This 

suggests that NGS can truly identify viral 

populations with high genetic diversity and 

can evaluate at an early stage patients who 

may develop resistance in the long run. 

Another study (Casadellà et al., 2016) using 

an NGS platform found a K65R prevalence of 

nearly 70% in subjects developing virological 

failure in first-line antiretroviral therapy (ART) 

containing TDF (tenofovir), which was missed 

by Sanger sequencing. 

ART is provided in low- and middleincome 

countries (LMIC) as a public health 

approach and policy. This leads to HIV drug 

resistance. However, no regular testing for 

the drug resistance is done. The present drug 

resistance testing is primarily for surveying 

to inform national and regional ART. NGS can 

become the best-suited technology platform 

if it is used in centralized laboratories to 

reduce the cost. This approach can enable 

large population coverage and identify 

non-responders or patients who are yet to 

develop drug resistance. 

NGS is likely to soon become a very 

important cornerstone technology for 

improved capabilities in diagnosing HIV drug 

resistance. The clinical value, prevalence 

of certain mutations and genetic barriers 

in drug resistance can be best understood 

and evaluated using NGS. Ultrasensitive 

genotyping has been proven to improve 

ART outcome predictions in treatment 

naïve subjects who are about to start 

on nevirapine or efavirenz and CCR5 

antagonists. It has become very clear that if 

we are to tackle HIV global pandemic, the 

question of making NGS accessible to LMICs 

must be resolved. In the best case scenario 

-- in which global HIV-1 eradication is seen 

as a possibility -- reducing costs in library 

preparation and bioinformatic analysis will 

be a good place to start. 


hospital news 

Nayati launches eICUs 

for critical care 

Nayati Healthcare has introduced digital 

intensive care units (eICU) at Nayati 

Medicity at Mathura. The launch of the 

state-of-the-art technology is aimed 

at bringing the world’s most advanced 

healthcare services and technology to 

the people in tier 2 and tier 3 cities, the 

hospital said 

Nayati Medicity has adopted a secured, 

cloud-based model which uses minimal 

infrastructure cost, making it affordable to 

the people in tier 2 and tier 3 cities. 

The technology, introduced in 

collaboration with Cohere Med, a healthtech 

company based in Bangalore, will 

allow clinicians to monitor multiple critically 

ill patients remotely. 

The newly installed system uses 

Cohere Med’s Critibot, a bot built to serve 

customized information for every doctor. 

The goal is to optimize clinical expertise 

and facilitate 24-hour-a-daycare by ICU 

caregivers, according to hospital officials. 

HCG introduces new-gen 

tomotherapy 

HealthCare Global Enterprises Ltd 

(HCG) has introduced Radixact X9 

– the new generation tomotherapy to 

treat cancer patients. 

The Radixact System is being used 

at HCG EKO cancer centre, a partnership 

between HCG and EKO X-Ray & Imaging 

Institute, a premier institute of diagnosis 

from Kolkata, 

The inbuilt CT scan imaging in a 

Radixact system allows treating bone 

marrow transplant patients accurately 

to the complete bone marrow instead 

of exposing all internal organs. One of 

the unique advantages of the system is 

treating children with medulloblastoma. 

In this case, the child can comfortably 

lie on his/her back and the radiation 

beam treats more than three times the 

length possible in regular machines in 

a single movement of the treatment 

couch. Radixact is both versatile and 

comprehensive. 

Introduction of the Radixact in 

Kolkata is to ensure that advanced care 

is accessible to the patients of West 

Bengal and the neighboring states so 

that they don’t have to travel to far 

off locations, away from their home 

and close ones for cancer treatment, 

according to HCG officials. 

HCG, which specialises in cancer 

care, was among the first in India to 

introduce the TomoH System, a fully 

integrated 3D conformal and imageguided 

intensity-modulated radiation 

therapy (IG-IMRT) system, and the 

CyberKnife Robotic Radiosurgery 

System, technology designed to deliver 

stereotactic radiosurgery (SRS) and 

stereotactic body radiation therapy 

(SBRT). 

Gleneagles wins two accreditations from SRC, USA 

Gleneagles Global Hospitals has won 

two accreditations from Surgical 

Review Corporation (SRC) of USA and 

has been certified as one of the leading 

hospitals in India as a ‘centre of excellence 

for metabolic & bariatric surgery’ and 

‘centre of excellence for hernia surgery’. 

Gleneagles Global Hospitals is to be 

conferred with this recognition in both the 

states of Telangana and Andhra Pradesh. 

For certifying, the authorities at SRC 

have taken into consideration parameters 

like processes, protocols, clinical pathways 

and volume of work. 

SRC provides accreditation, consulting, 

education and data for surgeons and 

facilities to advance the safety and quality 

of care for their patients. 


health insurance 

FEWER EXCLUSIONS 

All health conditions acquired after policy inception should be 

covered by insurers, moots IRDIA working group 

BANO SARKAR 

A 

working group constituted 

by Insurance Regulatory and 

Development Authority of India 

(IRDAI) under Suresh Mathur, Executive 

Director (Health), IRDAI, to study the 

standardisation of exclusions in health 

insurance sector has submitted its 

report. 

The working group submitted 

the report after carefully examining 

the suggestions made by various 

stakeholders and studying different 

exclusions in India and the practices 

followed in some of the developing 

as well as the developed countries. 

The working group also took into 

consideration the state of the 

healthcare sector in the country 

and the lack of unity and regulatory 

provisions in the sector. 

Commenting on the report, 

Vaidyanathan Ramani, Head of Product 

and Innovation at Policybazaar.com, 

said:“The report is very customer 

friendly. The objective of the committee 

is to try to reduce the ambiguity around 

health insurance exclusions and make 

them more standardised.” 

In its report, the working group 

recommended that all health conditions 

acquired after policy inception, other 

than those not covered under the 

policy contract, such as infertility 

and maternity, should be covered 

under the policy and cannot be 

permanently excluded. Thus, the 

exclusion of diseases contracted 

after taking a health insurance policy 

will not be permitted. The group has 

recommended that there should 

not be any permanent exclusion 

in the policy wordings for any 

specific disease, whether they are 

degenerative, physiological or chronic 

in nature. According to the working 

group, permanent exclusions can 

be incorporated only at the time of 

underwriting. 

Vaidyanathan Ramani said the 

working committee has recommended 

that there should be only 17 

defined exclusions which should be 

permanently excluded. “The exclusions 

will be clearly defined in keeping with 

THE WORKING GROUP 

RECOMMENDS ALLOWING 

INSURERS TO INCORPORATE 

PERMANENT EXCLUSIONS 

WITH DUE CONSENT 

OF THE PROPOSER 

customer understanding. Broadly, only 

17 exclusions will be allowed in general, 

but in specific cases, ,exclusions may 

come from the individual having a 

severe condition and with their due 

consent,” he said. 

Limited waiting periods 

The working group has also 

recommended allowing insurers to 

incorporate waiting period for any 

specific disease. But it should be for a 

maximum of four years. It suggested 

the inclusion of sub-limits or annual 

policy limits for specific diseases or 

conditions in terms of amount, a 

percentage of sum insured or by the 

number of days of hospitalization 

or treatment in the product design. 

However, the working group added 

that any limits or waiting periods 

incorporated by the insurers as a 

part of the product design shall be 

based on objective criteria and sound 

actuarial principles. Vaidyanathan 

Ramani felt that the waiting period 

must be reduced to 30 days for certain 

conditions like hypertension, diabetes 

and cardiac problems. 

The working group has 

recommended allowing insurers to 

incorporate permanent exclusions 

with the due consent of the proposer, 

which will allow a wider section of the 

population with serious pre-existing 

diseases to avail of health insurance, 

including persons with disabilities. It 

has observed that non-declaration or 

misrepresentation of material facts is 

a major concern in health insurance 

contracts. The insurance companies 

generally invoke cancellation clause for 

non-disclosure or misrepresentation. 

The working group has recommended 

that in such cases, the insurer can take 

consent from the insured person and 

permanently exclude the condition 

and continue with the policy if the 

non-disclosed condition is from the list 

of the permanent exclusions. But if the 

non-disclosed condition is not from 

the list of permanent exclusions, then 

the insurer can incorporate additional 

waiting period for a maximum of 4 

years for the condition non-disclosed 

from the date the non-disclosed 

condition was detected and continue 

with the policy. This will not prejudice 

the rights of the insurer to invoke the 

cancellation clause under the policy for 

non-disclosure or misrepresentation. 

The working group has 

recommended a period of eight years 

of continuous renewals for raising 

issues related to non-disclosure. 

After this, claims shall not be 


questioned based on non-disclosures 

or misrepresentations at the time 

of taking the policy. It has also 

proposed to review and standardize 

the exclusions applied by insurers for 

alcohol and substance abuse. 

Advanced treatments 

It suggested the formation of the 

Health Technology Assessment 

Committee for examining and 

recommending the inclusion of 

advancements in medical technology 

as well as new treatments and drugs 

introduced in the Indian market for 

coverage under Insurance. According 

to the working group, a detailed 

procedure based on international 

practices needs to be followed by the 

committee for inclusion and exclusion 

of modern or new technologies and 

treatments. It suggested that no 

exclusions should be permitted for 

any advancement in technology and 

advanced treatments if they are in the 

list approved by the committee. 

INSURERS SHOULD 

NOT DENY COVERAGE 

FOR CLAIMS OF ORAL 

CHEMOTHERAPY AND 

PERITONEAL DIALYSIS 

The working group further 

recommended that the insurers should 

not deny coverage for claims of oral 

chemotherapy, where chemotherapy 

is allowed, and peritoneal dialysis, 

where dialysis is allowed. It suggested 

that insurers start adopting an 

Explanation of Benefits (EOB) in their 

prospectus as well as policy schedule 

and wordings, which can be easily 

understood by customers. After 

reviewing the entire list of optional 

items, the working group suggested 

classification of existing optional items 

into items that may be retained as it 

is as optional items, costs that are to 

be subsumed into room charges, costs 

that are to be subsumed into specific 

procedure charges, costs that are to be 

subsumed into the cost of treatment 

and costs that are to be subsumed 

into diagnostics. 

The working group observed that 

the changes recommended in the 

report would have some effect on 

the pricing of the respective products. 

It proposed that policy wordings 

would also have to be reworked and 

filed with the regulator. The insurance 

companies also stated that the 

prices of policies are likely to go 

up if the recommendations are 

implemented. The working group also 

recommended that all deaths due 

to vector-borne disease should be 

classified as death due to disease and 

not as death due to accidents. But 

injuries or death caused by mauling 

by wild animals, snake bite, scorpion 

bite and dog bites can be termed as 

accidental injuries. 


policy 

WHAT KEEPS 

DRUG PRICES 

Information asymmetry and supplierinduced 

demand are significantly 

restricting consumer choice in Indian 

healthcare, according to a recent policy 

note issued by Competition Commision 

of India (CCI). 

CCI was established in 2003 under 

the Competition (Amendment) Act, 

2007 to eliminate practices having 

an adverse effect on competition and 

protect the interests of consumers in 

the markets of India. 

Over the nine years, the CCI has 

received 52 cases pertaining to the 

pharmaceutical and healthcare sector. 

Consumer choice is a condition 

necessary for well-functioning 

Competition 

Commission of 

India identifies 

the forces that 

restrict consumer 

choice in a recent 

policy paper 


markets. In the absence of an agency 

with the consumer, Various industry 

practices flourish which have the 

effect of choking competition and are 

detrimental to consumer interest, the 

commission observes in the policy 

paper titled `Making Markets Work for 

Affordable Healthcare'. 

The paper identifies unreasonably 

high trade margins, premium-priced 

branded generics and incentive-based 

referral system by doctors are some of 

the key factors contributing to the high 

drug prices in India. 

The CCI note discusses the issues 

and recommendations for policy/ 

regulatory reform suggested by 

stakeholders in the abstract of the 

presentation: 

Role of intermediaries in 

drug price build-up 

The Indian pharmaceutical industry 

currently produces around US $ 

33 billion worth of drugs, over 40 

percent of which are supplied to other 

countries. However, 50 to 65 percent 

of its people do not have regular 

access to essential medicines. Also, the 

majority of the healthcare expenditure 

is out-of-pocket, a significant proportion 

of which is spent only on medicines. 

