PHARMA PROFESSIONAL - Indian Pharmaceutical Association

The Indian Pharmaceutical Association 

PHARMA PROFESSIONAL 

Vol. 53 August 2010 

With the growth rate of 14 percent per year, the Indian pharmaceutical industry is well established for 

rapid expansion. Indian Inside Pharmaceutical the Issue Industry has made phenomenal progress over the years and made 

its impact in the global market. It has been recognized as a reliable source for drugs and drug 

• In intermediates Focus: Clinical and pharmaceutical Trails Market formulations. in India With the strengthening of the IPR scenario in the 

• News country, Brief the quarter ended December 31, 2005 witnessed major changes in the Indian pharmaceutical 

industry like the foreign MNCs increasing their presence in India through expansions and collaborations; 

• Product Indian companies Focus –Lipitor competing with them through new product launches and gaining more number of 

• Stock regulatory Scan approvals. Many multinational companies have penetrated into India with an objective to 

marketing drugs and conducting clinical trials. Thus, Indian pharmaceutical research, manufacturing and 

• Regulatory outsourcing Issues have received an impetus, thereby creating an image of a potential Pharma market and land 

• Upcoming of opportunities Events in the pharmaceutical division. Moreover the new Draft Drug Policy’ 2006 was released 

during this quarter. 

In Focus: Clinical Trails Market in India 

Introduction 

In the 21 st century, pharmaceutical industry is facing new challenges across the globe. Human population 

is confronted with several new diseases. Addressing these unknown diseases is becoming a major issue for 

the physician community. New diseases are testing the limits of science and technology development, 

globally. Another area of concern is that the existing diseases do not have appropriate drugs for treatment 

and control. 

After completion of Human Genome Project in 2003, the diagnostic science has taken the molecular 

direction to address many existing and newly developed diseases like AIDS, cardiovascular diseases, 

oncology, Alzheimer and Parkinson. With the help of advanced technology tools in life sciences, drug 

designing and development on the basis of genetic information of the disease has been the focus for 

many researchers in the pharmaceutical industry and life sciences research. Many pharmaceutical 

companies have started designing and developing the drugs on the basis of genetic information of 

diseases to avoid the trial and error method of development which was normally followed by the industry 

earlier. 

Clinical trial is a research study in human volunteers to address specific health queries to develop new 

drugs for a particular disease. Carefully conducted clinical trials are the fastest and safest ways to find 

treatments that work in people and ways to improve health. 

Global Scenario 

The global CRO market in value terms was US$19 billion in 2008 with a YOY growth rate of 14%. 

The traditional geographic areas of US, Western Europe and Canada, where clinical research has its roots, 

took a long time to reach the present quality. The market includes services such as clinical, bio-analytical, 

biostatistical, data management services, biomarkers, regulatory submissions, medical writing, an site 

management services for the four phases of clinical development of a NCE an the bio-analytical / bioequivalence 

services for generics. 

A joint Initiative by IPA and Cygnus to enable Pharma Professionals to be more 

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Indian Pharmaceutical Association 

Kalina, Santacruz (E), Mumbai – 400 098. 

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Email:ipacentre@ipapharma.org:: www.ipapharma.org 

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Pharma Professional August 2010 

The market is highly fragmented and the number of CROs worldwide has reached over 1,100 despite 

continued consolidation. The segment derives most of its revenues from the US base projects. 

Nonetheless, Europe and Asia are also important areas for CRO activity and the trends that affect 

industry players tend to operate on a global rather than regional basis. 

The road to the highly professional and ethical 

standards is littered with instances of poor protocol 

and study design, poor oversight of the trial by 

institutional review boards (IRBs). The various 

stakeholders have dealt freely, frankly and fairly with 

all these issues to uphold public trust in medical 

research. However, instances of professional 

misconduct that exist mostly do not include drug 

trials because of the stringent checks and balances 

that the FDA and International Conference on 

Harmonization (ICH) Good Clinical Practices 

(GCP) Guidelines impose. 

Others 

25% 

Phase IV 

17% 

Global CRO Market-2008 

Phase I 

IIa 

16% 

Phase 

IIb III 

42% 

According to Pharmaceutical research and manufactures of America (PhRma report, approximately 8,000 

drugs are always under development stage at a given time. Approximately 84,228 clinical trials were 

performed globally in 2009 and nearly nine million patients were participated in them. 

Indian Scenario 

In mid nineties, with the commitment to the 

WTO TRIPS (Trade Related Aspects of 

Intellectual Property Rights) agreement, Indian 

government started inflow of funds into 

research and development (R&D), both from 

local investors and multinational organisations 

with high potentiality. India possesses 

significant potential to become a preferred 

location for research and development for the 

global biotechnology and pharmaceutical 

sector. 

