71st INTERNATIONAL CONGRESS OF FIP - Indian Pharmaceutical ...

A Grand Opening …. 

World Congress of Pharmacy and Pharmaceutical Sciences 2011 

71 st INTERNATIONAL CONGRESS OF FIP 

Theme: Compromising Safety and Quality: A Risky Path 

The 71st World Congress of Pharmacy 

and Pharmaceutical Sciences of The 

International Pharmaceutical Federation 

(FIP), was hosted by India Host Committee 

of the Indian Pharmaceutical Association 

(IPA), from September 4 th , 2011 to 

September 9 th , 2011 at HICC, Hyderabad. 

Governor of Andhra Pradesh - Shri E. S. L. Narasimhan speaking on the occasion. Also seen on the 

dias (L - R) Chairman of India Host Committee - Dr. B. Suresh & Past President, IPA - Prafull Sheth. 

The 2011 Congress opened with a 

monumental visit by the President of India, 

Her Excellency, Mrs. Pratibha Devisingh 

Patil, accompanied by Governor of Andhra 

Pradesh - Shri E. S. L. Narasimhan and 

Chief Minister of Andhra Pradesh - Shri N. 

Kiran Kumar Reddy. On this occasion, 

Following the visit of the President and 

other dignitaries, the Assistant-Director 

General of the World Health Organization 

(WHO), Dr. Nakatani signed the official 

WHO-FIP Joint Statement on the Role 

of the Pharmacist in Tuberculosis Care 

Pharma Times - Vol. 43 - No. 10 - November 2011 16 

and Control with FIP President Dr Michel 

Buchmann. This statement will set the stage 

for increased pharmacist involvement in 

the prevention of and care of patients with 

tuberculosis; a timely and relevant issue 

considering the spread of tuberculosis in 

India. The landmark statement establishes 

Chief Minister of Andhra Pradesh 

- Shri N. Kiran Kumar Reddy 

welcoming the delegates 

President of FIP - Dr. Michel 

Buchmann making the 

introductory remarks. 

FIP Distinguished Practice Award 

Dr. Marianne F. Ivey (USA) 

FIP Lifetime Achievement In 

Pharmaceutical Practice Award 

Dr. Th. (Dick) Tromp (Netherlands) 

FIP Fellows 

Dr. Max Brentano (Switzerland) 

Mr. Mehmet Serif Boyaci (Turkey) 

Mr. Azubike Okwor (Nigeria) 

Prof. Adel Sakr (Egypt) 

Dr. Eduardo Savio (Uruguay) 

Dr. Régis J.M. Vaillancourt (Canada) 

Høst Madsen Medal 

Prof. Malcolm Rowland (UK) 

FIP Honorary Membership 

Prof. Tsuneji Nagai (Japan) 

Chairman of India Host 

Committee - Dr. B. Suresh 

welcoming the delegates.

a series of measures to help detect TB, 

offer treatment support to TB patients, 

and substantially reduce the number of 

deaths from TB. This would be achieved 

by encouraging the FIP’s network of two 

million pharmacists and pharmaceutical 

scientists around the world to become 

fully engaged in national TB care and 

control efforts. Speaking at the opening 

ceremony, Dr Hiroki Nakatani, WHO 

Assistant Director-General for HIV/AIDS, 

Tuberculosis, Malaria and Neglected 

Tropical Diseases, welcomed the new 

accord with FIP: “Pharmacists can be the 

gatekeepers to vital TB health services. 

WHO welcomes the opportunities that 

further collaboration with the federation’s 

President of IPA - 

Dr. C. Gopalakrishna Murty 

delivering the vote of thanks. 




network of pharmacists will bring in helping 

many people with tuberculosis gain early 

access to the care and treatment they 

need.” 

His comments were echoed by Dr Michel 

Buchmann, the President of FIP: “While 

recognizing the broader role of pharmacists 

in the development and use of anti-TB 

medicines, this Joint Statement focuses on 

the role of pharmacists directly involved in 

the care of people with TB. The International 

Pharmaceutical Federation will endeavor to 

support WHO and their Member States in 

enabling national tuberculosis programmes 

and national pharmacy associations to 

strengthen their collaboration towards care 

Dr. C. Gopalakrishna Murty & Dr. B. Suresh presenting a memento to the President of India. 

Prafull Sheth announcing the 

FIP Fellowships 

Prof. T. Nagai receiving the 

Honorary Membership from 

Dr. Michel Buchmann 

Padmashree Dr. Ananda Shankara Jayanta & her troupe presenting recitals of classical Indian dance & music 

and control of TB and multidrug-resistant- 

TB globally.” 

This was followed by the awards 

presentation ceremony, where the most 

prestigious FIP awards were presented to 

pharmacy professionals from across the 

globe. Almost 2000 delegates from over 

98 countries convened at Hyderabad for 

the program centered on increasing safety 

and quality of medicines and patients on a 

global level. The delegates were regaled 

by stunning classical Indian dance and 

music recitals by Padmashree Dr. Ananda 

Shankara Jayanta & her troupe from 

Shankarananda Kalakshetra. 