Thus, ensuring affordable drugs is a 

necessary pre-requisite for bringing 

down the overall healthcare expenses 

and to achieve the overall goal of 

affordable healthcare for all, states the 

report. 

One major factor that contributes 

to high drug prices in India is the 

unreasonably high trade margins. 

The extent to which trade margins 

THE CCI POLICY NOTE 

RECOMMENDS PUBLIC 

PROCUREMENT AND 

E-PHARMACY TO LIMIT 

THE INTERMEDIARY 

INVOLVEMENT IN 

DRUG PRICING 

contribute to the price-build up 

is discernible from the enormous 

differences between market prices 

of drugs and the price points at 

which states such as Tamil Nadu 

and Rajasthan provide the same 

drugs procured directly from the 

manufacturers under their public 

procurement and distribution systems. 

Pecuniary motivation in terms 

of margin influences which drug is 

dispensed by traders. The high margins 

are a form of incentive and an indirect 

marketing tool employed by drug 

companies. Further, self-regulation by 

trade associations also contributes 

towards high margins as these trade 

associations control the entire drug 

distribution system in a manner that 

mutes competition. 

The CCI policy note recommends 

public procurement and e-pharmacy 

to limit the intermediary involvement 

in drug pricing. Public procurement 

of drugs can be an important means 

of making essential drugs available 

to consumers at affordable prices. 

Efficient and wider public procurement 

of essential drugs can circumvent 

the challenges arising from the long 

distribution chain, supplant sub-optimal 

regulatory instruments such as price 

control and allow for access to essential 

medicines at lower prices. Electronic 

trading of medicines via online 

platforms, with appropriate regulatory 

safeguards, can bring in transparency 

and spur price competition among 

platforms and among retailers, as 

has been witnessed in other product 

segments. 

The health ministry has taken 

a positive step in this direction by 

releasing draft rules on Drugs (Sale and 

Distribution) Rules, 2017 which aims at 

removing ambiguity on regulations to 


facilitate sales of drugs 

Competition Commission of India 

online. It is required that a level playing 

field is created between online and 

offline platforms for the sale of drugs. 

Quality perceptions behind 

proliferation of ‘branded’ generics 

Worldwide, low-cost generic drugs 

are seen as a key competitive force 

against the patent-expired brand name 

drugs marketed at monopoly prices, 

but in India pharmaceutical market 

is dominated by "branded" generics. 

Competition between these ‘branded 

generic’ versions of drugs is largely 

based on brand and not on price, thus 

limiting the effect of generic-induced 

competition in the market, the paper 

points out. Although there exists little or 

no difference in the quality and efficacy 

of branded and unbranded generics 

given the same regulatory rigour 

applied to them, still the branded 

generics are marketed and prescribed 

based on the perceived higher efficacy 

and therapeutic advantage associated 

with them. 

Further, both the doctors and 

pharmacists prescribe and sell these 

drugs in order to gain incentives and 

higher margins. It is very well possible 

that quality consideration may be 

a reason behind the prescription of 

branded generics by doctors. 

But it is also equally possible this 

brand proliferation is to introduce 

artificial product differentiation in 

the market offering no therapeutic 

difference but allowing firms to extract 

rents. 

To stem the proliferation of 

`branded' generics, effective and 

uniform quality control of drugs 

and One company-one drug-one 

brand name-one price policy are 

recommended. 

The root cause of brand 

proliferation is the trust-deficit in the 

regulatory apparatus for licensing 

and inspection, which needs to 

be addressed through consistent 

application of statutory quality control 

UNLESS THE QUALITY OF 

DRUGS SOLD IN MARKETS 

CAN BE TAKEN TO BE IN 

CONFORMANCE OF THE 

STATUTORY STANDARDS, 

GENERIC COMPETITION 

CANNOT TAKE OFF 

measures across states and better 

regulatory compliance. 

Unless the quality of drugs sold 

in markets can be taken to be in 

conformance of the statutory standards 

regardless of their brand names, 

generic competition in the true sense of 

the term cannot take off. Furthermore, 

the practice of creating artificial product 

differentiation needs to be addressed 

through a one-company-one drug-one 

brand name one price policy. 

Vertical arrangements in 

healthcare services and lack 

of transparency 

The presence of information 

asymmetry and lack of agency 

does not allow consumers to make 

informed choice of service providers 

and also that of various services 

such as diagnostics, procedures etc. 


provided by the hospitals. Hospitals 

often have exclusive arrangements 

with in-house pharmacies, diagnostic 

labs etc. and may provide multiple 

services in a bundle or a package. 

Such arrangements driven purely by 

efficiencies are reasonable but when 

guided by the private interests of the 

healthcare providers, result in vitiating 

the market dynamics. In the absence of 

well-implemented regulations ensuring 

transparency and ethical practice, 

competition between hospitals on the 

parameters of price, quality or choice is 

almost non-existent in India, observes 

the policy paper. 

There are instances where 

the patient is forced to purchase 

consumables such as medicines, 

syringes etc. at printed MRP from the 

in-house pharmacy of the hospital 

when the same is available at 

significantly lower prices outside the 

hospital premises. It has also been 

observed that hospitals commonly 

reject even recent reports of diagnostic 

tests conducted outside the hospital 

and mandates repeat tests from their 

in-house diagnostic labs. Further with 

no regulatory framework that ensures 

and governs portability of patient 

data, the switching cost for a patient 

becomes high. 

In this case, the CCI paper 

recommends Recommendation 

strong regulatory framework ensuring 

transparency, data portability and 

standardisation of diagnostic labs. 

The note says that to help the 

consumers in making an informed 

choice about their healthcare 

services, there should be a mandatory 

declaration of vital data such as 

mortality rate, infection rate etc. by 

the hospitals. Further, it is necessary 

to ensure that the same degree of 

reliability and accuracy of test results 

are applicable across labs. There is 

also a need of a strong regulatory 

framework to ensure that the hospitals 

put no restriction the purchase of 

standardised products from the open 

market, accept and initiate treatment 

based on test reports of outside labs 

COMPULSORY TYING OF CONSUMABLES, 

DIAGNOSTIC SERVICES 

The consumables such as medicines, 

syringes etc. are often to be 

compulsorily purchased at printed MRP 

from the in-house pharmacy of the 

hospital. Many instances have been 

reported where the same product 

was available at a significantly lower 

price, i.e. at a discounted price below 

the printed MRP or at a lower MRP at 

outside pharmacies but consumers 

were not allowed to buy the same on 

the pretext of quality concern. 

The hospitals would charge the 

MRP thus retaining the entire margin. 

It is also reported that hospitals 

prescribe such products among a set 

of alternatives available, in which they 

have the highest margin. 

It has also been observed that 

hospitals commonly reject even recent 

reports of diagnostic tests conducted 

outside the hospital and mandates 

and allow portability of patient data. 

Regulation of pharmaceutical 

sector and competition 

Regulation of manufacturing, 

distribution, sale, and import of drugs 

is essential for ensuring the safety, 

efficacy, and quality of drugs produced 

and sold in the country. The regulatory 

framework that governs these aspects 

has a concomitant influence on the 

entry of drugs as well as players into 

repeat tests from their in-house 

diagnostic labs. The proffered rationale 

is the lack of reliability and accuracy of 

the outside reports. 

The patients thus have to incur 

diagnostic expenditure again in the 

hospital in order to proceed with 

the treatment. Moreover, there is no 

regulatory framework that ensures 

and governs portability of patient 

data, treatment record, diagnostic 

reports between hospitals. This acts as 

a constraint for patients in switching 

from one hospital to another and 

creates a lock-in effect. This problem 

is compounded by the fact that 

traditionally the medical data of a 

patient is paper-based and it is next to 

impossible for the patient to get access 

to their data if she intends to switch 

services of a doctor/hospital, according 

to a recent policy note by CCI. 

the market. Inconsistent application of 

regulations may lead to irrational entry 

restriction and/or distortion of the level 

playing field. Thus, it is important that 

regulations strike the right balance 

between preventing sub-standard 

drugs from being manufactured or sold 

in the markets while making sure entry 

is not unnecessarily deterred or made 

difficult. 

In India, there are multiple 

regulators governing the 


Doctor-hospital nexus 

The consumers’ choice of a hospital is often guided 

by a doctor’s reference and is not based on any 

objective criteria, says a policy note released by 

Competition Commission of India, recently. 

Even if one were to make an objective 

assessment of a hospital in terms of mortality 

rate, infection rate, cost of each procedure, etc., 

that would not have been possible owing to nonavailability 

of any such data. While there is no 

denying that doctors are best-positioned to select 

a hospital for a particular secondary or tertiary 

healthcare need on behalf of the patient, the 

referrals in certain instances may be driven solely 

by incentives that are offered to the doctor for such 

referrals. Thus, the choice of hospital, even based 

on a doctor’s advice, may not necessarily be an 

informed choice, it points out. 

pharmaceutical sector at the centre 

and state level. As a result of which 

implementation of regulations is not 

uniform across the country. This has 

resulted in multiple standards of same 

products and also different levels of 

regulatory compliance requirements. 

There are no statutory timelines 

prescribed for processing of new 

drug applications. Further, the dual 

requirement of treating each 

biological medicine from a nonoriginator 

source as a new drug, with 

the additional requirement of proving 

bio similarity, takes so much time 

and investment that a handful of 

companies compete thereby softening 

competition. 

Harmonisation of processes 

through effective center-state 

coordination and time-bound approval 

for new drugs are recommended to 

address this issue There is a need 

to ensure harmonisation of criteria/ 

processes followed by the state 

licensing authorities and centralisation 

of training of inspectors to ensure 

THE INNOVATOR 

COMPANIES ARE FILING FOR 

INJUNCTION WITH THE AIM 

TO PRE-EMPT COMPETITION 

AND DELAY EXPORTS OF 

GENERICS 

uniformity in interpretation and 

implementation. It is also imperative to 

make the approval of new drug timebound 

along with detailed guidelines 

governing each stage of new drug 

approval process. 

CCI to enforce anti-trust rules 

CCI will continue to enforce antitrust 

rules in the pharmaceutical and 

healthcare sector via its instruments of 

enforcement and advocacy, the note 

says. The focus areas for enforcement 

will inter alia include activities of trade 

associations in the pharmaceutical 

distribution chain and the practices in 

delaying or hampering the introduction 

of generic medicines upon patent 

expiry. 

Trade associations control 

supply chain 

The cases before the commission 

have shown that the entire supply 

chain of drugs is self-regulated by 

the trade associations who regulate 

entry by mandating a NOC prior to 

the appointment of stockists, control 

distribution by restricting/controlling 

the number of stockists and influence 

price by deciding the wholesale and 

retail margins of drugs. The innovator 

companies are filing for injunction 

with the aim to pre-empt competition 

and delay exports of generics. They 

have succeeded in some cases in 

getting injunctions from the Courts. 

The stakeholders are of the view that 

the CCI should take up the issues of 

frivolous litigation not only through 

enforcement but also for discussion 

with the judiciary and other relevant 

forums, the commission says. 


clinical practice 

ALLOPATHS PROTEST 

‘MYXOPATHY’ 

Medical bodies oppose states allowing bridge course to AYUSH practitioners 

Even as the union cabinet struck 

down the bridge course proposed 

in the National Medical Commission 

Bill for AYUSH doctors, it left it to the 

state governments to take necessary 

measures for addressing and promoting 

primary health care in rural areas. 

AYUSH stands for Ayurveda, Yoga, 

and Naturopathy, Unani, Siddha and 

Homoeopathy -- the traditional forms 

of medicine practised in India. The 

bridge course was proposed to enable 

AYUSH doctors to practice and prescribe 

allopathic medicine. The union cabinet 

removed the provision from the bill after 

a Parliamentary Standing Committee 

recommended against making it a 

mandatory part of the same. 

The parliamentary standing 

committee was set up following 

objections raised by Indian Medical 

Association, the largest body of 

allopathy practitioners in India. IMA had 

staged nationwide protests and alleged 

that the move would promote quackery. 

“IMA is against myxopathy and there 

is no scope for any mixing. By allowing 

ayurveda doctors to practice modern 

medicine, you are giving a message that 

they cannot treat common illness with 

ayurveda,” said Dr. K.K. Agarwal, former 

national president of IMA. 