US$ million 

India Clinical Trials Expected Growth 

700 

630.12 

600 

500 

400 

320.21 

300 

200 

200 

100 

0 

2007 2009 2012 

To encourage R&D culture of innovation that would provide certainty to investors in medicinal R&D, 

India has prepared Patent Bill in January 2005. The new laws are expected to encourage more Foreign 

Direct Investments (FDI) in India and at the same time create an impact and encourage R&D in India. 

This is evident from the number of Clinical Research Organisations (CROs) who, encouraged by the 

recent regulatory reforms, are setting up operations in India. It is thus expected that with the new patent 

regime, India will soon make a mark for itself in the area of clinical research. 

Clinical trials outsourcing is now a major business in India (estimated to be US$3.2 billion by 2010). Over 

100 companies are currently involved in outsourcing in the country, ranging from Fortune 100 

heavyweights such as Pfizer and Merck, to Indian companies that have built their name mainly on 

generics, such as Daiichi Sankyo and Dr. Reddy's. 

In India, around 700-800 clinical studies were done in 2008, in which roughly 440 clinical studies were 

involved multinational companies, which is very much lower than the other competing countries like 

Korea with 740 trials and china with 670 trials. Moreover India participates in 7% of global phase III and 

3.2% of phase II trials (that were started in 2008) with industry sponsored trial have grown at a 

spectacular 39% CAGR during 2004-08. 


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India has become a favourite location for global pharmaceutical and biotech companies for clinical trials 

in new products. The simple reasons are: firstly, India has recently emerged as a hot destination for 

clinical trials. Secondly, Due to the multitude of benefits it offers, the country is fast growing as a centre 

for conducting clinical trials for many international companies. Lastly but not the least India has huge 

patient base, low cost advantage; can complete clinical trials on time; is improving its infrastructure with a 

strong government support. 

According to a McKinsey report, employee costs of a lab technician in India are only 6% of that in the 

US, and 8 % in the case of a quality control scientist. It is well documented that the average costs of 

doing Phase I/II/III drug trials in US are US$20/50/100 million respectively whereas in India they are 

50-60% of the same and could be up to 75% faster (Table I). India also has the advantage of having a 

large pool of highly trained physicians, nurses, and technical personnel; numerous world-class medical 

facilities; broadly developed information technology infrastructure; a favourable IPR environment after 

signing the WTO and use of English as the primary business and medical language making it an attractive 

option for health care companies for clinical trials. 

Cost of clinical trials in US vis-a-vis India 

Study 

Average US cost India Cost 

(In millions) 

Phase 1 (normally tests on small groups of 

healthy humans) 

US$20 

50% less than the average 

cost in US 

Phase II (tests on individuals afflicted with 

the condition for which the drug was 

developed) 

US$50 


cost in US 

Phase III (tests on large groups of afflicted 

patients) 

US$100 


cost in US 

According to Indian industry, clinical-trials outsourcing is a "tempting" opportunity for the country's drug 

industry. 

In 2009, clinical trials were reckoned to have generated US$320 million in revenues for the industry, 

which could grow to US$389 million in 2010 and anywhere between US$550 million and US$630 million 

by 2012. 

According to industry standards, a volunteer earns anything between Rs.3,000 and Rs.15,000 based on the 

requirement of the study and could take part in three studies in a year. 

Rising tide of research and clinical trials 

Currently, about 80 government and privately owned Indian hospitals are engaged in global and local 

clinical trials. According to unofficial sources, this figure will increase exponentially in India to an 

estimated 35,000 hospitals, 668,644 lakh doctors, 0.8 million beds, 300 medical colleges and 28,158 

medical graduates per year. 

The total market value of clinical research performed in India in 2008 was about US$ 489 million and 

shared about 2.59% of global clinical trials, which grew by 42% when compared to previous year. The 

firm increase in CRO activities can be attributed to large subject pools in most major therapeutic areas, 

improved medical infrastructure and increased awareness of the ICH Guideline for Good Clinical 

Practice and formation of specialised pool research investigators. Increased awareness of good clinical 

practice (GCP) and strong desire for international acceptance of research has brought positive changes in 

the attitudes of clinicians all over India. Investigators, most of who have been trained in Western Europe 

or the United States, are now consolidating their extensive research experience base and are eager to show 

the world that India can accommodate large clinical studies. 


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India announced that all pharmaceutical clinical research must strictly follow government-issued GCP 

guidelines. These guidelines were formulated by an expert committee set up by the Central Drugs 

Standard Control Organization in consultation with relevant experts. Consequently, the level of research 

and ethics in some institutions is now on par with international standards. 