Dr. T. K. Ravi & Dr. Alka Mukne 

conducting the inaugural session 

Prafull Sheth presented 

with FIP – IPS Medal 

Prafull Sheth, 

Past President 

of IPA 

and current 

Vice President 

of FIP 

was presented 

with the 

FIP-Industrial 

P h a r m a c y 

Section (FIP- 

IPS) Medal at 

the IPS business 

meeting 

Dr. Linda Hakes presenting 

the FIP-IPS Medal to Prafull 

Sheth 

held on September 7 th , 2011, during the 

Congress. The medal was presented to 

Mr. Sheth by Dr. Linda Hakes, Chairperson, 

FIP – IPS. Mr. Sheth was honored 

with this unique distinction for his sterling 

contribution to the global pharmaceutical 

industry through his continued influence 

and impact on industrial pharmacy developments, 

over an extended period of 

time. On this occasion, Mr. Prafull Sheth 

also delivered a lecture on Balancing 

Science & Practice : Pharmacy profession’s 

Challenge for Inclusive Growth & 

Service Delivery. 

Pharma Times - Vol. 43 - No. 10 - November 2011 17

Speech of the President of India, Her Excellency Smt. Pratibha Devisingh Patil at the 

inauguration of the 71st World Congress of Pharmacy and Pharmaceutical Sciences of 

FIP on September 4 th , 2011 at HICC, Hyderabad 

Ladies and Gentlemen, 

I am pleased to inaugurate the World 

Congress of Pharmacy and Pharmaceutical 

Sciences 2011 and the 71st Congress 

of the International Pharmaceutical 

Federation (FIP), an organization which 

will be celebrating the Centenary year of 

its establishment next year. I congratulate 

the FIP, as also the Indian Pharmaceutical 

Association who have jointly organized 

this Conference, where the theme is 

“Compromising Quality and Safety - A 

Risky Path”. It is a very appropriate topic, 

given that safe and good quality medicines 

along with their responsible use, is a very 

critical area in the field of healthcare. 

Medical science has made tremendous 

progress, newer machines, better 

technologies and new drugs are now 

available. But the other side of the story, 

and a matter of concern, is that a very 

large part of the world population, mostly 

in developing countries has inadequate 

or no access to healthcare or essential 

medicines at affordable cost. Resultantly, 

the mortality rate and disease incidence 

is high. The health sector is linked with 

creating a better and healthy world. Of 

the Millennium Development Goals, 

those relating to child health, maternal 

health, and combating HIV/AIDS, malaria 

and other diseases, are dependent on 

providing healthcare. Disease reduces the 

capacity to work, and is a major reason that 

poor patients borrow, and then get trapped 

in the vicious circle of debt and poverty. 

How to achieve access to healthcare and 

essential good quality medicines for all, at 

a reasonable cost, must be an essential 

part of any discussion on pharmaceutical 

sciences. The developed countries need to 

work closely with developing countries, in 

addressing healthcare issues and sharing 

their expertise and experiences. 

In India the development of health 

services and infrastructure is one of the 

priority areas. The sector is expanding 

and has also achieved much. Hospital and 

medical facilities in India are an attractive 

destination for medical tourism. Our 

mission however, is to extend the coverage 

of healthcare, particularly amongst our 

urban poor and to rural areas. This offers 

many opportunities for Public-Private 

Partnerships. I do hope that many of you 





present here will come forward to work in 

expanding health coverage in India. 

Alongwith skilled and dedicated 

healthcare providers, treatment with 

medicines are one of the most cost-effective 

medical interventions known. Most illnesses, 

especially infectious diseases, are either 

preventable or treatable with medicines. But 

it is estimated, that more than 50 percent 

of all medicines worldwide are prescribed, 

dispensed, or sold inappropriately. 50 

percent of patients fail to take them correctly. 

This results in health complications. Aware 

of the enormity of the task of ensuring the 

safe and judicious use of medicines, the 

Government of India initiated a National 

Pharmacovigilance Programme in July 

2010. It is designed to monitor adverse 

drug reactions of medicines on the Indian 

population, so that based on data; decisions 

can be taken about appropriateness of 

medicines. 

Measures to improve the rational use 

of medicines bring into play the role of 

pharmacy professionals, whose role in 

recent years, has evolved. New drugs 

are being introduced, which include high 

tech pharma products, vaccines as well as 

new dosage forms and new routes of drug 

administrations. Patients now need much 

counseling on how to take medicine safely. 

Pharmacy is an important component of 

the multidisciplinary Health Care Sector. 

Pharmacists must have new knowledge and 

skills and many countries are introducing, 

expanding and undertaking major reforms 

in pharmacy education. This must be 

accompanied by robust systems to assure 

the quality of educational structures, 

processes and outcomes. In India the 

inflow of pharmacy professionals per 

annum is around 41,000 from diploma 

institutions and around 50,000 from degree 

institutions. The Pharma D. programme 

has been introduced, as also the National 

Institutes of Pharmaceutical Education and 

Research (NIPER) have been established 

in the country, to focus on pharmaceutical 

sciences. Looking at the future, India is 

aware of the need to increase the strength 

of clinically and technologically trained 

pharmacy professionals, to meet growing 

requirements, including for its expanding 

pharma industry. 