Even though the union 

government removed the provision 

of bridge course from the bill, the 

Maharashtra government stated that 

it would continue with a bridge course 

started for homeopathy doctors to 

enable them to practice allopathy. 

Maharashtra government started a 

one-year certificate course of Modern 

Pharmacology in 2016 to train 

homeopathy doctors in certain areas 

EVEN THOUGH THE UNION 

GOVERNMENT REMOVED 

THE PROVISION OF BRIDGE 

COURSE FROM THE NMC 

BILL, MAHARASHTRA SAID 

IT WOULD CONTINUE WITH 

A COURSE STARTED 

FOR HOMEOPATHY 

of allopathy excluding major surgeries, 

citing an acute shortage of doctors in 

rural areas. Gujarat government also 

recently invited applications for a sixmonth-long 

bridge course for ayurveda 

doctors to enable them to practice 

allopathy. Though IMA’s Gujarat unit 

approached the Gujarat High Court, it 

referred the matter back to the state 

health department. 

But the All India Homoeopathy 

Doctors Federation is very vocal in their 

demand for bridge courses and has 

staged protests against the decision 

to remove the bridge course. The 

Homoeopathic Medical Association 

of India, which had earlier protested 

against the provision of bridge course 

in the bill, subsequently changed its 

stand. “Now, the central government 

has removed the provision of a bridge 

course from the bill and given state 

governments the power to decide 

on the same. The requirement of one 

state is different from another. If the 

homeopathy practitioners are interested 

to work with state governments after 

undergoing the bridge course, we are 

not against it,” said D. Bhaskar Bhatt, 

President, The Homoeopathic Medical 

Association of India. He added that it will 

not have any impact on homoeopathy 

practice in the country. 

In another development, a 

parliamentary standing committee has 

recommended changes in the curricula of 

modern systems of medicine as well as 

AYUSH systems in an effort to integrate 

medical education. The committee 

observed that an integrated approach 

would help in understanding the 

strengths of each system of medicine. 

Meanwhile, in a major relief to the 

practitioners of Integrated Systems 

of Medicine (ISM), the Supreme Court 

recently ordered that no coercive 

action shall be taken against persons 

who are practising Integrated Systems 

of Medicine pursuant to degrees or 

diplomas obtained from universities 

that are recognized for teaching the 

same, till a decision is reached by the 

court. The apex court’s interim order 

came in a petition filed by All India 

Indian Medicines Graduate Association 

challenging the order of the Delhi High 

Court that the ISM practitioners cannot 

prescribe allopathic medicines. In their 

plaint, the petitioners stated that ISM 

practitioners undergo training in both 

modern medicine and ISM as part of 

their training. 


technology 

NANO DETECTION OF CANCER 

Indian researchers develop carbon nanodots for cancer diagnostics 

Researchers from the Indian 

Institute of Technology Roorkee, 

Delhi have developed fluorescent 

carbon nanodots that can aid in the 

diagnosis and treatment of cancer. 

The team of researchers led by Dr P 

Gopinath extracted the nanosized (10 -9 

metre) carbon materials from the leaves 

of the rosy periwinkle plant for the study. 

Their work, supported by the Science 

and Engineering Research Board (SERB) 

and Department of Biotechnology 

(DBT), Government of India, has recently 

been published in Colloids and Surfaces 

B: Biointerfaces. 

The identification of cancer cells and 

their inhibition/destruction processes 

have been continuing a challenge for 

researchers working in the field of 

oncology and cancer drug research for 

many decades. 

Fluorescent signalling 

In the past few years, nanotechnology 

has emerged as one of the most 

promising areas in cancer diagnostics 

and treatment and nanomaterials – 

materials having dimensions in the 

nanometre (10 -9 m) range – are being 

increasingly studied as agents in 

molecular tumour imaging, molecular 

diagnosis and targeted therapy. 

Of the many types of nanomaterials 

studied, carbon nanodots show 

considerable potential. “carbon 

nanodot” refers to fluorescent carbonbased 

nanomaterials. Carbon dots, 

also called carbon quantum dots, 

are fluorescent materials that are 

well-suited as both therapeutic and 

diagnostic agents for cancer because 

of two unique characteristics: they 

are biocompatible and can be rapidly 

excreted from the body Nanodot 

particles also have low toxicity and 

they produce a reliable optical signal. 

In addition, they can be chemically 

RESEARCHERS 

SYNTHESISED CARBON 

NANODOTS BY HEATING THE 

LEAVES OF CATHARANTHUS 

ROSEUS, COMMONLY 

CALLED ROSY PERIWINKLE 

modified for use as multimodel probes 

and therapeutic conjugates. 

The researchers synthesised carbon 

nanodots by heating the leaves of 

Catharanthus roseus, commonly called 

rosy periwinkle and Vinca rosea, in a 

process called hydrothermal reaction. 

The nanodots were found to exhibit 

strong fluorescence, which makes them 

suited for diagnostic functions, while 

also mediating anti-cancer activity, as 

was seen from in vitro studies. 

When embryonic fibroblast cells 

of the mouse were incubated in 

the presence of carbon nanodot 

suspensions for a few hours, the cells 

exhibited fluorescence, which showed 

that the carbon dots had entered the 

cells. The team also found that nanodots 

inhibited microtubule formation in the 

cell nuclei. 

Microtubule inhibition 

In addition, microtubule inhibition 

destabilises the cytoskeletal framework 

of the cells and causes cytoplasmic 

constriction, all of which leads to the 

death of the cell itself. Earlier research 

has shown that the alkaloids in Vinca 

rosea inhibit microtubule formation and 

it is interesting that the carbon nanodots 

derived from Vinca rosea retain the 

inhibition effect, in addition to providing 

a handle for fluorescent labelling of the 

cancer cells. 

“Such events of real-time imageguided 

anticancer therapy by a single 

system open a new paradigm in the 

field of anticancer therapy”, said Dr. 

Gopinath, commenting on the benefits 

of these theranostic tools in a press 

release. 

Dr. Gopinath and his team are 

planning next stage animal studies for 

further evaluation of these nanomaterials 

in oncological applications, for both 

diagnostics and treatment. 


public health 

MALARIA CONTROL BACK ON TRACK 

India represents 4% of the global malaria burden 

Reductions in malaria cases have 

stalled after several years of 

decline globally, according to 

the new World malaria report 2018. 

To get the reduction in malaria deaths 

and disease back on track, WHO and 

partners are joining a new country-led 

response, to scale up prevention and 

treatment, and increased investment, 

to protect vulnerable people from the 

deadly disease. 

For the second consecutive year, 

the annual report produced by WHO 

reveals a plateauing in numbers of 

people affected by malaria: in 2017, 

there were an estimated 219 million 

cases of malaria, compared to 217 

million the year before. But in the years 

prior, the number of people contracting 

malaria globally had been steadily 

falling, from 239 million in 2010 to 214 

million in 2015. 

Malaria hot zones 

In 2017, approximately 70% of all 

malaria cases (151 million) and deaths 

(274 000) were concentrated in 11 

countries: 10 in Africa (Burkina Faso, 

Cameroon, Democratic Republic of the 

Congo, Ghana, Mali, Mozambique, Niger, 

Nigeria, Uganda and United Republic 

of Tanzania) and India. There were 3.5 

million more malaria cases reported 

in these 10 African countries in 2017 

compared to the previous year, while 

India, however, showed progress in 

reducing its disease burden. 

Despite marginal increases in 

recent years in the distribution and 

use of insecticide-treated bed nets in 

sub-Saharan Africa – the primary tool 

for preventing malaria – the report 

highlights major coverage gaps. In 

2017, an estimated half of at-risk 

people in Africa did not sleep under 

a treated net. Also, fewer homes are 

being protected by indoor residual 

spraying than before, and access 

to preventive therapies that protect 

pregnant women and children from 

malaria remains too low. 

Need for high impact response 

WHO has launched the new countrydriven 

“High burden to high impact” 

response plan to support nations with 

most malaria cases and deaths. It is 

based on four pillars: 

1) Galvanizing national and global 

political attention to reduce malaria 

deaths 

2) Driving impact through the 

strategic use of information 

3) Establishing best global guidance, 

policies and strategies suitable for all 

malaria-endemic countries and 

4) Implementing a coordinated 

country response. 

Catalyzed by WHO and the RBM 

Partnership to End Malaria, “High 

burden to high impact” builds on the 

principle that no one should die from 

a disease that can be easily prevented 

and diagnosed, and that is entirely 

curable with available treatments. 

India – a country that represents 

4% of the global malaria burden – 

recorded a 24% reduction in cases in 

2017 compared to 2016. 



guidelines 

NON-CLINICAL 

INTERVENTIONS 

TO REDUCE 

CAESARIAN 

SECTIONS 

WHO has released evidence-based 

recommendations to bring down unwanted CS rates 

As with any surgery, caesarean 

section is associated with 

short- and long-term risks. 

These can extend many years beyond 

the current delivery and affect the 

health of the woman, the child and 

future pregnancies. Caesarean section 

increases the likelihood of requiring a 

blood transfusion, the risks of anesthesia 

complications, organ injury, infection, 

thromboembolic disease and neonatal 

respiratory distress, among other shortterm 

complications. 

Cesarean section has been 

associated in the long term with an 

increased risk of asthma and obesity 

in children, and complications in 

subsequent pregnancies, such as uterine 

rupture, placenta accreta, placenta 

praevia, ectopic pregnancy, infertility, 

hysterectomy and intraabdominal 

adhesions, with the risk of these 

morbidities. 

According to the latest data from 

150 countries, currently, 18.6% of all 

births occur by caesarean section, 

ranging from 1.4% to 56.4% (11). Latin 

America and the Caribbean currently 

have the highest caesarean section 

CAESAREAN SECTION 

According to the latest data 

from 150 countries, currently, 

18.6% of all births occur by 

caesarean section, ranging 

from 1.4% to 56.4% (11). 

North 

America 

32.3% 

Latin 

America 

40.5% 

Africa 

7.2% 

Europe 

25% 


ates (40.5%), followed by North 

America (32.3%), Oceania (31.1%), 

Europe (25%), Asia (19.2%) and Africa 

(7.3%). 

Trend analysis based on data from 

121 countries shows that between 

1990 and 2014, the global average 

caesarean section rate almost tripled 

(from 6.7% to 19.1%) with an average 

THE GLOBAL AVERAGE 

CAESAREAN SECTION RATE 

ALMOST TRIPLED FROM 

6.7% TO 19.1% WITH AN 

AVERAGE ANNUAL 

RATE OF 4.4% INCREASE 

annual rate of increase (AARI) of 4.4%. 

The largest absolute increases occurred 

in Latin America and the Caribbean (by 

19.4 percentage points, from 22.8% 

to 42.2%), followed by Asia (by 15.1 

points, from 4.4% to 19.5%), Oceania 

(by 14.1 points, from 18.5% to 32.6%), 

Europe (by 13.8 points, from 11.2% to 

Asia 

19.2% 

Oceania 

31.1% 


25%),North America (by 10 points, from 

22.3% to 32.3%) and Africa (by 4.5 

points, from 2.9% to 7.4%). 

This steady and unprecedented 

rise in the use of caesarean section in 

the last decades has resulted in global 

concern, debate and a call for action 

from the scientific, public health and 

medical communities, particularly in view 

of the 2015 World Health Organization 

(WHO) statement on caesarean section 

rates. 

WHO statements on caesarean 

section rates 

For nearly 30 years, the international 

health-care community has considered 

the ideal rate for caesarean section 

to be between 10% and 15%. This 

has been based on the following 

statement by a panel of reproductive 

health experts at a meeting organized 

by the World Health Organization in 

1985, in Fortaleza, Brazil: “[T]here is no 

justification for any region to have a 

rate higher than 10–15%”. The panel’s 

conclusion was drawn from a review 

of the limited data available at the 

time, mainly from northern European 

countries that demonstrated good 

maternal and perinatal outcomes with 

this rate of caesarean section. 

Why this guideline 

The rise in caesarean section rates is 

a universal problem. It affects low-, 

middle- and high-income countries, 

although the consequences of 

unnecessary caesarean sections may be 

different across settings and countries, 

THE INTERNATIONAL 

HEALTH-CARE COMMUNITY 

HAS CONSIDERED THE IDEAL 

RATE FOR C-SECTION TO BE 

BETWEEN 10% AND 15% 

depending on the human or financial 

resources available, and the capacity to 

perform caesarean section safely and to 

manage associated complications. 