CRO is a Contract Research Organization, offering clinical studies, monitoring, regulatory and 

compliance services for new drug development, medical devices and biologics and combination of 

products. CROs also provide clinical testing services to the pharmaceutical industry for prescription, 

consumer and over-the-counter medications. 

India Clinical Trials Done 

In India, phase III clinical trials are having major share with 65% then followed by phase II (20%) and 

phase IV (10%) respectively. In that, majority of the clinical trials are sponsored by industry (74%) for 

407 clinical trials then by Govt/ NGO/ others for 125 clinical trials, which is 24%. 

2.5.1 Indian Companies 

In the coming years, Indian CROs stand to gain as the clinical trials market is expected to record a 

double-digit growth over the next decade. It will be driven by increasing outsourcing by drug developing 

companies. Currently, Indian clinical trial organisations are in their infancy with the global share of 2.59% 

(2008) in global clinical trials market. Over the years, Indian firms were able to offer complete services in 

animal toxicology, BE/BA studies, Pharmacokinetics, etc. Chembiotek, Vimta labs and Lotus labs are the 

leading players in this segment. The companies like Clingene, Syngene international ACT and Siro 

Clinpahram are the upcoming CROs and showing strong growth. Companies are moving to provide all 

the services in this segment from back office support, medical writing, statistical analysis and SAS 

programming, data management, etc. The activity in India is being fuelled by the direct presence in the 

country of over 20 prominent Contract Research Organisations (CROs), which are now operating in the 

country, attracted by India's ability to offer efficient R&D on a low-cost basis. 

Multinational Companies 

Multinationals are also stepping into the Indian market, attracted by the vast pool of scientific talent. 

Multinational companies operating in India will control nearly 8-10% of the total market with their 

patented medicine worth US$8 billion in the domestic pharmaceutical market by 2015. During 2004-08, 

India involved in 7% & 3.2% of global phase III & II clinical trial with industry sponsored trials. Top tier 

pharma companies like GSK, Aventis, Novartis, Novo Nordisk, Astra Zenica, Eli Lilly, etc., are also 

conducting clinical trials in India. Also, several Indian and global organizations such as Quintiles, 

Omnicare and Pharm-Olam are holding clinical trials in India on behalf of US-based pharmaceutical 

companies. More are likely to follow the suite after the introduction of product patents in 2005 and some 

clarity emerges on data protection. MNC players in the CRO segment are ICON Clinical Research, 

Omnicare Clinical Research, Pharmanet global, Pharm-Olam, ClinTec International and Quintiles 

Spectral. 

Future Outlook 

Indian pharmaceutical industry is one of the fastest growing sectors in the Indian economy and has made 

rapid strides over the past few years. The industry has achieved self-sufficiency and gained global 

recognition as a producer of low cost, high quality bulk drugs and formulations. Having proved itself in 

the international market, India is ready to face the challenges of proving its efficiency as the preferred 

destination for global clinical trials. Nascent markets like Phase I and pre-clinical toxicology will see 

growth due to the pressure from the industry on government and the industry’s need to become a onestop 

solution for its clients. 

Though clinical research was predominantly conducted in the West in the past, it is unlikely to hold good 

in the future. Developing countries such as India, China, those in Latin America and South East Asia are 

increasingly becoming capable of catering to the growing needs of the industry. With the increasing 

business opportunities in these future’s markets pharmaceutical companies are devising tailor-made 

strategies for the developing countries, which include exploiting the potential for clinical research. 


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Indian CROs stand to gain in the coming years as the clinical trials market is expected to record a doubledigit 

growth over the next decade propelled by increasing outsourcing by drug developing companies. In 

Asian countries, alliance & acquisition will be seen as strategy among CROs. 

Clinical research outsourcing industry in 

India is set for a major growth in terms of 

revenue, thanks to the country’s inherent 

advantages like low cost, fast patient 

recruitment, large pool of patients, large 

base of qualified personnel, etc. Based on 

these advantages, the number of clinical 

trials in India is expected to grow 

exponentially over the next five to ten 

years. Globally, the market for clinical trials 

and data management is estimated at 

around US$45 billion, the market has the 

potential to outsource 50-60% of it to 

destinations like India. 


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US$ million 

1200 

1000 

Figure 9.1:India Clinical Trial Market 

Projections(2010-14) 

Indian clinical trials market in 2009 was worth US$ 320 million. The market has been growing at a CAGR 

of 34% for the last 5 years. The industry is estimated to reach US$1.08 billion by 2014. In the coming 

years, with the current revenue the Indian clinical research outsourcing market is likely to grow at a 

phenomenal rate of 30-40%. As per McKinsey within five years, 1,500 to 2,000 GCP studies will be 

conducted in India per year, requiring 10,000 to 15,000 GCP-trained investigators, and supported by 

50,000 clinical research professionals. 