Ladies and Gentleman, 

The Indian pharmaceutical industry 

has a wide range of capabilities, and is 

already contributing a substantial share to 

global production. By 2015, it is expected 

to become a U.S. $ 20 billion industry, from 

its present turnover of U.S. $ 12 billion. It 

is already the third largest in the world, by 

volume. Indian pharma companies have 

an extensive presence in many parts 

of the world, and our pharmaceutical 

products are known to be of good quality, 

safety and efficacy. Indian generic drugs 

have helped in bringing down the cost of 

treatment of various diseases world-wide, 

which includes HIV/AIDS. 

The pharma industry must respond to 

the emerging patterns of diseases, and to 

growing concerns about disease causing 

agents becoming resistant to existing 

drugs. This necessitates increased focus 

on research and development, including 

in the newer frontiers of medicine like 

bio-technology. With its proven IT sector, 

demonstrated leadership in bio-technology, 

a vast pool of trained personnel and cost 

advantages, India can emerge as a 

significant player in global pharmaceutical 

research. It already has the largest number 

of US FDA approved plants outside of 

the U.S.A., and is expected to be among 

the world’s top five innovative hubs with 

contributions of around 50 percent to 

drugs discovered worldwide. It has a 

competitive cost advantage and a pool

of skilled workforce, of high managerial 

and technical competence. Hence, 

several MNC pharma companies are 

increasingly making India their Research 

and Development hub. 

The holding in India, of this Conference 

on Pharma and Pharmaceutical Sciences, 

is a recognition of India’s strength in 

these. I also believe that we should draw 

on the rich resource of our indigenous 

knowledge of medicine, and reach out to 

those who have effective remedies but 

are hesitant to disclose them, and bring 

these into broader usage. Producing 

some ayurvedic drugs is tedious and a 

time-consuming process. A short cut for 

their procedure reduces the efficacy of 

such a drug. This should not be lost sight 

FIP AIM Deans Forum 

Meeting 2011 

The second AIM Deans Forum meeting 

was held on 3 rd and 4 th September, 2011 

at the FIP Congress at Hyderabad. 

The purpose of AIM Deans Forum 

was to address the issues related to 

pharmaceutical education across the globe 

and to highlight the importance of social 

accountability of pharmacy education and 

the best practices of pharmacy. Nearly 

30 Deans representing different nations 

and continents participated in the two day 

deliberations. This year’s programme was 

divided in to three symposia. The first 

symposium was on “New Schools and 

Programmes”; the second symposium was 

on “Strategic planning and expanding”; 

the third symposium was on “Interaction 

and interactive”, respectively. In each of 

the symposium 3 to 4 Deans spoke on 

their experiences. 

Dr Peter Jewesson, Dr Tim Rennie, Dr 

Ieva Stupans and Dr Yousif Asiri spoke on 

the developments of new schools at Qatar 

University, in Namibia, in Australia and in 

Saudi Arabia, respectively. The discussion 

was focussed on the distance mode of 

pharmacy education at Australia. 

In the second symposium, Dr Patricia 

Acuna-Johnson of Chile, and Dr Bart 

Rombaut of Brussels spoke on the best 

practices for developing strategies in 

South America and European Union, 

Paper presentations by 

Community Pharmacists at 

71 st FIP Congress, Hyderabad 




of while producing Ayurvedic medicines. 

India has much to offer the world in terms of 

alternative medicine and its potential must 

be tapped. Greater focus is required in this 

regard to propagate its efficacy. 

It is the responsibility of every healthcare 

provider and healthcare organizations in 

a country, to ensure that the quality and 

safety of medicines are not compromised. 

There are instances of spurious drugs, 

which are so harmful to health, being 

produced. This is a crime and an unethical 

practice. So, the theme of this meeting 

“Compromising Quality and Safety - A 

Risky Path” is important. It should not be 

left to the Government alone to identify such 

unscrupulous producers, the industry must 

also have a wing to find out such practices, 

Prof. S. K. Kulkarni (2 nd from right) along with the participants at the FIP AIM Deans Forum Meeting. 

Also seen in the 2 nd row, extreme right Dr. Bala Prabhakar 

respectively. The discussion was focussed 

on the practices in European Union and 

United Kingdom. 

The third symposium addressed the 

issues of interaction and interactivity. Dr 

Adel Sakr of Egypt spoke on expanding 

industry partnerships in his country. Dr S.K. 

Kulkarni represented India and he spoke 

on Translation approach in pharmaceutical 

teaching and training-a new window of 

opportunity. The discussion was focussed 

on bringing together practice and science-a 

case study for India. Dr Maria Bystrin of the 

University of Toronto spoke on continuing 

professional development. 