The causes of the increase are 

multiple. Changes in the characteristics 

of the population such as the increase 

in the prevalence of obesity, or the 

increases in the proportion of nulliparous 

woman, older women or in multiple 

births, have been cited to contribute to 

the rise. 

These factors are unlikely, however, 

to explain the large increases observed 

and the wide variations between 

countries. Other factors such as 

differences in style of professional 

practice, increasing fear of medical 

litigation, and organizational, economic, 

social and cultural factors have all been 

implicated in this trend. 

Concerned with the potential 

medical and epigenetic consequences 

of this situation, clinicians, hospital 

administrators, policy-makers and 

governments are in need of evidencebased 

guidance to address the 

increasing use of caesarean section 

without medical indication. Unlike 

for clinical interventions, there are 

no previous WHO guidelines on 

non-clinical interventions to reduce 

caesarean births. The objective of 

this guideline is to provide evidencebased 

recommendations on nonclinical 

interventions specifically designed to 

reduce caesarean section rates. 

Maternal and perinatal morbidity 

Caesarean section is a surgical 

procedure that can effectively prevent 

SUMMARY LIST OF RECOMMENDATIONS ON NON-CLINICAL INTERVENTIONS TO REDUCE UNNECESSARY C - SECTIONS 

A. INTERVENTIONS 

TARGETED AT WOMEN 

Recommendation 1: Health 

education for women is 

an essential component of 

antenatal care. The following 

educational interventions 

and support programmes 

are recommended to reduce 

caesarean births only with 

targeted monitoring and 

evaluation. 

(Context-specific 

recommendation, Lowcertainty 

evidence) 

Childbirth training 

workshops (content includes 

sessions about childbirth fear 

and pain, pharmacological 

pain-relief techniques 

and their effects, nonpharmacological 

pain-relief 

methods, advantages and 

disadvantages of caesarean 

sections and vaginal 

delivery, indications and 

contraindications of caesarean 

sections, among others). 

Nurse-led applied relaxation 

training programme (content 

includes group discussion of 

anxiety and stress-related 

issues in pregnancy and 

purpose of applied relaxation, 

deep breathing techniques, 

among other relaxation 

techniques). 

Psychosocial couple-based 

prevention programme 

(content includes emotional 

self-management, conflict 

management, problem 

solving, communication and 

mutual support strategies that 

foster positive joint parenting 

of an infant). “Couple” in this 

recommendation includes 

couples, people in a primary 

relationship or other close 

people. 

Psychoeducation (for women 

with fear of pain; comprising 

information about fear and 

anxiety, fear of childbirth, 

normalization of individual 

reactions, stages of labour, 

hospital routines, birth 

process, and pain relief [led 

by a therapist and midwife], 

among other topics). 


maternal and newborn mortality 

when used for medically indicated 

reasons. Caesarean section rates have 

increased steadily worldwide over the 

last decades. This trend has not been 

accompanied by significant maternal 

or perinatal benefits. On the contrary, 

there is evidence that, beyond a certain 

threshold, increasing caesarean section 

rates may be associated with increased 

maternal and perinatal morbidity. 

Caesarean birth is associated 

with short- and long-term risks that 

can extend many years beyond the 

current delivery and affect the health 

of the woman, the child and future 

pregnancies. High rates of caesarean 

section are associated with substantial 

health-care costs. 

The factors contributing to the rise 

in caesarean section rates are complex, 

and identifying interventions to address 

them is challenging. Factors associated 

with caesarean births include changes 

in the characteristics of the population 

such as an increase in the prevalence of 

obesity and of multiple pregnancies and 

increase in the proportion of nulliparous 

women or of older women. 

These changes are unlikely, however, 

to explain the large increases and wide 

When considering the 

educational interventions 

and support programmes, no 

specific format (e.g. pamphlet, 

videos,role play education) 

is recommended as more 

effective. 

(Low- to moderate-certainty 

evidence) 

B. INTERVENTIONS 

TARGETED AT 

HEALTHCARE 

PROFESSIONALS 

Recommendation 1: 

Implementation of evidencebased 


guidelines combined with 

structured, mandatory second 

opinion for caesarean section 

indication is recommended 

to reduce caesarean births 

in settings with adequate 

resources and senior clinicians 

able to provide mandatory 

second opinion for caesarean 

section indication. 


recommendation, Highcertainty 

evidence) 

Recommendation 2: 

Implementation of evidencebased 


guidelines, caesarean section 

audits and timely feedback 

to health-care professionals 

are recommended to reduce 

caesarean births. 

(Recommended, Highcertainty 

evidence) 

C. INTERVENTIONS 

TARGETED AT HEALTH 

ORGANISATIONS, 

FACILITIES OR 

SYSTEMS 

Recommendation 1: For the 

sole purpose of reducing 

caesarean section rates, 

collaborative midwiferyobstetrician 

model of care 

(i.e. a model of staffing based 

on care provided primarily 

by midwives, with 24-hour 

back-up from an obstetrician 

who provides in-house labour 

and delivery coverage without 

other competing clinical 

duties) is recommended only 

in the context of rigorous 

research. This model of 

care primarily addresses 

intrapartum caesarean 

sections. 


recommendation, Lowcertainty 

evidence) 

Recommendation 2: For the 

sole purpose of reducing 

unnecessary caesarean 

sections, financial strategies (i.e 

insurance reforms equalizing 

physician fees for vaginal 

births and caesarean sections) 

for health-care professionals 

or health-care organizations 

are recommended only in the 

context of rigorous research. 


recommendation, Very lowcertainty 

evidence) 


variations in caesarean section rates 

across countries. Other non-clinical 

factors such as women increasingly 

wanting to determine how and when 

their child is born, generational shifts 

in work and family responsibilities, 

physician factors, increasing fear 

of medical litigation, as well as 

organizational, economic and social 

factors have all been implicated in this 

increase. 

The sustained, unprecedented rise in 

caesarean section rates is a major public 

health concern. There is an urgent need 

for evidence-based guidance to address 

the trend. 

Clinical interventions that could 

help to reduce caesarean section rates 

have been addressed in previously 

published WHO guidelines. Until now, 

there have been no global guidelines 

on non-clinical interventions (defined as 

interventions applied independently of 

a clinical encounter between a healthcare 

provider and a patient in the 

context of patient care). The objective 

of this guideline is to provide evidencebased 

recommendations on non-clinical 

interventions specifically designed to 

reduce caesarean section rates. 

Target audience 

The primary audience for this guideline 

includes healthcare professionals 

responsible for developing regional, 

national and local health protocols 

and policies, as well as obstetricians, 

midwives, nurses, general medical 

practitioners, managers of maternal and 

child health programmes and public 

health policy-makers in all settings and 

countries. 

This guideline was developed in 

accordance with standard procedures 

set out in the WHO handbook for 

guideline development. 

Evidence on the effectiveness of 

interventions was derived from an 

updated Cochrane review of 29 studies. 

Judgements about values, 

acceptability, equity, resource 

implications and feasibility of 

interventions were informed by three 

systematic reviews of 49 qualitative 

studies. The certainty of evidence on 

safety and effectiveness outcomes 

was assessed using Grading of 

Recommendations Assessment, 

Development, and Evaluation (GRADE). 

Confidence in the qualitative findings 

was assessed using Confidence in the 

Evidence from Reviews of Qualitative 

research (CERQual). The framework 

for Developing and Evaluating 

Communication strategies to support 

Informed Decisions and practice based 

on Evidence (DECIDE) was used to 

integrate and present research evidence 

and relevant considerations to the 

Guideline Development Group (GDG). 

—Source: WHO 

The GDG convened 

in September 2017 in 

Geneva, Switzerland, to 

review the summarised 

evidence and formulate 

recommendations. The 

members of the GDG 

made three types of 

recommendation: 

1 

2 

3 

Recommended 

The benefits of implementing this option 

outweigh the possible harms. This option can 

be implementedv, including at a large scale. 

Context-specific recommendation 

Recommended only in the context of 

rigorous research: This option indicates 

that there are important uncertainties 

about an intervention. In such instances, 

the implementation can still be undertaken 

at a large scale, but only as research that is 

able to address unanswered questions and 

uncertainties related both to the effectiveness 

of an intervention and its acceptability and 

feasibility. 

Recommended only with targeted 

monitoring and evaluation: This option 

indicates uncertainty about the effectiveness 

or acceptability of an intervention, especially 

regarding particular contexts or conditions. 

Interventions classified as such can be 

considered for implementation (including at 

large scale), provided they are accompanied 

by targeted monitoring and evaluation. 

Not recommended 

This option should not be implemented. 

RECOMMENDATIONS 

This guideline targets settings with high rates 

of caesarean birth, where large numbers 

of caesarean sections are assumed to be 

unnecessary. The proportion of unnecessary 

caesarean sections was not reported in the 

included studies, however. It is therefore 

unclear whether the observed changes 

in caesarean section rates had been 

accounted for exclusively by those considered 

unnecessary. 

Given this uncertainty, caution should 

be exercised when interpreting the 

recommendations in this guideline. 

The GDG made five recommendations on 

nonclinical interventions to reduce caesarean 

births. The recommendations are grouped 

according to the target of intervention: 

(a) interventions targeted at women, 

(b) interventions targeted at health-care 

professionals and (c) interventions targeted at 

health organizations, facilities or systems. 

The recommendations are intended to inform 

the development of national and subnational 

policies and protocols to reduce caesarean 

births. They should be implemented alongside 

other proven interventions to improve the 

quality of care for mothers and newborns 

during childbirth. 


devices&gadgets 

Shoulder 

arthroplasty 

system approved 

S 

houlder Innovations 

received US FDA approval 

for InSet Humeral Short Stem 

System. 

The clearance covers 

products meant for partial or 

total shoulder arthroplasty 

used in the treatment of 

degenerative, rheumatoid 

or traumatic arthritis in the 

shoulder. 

The new InSet shoulder 

system provides innovative 

features and solutions to 

address potential problems 

encountered with current 

total shoulder replacement 

systems. 

Leveraging its 

breakthrough InSet glenoid 

design, Shoulder Innovations 

is commercialising a shoulder 

replacement implant system 

focused on improving 

outcomes related to glenoid 

loosening. This forms the 

leading cause of shoulder 

replacement failure. 

The InSet technology 

has been shown in testing 

to significantly reduce 

glenoid implant micromotion 

and simplifies the 

surgical technique, potentially 

reducing complications or 

increase implant longevity, 

according to a company 

release. 

Device to treat urinary 

incontinence gets nod 

Atlantic Therapeutics said the US FDA 

granted a DeNovo clearance for its 

Innovo therapy device, an externally 

worn electrical muscle stimulator for the 

treatment of stress urinary incontinence in 

adult females. 

FDA cleared the transcutaneous 

electrical stimulation continence device 

following the results of two randomized 

controlled trials demonstrating it to be 

an effective and low-risk device for the 

treatment for stress urinary incontinence in 

adult females. 

The data from its pivotal US trial 

showed 87.2% of patients were dry or 

mild after a 12-week treatment period, 

with 93% of patients experiencing 

improvement in just 4 weeks. 

This follows the presentation of data 

from an earlier placebo-controlled trial 

conducted in Europe that demonstrated 

significant improvement across all study 

endpoints. 

Innovo’s Multipath technology 

uses electrical muscle stimulation to 

deliver 180 perfect and complete pelvic 

floor contractions to the entire network of 

pelvic floor muscles in every 

30-minute session. It is designed 

to optimally 

strengthen the 

pelvic floor and 

re-educate the 

muscles that 

control bladder 

function. 

EAP for AI tech 

to detect 

haemorrhage 

software medical 

A device for intracranial 

haemorrhage detection has 

been granted the Expedited 

Access Pathway (EAP) 

designation by the USFDA. 

The device, based on 

deep learning technologies, 

automatically analyses 

noncontrast head CT images. 

It is designed to be highly 

sensitive to the presence of 

intracranial haemorrhage 

(ICH) in these scans and to 

alert the treating physician 


Health, Labor and Welfare 

(MHLW) in Japan, the 

company announced. 