India has substantial capacity to meet the rapidly growing demand for clinical trials. It has 300 

universities, over 750 graduate and post-graduate programmes, and about 50 million college graduates. 

The crucial aspects that would impact and influence the success rate of India’s CRO endeavours include 

good quality of data, adherence to good clinical practices and superior economic metrics, pursuing ethical 

practices. Lack of good clinical practice (GCP) certified sites and investigators always impede the growth 

of the clinical research in the country. Be it costs, patient recruitment rate, facilities and investigator pool 

or revamp on the regulatory front, Asian countries and those in Eastern Europe are slowly closing the 

gap with India. In the current context it is important that Indian CROs offer most cost effective trials 

solutions which should bring down the cost of research trials significantly. Global recession has made 

every pharmaceutical and biotech company considering how to speed the clinical trials process, track 

progress, control performance and save costs. Therefore, there is a greater emphasis on ensuring that the 

clinical trials that do survive budget cuts provide the best possible return on investment. Surely there 

would be pressure on the budget for the new drug discovery due to current global recession and increased 

penetration of generics in the global market particularly the US which may restrict the growth in 

outsourcing clinical trials in the countries like India and China to some extent. However, India and China 

become highly attractive propositions for drug developers not only because outsourcing clinical trials to 

these countries are cheaper but also an appreciation of their potential as emerging pharmaceutical 

markets. Cygnus estimates that during 2010 -2015 clinical trials market will grow at a CAGR of 30%. 

Unmet medical needs in oncology, CNS, cardiovascular, and infectious diseases will continue to be major 

drivers of drug development globally. CROs focusing on full-service offerings in these therapeutic areas 

will continue to grow profits. In conclusion, one could state that unlike in other industries, the current 

financial crisis will create opportunities for contract research organizations. The recession might result in 

reduced growth rate, but the mid- and long-term effects of downsizing of R&D in the pharmaceutical 

industry will create opportunities for contract researchers. Currently India manages 15% of the global 

outsourcing of clinical trials. Cygnus estimates that by 2015, Indian CROs would be capable enough to 

manage about 25% of the global clinical trials outsourcing by improved regulatory environment, qualified 

and experienced personnel and stringent data management practices. 

800 

600 

400 

200 

0 

398 

498 

630 

826 

1082 

2010 2011 2012 2013 2014 

Source: Cygnus Research 




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News Briefs 

MARKETING 

Americas 

Watson Pharma launches generic Exelon in US market 

Watson Pharmaceuticals, Inc. has a settlement with Novartis Pharmaceuticals Corporation, Novartis 

Pharma AG, Novartis AG, Novartis International Pharmaceutical Ltd., and Proterra AG (collectively 

Novartis), Watson has commenced shipment of a generic version of Exelon (rivastigmine tartrate) 1.5mg, 

3mg, 4.5mg and 6mg capsules. Exelon is used to treat dementia (a brain disorder that affects the ability to 

remember, think clearly, communicate, and perform daily activities and may cause changes in mood and 

personality) in people with Alzheimer's disease. Under the terms of the settlement agreement, Novartis 

granted Watson a license to its US patents covering Exelon for a generic version of Exelon. 

Holzkirchen: Sandoz introduces generic version of Lovenox in US 

Sandoz introduced enoxaparin sodium injection, the first generic version of Lovenox, in the US. Product 

shipment began immediately following approval by the US Food and Drug Administration (FDA). 

Sodium injection is the best-selling hospital medicine in the US, and has been described as the 'gold 

standard' for anti-thrombotic treatments. Lovenox, the reference product, recorded US sales of US$ 2.7 

billion in 2009 and has been used to treat an estimated 200 million patients worldwide since it was 

launched. 

Pittsburgh: Mylan launches generic version of Solodyn tablets in US 

Mylan Inc. received final approval for its Abbreviated New Drug Application (ANDA) for Minocycline 

Hydrochloride Extended Release tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version 

of Solodyn ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Mylan 

Pharmaceuticals Inc. commenced immediate shipment of the product after approval. It reached 

settlement and license agreements with Medicis resolving patent litigation relating to Minocycline ER, and 

the company has ceased additional distribution. Pursuant to the terms of the agreements, Medicis will 

release Mylan from any liability related to the prior sales of this product, and will have the right to market 

Minocycline ER in the US beginning in November 2010. 