On the second day, ie; 4 th September, 

Participation of community pharmacists 

in national or international conferences 

has been very rare. But 71 st FIP Congress, 

Hyderabad was an exception & Over 50 

and bring it to the notice of the Government 

to take action. The Conference should 

look at issues of how to create access 

to affordable, quality medicines within a 

sound regulatory environment. How can 

we bring about paradigm shifts in drug 

discovery, development, regulation and 

usage of medicines, particularly relevant 

to emerging disease profiles? How can 

pharmacy education be challenged to meet 

the demands of industry, the regulatory 

bodies and hospital pharmacists? 

With these words I wish all the participants 

success in their deliberations. 

Thank you. 

JAI HIND! 

2011 Dr Henri Manasse, the Professional 

Secretary of FIP spoke at length on 

social accountability-an imperative for 

all pharmacy curricula. The discussion 

was on pharmacists as agents of change 

and common competencies in curricula. 

Dr Kenneth Roberts of University of 

Kentucky spoke on managing up-how to 

effectively have influence on university 

leaders and funders. On the third day, ie; 

5 th September, 2011 Dr Henri Manasse 

gave a presentation on how WHO and 

FIP partnering in addressing health needs 

and challenges of the society and global 

task force. 

- Prof. S. K. Kulkarni 

Director, Bombay College of Pharmacy 

pharmacists attended the Congress. There 

were 30 pharmacists from Maharashtra. 

They were well supported by State 

Chemist Association & AIOCD. IPA 


Community Pharmacy Division took the 

initiative & motivated the pharmacists for 

participation as well for paper presentations. 

First time ever, in the history of Indian 

community pharmacy, 2 community 

Mahadev Patel with a delegate (L-R) Raj Halwai, Sagar Kulkarni, 

Manjiri Gharat & Raj Vaidya 

Latvian Delegation at the 

FIP Congress in Hyderabad 

As well as being the Congress’ first 

visit to India, it was also the first visit there 

by the participants from Latvia. As it is 

one of the most developed regions in the 

pharmaceutical industry we eagerly took 

in all the impressions we gained at the 

Congress and at the excellently organised 

social events that went with it. We took part 

in the Congress’ opening ceremony with 

great pleasure, which was honoured by 

Her Excellency Smt. Pratibha Devisingh 

Patil, President of India, who delivered 

an important speech to the audience. 

In relation to the quality and safety of 

medicine, it is clear to everyone that there 

is no place for compromise. 

This was my ninth participation in the 

FIP Congress, so I was able to compare it 

with other similarly organised congresses 

held in various countries around the 

world. I mainly took part in the work of the 

The 71 st International Congress of 

FIP held in historic city of Hyderabad and 

first time ever in India was truly historic 

in many ways. The venue Hyderabad 

International Convention Centre, located 

near newly evolved Hitec city offered 

top class facilities for a global event 

besides the magnificence of surrounding 

Novotel complex. It was wise of FIP to 





pharmacists presented posters. Mr. Sagar 

Kulkarni, Yashasri Medical, Kalyan, Mumbai 

presented his work on “Implementation of 

Good Pharmacy Practices in my Pharmacy: 

Sharing of experiences”. His paper was 

Left-to-right, Latvian delegates Nora Krauja, Vita Ozoliņa, Ināra Rubene (press), 

Ieva Stupāns (a Latvian from Australia), and Inta Saprovska. 

Industrial Pharmacy Section (IPS) as well as 

being able to enjoy the opportunity for the 

purposes of an exchange of experiences 

when I was able to visit one of the local 

production sites, the Hetero Plant, where 

I was made to feel very welcome by the 

staff there. 

India welcomed us very warmly, and 

everyone we talked to or who we cooperated 

with was remarkably obliging and helpful. 

We greatly enjoyed the sunshine and 

Special features of 71 st International Congress of FIP 

venture out of Europe and land into India, 

a land of cultural diversity and citadel of 

pharmaceutical industry. 

The main theme – Compromising safety 

and quality - a risky path seemed not as 

large as the event. The contemporary 

proceedings deserved a rather finer title 

like evolving new bench marks for safety 

also selected for oral presentation in 

Community Pharmacy Section of FIP. 

The audience received his talk very well 

& delegates from African countries/Sri 

Lanka appealed to Mr Sagar to help them 

to set up GPP in their pharmacies. 

Mr Mahadev Patel, Patel Medical, 

Mulund, Mumabi presented poster 

on “Professionalizing services at my 

Pharmacy: Evolving from Medicine vendor 

to being an integral part of health care 

team”. He received very good response 

& there was excellent interaction with 

foreign delegates. 

These papers were co-authored by 

Mr. Nitin Maniar, Mr. Sunil Chavan & Mrs. 

Manjiri Gharat. 

- Manjiri Gharat 

Hon. Secretary, IPA-CPD 

the contacts we were able to make 

with colleagues from other countries in 

Hyderabad, and brought home with us 

the information and knowledge that we 

had gained in the Congress lectures. The 

Congress ended with a beautiful gala 

dinner and a wonderfully tasty meal. Surely 

we can say that we are looking forward to 

the opportunity to travel to India again. 

- Inta Saprovska, 

Head of IPS Latvia 

and quality-path for tomorrows. The 

Indian Pharmaceutical Congress (IPC) 

should take a leaf from this august event 

in organizing the program. 