The UroLift permanent 

implants, delivered during 

a minimally invasive 

transurethral outpatient 

procedure, relieve prostate 

obstruction and open the 

urethra directly without 

cutting, heating, or removing 

prostate tissue. 

Clinical data from a pivotal 

206-patient randomized 

controlled study showed 

that patients with enlarged 

prostate receiving UroLift 

implants reported rapid and 

durable symptomatic and 

urinary flow rate improvement 

without compromising sexual 

function. 

NeoTract plans to focus on 

establishing reimbursement 

over the next 12-18 months, 

followed by a launch of 

when ICH is detected. 

Noncontrast head CT 

is the standard for initial 

assessment of potential ICH in 

emergency medicine settings. 

MedyMatch has developed 

a broad machine vision and 

deep learning platform to 

support the assessment of 

multiple clinical indications. 

The EAP programme is 

designed to facilitate rapid 

patient access to medical 

devices that demonstrate 

the potential to address 

unmet medical needs for 

life-threatening or irreversibly 

debilitating diseases or 

conditions. 

Based in Tel Aviv, Israel, 

MedyMatch is a medical AI 

company delivering a clinical 

decision support platform to 

improve patient outcomes in 

acute medical scenarios. 

Japanese nod 

for UroLift to 

treat BPH 

UroLift System for the 

treatment of benign 

prostatic hyperplasia (BPH) 

has been granted approval for 

marketing in Japan. 

NeoTract, a wholly 

owned subsidiary of Teleflex 

Incorporated focused on 

urology, has received Shonin 

approval from the Ministry of 

US FDA okays HIV combo 

reagent pack 

Ortho Clinical 

Diagnostics announced 

that the Vitros HIV Combo 

test received approval from 

the US FDA for use on the 

company’s Vitros 5600 

Integrated System. 

Vitros HIV Combo, a 

fourth-generation test, 

detects both HIV-1 and 

HIV-2 antibodies and the 

p24 antigen, enabling 

detection of acute HIV-1 

infection earlier than 

third-generation tests, the 

company said. 

The clinical and 

technical performance 

of the Vitros HIV Combo 

test was evaluated at 

three external testing 

laboratories in the US and 

at Ortho's research and 

development laboratories. 

This assessment confirmed 

that the test provides 

competitive sensitivity and 

specificity when compared 

to a leading commercially 

available fourth-generation 

test. 

In the comparison 

studies, assay sensitivity 

was evaluated on 

seroconversion panels. 

The Vitros test showed 

earlier detection of acute 

HIV infection in six of 32 

seroconversion panels 

when compared to a 

leading commercially 

available fourth-generation 

Ag/Ab test, indicating that 

the assay performance 

is very competitive in 

shortening the diagnostic 

window - a valuable 

attribute in HIV testing. 

The test's p24 

sensitivity with 

specificity is enhanced 

by a combination of 

technologies available on 

Vitros Systems, according 

to Ortho. 

the UroLift System in select 

academic medical centres 

to build strong initial clinical 

experiences, before a full 

commercial launch. 

Devices to detect 

parathyroid 

tissue 

The US FDA has granted 

marketing approval for two 

devices that provide real-time 

location of parathyroid tissue 

during surgical procedures 

such as thyroidectomy and 

parathyroidectomy. 

The Fluobeam 800 Clinic 

Imaging Device is used to 

assist in the imaging of 

parathyroid glands and can be 

used as a companion method 

to assist surgeons in locating 

parathyroid tissue visually 

during surgery. Parathyroid 

tissue emits a fluorescent 

glow when exposed to the 

device’s light source, avoiding 

the need for a contrast agent. 

The device was previously 

cleared as an imaging system 

used to capture and view 

fluorescent images for the 

visual assessment of blood 

flow as an adjunctive method 

for the evaluation of tissue 

perfusion. 

The Parathyroid Detection 

PTeye System aids in 

detecting parathyroid tissue 

during surgery by using a 

probe that emits fluorescence 

light. Tissue detection is based 

on how the parathyroid tissue 

reacts to the fluorescent light. 

When parathyroid tissue 


Voyant for spine surgery gets US FDA approval 

Viseon Inc said it received clearance 

from the USFDA for Voyant 

System for minimally invasive spine 

surgery, featuring HD imaging sensor 

and illumination technology. 

The Voyant System is composed 

of a sterile single-use, disposable 

retractor device with integrated stateof-the-art 

visualisation technology, 

and a reusable controller enabling 

digital intraoperative manipulation of 

the surgical site image displayed on 

existing operating room HD flat-panel 

display monitors. The sterile device 

also allows the surgeon to adjust the 

intraoperative depth of focus. 

This system offers an alternative 

to the surgical microscope and 

surgical loupes visualisation for many 

minimally invasive spine surgery 

procedures, eliminating ergonomic 

consequences and multiple scope 

repositioning maneuvers and 

refocusing, according to Viseon. 

Viseon has demonstrated 

clinical utility in posterior lumbar 

decompression and interbody fusion 

procedures and is expanding into 

lumbar lateral access and anterior 

cervical decompression fusion 

applications. 

is detected, the system 

provides an audio and 

visual display to indicate 

its presence. 

For the Fluobeam 800, 

the FDA reviewed data 

from five peer-reviewed 

published studies, 

including one study 

that compared the rate of 

postoperative hypocalcemia 

(PH), or a temporary 

reduction in calcium in the 

blood, that occurs when 

healthy parathyroid 

tissue is inadvertently 

removed. 

The FDA reviewed data 

from a single-blinded study 

of 81 patients who had 

surgery using the device for 

the PTeye System. Results 

demonstrated that the PTeye 

could correctly identify the 

presence of parathyroid tissue 

as compared to histology 

93 percent of the time and 

correctly identify the 

absence of parathyroid 

tissue as compared 

to intraoperative 

visualization by an 

expert 97 percent 

of the time, 

with an overall 

accuracy of 96 

percent. 

DNA-based test 

for blood 

compatibility 

The US FDA approved ID 

CORE XT, a molecularbased 

assay used in blood 

transfusion medicine to help 

determine blood compatibility. 

The assay can be used to 

determine blood donor and 

patient non-ABO red blood 

cell (RBC) types. ID CORE 

XT is the second molecular 

assay approved for use in 

transfusion medicine, and 

the first to report genotypes 

as final results, according 

Progenika Biopharma S.A. a 

Grifols company. 

Traditionally, red blood 

cell antigens have been 

identified using serological 

methods that involve the use 

of antisera, a blood serum 

that contains antibodies for 

testing. Serologic testing 

presents limitations and 

certain antisera may be scarce 

or unavailable. 

A study was conducted 

to compare the typing results 

of the ID CORE XT Test with 

licensed serological reagents, 

the first FDA-approved 

molecular assay, and DNA 

sequencing tests. The results 

demonstrated comparable 

performance between the 

methods. 


RaySearch 

releases onco 

info system 

RaySearch Laboratories 

AB has released RayCare 

2B, the latest version of the 

oncology information system 

(OIS). RayCare is designed 

to support the workflow in 

a modern oncology centre, 

connecting the different 

oncology disciplines, boosting 

efficiency and ensuring 

optimal use of resources. 

The first clinical version 

of RayCare was released in 

December 2017. 

RayCare 2B introduces 

new features and usability 

improvements throughout the 

system, including a feature 

to support a full treatment 

delivery and manage 

workflow and task-based 

offline image review. Other 

care administration features 

include support for financial 

information, such as insurance 

information and authorisation 

management, and support for 

managing external contacts, 

referring clinicians and other 

external entities. 

RayCare will integrate the 

high-performance radiation 

therapy algorithms available 

in RayStation with advanced 

features for clinical resource 

optimisation, workflow 

automation, and adaptive 

radiation therapy. 

RayStation integrates 

all RaySearch’s advanced 

treatment planning solutions 

into a flexible treatment 

planning system. It combines 

features such as multi-criteria 

optimization tools with full 

support for 4D adaptive 

radiation therapy. 

Roche launches 

blood test for 

genomic profiling 

Roche announced the 

global availability of 

FoundationOne Liquid, a liquid 

biopsy test. FoundationOne 

Liquid can identify circulating 

Abbott's Troponin-I blood test gets CE mark 

Abbott said its Troponin-I 

blood test received CE 

mark. The troponin test can 

more accurately predict the 

chances of having a heart 

attack or other cardiac event 

potentially months to years 

in advance in people who 

otherwise appear healthy, 

according to the company. 

Troponin-I proteins are 

released from the heart and 

can be found at elevated 

levels in the blood when 

the heart muscle has been 

damaged due to lack of 

blood flow. 

Abbott’s Architect Stat 

High Sensitive Troponin-I 

blood test has been used 

in emergency rooms across 

Europe over the past five 

years to help physicians 

detect heart attacks faster 

and more accurately, 

particularly among women 

who often have lower 

troponin levels. 

Because of its high 

tumour DNA in the blood of 

people living with cancer and 

can identify 70 of the most 

commonly mutated genes 

in solid tumours, including 

microsatellite instability, a 

genomic signature which 

may help inform cancer 

immunotherapy based 

treatment decisions. 

FoundationOne Liquid 

helps comprehensive genomic 

profiling for people who have 

an insufficient or inadequate 

tissue, including those with 

1 2 3 

Single blood draw 

of two tubes of 

blood 

FoundationOne Liquid 

detects the four main 

classes of genomic 

alterations and reports 

MSI High 

A clear, in‐depth 

report supports 

your clinical 

decision making 

sensitivity, the Troponin-I 

test can detect very low 

levels of troponin.The 

test now can be used to 

determine cardiac risk in 

people with no reported 

symptoms of heart disease. 

Using this diagnostic test 

during the same blood draw 

of a routine health exam, 

doctors will be able to look 

at what’s actually happening 

to the heart and better 

determine their patients’ 

risk of developing heart 

diseases, such as a heart 

attack or other cardiac 

event, in the future. 

In addition to 

determining a 

patient’s cardiac 

risk, Abbott’s 

Troponin-I test is 

designed in such 

a way that biotin 

doesn’t affect test 

results. Biotin 

may interfere with 

some lab tests, including 

advanced non-small cell lung 

cancer, where an estimated 

15 percent of patients are 

not eligible for tissue biopsy 

and approximately 10 percent 

have a biopsy size that is 

insufficient to evaluate. 

The liquid biopsy 

utilises circulating tumour 

DNA (ctDNA) test that 

complements FoundationOne 

CDx, a tissue-based test. 

The blood sample is sent to 

a Foundation Medicine lab 

where the test is performed 

using next-generation 

sequencing to analyse 

the four main classes of 

genomic alterations as well 

as microsatellite instability, an 

indicator that may help inform 

immunotherapy treatment 

decisions using ctDNA isolated 

from plasma derived from 

peripheral whole blood. 

cardiac ones, potentially 

leading to false positive or 

false negative results. 

The Troponin-I test is 

now available to be used on 

Abbott’s Architect system for 

cardiac risk assessment in 

CE marked countries and in 

countries where regulatory 

registration is not required 

for this product. 


ADVERTORIAL 

Philips debuts 

noninvasive ventilator 

with high flow therapy 

Philips V60 plus ventilator is a 

comprehensive solution integrating both 

non-invasive ventilation (NIV) and high 

flow therapy (HFT) in a single device. 

It delivers a wide range of advanced 

minimally-invasive support for the 

patients, facilitating the clinicians in 

weaning the patients off the NIV therapy 

with least complications. 

Royal Philips’ V60 ventilator has 

received its CE certification and is 

commercially launched in Europe. 

The high flow function of V60 plus 

is designed to save time and space 

with its integrated system. It also 

provide a high quality cannula which is 

easily adjustable and lies soft 

against the patient’s skin. V60 also 

claims to provide much quieter system 

compared to their standalone high flow 

system. 

Designed to include paediatric use 

and equipped with several modes, the 

V60 helps deliver to the specific needs of 

the patients. The Auto-trak technology 

used in V60 provides advanced noninvasive 

ventilation with its autoadaptive 

leak compensation, inspiratory 

triggering and expiratory cycling. 

This advanced breath delivery 

technology is designed to maximize 

performance in a leak prone 

environment, adapting to the changing 

ventilation demand of the patients 

by constant bed-side supervision and 

manual adjustments. V60 provides 

multiple hospital modes and options 

including AVAPS, PCV, CPAP with C-Flex, 

PPV and Auto-Trak Plus. 