Asia-Pacific 

India: Merck Millipore to focus on high margin specialty products in growth markets 

Merck Millipore focuses on the rapidly growing and highly profitable sector of bio-pharma research and 

production. The division operates as EMD Millipore only in US and Canada. Merck assumes annual cost 

synergies of around € 75 million (US$ 100 million), expected to be realized by 2012 end. The Merck 

Millipore transaction views on primarily combining expertise and capabilities. Key cost synergies will 

come from streamlining global general and administrative functions and implementing best practices. The 

new division is almost twice the size of Millipore or Merck Performance Chemicals alone, with around 

10,000 employees in 64 countries. 

Sun Pharma gets US FDA nod to market generic Flomax 

Sun Pharmaceutical Industries Ltd. has granted approval for its Abbreviated New Drug Application 

(ANDA) to market a generic version of Flomax, tamsulosin capsules. Tamsulosin hydrochloride capsules, 

0.4mg are therapeutically equivalent to Flomax capsules 0.4mg from Boehringer Ingelheim 

Pharmaceuticals, Industry Tamsulosin hydrochloride capsules are indicated for the treatment of the signs 

and symptoms of benign prostatic hyperplasia. 


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Bafna Pharma gets UK MHRA approval for clonazepam 

Bafna Pharmaceuticals engaged in the business of manufacturing of pharmaceutical formulations of betalactum 

and non–beta-lactum, has received approval from Medicines and Healthcare products Regulatory 

Agency of the UK (UK MHRA) for manufacturing clonazepam 0.5mg and 2mg tablets. Following this 

development, it is the ninth formulation approval received for a product by the company for contract 

manufacturing. The approval will provide further momentum to expand business in the European market 

and will enable Bafna Pharma to widen the customer base in Europe. 

EUSA Pharma grants Japanese rights of Erwinase oncology therapy to Ohara Pharma 

EUSA Pharma has focused on oncology, pain control and critical care, has granted the Japanese 

development and commercialization rights to its oncology therapy Erwinase to Ohara Pharmaceutical 

Company Limited. The agreement represents the first product partnership EUSA has established in 

Japan. Under the terms of the companies' agreement, Ohara will be responsible for any late-stage 

development required by the Japanese authorities, and will pay EUSA an upfront fee and royalties on 

future sales. 

Wyeth launches 'Prevenar 13' vaccine in India to treat pneumonia 

Wyeth has launched Prevenar 13, an advanced pneumococcal conjugate vaccine to protect infants and 

young children from pneumococcus, a bacterium that causes pneumonia, meningitis and sepsis. The new 

vaccine covers serotypes 1 and 5 that are associated with complicated pneumonia. Further, it covers 

serotype 19A which has globally emerged a leading cause of pneumococcal disease in children less than 5 

years of age. Currently, the cost of Prevenar 13 vaccine is Rs3800 in India and few emerging markets for 

the full 3-dose series. 

Indian APIs flying high in global market 

Active Pharma Ingredient (API), the main ingredient in a pharmaceutical product is responsible for the 

potency and efficacy of a drug and at the same time for the major portion of overall costs of a drug. 

Therefore, companies need to look for high quality and cost-effective APIs. Qualitative API will produce 

drugs with superior quality enabling the company to pass through the Food and Drug Administration 

(FDA) approval process with relative ease, while reducing the cost of manufacturing and increasing 

margins. 

Europe 

England: New Research Project to Develop Reliable and Cost-Effective Virtual Autopsies 

New research project at the University of Leicester is set to play a vital role in continuing research into 

viable alternatives to invasive autopsies, which many families find to be unpleasant. Currently, diagnoses 

such as coronary heart disease cannot be made by using CT scans. It is hoped that this new project will 

develop a reliable and cost-effective system that can be used to diagnose coronary heart disease from CT 

scans. The technology will be used to visualize coronary arteries in cadavers and make a diagnosis 

comparable to current autopsy practice. 

Skin Cells Could Help Discover Cause of Parkinson Disease 

Researchers are applying new stem cell technology to use skin samples to grow the brain cells thought to 

be responsible for the onset of Parkinson's disease, according to a presentation at the UK National Stem 

Cell Network (UKNSCN) annual science meeting. Team will be gathering data from over 1,000 patients 

with early stage Parkinson's disease and taking small samples of skin tissue to grow special stem cells -- 

induced pluripotent stem cells (iPS) cells, which can be generated from accessible tissue such as the skin 

and then used to generate specific types of cell. The researchers will use the iPS cells to grow dopamine 

neurons -- the brain cells responsible for the production of dopamine, as it is these cells which die in 

patients with Parkinson's, leading to the onset of the disease. 