The touchiest aspect about the event 

was the way one would identify oneself. 

Identifying oneself with the nation – ‘I am 

ABC from United States’ or ‘I am XYZ from 

India was a very satisfying experience. 

The most significant thing I learnt from the

congress was that industrial pharmacy 

and academic pharmacy are among nine 

different facets of pharmacy profession 

practiced by pharmacists. What I believed 

hitherto was generally recognized concept 

that community pharmacy, hospital 

pharmacy and pharmacy information 

services etc only represent pharmacy 

practice and that rest is pharmaceutical 

sciences. The organization of FIP into 

Board of Pharmaceutical Practice and 

Board of Pharmaceuticals Sciences meant 

that pharmacy science and pharmacy 

practice are intertwined and not mutually 

exclusive. While the former focuses on 

theory, the latter focuses on practical 

aspects. It was heartening to learn about 

the scope of activities of International 

Pharmaceutical Students’ Federation 

(IPSF) and Young Pharmacists Group 

(YPG) from different sessions organized 

by them. 

The organization of the event was 

truly professional. FIP had obtained 

accreditation for continuing education (CE) 

Sessions by FIP – Industrial 

Pharmacy Section 

Kaushik Desai, Chairman of IPA 

- Industrial Pharmacy Division and Vice 

President of Indian Pharmaceutical 

Association was the Session Chair along 

with Dr. Michael Anisfeld, Vice President, 

Industrial Pharmacy Section (IPS) of FIP 

in the session on ‘Good Manufacturing 

Practices: Expectations for the coming 

Decade’ on September 8 th 2011. 

While speaking on the ‘Need for 

education in Pharmaceutical Technology in 

the coming decade: Industry perspective’, 

Mr. Desai touched upon three areas 

namely, overview of Pharmaceutical 

Industry, Indian Education scenario and 

what needs to be done to meet challenges 

of next decade. Industry, Academia 

and Association will have to play a vital 

role in the development of industrial 

pharmacists’ skills and knowledge. The 

IT applications shall be integrated into 

pharmacy education and curriculum 

as well. The exposure of Industry and 

teachers to emerging and newer trends 

in their respective discipline is the need of 

the hour. In conclusion, Mr. Desai stressed 

the need to start value added courses in 

the pharmaceutical technology and gave 




for all/most sessions from several countries 

like Austria, China, France, Germany, 

Japan, Netherlands, Switzerland, UK etc. 

The congress would issue a statement 

of sessions attendance mentioning the 

date and duration upon the request by the 

delegate. This was besides the regular 

certificate of participation. Each speaker 

deliberated on the subject for about 20 

to 30 minutes and paid equal attention to 

question-answer session. The focus was 

on quality and not quantity of audience 

and speakers stuck to their task devotedly 

irrespective of the number of attendants. 

The formalities were reduced to only 

essentials like presenting a few slides about 

the organizers of the session, statement 

of no conflict of interest among speakers 

and very brief introduction of the speaker 

by chair/co-chair who in many cases also 

served as one of the speakers. There were 

no bouquets or mementoes offered to the 

speakers. The programs started at 9 am 

and concluded at 6 pm giving enough time 

for the delegates to relax and move around 

in the evenings. 

Kaushik Desai Dr. T. V. Narayana 

his insight on what is needed to be done 

both by Industry and Academia to meet the 

challenges of next decade. 

Mr. Kodandaram, Drug Controller 

of Andhra Pradesh share his thoughts 

on ‘Indian Drug Legislation and GMP 

inspections in India’. Mr. Kodandaram 

informed the august audience about 

recent steps taken by Indian regulators 

in bringing systems and new procedures 

to monitor clinical trials in India. India will 

need separate skills for medical devices 

which are another upcoming development. 

The Indian Pharmacopeia will have work 

towards inclusion of specifications for 

flavours, colours and taste masking resins 

to maintain the uniformity in standards. Mr. 

Kodandaram gave insight into changes 

expected in Indian drug legislations to meet 

the future requirements and bring India in 

par with global standards. 

Brief introductory session for the 

first timers was a welcome initiative. 

FIP showcase after the opening of the 

exhibition provided perfect opportunity 

to learn about FIP sections and special 

interest groups (SIGs) and forums. The 

exhibition included posters from each 

of these FIP bodies. The exhibition was 

good but did not offer much for people 

from pharma industry. The welcome party 

for all on first day and sectional dinners 

held separately for each section provided 

wonderful events for socializing. 

The Congress brought pharmacy 

professionals from India closer to their 

professional colleagues from rest of the 

world and helped them share mutual love 

and respect. The Indian Pharmaceutical 

Association, a constituent member of FIP 

and India Host Committee has added 

a feather in their cap by successfully 

organizing the historic global event. 

Dr. Jayant B Dave 

Hon. Secretary - IPA Gujarat State Branch 

Mr. T Rajamannar from Sun Pharma 

Advanced Research Centre shared his 

expertise on the ‘Future developments 

in ICH – Development & manufacture of 

drug substances.’ He explained ICH Q11 

guidelines in detail in a simple language 

and what is expected to change from the 

current scenario after implementation of 

this draft guideline. 