Features 

Auto-Trak plus uses a customized 

titration of triggering and cycling 

criteria for patients with low compliance 

letting clinicians make finely tuned 

adjustments to achieve patient ventilator 

synchrony. 

CPAP (Continuous Positive Airway 

Pressure) with C-flex offers three levels 

of flow-based expiratory pressure 

relief. This option leads to improved 

sleep quality and patient comfort, 

adding greater flexibility and improved 

treatment acceptance. 

Automatic mask calibration 

offers pre-defined settings that help 

in automatically calibrating flow 

characteristics facilitating for better 

monitoring and therapy by saving time. 

The automatic mask calibration system 

increases speed and ease of treatment 

initiation. 

AVAPS (Average Volume Assured 

Pressure Support) m aintains a target 

tidal volume in a pressure limited mode. 

It provides extra assurance similar to a 

volume limited mode with the safety of a 

pressure limited mode 

Proportional Pressure Ventilation 

(PPV) provides inspiratory flow and 

pressure in proportion to the patient’s 

variable breathing patterns, improving 

patient control over their ventilation, 

enhancing comfort. 

Standby mode supports an 

uninterrupted patient/clinician 

interaction by avoiding any distractions 

Flexible and upgradable. With an 

internal 6-hour battery, V60 allows intrahospital 

transport.The high-resolution 

expansive colour touchscreen makes 

operation easy and facilitates waveform 

interpretation.It also offers a remote 

connection tool Respi-Link* 

that performs efficient system 

diagnostics and easily apply upgrades 

via internet. 

This is a sponsored article. FM editorial holds no responsibility for the information therein. 


PHOTO: RAVI KUMAR 


CENTRE FOR 

SPORTS SCIENCE, 

CHENNAI 

A research hub, CSS focuses on exercise science and 

sports medicine and provides world-class services in 

teaching and training 

India’s ace rower Dattu Baban 

Bhokanal was the best bet for the 

country to qualify for the semifinals 

in the 2016 Rio Olympic Games. His 

beginning in the quarter-finals of the 

men’s single sculls was strong. He kept 

a steady pace, maintaining the second 

position in most part of the race. But 

then gradually slowed down to lose 

his chance of advancing, and finished 

fourth, just behind the last qualifier. 

Again in 2018, Bhokanal had another 

forgettable show in the Asian Games 

when he failed to complete the men’s 

single sculls, though he commenced 

strong. 

This is typically the case with many 

Indian athletes, who are mostly not 

trained to maintain and optimise their 

energy levels with the best control on 

body movements all through the race. 

Naturally. that causes them to lose the 

last milliseconds that separates the 

gold and the silver. On the other hand, 

sportsmen from winning countries 

are used to the concept of sports 

science that makes them fully prepared 

for enhancing the performance 

scientifically. 

As the difference between winning 

and losing is getting slimmer and 

slimmer in today’s competitive sports, 

the role of sports science is becoming 

critical. In this context, what India 

lacked was a clear understanding of 

this concept and, certainly, a competent 

facility to assess the strengths and 

weaknesses of its sportsmen and help 

them perform at their best through 

scientific training. Making things worse 

for Indian athletes, there weren’t even 

good facilities in the country that 

practised sports medicine to train 

them to avoid injuries and recover 

when injured, forcing them to look for 

a few centres abroad that cost them a 

fortune. 

Reversing the trend 

“Though India has been scoring the 

world’s best in many areas, including 

science, software and space, it has 

failed to make a mark in world sports 

so far. This is not because it lacked 

talent, but due to its unscientific 

approach,” says Dr S Arumugam, an 

orthopaedic surgeon and an avid rower, 

who has been trying to reverse the 

trend. 

Dr Arumugam set up the country’s 

first fully integrated centre of sports 

science, research and training, making 

Chennai a hub for world athletes. The 

Centre of Sports Science (CSS) at the Sri 

Ramachandra Medical College (SRMC) 

campus at Porur is currently a regular 

hang-out for several sports celebrities, 

including Bhokanal, from India and 

abroad. 

“As a consultant arthroscopy 


surgeon, I have been attending to 

injured athletes at sports medicine 

speciality centres across the globe 

and as a passionate rower myself, I 

knew very much what our country 

lacked,” said Dr Arumugam, in a recent 

interview with Future Medicine. 

The idea for developing such a 

specialised facility for sports testing 

and training in India materialised when 

Prof. Tim Noakes of the University of 

Cape Town visited India four years ago, 

added Dr Arumugam, 

who has specialised in both 

medicine and surgery with American 

Board Diplomate in Internal Medicine 

and M.S degree in Orthopaedics. He 

has also received an Honorary FRCS 

award from the Royal College of 

Surgeons. 

SRMC and University of Cape Town, 

which runs one of the world’s best 

sports science centre, has signed an 

academic and research collaboration 

for this unique centre in Chennai. 

Commissioned in 2014, CSS aims 

at nurturing sports and physical 

activity among Indian sportspersons 

and aspirants to enhance their 

performance and health through 

specialised educational, research and 

training modules. As a research hub, it 

also focuses on exercise science and 

sports medicine, and on disseminating 

and applying the knowledge 

As a consultant 

arthroscopy 

surgeon, I have 

been attending to 

injured athletes at 

sports medicine 

speciality centres 

across the globe 

and as a passionate 

rower myself, I 

knew very much 

what our country 

lacked. 

Dr Arumugam 

through its services. 

“This will, in turn, help spread 

the knowledge of sports medicine 

in the country and also advance the 

sports-related medical care to athletes 

through research and best-in-class 

services to our athletes at a fraction 

of the cost of foreign centres,” added 

Arumugam. 

But he laments that the 

concept hasn’t fully got into the 

conventional mindset here. 

Infrastructure 

The 1.6 lakh square feet centre, which 

was conceived and designed on the 

lines of one of the world’s best sports 

science centres -- the University of 

Cape Town, has all the necessary 

infrastructure and international expertise 

needed for grooming the athletes. 

According to Dr. K A Thiagarajan, 


PHOTOS: RAVI KUMAR 

a sports medicine specialist at 

CSS, the centre currently offers a 

host of multidisciplinary services to 

sportspersons through a team of 

professionals and international experts 

in various areas like sports medicine, 

physiotherapy, biokinetics, biomechanics, 

nutrition and sports psychology. 

Since the centre is located alongside 

Sri Ramachandra Medical Centre and 

Hospital, which offers medical care 

such as minimally invasive arthroscopy 

surgery for sportspersons, rehabilitation 

of injured athletes is provided by an 

expert team led by Prof Arumugam 

himself. 

Besides, the infrastructure includes 

exercise physiology labs, an isokinetic 

testing and training lab, a biomechanical 

lab, a sports rehabilitation 

unit with physiotherapy and 

hydrotherapy, a multi-sports testing and 

training hall, a high performance centre, 

a fitness centre with an indoor running 

track, an indoor swimming pool, a sport 

shooting facility with 10m, 25m and 

50m ranges, a video and game analysis 

room, a sports cafeteria, a turf sport 

ground, boarding and lodging facilities, 

specialist consultation suites, board 

rooms, classrooms, a library, a sports 

museum, an environmental chamber 

and a large aerobics and yoga hall. 

Education in sports medicine 

CSS, as a part of SRMC Hospital, has also 

conceptualised and developed a twoyear 

postgraduate degree programme in 

sports medicine — MD Sports Medicine, 

adhering to the curriculum of leading 

universities worldwide. It was the first 

of its kind in the country, which was 

recently approved by Medical Council of 

India. 

Recently, the centre has initiated an 

undergraduate course — B.Sc. Sports 

and Exercise Sciences - in academic 

collaboration with the University of Cape 

Town, and is currently planning a few 

more allied courses in the field of sports 

science, including Sports Nutrition, 

Sports Physiotherapy, Biokinetics, Sports 

Psychology and Biomechanics as twoyear 

master programmes. 

“We are also planning to introduce 

programmes for practising clinicians and 

sports medicine graduates to specialise 

on various disciplines in sports science. 

This will not only help them seek 

opportunities in this emerging field, but 

also create better awareness on such 

subjects among the medical fraternity,” 

said Dr Arumugam. 

“Coaches and trainers play a crucial 

role in building and shaping the career 

of any sportsperson. A thorough 

knowledge of the basics of sports 

sciences and an understanding of the 

principles behind modern scientific 

training of players will be a huge 

advantage for them,” he said, adding 

that CSS is now partnering with Exercise 

& Training Academy (ETA), Cape Town, 

for providing education and training 

certification for coaches and trainers. 

This will indirectly but definitely help the 

athletes, he added. 

This is part of a new series that features 

India’s First & Most Unique institutions, 

facilities, technologies, products etc in the 

medical and healthcare space. 


events 

India’s first Proton Therapy Conference 

highlights new cancer care experience 

Two-day meet focuses on the application of the technology in clinical practice 

Global oncology specialists shared 

their insights at the country’s 

first proton therapy conference 

organised jointly by Apollo Hospitals 

and Particle Therapy Cooperative Group 

(PTCOG) in Chennai. 

Proton therapy, one of the most 

advanced and targeted radiation 

cancer treatments with a superior dose 

distribution and minimal side effects, is 

claimed to be helpful in treating cancer 

more effectively and efficiently. 

The Chennai conference on proton 

therapy was organised for oncologists 

from South East Asian countries. The 

region’s first proton beam therapy 

centre will soon be commissioned by 

Apollo Hospitals in the city. 

Over 400 delegates from across 

India and Asia gathered at this first 

international proton therapy conference, 

which was iinaugurated by Dr. 

Motosoahae Thomas Thabane, Prime 

Minister of Lesotho. 

The conference was divided into 

sessions around key topics such as 

the basic science behind proton beam 

Dr Rakesh Jalali, 

Medical Director, Apollo 

Proton Cancer Centre 

OVER 400 DELEGATES FROM 

ACROSS ASIA GATHERED 

AT THIS FIRST 

INTERNATIONAL PROTON 

THERAPY CONFERENCE 

delivery and on how to assemble the 

infrastructure. 

Proton therapy centres are heavily 

dependent on the support of engineers 

and scientists to assemble the 

infrastructure. The machinery involved 

is far more complicated compared to 

standard radiation equipment and 

requires a greater level of customisation. 

Standard radiation therapy 

comprises of X-ray beams that deposit 

their energy along the path of the beam, 

to the tumour and beyond, resulting 

in radiation being delivered not only 

to the tumour but also to the healthy 

tissues around the tumour. This causes 

damage to normal tissue or organs 

near the tumour. With proton therapy, 

it is possible to control the location of 

the release of the energy and precisely 

target the tumour, causing the most 

damage to the targeted tumour cells, 

while sparing healthy tissues and 

organs. 

A proton beam is just millimetres 

wide and facilitates effective treatment 

of complex tumours in the eye, the 


Dr Jay Flanz, 

Massachusetts General 

Hospital, USA. 

brain, the prostate, as well as cancers 

in children, with the advantage that 

healthy tissue and critical organs are 

not harmed. It gives the patient a better 

quality of life during and after treatment. 

“First of all, in proton beam therapy, 

no two machines are alike and the 

system at every centre needs heavy 

customisation, which is critical for the 

efficient delivery of the therapy,” said Dr. 

Ramesh Rengan, professor, Department 

of Radiation Oncology, University of 

Washington School of Medicine. 

“More importantly, there was also 

a substantial amount of thought that 

was put into the aspect of the kind of 

cancer patients present in this part of 

the world, which is significantly different 

from those in other regions,” Dr Rengan 

added. 

The two-day-long interactive 

programme saw specialists from Austria, 

Denmark, India, Sweden, Switzerland 

Dr Tony Lomax, 

Paul Sherrer Institute, 

Switzerland 

Dr Preetha Reddy, 

Vice Chairperson, 

Apollo Hospitals. 

PHOTOS: UMESH GOSWAMI 

THOUGH THERE ARE 

UNCERTAINTIES ON 

QUANTIFYING THE BENEFITS 

OF PROTON THERAPY, 

EXPERTS ARE OF THE VIEW 

THAT PATIENTS EXPERIENCE 

FEWER SIDE EFFECTS IN 

GENERAL 

and the US sharing their knowledge 

on various aspects of proton therapy 

technology and treatment, and an 

overview of its application in clinical 

practice. 