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Middle East 

Venus Remedies plans brand building exercise to tap Middle East markets 

Venus Remedies is gearing up to step up its presence in the Middle East markets. The company which is 

in the early phase of exporting is confident of garnering a 20% market share with its range of oncological 

and cephalosporin injectable products in a couple of years. The focus is on 'Brand Building' only across 

all markets but particularly Middle East. The company will expand markets and romp up staff. Its key 

strengths are 59 international GMP certifications from different countries for its nine super speciality 

injectable manufacturing facilities. Venus has filed 10 dossiers for oncology, cephalosproin and 

carbepenem products in many global markets. 

GlaxoSmithKline sells Italian research facility to Aptuit 

GlaxoSmithKline (GSK) and Aptuit, Inc have finalised an agreement for Aptuit to acquire operations at 

GSK’s Medicines Research Centre in Verona, Italy. The arrangement, which is effective provides for 

ongoing employment of the staff at the centre and for Aptuit to supply GSK with R&D services from the 

facilities. Financial terms have not been disclosed. Under the agreement Aptuit will gain the scientific 

expertise and knowledge at the research centre through the transfer of the facility’s approximately 500 

staff from GSK to Aptuit. This will help maintain the life sciences research and talent pool in Italy and 

also allow Aptuit to provide integrated development services to its global customers. 

INVESTMENTS 

Americas 

Sunesis Pharma receives European patent covering voreloxin combination 

Sunesis Pharmaceuticals, Industry has granted a European patent covering combinations of the 

company's lead drug candidate, voreloxin, with cytarabine. This patent is an important new addition to 

company intellectual property estate. Company is pursuing a sophisticated and deliberate strategy to 

provide exclusive coverage in the voreloxin patent estate out to 2030. Company has filed patent 

applications covering formulations, combination uses, dosing, manufacturing processes and composition 

of matter claims and look forward to the successful prosecution of these patent applications in multiple 

territories around the world. 

Centre plans to invest Rs15 billion for Pharma research infrastructure 

The Government is planning to spend around Rs10-15 billion towards improving the infrastructure for 

the pharmaceutical research to encourage new drug discovery during the next 15 years as part of the 

ambitious Pharma Infrastructure and Innovation Development Initiative. The Centre will be putting this 

money as the corpus fund for the initiative which will be run by a venture capital fund with the 

participation of the private sector and aimed at making the domestic industry globally competitive 

through medium and long term development plans. 

Asia-Pacific 

India: GSK forms new operating unit for Least Developed Countries 

GlaxoSmithKline (GSK) creating a new operating unit dedicated to the Least Developed Countries 

(LDCs). A new Developing Countries and Market Access operating unit has been created which will 

integrate GSK's pharmaceutical business in LDCs into one group. The group will provide a dedicated 

focus on the strategic approaches needed to expand access to medicines for patients living in these 

countries. Creating an operating unit specifically for the Least Developed Countries builds on company 

commitment to change the landscape of healthcare for the world poorest people. 


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Mergers & Acquisitions 

Americas 

Ortho-McNeil-Janssen Pharma signs pact with Koch Institute for Integrative Cancer Research 

Ortho-McNeil-Janssen Pharmaceuticals, Inc (OMJPI) has signed a five-year collaboration agreement with 

the David H Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology 

(MIT) called TRANSCEND, the collaboration agreement that will foster oncology research and 

technology development in the areas of cancer diagnostics, cancer biology pre-malignancies, genetic 

models of disease, and profiles of the tumour microenvironment. By collaborating with leading academic 

institutions and colleagues at the interface of engineering and biology, company able to bring together the 

best scientific minds in industry and academia to meet unmet medical needs in patients with cancer. 

Lilly to acquire biotech company Alnara Pharma 

Eli Lilly and Company and Alnara Pharmaceuticals, Inc have signed a definitive merger agreement 

whereby Lilly will acquire Alnara, a privately held biotechnology company developing protein therapeutics 

for the treatment of metabolic diseases. Alnara’s lead product in development is liprotamase, a nonporcine 

pancreatic enzyme replacement therapy (PERT). Liprotamase is under review by the US Food 

and Drug Administration for the treatment of exocrine pancreatic insufficiency (EPI). 

Watson Pharma acquires rights to Itero Biopharma rFSH product 

Watson Pharmaceuticals, Industry worldwide licensing agreement with Itero Biopharmaceuticals, Inc., a 

venture-backed specialty biopharmaceutical company, to develop and commercialize Itero's Recombinant 

Follicle Stimulating Hormone (rFSH). The product is currently in preclinical development as a biosimilar 

molecule for the treatment of female infertility. Under the terms of the agreement, Watson will pay Itero 

an undisclosed licensing fee and make additional payments based on the achievement of certain 

development and regulatory performance milestones. 