Dr. P Khadgapathi, Director, 

Pharma, Hetero Group elaborated on 

‘Indian Pharmaceutical Development 

– the challenges of the coming decade’ 

in his presentation. He outlined the 

various developmental challenges during 

the development of pharmaceutical 

product and the drug substance. He 

also mentioned that the industry will 

have to address the issues with regard 

to new technological advances and 

simultaneously tackle the infrastructure 

development issues to meet the future 

requirements. 

Dr. T V Narayana, Chairman, 

Education division of IPA talked on 

‘Need for education in Pharmaceutical 

Technology in the coming decade: 

Education perspective.’ While concurring 

with Mr. Desai on several aspects, 

he detailed the initiative taken by 

Pharmacy Council of India, the Indian 


(R-L) Dr. Mike Anisfield, Ram Banarase, 

Dr. Khadagapathi & Kaushik Desai 

regulatory agency to set standards of 

education in India, in framing of the new 

curriculum for pharmacy education both for 

undergraduate and post graduate degree 

courses. He also mentioned that although 

due importance is given in new proposal 

for Continuous Improvement Programmes 

(CEP) for teachers; the industry shall come 

forward and support this initiative. 

In addition to above, there were other 

experts from globe who shared their 

expertise during the session. Dr. Michael 

Anisfeld kick started the session by 

presenting on ‘GMP Expectations for the 

coming decade – where the GMP world 

is heading for 2020.’ He outlined the 

important features of GMPs followed by 

number of countries and gave update on 

recent developments in PIC. He shared 

his thoughts on his predictions for 2020. 

The important being incorporation of ICH 

Guidelines with GMPs, merger of ICH and 

PIC and having one global harmonized 

GMP by 2020. 

Dr. Tom Sam, Secretary of IPS, 

FIP shared his expertise on ‘Quality by 

Design –Implications for drug development 

and manufacture.’ He simplified QbD 

The 71 st FIP Congress witnessed 

an unprecedently high participation of 

Indian technocrats, scientists & leaders 

as resource persons. With sessions on 

topics as diverse as pharmacogenomics, 

pharmaceutical manufacturing, regulatory 

guidelines, pharmacoeconomics, military 

& emergency pharmacy, education, 

social & administrative pharmacy, public 

health, careers in pharmacy and so on, the 

Congress had something for everybody. 

Here we give you a glimpse of the 

presentations made by a few of the Indian 

speakers in the Congress … 





Delegates at Hetero during the industrial tour Dr. P. Khadagapathi presenting a bouquet 

to Dr. Mike Anisfield. Also seen on the left, 

terminology by saying that it is nothing but 

all about Science and Risk management. 

By taking example from report published by 

IBM on drug design, he explained the QbD 

principles and how it can help in smooth 

development of a product. 

Mr. Bruss Rose, representing US FDA 

India office talked about ‘FDA expectations 

and experiences when inspecting India drug 

and API manufacturers.’ Mr. Ross gave 

statistical information about the total number 

of inspections done by FDA in US and 

outside US. He explained in detail the top 

ten deficiencies observed during inspections 

and asked industry experts to take a note of 

these observations in preparing their sites 

for future inspections. FDA India office is 

established to help Indian manufacturer 

in clearing their doubts and educate the 

industry professionals in the new regulatory 

developments. 

The IPS FIP session ended with highly 

interactive question – answer session with 

closing remarks from Michael Anisfeld. 

=============================== 

A industrial tour was organized to M/s Hetero 

Drugs formulation manufacturing site for the 

members of Industrial Pharmacy Section 

Indian voice in the Congress 

(contributed by Dr. J. B. Dave, Raj Vaidya, Dr. T.K. Ravi & Manjiri Gharat) 

Dr. Bhojraj Suresh, Chairman, India Host 

Committee & President, Pharmacy Council 

of India 

Mapping a new vision – Translating ideas 

into practice 

“I extend greetings from one million pharmacists 

from India. We require ultimate competence 

level in pharmacists at all levels. In 

India, we have 6 lakhs pharmacists manning 

community pharmacy that are qualified but 

not trained in all aspects. We should not delink 

pharmacy practice and pharmacy science. 

What is good in developed countries 

Kaushik Desai 

of FIP. The members had a chance to 

see the world class manufacturing oral 

solid dosage manufacturing facility. On 

behalf of Dr. Parthasarathy Reddy, MD 

and Chairman of Hetero group of cos. 

Dr. P Khadgapathi welcomed the IPS 

members representing various countries 

and gave brief introduction about the 

company before tour. The members 

were highly appreciative of the facility, 

arrangements and the hospitality offered 

by Hetero. The visit was facilitated by 

Industrial Pharmacy Division of Indian 

Pharmaceutical Association. 