Apollo’s proton therapy centre -- 

Apollo Proton Cancer Centre (APCC) -- 

which will have a pencil beam scanning 

facility -- one of the most advanced 

proton therapy technologies -- is largely 

in line with standards that are in practice 

globally. Technical sessions on aspects of 

testing and treatment were at par with 

the latest technology trends in this area. 

“The Proton Therapy Educational 

Programme will help physicians and 

oncologists understand the potential 

of this new technology to treat cancer,” 

said Dr Preetha Reddy, Vice Chairperson, 

Apollo Hospitals. 

“With the cancer burden in India 

increasing day by day, we are glad 

to be at the forefront in taking up 

the challenge of providing the best 

treatment option available in the world,” 

she added. “It will be the first in South 

East Asia and a major milestone in our 

concerted focus to battle and conquer 

cancer.” 

Dr Rakesh Jalali, Medical Director 

at Apollo Proton Cancer Centre, said 

proton therapy has “phenomenally 

transformed” cancer therapy. 

“It helps in treating tumours located 

in especially difficult areas such as in the 

head, the neck, the pancreas and the 

prostate. It is very effective to control 

and manage cancer while reducing 

damage to vital organs and healthy 

tissues due to the possibility of giving 

higher doses of radiation,” he added. 

Though there are issues like the 

high cost of therapy and uncertainties 

on quantifying the benefits of proton 

therapy, experts are of the view 

that patients experience fewer side 

effects in general and, in certain cases, 

have a lower chance of recurrence 

due to the high dose delivered to the 

tumour. 

On issues such as the risk-benefit 

ratio and the type of patients who 

stand to benefit the most from the 

treatment, Dr Rengan says: “Typically, 

the best candidates for proton therapy 

are children and adults with skull-based 

tumours, tumours in and around the 

spine, orbital and eye tumours.” 

Patients with cancers of the head 

and neck, oesophagus, pancreas and 

hepatobiliary system, sarcomas and 

certain breast cancer too have benefited 

from the therapy, he said. 


events 

Kerala must leverage its innovation potential 

to transform healthcare: TiEcon 2018 

7th edition of entrepreneurship conference calls for making Kerala 

an ideal location for life sciences 

DIVYA CHOYIKUTTY 

Kerala must focus on its inherent 

qualities of creativity and 

innovation to develop itself as an 

ideal location for implementing fresh 

concepts in life sciences and health 

care. The modern healthcare industry, 

together with alternative medicine, can 

jointly provide a holistic approach in 

promoting health and tourism in the 

state, participants pointed out. 

Another area that the state can really 

make a difference is in the development 

of virtual centres for counselling and 

behavioural therapy, say industry experts 

who participated in a thought-provoking 

discussion at the TiEcon 2018. The 

7th edition of the entrepreneurship 

conference was conducted around 

the theme of “Rebuilding Kerala” 

by leveraging entrepreneurship and 

emerging technologies, on Nov 16-17 at 

Kochi. 

More than 1,000 delegates, including 

entrepreneurs, technocrats, researchers 

and professionals, participated in the 

two-day conference. The conference 

sessions highlighted the importance 

of creating opportunities in multiple 

industry and service sectors within the 

state. 

“This time, we had an increased focus 

towards technocrats and industrialists, as 

we could use their resources and ideas 

to rebuild our state, while creating more 

job opportunities for the people. This will 

also, in turn, help the state to overcome 

the recent crisis caused by the floods,” 

said Wg. Cdr K. Chandrasekhar, Executive 

Director, TiE Kerala. 

“We need to have an affordable, 

quality healthcare which can be 

made possible through technological 

advancements,” said Dr. Rajeev 

Jayadevan, deputy medical director, 

Sunrise Hospital, Kochi, summarising the 

panel discussion on emerging trends in 

health care. 

A panel discussion on life sciences 

called for support and exposure for 

small and medium-sized enterprises. 

“I do not think what we need now 

is a startup explosion. Rather, Kerala 

needs an SME exposure which can 

help provide jobs to many people at 

this time,” emphasized Leo Mavely, 

Founder and CEO of Axio Biosolutions, 

while participating in the discussion on 

investments in the life sciences sector. 

“We have lots of talent available 

in the state, offering immense 

opportunities for startup companies 

and the innovative young generation 

to come up. But somewhere, there is a 

disconnect that blocks the investments. 

It is perhaps the fear of failure or the 

lack of exposure and visibility to the 

market space,” stated C.H. Unnikrishnan, 

founder and editor, Future Medicine, 

while summarizing a panel discussion on 

entrepreneurship in life sciences. 

Discussing the stability of business, 

C. Padmakumar, chairman and 

managing director, Terumo Penpol Pvt. 

Ltd , the country’s largest blood-bag 

maker, underscored Kerala as the state 

which provides the most consistent 

business environment by enforcing laws 

and policies. 


events 

IRCON 2018 stresses need for 

multi-disciplinary approach 

Interventional radiologists gather to explore ways to complement 

skills with various specialties 

DIVYA CHOYIKUTTY 

Interventional Radiologists from 

across the nation rubbed shoulders 

with clinicians of various specialties 

at the IRCON 2018 held at Kochi on 10 

November, 2018, commemorating the 

International Radiology day. 

The one-day meet, which was 

titled “Interventional Radiologists Meet 

Referring Specialities” and organized 

by the Interventional Radiologists 

Association of Kerala, highlighted various 

advanced treatment options available 

in the field today and their relevance 

to specialties such as hepatology, 

nephrology, urology and gynecology. 

“The basic idea of the conference 

was to encourage other radiologists 

and to create awareness among 

other specialties of the pivotal role 

interventional radiologists play in patient 

care,” said Dr. Lijesh Kumar, organizing 

secretary and consultant radiologist at 

PVS hospital, Kochi. 

The conference discussed various 

treatment techniques, including 

ablation therapy, embolisation, aortic 

stenting, balloon-occluded retrograde 

transvenous obliteration (BRTO) and 

transjugular intrahepatic portosystemic 

shunt (TIPS), underscoring their role in 

helping patients with bleeding, while 

enhancing their survival chances by 

providing quality time for a definitive 

therapy. 

“Over 90% of liver cancers are now 

treated by interventional radiologists 

where we can go through the arteries 

and ablate the tumours, thereby 

improving the condition of the patient 

by avoiding major surgeries. Mostly, 

MANY CLINICIANS WHO 

HAVE NOT INTERACTED 

WITH INTERVENTIONAL 

RADIOLOGISTS ARE MOSTLY 

UNAWARE OF THEIR WORK 

only 20-30% of liver cancers due to 

cirrhosis are operable, while we can do 

the therapy even in patients who cannot 

undergo surgery,” says Dr. Amar Mukund, 

Associate Professor Institute of Liver and 

Biliary Sciences, New Delhi. 

He also emphasized the prognostic 

value of techniques like hepatic venous 

pressure gradient (HVPG), which can be 

used as the gold standard for patients 

at risk of liver cirrhosis. 

“Techniques like HPVG should 

be accessible at every hepatology 

centre in India,” said Dr. G.N. Ramesh, 

participating in a panel discussion on 

treating the complication of variceal 

bleed. 

“We are changing, but right now we 

have so many barriers and are lacking 

in the number of experts and facilities 

in interventional radiology in most 

hospitals,“ says Dr. Philip Augustine, 

Gastroenterologist, Ernakulam Medical 

Center. 

“With its image-guided 

interventional procedures, IR has already 

enabled safe renal transplantation. We 

need more dedicated experts to train IR 

and increase public awareness, making 

it accessible at the medical college 

level,” said Dr. Gireesh, Warawdekar 

senior Interventional Radiologist, Lilavati 

Hospital & Research Centre, Mumbai. 

The conference discussed the need 

for a multidisciplinary board meeting 

where all the specialties can convene 

and narrow down the best treatment, 

providing a tailor-made approach for 

each patient. 

The conference also involved 

workshops on biopsy and drainage 

techniques and aortic stenting, and was 

attended by over 270 participants. 


essay 

CRISPR STEALS 

THE SHOW IN 

MOLECULAR LABS 

Industries have started exploiting the new gene 

editing tool for various purposes 

CONFERENCE 

2018 

competition 

Sara Anisa George, 

Jr Research Fellow, 

Laboratory of Molecular 

Oncology, Centre for 

DNA Fingerprinting and 

Diagnostics, Hyderabad, 

India 

SARA ANISA GEORGE 

The term ‘CRISPR technology’ has 

of late, been making waves both 

within and outside the scientific 

community. The potential power of this 

novel and ground-breaking technology 

to completely change the face of 

science and give scientists the ability 

to play God has sent the world into 

a tizzy. First discovered in Escherichia 

coli by Yoshizumi Ishino in 1987 and 

later by Francisco Mojica in Haloferax 

mediterranei in 1992 (Mojica et al, 

1993), Clustered Regularly Interspaced 

Short Palindromic Repeats (CRISPRs) 

were then identified in other bacteria. 

In-depth studies recognised the role 

of CRISPRs and their associated Cas 

enzymes in the prokaryotic adaptive 

immune response against invading 

viruses. Further research by other 

groups into this newly discovered 

bacterial anti-viral response led to 

the elucidation of its mechanism 

as an RNA-guided editing tool that 

generates double-stranded breaks in 

target DNA. However, it was only after 

the report of the ability of the Cas9- 

CRISPR combination to edit nearly 

any chosen sequence of DNA, by the 

labs of Emmanuelle Charpentier and 

Jennifer Doudna in 2012 (Jinek et al, 

2012) that the possibility of using this 

technology as a gene-editing tool in 

higher eukaryotes was considered. This 

theory was proven by the research 

groups of Feng Zhang and George 

Church in human cell-lines, the 

following year (Cong et al, 2013; Mali 

et al, 2013). This technology has been 

gaining popularity at an exceedingly 

increased pace and has now become 

a staple in most molecular biology 

laboratories around the world, which 

has led to the development of 

DUE TO ITS RELATIVE 

SIMPLICITY AND EASE OF 

USE CRISPR/CAS9 AND ITS 

DERIVED TECHNOLOGIES 

HAVE FOUND USES IN THE 

FIELD OF MEDICINE AND 

HEALTHCARE 

several modifications to the original 

CRISPR components based on the 

downstream use, enabling more 

precision and specificity in gene 

editing properties. 

Impact in medicine 

Due to its relative simplicity and ease 

of use in comparison to previously 

known genome editing tools such as 

RNAi, zinc-finger nucleases (ZFNs) 


and transcription-factor like effector 

nucleases (TALENS), CRISPR-Cas9 

and its derived technologies have 

found uses in several areas of modern 

science, but its greatest impact has 

been in the field of medicine and 

healthcare. Initial studies focused on 

in-vitro research in animal cell-lines 

and embryos to study genes involved 

both in normal metabolism as well as 

in disease development (Wang et al, 

2014; Zhou et al, 2014; Roy et al, 2015; 

Zhang Y et al, 2018; Van Treuren et 

al, 2018; Ojalill et al, 2018). However, 

due to the rapid pace of development 

of this technology, at present, several 

in-vivo studies are already in progress 

to develop CRISPR-based strategies 

that can be used in the treatment of 

previously incurable genetic disorders. 

Some of the examples of the use of 

this technology include the treatment 

of disease models of Huntington’s 

disease, phenylketonuria, Duchenne’s 

muscular dystrophy, etc.(Yang et al 

2017; Villiger et al, 2018; Amoasii et al, 

2018). Gene editing studies have not 

been restricted to metabolic disorders, 

in fact, a number of 

research groups have transferred 

their focus on inventing techniques 

to control the spread of infectious 

diseases such as AIDS, malaria, 

candidiasis, herpes, etc. by either 

manipulating the pathogen itself or 

its transmitting vector (Gantz et al, 

2015; Vyas et al, 2015; Hammond 

et al, 2016; Van Dieman et al, 2016; 

Kaminski et al, 2016; Yin et al, 2017). 