Aeterna Zentaris collaborates with Almac to develop therapy & companion diagnostic in cancer 

Aeterna Zentaris Industry had a collaborative study with Almac’s Diagnostics division for the company’s 

doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108, 

aimed at determining LHRH receptor expression through the development of a companion diagnostic 

tool. Selection for treatment with AEZS-108 is determined on the basis of LHRH receptor expression, 

currently measured immunohistochemically. Company pleased with the collaboration with Almac who 

have proven experience in the development and validation of companion diagnostic tools and potential 

biomarkers in cancer indications. 

Europe 

France: Sanofi-aventis to acquire US biopharma firm TargeGen for US$560m 

Sanofi-aventis has signed an agreement for the acquisition of TargeGen Inc (TargeGen) a privately held 

US biopharmaceutical company developing small molecule kinase inhibitors for the treatment of certain 

forms of leukaemia, lymphoma and other haematological malignancies and blood disorders. Sanofiaventis 

brings much strength to the continued development and potential commercialization of 

TG101348. The acquisition of TargeGen represents a further significant step to increase the engagement 

in the field of haematological malignancies and also strong commitment to oncology to provide patients, 

physicians and public health stakeholders with breakthrough medicines addressing unmet medical needs. 

Asia –Pacific 

India: Fortis Healthcare Offers To Buy Parkway Holdings For US$2.3 billion 

India's Fortis Healthcare and its promoters have offered to buy all the shares of Singapore's Parkway 

Holdings for US$2.3 billion. Parkway Holdings is a major player in health sector that operates 16 

hospitals in the Asia-Pacific region. This is a major initiative by Indian based Fortis Healthcare after 

partial takeover of 24% shares by the rival Malaysian state fund, Khazanah Nasional Berhad. The 

Malaysian company offered the company's shares at Singapore S$3.78 per share. Fortis Healthcare is 


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promoted by brothers Malvinder and Shivinder Singh and is in a battle with Khazanah for control over 

the hospital chain. Fortis would be a subsidiary of Parkway holdings after the successful bid and can make 

its entry into other markets under the Parkway banner. 

TECHNOLOGY 

Americas 

California: Studies Gauge Techniques for Measuring Breast Density 

Two new studies have tested three different methods for accurately measuring breast density the relative 

portion of tissue to fat in a woman's breasts and a strong indicator of breast cancer risk. Better measure 

of breast density should yield a more accurate assessment of risk for developing breast cancer the research 

applied dual energy mammography to 20 pairs of postmortem breasts. The technique makes use of dual 

energy X-ray imaging, where overlapping tissue signals can be isolated and quantified by exploiting the 

change in X-ray attenuation at different energies. 

Image-Processing Algorithm Reduces CT Radiation Dose by as Much as 95% 

Perfusion CT scanning, an emerging imaging technology, got a bad rap last year when a machine set to 

incorrect radiation levels overdosed hundreds of people in Los Angeles. In the wake of this incident, 

researchers at the Mayo Clinic, excited by the technology's promise for diagnosing stroke, cancer, and 

possibly heart disease, have developed a way to reduce the amount of radiation involved in the procedure 

-- which, when done properly, already involves very little risk. Typical CT perfusion procedure lasts about 

half a minute and scans the same tissue many times, each scan at a low dose. These scans both reveal the 

internal anatomy of the patient and show how levels of a contrast agent, such as iodine injected into the 

bloodstream, change of over time. 

Technology Improve Treatment for Children with Brain Cancer 

The American Association of Physicists in Medicine (AAPM) shows that children with brain tumors who 

undergo radiation therapy (the application of X-rays to kill cancerous cells and shrink tumors) may benefit 

from a technique known as "intensity modulated arc therapy. This technique relies upon new features on 

the latest generation of X-ray therapy equipment that allow X-ray sources to be continuously rotated in 

any direction around a patient during treatment, potentially increasing the number of directions that the 

beams come from. 

Scientists Take High Resolution Photo of a K+ Channel 

Research team from the University of Oxford, for the first time, were able to take a high resolution 

picture of the open state of a K+ channel, allowing to comparatively analyze gating mechanisms 

important to heart function and nerve signaling in addition these techniques have already permitted Case 

Western investigators to gain a deeper understanding of G-protein coupled receptors. GPCR the targets 

of more than half of all pharmaceutical drugs, are important signaling molecules and help regulate proper 

channel function. With a new window on the open state of the channel, researchers have an opportunity 

to better understand the effectiveness of drugs used to treat and prevent cardiovascular diseases. 

MRI Better than CT Scans at Diagnosing Stroke 

Doctors use a diffusion MRI scan to diagnose stroke instead of a CT scan, according to a new guideline 

from the American Academy of Neurology. While CT scans are currently the standard test used to 

diagnose stroke, the Academy's guideline found that MRI scans are better at detecting ischemic stroke 

damage compared to CT scans that are a specialized kind of X-ray taken of the brain while MRI uses 

magnets and radio waves that show clearer images of brain tissue. Diffusion MRI measures molecular 

water motion in the tissue, showing where water diffusion is restricted and therefore brain damage has 

occurred. 