=============================== 

Dr. C Gopalakrishna Murty, President of 

IPA and Mr. Kaushik Desai, Vice President 

and Chairman of Industrial Pharmacy 

Division of IPA were felicitated by Michael 

Anisfeld, Vice President, FIP Industrial 

Pharmacy Section during annual general 

body meeting of IPS for their active role in 

helping IPS in identifying expert speakers 

from India, the organization of IPS sessions 

and the industrial tour. 

- Kaushik Desai 

Chairman, IPA- Industrial Pharmacy 

Division & Vice-President, IPA 

may take long 

time for achieving 

in developing 

countries. We 

need to develop 

Systems and 

A s s o c i a t i o n s 

to share wisdom 

and translate 

ideas into 

practice. Pharmacy 

practice 

regulations are in the offing in India” 

were the opening remarks of

Dr. B. Suresh. During his talk, Dr. Suresh 

charted out the roadmap for actualizing 

the potential of pharmacy profession in 

the developing nations. 

Subodh Priolkar, General Manager, 

Colorcon - Asia Pacific Pvt. Ltd. & Past 

President - IPA 

Ensuring Quality & Safety in Outsourcing 

Subodh Prio 

l k a r g a v e a n 

overview of the 

current & projected 

future global outsourcing 

market. 

After dwelling on 

the key drivers for 

outsourcing, Mr. 

Priolkar emphasized 

on the need 

to select the right outsourcing partner & 

the risks & challenges associated with the 

process. He emphasized the role of key 

activity metrics in lowering the associated 

risks & the importance of Quality Management 

System in building excellence as an 

outsourced partner is concerned. 

Raj Vaidya, Chairman, IPA-Community 

Pharmacy Division & Vice-President, IPA 

Managing risks, reducing costs - What is 

the impact on the individual pharmacist? 

R a j V a i d y a 

talked about how 

working Pharmacists, 

risks and 

costs in the pharmacy 

are a triad, 

each one affecting 

the other two 

In the pharmacy 

generally there are 

high prescription 

numbers, and a compulsion for the pharmacist 

to check each one of them for errors, 

drug interactions, and that medicines 

are correctly dispensed. There is a need 

to provide counselling or instructions to 

some or many of these prescriptions – and 

spend sufficient time with the patient to 

guide him on proper use of medicines. 

Besides, pharmacist may be needed to 

advise patients on general well-being and 

OTC medications. 

Dr. T. K. Ravi, Member, IPA- Education 

Division 

Can technology be useful in developing 

countries to improve teaching and 

learning? 




Dr. T. K. Ravi discussed 

the present status 

of teaching - learning 

process and the 

technologies adopted 

in these countries. The 

challenges to adopt 

these technologies and 

involvement of regulatory 

authorities like 

councils, accreditation 

boards, professional associations, universities 

and other professional stakeholders for 

monitoring and suggesting the inclusion of 

newer technologies(teaching using Smart 

boards, Computer Aided learning, Simulated 

learning, Audience response System, 

E-Learning, etc.) for teaching learning and 

evaluation of expected outcomes. 

Manjiri Gharat, Hon. Secretary, IPA- CPD 

& Chairperson, IPA DOTS TB Pharmacist 

Project 

India Round Table,organized by SEARPharm 

Forum 

Manjiri Gharat 

presented the DOTS 

T B P h a r m a c i s t s 

project, Mumbai & 

the proposed national 

scale up of this innovative 

public-private 

partnership. She, in 

detail spoke about 

the benefits of this 

pharmacists model 

for the National TB Control Programme 

& for the society. She acknowledged the 

socio-professional work of all participant 

pharmacists who were doing this noble work 

without any financial incentives. 

Jagganath Shinde, President, All India 

Organisation of Chemists & Druggist 

(AIOCD) 

India Round Table,organized by SEARPharm 

Forum 

J a g g a n a t h 

Shinde talked about 

the drug distribution 

system in India and 

how it works. He 

elaborated about AI- 

OCD’s professional 

inititative such as 

continuing education 

of pharmacists, 

computerization of 

pharmacies, etc. He emphasized that 

AIOCD’s vision was to develop a professional 

pharmacist. 

Archana Mudgal, Secretary, Pharmacy 

Council of India 

Vision of Regulatory bodies & four stages 

of growth 

Regulatory body is 

a statutory body & has 

a pool of talents from 

all facets that helps 

it in drawing policy 

and implementing the 

same. Statutory body 

requires visionary 

leadership that is ever 

evolving. Vision leads 

to mission and then 

establishment of strategies. There are 

four stages of growth - One, Retention 

of present; two, forecast based planning; 

three, global competence and four, 

strategic management. The first step 

involves accreditation of curriculum & 

institutions, adding new skills, continuing 

education program, planning bridge 

courses etc. The second stage is based 

on increased per capita income, increased 

literacy rate, increased awareness, 

increased quality of services and increase 

in need of professional excellence. Third 

stage involves mutual recognition of 

strengths & the fourth stage is based 

on requirement of environment of self 

regulation and self realization. 