The CRISPR pioneering laboratories of 

Doudna at the University of California 

and Zhang at the Massachusetts 

Institute of Technology have utilized 

their expertise to design kits that will 

ensure more precise and sensitive 

for pathogen detection and disease 

diagnosis (Myhervold et al, 2018; Chen 

et al, 2018). In addition, other labs and 

start-up industries have also started 

exploiting this new technology for 

similar purposes (Koo et al, 2018). 

Agri and food industry 

The advances in the field of 

agriculture and in the food industry 

are not far behind. With a steady 

rise in populations especially in the 

developing parts of the world, there 

has been an increasing demand 

for the production of high-quality 

varieties of crop plants, and agricultural 

scientists have till date relied on 

traditional breeding methods to meet 

this need. CRISPR-derived methods 

have been used to generate high 

yielding, disease resistant and 

nutrient-rich crops that cater to the 

CRISPR-DERIVED METHODS 

HAVE BEEN USED TO 

GENERATE HIGH YIELDING, 

DISEASE RESISTANT AND 

NUTRIENT-RICH CROPS 

THAT CATER TO THE NEEDS 

OF THE MASSES 

needs of the masses (Jacobs et al, 

2015; Tashkandi et al, 2018; Shimatani 

et al, 2018; Chen et al, 2018; Zhang 

et al, 2018). The use of CRISPR in the 

food industry is as yet in its 

early stages especially due to hesitance 

from the general public to adopt 

this novel technology, but further 

developments are believed to bring 

about a revolution in the way we 

perceive food. 

Like all good things have a 

downside to them, similarly, there 

have been concerns with regard to the 

indiscriminate use of CRISPR for gene 

editing. Studies are already underway 

to attempt editing human embryos for 

the purpose of developing disease-free 

humans (Liang et al, 2015; Kang et al, 

2016). CRISPR’s reported off-target 

editing effects also prove to be an 

enormous disadvantage due to the 

possibility of generating undesirable 

mutants that may have serious effects 

in the long run, especially if used in 

humans. What this new technology has 

in store for mankind will soon become 

a reality. 


calendar 

Upcoming conferences 

DECEMBER 

4-7 BIOETHICS 

World Congress of Bioethics 

(WCB) 

New Delhi 

5-7 BIOETHICS 

World Congress Of Bioethics 

(WCB) 

Bengaluru 

7-8 CLINICAL RESEARCH 

SCDM India Conferenc 

Hyderabad 

6-9 RHEUMATOLOGY 

IRACON 

Guwahati 

13-16 NEUROLOGY 

Conference of Neurological 

Society of India (NSICON) 

Jaipur 

NEONATOLOGY 

Annual Convention of National 

Neonatology Forum (NEOCON) 

Varanasi 

14-16 GYENAECOLOGY 

Annual Congress of Indian 

Fertility Society (Fertivision) 

Kochi 

RADIOLOGY 

Annual State Conference of the 

TN & PY Chapter of IRIA 

Chennai 

PEDIATRIC UROLOGY 

Asia-Pacific Association Of 

Pediatric Urologists Congress 

(APAPU) 

New Delhi 

20-23 NEPHROLOGY 

Indian Society of Nephrology 

Conference (ISNCON) 

Bhubaneswar 

26-30 SURGERY 

Conference of Association of 

Surgeons of India 

Chennai 

JANUARY 

4-6 CLINICAL RESEARCH 

Joint International Conference 

Ahmedabad 

NEUROLOGY 

Neuro Updates Conference 

Chennai 

9-11 MENTAL HEALTH 

DYUTI International Symposium 

on Evidences in Global Mental 

Health 

Kakkanad 

17-19 

VENOUS DISEASES 

Vaicon 

Hyderabad 

17-20 DERMATOLOGY 

National Conference of Indian 

Association of Dermatologists, 

Venereologists & Leprologists 

Bengaluru 

RADIOLOGY 

Annual Conference of the 

Indian Radiological and Imaging 

Association (IRIA) 

Chandigarh 

23-26 UROLOGY 

Annual National Conference of 

The Urological Society of India 

Bhubaneswar 

24-26 GASTRO-ENTEROLOGY 

National Conference on Obesity 

and Metabolic Surgery Society 

of India 

Kolkata 

24-27 SURGERY 

Annual Conference of The 

Asociation of Spine Surgeons of 

India (ASSICON) 

Ahmedabad 

25-27 NEUROSURGERY 

International Conference on 

Complications in Neurosurgery 

(ICCN) 

Mumbai 

30-31 

31- 

Feb2 

ONCOLOGY 


Cancer Rehabilitation (CAN- 

REHAB) 

Mumbai 

CRITICAL CARE 


Indian Society of Critical Care 

Medicine (CRITICARE) 

Mumbai 

PSYCHIATRY 


Indian Psychiatric Society 

Lucknow 

FEBRUARY 

6-10 PAEDIATRICS 

Illness to Wellness Pedicone 

Mumbai 

7-9 GASTRO-ENTEROLOGY 

Annual Congress of Indian 

Association of Gastrointestinal 

Endosurgeons (IAGES) 

Bhubaneswar 

8-9 CLINICAL ANATOMISTS 

Society of Clinical Anatomists 

Chennai 

8-10 PLASTIC SURGERY 

Annual Meeting of Indian 

Society of Cleft Lip Palate 

and Craniofacial Anomalies 

(Indocleftcon) 

Varanasi 

ONCOLOGY 

Conference of Society of 

Oncologic Imaging India 

(SOIICON) 

New Delhi 

14-15 NEUROSURGERY 


Conjoined Twins (ICCT) 

New Delhi 

15-17 PHYSIOTHERAPY 

Society of Indian Physiotherapist 

Annual Conference (Society of 

Indian Physiotherapist Annual 

Conference) 

New Delhi 

NEUROLOGY 

Annual Conference of the Indian 

Society of Neuroanaesthesiology 

and Critical Care (ISNACC) 

Gurgaon 

HEPATOLOGY 

Advanced Institute of Liver 

& Biliary Science (AILBS) 

International Conference 2019 

New Delhi 

21-24 CARDIOLOGY 

ASCVTS & IACTSCON 

Chennai 


World Congress on Cardiac 

Imaging Clinical Cardiology 

(WCCICC) 

Mumbai 

ANAESTHESIOLOGY 

Conference of the Indian 

Association of Cardiovascular 

Thoracic Anaesthesiologists 

(IACTACON) 

Kolkata 

NEUROLOGY AND 

PSYCHIATRY 

MDSICON 

New Delhi 


India Live Conference 

Mumbai 

The announced dates of the conferences may change 


ook review 

TERRAINS OF HUMAN 

EXPERIENCE 

THINK TANK: 

FORTY 

NEUROSCIENTISTS 

EXPLORE THE 

BIOLOGICAL 

ROOTS OF HUMAN 

EXPERIENCE 

Edited by David J Lindon 

Pp 312 

Yale University Press 

human brains were not 

designed all at once, by a 

“Our 

genius inventor on a blank sheet 

of paper. It is a cobbled-together mess 

that nonetheless can perform some very 

impressive feats,” observes Dr David J Linden, 

introducing the book Think Tank: Forty 

Neuroscientists Explore the Biological Roots 

of Human Experience, a collection of essays. 

The intriguing ways of the human 

brain have always been a mystery. This 

amazing organ continues to perplex 

researchers by simply refusing to unravel. But 

in the age of the brain, the world is hungry 

to know more about the quirky organ and 

the biological basis of human experience. 

Most of what is available on the brain is 

uninformed or even fraudulent. It’s nothing 

but “neurobulshit”, in the words of Dr Linden, 

a neuroscientist. 

Clearly, that is the reason why Dr Linden 

approached the world’s top neuroscientists 

with the question: “What idea about brain 

function would you most like to explain 

to the world?” The result is a collection of 

essays that explore various aspects of brain 

function. 

Contributors with varied expertise survey 

the underlying biology of the eternally 

fascinating topics of personality, substrates 

of aesthetic responses, subconscious drives 

for love, sex and food, and psychoactive 

drugs. Alongside, they examine the origins of 

human individuality, empathy and memory 

from different perspectives, such as that 

of human behaviour, molecular genetics, 

evolutionary biology and comparative 

anatomy. 

Authors discuss how present concepts 

about the working of the brain are getting 

refined with progress in neuroscience, even 

though we are still quite some distance 

from a satisfactory understanding of many 

of the processes. Slowly, we come to a new 

realisation that several regions of the brain 

may be critically involved in mechanisms not 

attributed to them hitherto. 

The hypothesis of developmental 

diaschisis, for instance, now opens the 

MOST OF WHAT IS AVAILABLE 

ON THE BRAIN IS UNINFORMED 

OR EVEN FRAUDULENT. IT’S 

NOTHING BUT “NEUROBULSHIT”. 

possibility that the treatment of autism could 

end up in areas of the brain such as the 

cerebellum -- a part of the brain previously 

unconnected to cognitive or social functions. 

The cerebellum is thought to predict near 

future, and in this way, adjust and guide 

both movement and thought. A failure of 

the cerebellum to predict the near future 

could make it hard for babies at risk for 

autism to learn properly from the world. This 

understanding could change the way we 

treat autism. Currently, the most effective 

treatment for autism is applied behaviour 

analysis. But it works on only half the kids 

with autism. Manipulation of brain activity in 

the cerebellum may help applied behaviour 

analysis work better and help more kids. The 

essays are also notable for their brevity and 

variety. 


CONFIDENCE AND CONTENTMENT 

ARE ULTIMATE SAVIOURS 

DR K M CHERIAN 

Chairman and CEO, Frontier Lifeline Hospital, Chennai 

Be always prepared for discouragements and 

disappointments that can pull you down in this 

profession. One should be aware that there are 

traps all around you, especially at a time when the 

organisational, social and political systems often turn 

hostile to committed services and endeavours. 

In an era when corporatisation is tightening its 

grip on the patient-care business, doctors should 

train themselves not to fall into the trap of the 

management, though sustainability of the organisation 

is as important as medical ethics and morality. But it 

is important to ensure that the commitment towards 

patient care and safety should never get compromised 

in the process. 

Besides patient care, biomedical research is a great 

opportunity awaiting young and enthusiastic doctors 

who are passionate about serving the world with their 

academic quest. But, remember, this is another area 

where one will come across greater challenges too. 

Research projects are obviously expensive and 

risky. Such projects are often not possible without 

government or institutional support. At the same time, 

there is the possibility that these supporting factors 

would create bigger hurdles than natural challenges. 

In both these areas, care as well as research, one 

may often come across stumbling blocks despite his 

or her best efforts. This is typical to countries like India, 

where there is a lack of an organizational structure 

and a robust professional culture in the government. 

One of the main reasons for such disappointing 

experiences is ulterior motives by which selfish 

interests are protected. In such setups, larger interests 

of the public or the best benefits for the needy are 

circumvented. 

Therefore, it is always advisable to have the 

courage and the commitment to stick to your 

objectives and keep pursuing the same with 

confidence. That is the ultimate saviour for you in this 

profession, in which self-contentment is an impactful 

feeling. 

— As told to CH Unnikrishnan 


A New Dawn... A New Hope 

With Passion and Expertise 

After redefining the healthcare scenario in Middle East Asia, 

Visionary Leader & Padmashri, Dr B R Shetty is now focusing on the Indian subcontinent with 

his healthcare enterprise 

“ 

With a mission of creating a healthier world by encompassing the values of care, compassion 

and clinical excellence, BR Life intends to become the numero uno network of hospitals across 

India and the Indian subcontinent. 

“ 

We deliver 

Evidence based clinical practice for best patient outcomes 

Ergonomically designed state-of-the-art infrastructure 

Worldclass affordable healthcare backed with cutting 

edge medical technologies 

The BR Life Group of Hospitals 

BR Life SUT Hospital, Pattom, 

Thiruvananthapuram, Kerala 

BR Life SSNMC Superspecialty Hospital, R R Nagar, 

Bengaluru, Karnataka 

BR Life Mother & Child Hospital, Udupi 

Karnataka. 

BR Life Kalinga Superspecialty Hospital, Gautamnagar 

Bhubaneswar, Odisha 

 

No. 8, Ideal Homes HBCS Layout, Rajarajeshwari Nagar, Bengaluru - 560 098, Karnataka, India. Tel: +91 80 6766 6766

RNI Number KERENG/2012/44529

FM DECEMBER 2018 ISSUE - digital edition

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