Dr. Arun S. Nanivadekar, Medical 

Consultant 

Clinical practice, Clinical Research & 

Public Health –A Continuum 

Dr. Arun Nanivadekar discussed 

in detail the aspects 

involved in 

clinical practice, 

research & public 

health. Research 

in clinical practice 

is the need 

of the hour and 

this would include 

focus on relevant 

data, emphasis 

on accuracy & completeness, standard 

methods & procedures, databases for 

pooling, co-ordination of planning & data 

management, networking of research oriented 

practices by therapeutic areas and 

regulatory acceptance subject to some 

conditions of standardization. There is a 


need to evolve a new model for clinical 

trial where research can be based on clinical 

practice with good networking. Model 

should be based on Relton c et al model 

published in BMJ 2010:340: C 1066 

Dr. D. B. A. Narayana, Unilever Ltd. 

Quality of herbal medicines with regards to 

safety – Authentication, contamination & 

adulteration problems: Need for sustainable 

management of medicinal plants 

Dr. D. B. A. Narayana 

outlined the safety 

& quality issues associated 

with herbal 

products. He gave an 

update on pharmacopoeialspecifications 

of the various 

standard texts & the 

challenges associated 

with the newer tools of herbal drug 

evaluation. He concluded with discussing 

techniques of sustainable medicinal plants 

management. 

Dr. Michel Buchmann presenting a memento to Dr. B. Suresh. 

Also seen Dr. Gopalakrishna Murty & Ton Hoek. 

Mrs. Kamal Midha (left) with 

Mrs. B. Suresh 

(seatedL-R) S.D. Joag with Dr. & Mrs. Gopalakrishna Murty. (Standing 

L -R) Mrs. & Mr. Jayapal Reddy, Mr. & Mrs. Vasu Rao & Dr. Alka Mukne 

Sunitha C. Srinivas 





Associate Professor, Pharmacy Administration 

and Practice, Faculty of Pharmacy 

Empowering Women Pharmacists 

“In today’s world Goddesses are more 

powerful than Gods. The plight of women in 

developing countries is very encouraging. 

I have witnessed this in transition of my 

career from pharmaceutical chemistry 

in India to DIC in Karnataka to public 

health department in South Africa. I have 

realized that one has to establish goal or 

vision at every stage in one’s journey and 

that time is the essence – right time, right 

message & so on. We need more women as 

working pharmacists”, were some of Sunita 

Srinivas’s reflections in her session. 

Krishan M. Ella, Bharat Biotech International 

Ltd 

Biosimilars – Challenges & opportunities 

The regulators are faced with different 

challenges while dealing with biogenerics. 

Even if the end product & efficacy is same, 

Closing Dinner 

The Congress closed with a sparkling dinner where the delegates let 

their hair down to the tunes of some of the most glitzy Bollywood song & 

dance razzmatazz. In the midst of spectacular fireworks & carnival-like 

ambience, coupled with scrumptious seven course spread, the symbolic 

flag for the next FIP Congress marking the centennial celebrations of 

FIP, was formally handed over to the team from Amsterdam, marking 

the formal closing of the 7-day long mega meet. 

there are differences in adverse/toxic 

reactions due to differences in impurities 

and adventitious antigens. The US leads 

in biologic products. EMEA guidelines for 

biogenerics are very useful reference. 

Even after execution of material transfer 

agreement, moral rights of organs /cell 

lines etc rest with the innovator company. 

The position of Generic Pharmaceutical 

Association is that changes occur not due 

to variations in SOP but due to inherent 

biologic variation. The Indian regulatory 

scenario is that all biologics are treated 

as new drug and have to comply with 

requirements of Schedule Y. One requires 

performing only toxicity, phase I & III 

trials. The phase II trial is not required 

as innovator has established the dosage 

already. Alternatively, phase II & III can be 

combined. Biobetter products which claim 

better purity and safety due to improved 

technology require phase II trials as well. 

Although, bioinnovators will take little 

longer than generics, it is prudent to go for 

NDA than ANDA type of products. 

Dr. Renuka Datla (L-R) S. D. Joag, Prafull Sheth, Mrs. Sheth & Mrs. Vinod Shah 

Delegates enjoying themselves 

Dr. T. V. Narayana with Mrs.Narayana

(L-R) S. D. Joag, Dr. C. Gopalakrishna Murty, Dr. B. Suresh, Prafull Sheth, 

J. A. S. Giri & Jaypal Reddy at the press conference 

Dr. C. Gopalakrishna Murty addressing the invitees at the FIP 

Council Dinner, as Dr. B. Suresh looks on 




Dr. B. Suresh welcoming the invitees to the 

FIP Council Dinner 

Dr. Michel Buchmann with Dr. Vinod Shah Ton Hoek, CEO-FIP 

AIOCD booth at the exhibition 

Dr. Divakar Goli along with volunteers at the IPA booth in the exhibition Dr Rao Vadlamudi 


Dr. H. G. Koshia (2nd from right) along with Dr. K. Veerasuriya 

(2nd from left), along with other dignitaries 

Group of pharmacists Registration Counter 





Student volunteers with IHC members 

Delegates during the Congress 

Dr. T.V. Narayana with media representatives

71st INTERNATIONAL CONGRESS OF FIP - Indian Pharmaceutical ...

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