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FDA APPROVAL 

Glen mark Generics gets US FDA nod for norethindrone acetate tabs 

Glen mark Generics Industry has received final ANDA approval from US FDA for norethindrone 

acetate 5mg tablets and will commence marketing and distribution of the product immediately. 

Norethindrone acetate is the generic version of Duramed Research, Industry Aygestin and is indicated for 

the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal 

imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. According 

to IMS Health, these tablets garnered approximately US$27m in sales for the 12 month period ending 

March 2010. 

APP Pharma gets US FDA nod to market preservative-free Heparin Lock Flush Solution 

APP Pharmaceuticals, Inc has received clearance from the US Food and Drug Administration (FDA) to 

market preservative-free Heparin Lock Flush Solution, USP in two dosage strengths, 10 USP Units/1 mL 

and 100 USP Units/1mL, and will soon launch these single dose vial presentations. The US FDA 

clearance to market a preservative-free Heparin Lock Flush Solution provides healthcare professionals 

with a safer alternative to maintain the patency of intravenous injection devices used in neonates and 

paediatric patients. This approval further expands comprehensive heparin product line. 

Glenmark subsidiary receives US FDA nod for Theophylline tablets 

Glenmark Generics Industry have been granted ANDA approval from the United States Food and Drug 

Administration (US FDA) for Theophylline extended-release tablets, the generic version of Purdue 

Pharmaceutical Products, LP Uniphyl. These tablets are available in strengths of 400 mg and 600 mg. The 

company will commence marketing and distribution of this product immediately in the US and anticipates 

a successful launch based on limited competition existing in this niche segment. It had annual sales of 

US$8m. 

Synageva BioPharma SBC-102 gets US FDA orphan drug 

Synageva BioPharma Corp has granted orphan drug designation for SBC-102, the company’s enzyme 

replacement therapy in development to treat Lysosomal Acid Lipase (LAL) Deficiency, also known as 

Wolman Disease and Cholesteryl Ester Storage Disease (CESD), a condition for which there is currently 

no approved treatment. The orphan drug designation, Synageva BioPharma will be eligible to receive a 

number of benefits, including access to grant funding for clinical trials, tax credits, waiver of the US FDA 

filing and registration fees, and seven years of market exclusivity upon approval. US orphan drug 

designation is granted to a product that treats a rare disease, a condition that affects fewer than 200,000 

Americans. 

Alimera seeks US FDA priority review for its Iluvien NDA to treat diabetic macular edema 

Alimera Sciences, Inc., a biopharmaceutical company specializes in the research, development and 

commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application 

(NDA) to the US Food and Drug Administration (FDA) for Iluvien, (flucocinolone acetonide intravitreal 

insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone 

acetonide for the treatment of diabetic macular edema (DME). In the submission, Alimera requested 

priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of 

2010. 

Lupin's famotidine for oral suspension gets US FDA approval 

Lupin Pharmaceuticals, Inc. has received final approval for the company's Abbreviated New Drug 

Application (ANDA) for famotidine for oral suspension (40mg/5 ml) from the US Food and Drug 

Administration (FDA). Commercial shipments of the product have already commenced. Lupin's 

famotidine for oral suspension is the AB-rated generic equivalent of Merck's Pepcid indicated for the 

short-term treatment of active duodenal ulcer, active benign gastric ulcer, and gastroesophageal reflux 

disease (GERD). Pepcid for oral suspension had annual sales of approximately US$29m for the twelve 

months ended March 2010. 


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Asia pacific 

DoP DBT, industry to set up working group to tap potential of biopharma sector 

The Department of Pharmaceuticals (DoP) will form a working group with representatives from the 

Department of Biotechnology (DBT), industry bodies like FICCI and the leading industry players to work 

out strategies to make India a leader in the biopharma sector, through various initiatives including 

streamlining the regulatory system. Both the industry and the Government decided to focus on 

biopharma which is growing fast in other regions of the world. The overall goal, is to make India a 

leading producer of affordable biopharmaceutical products by 2020. The DoP also assured the industry to 

look into the demand for the simplification of the regulatory system by setting up a single window 

clearance instead of having multiple bodies. 

Pfizer expands Asian manufacturing facility, invests US$100m in Singapore nutrition plant 

Pfizer Inc announced a US$100m investment into the expansion of its Singapore Nutrition Plant, helping 

it continue to set the standard for the manufacture of high-quality, safe and environmentally sustainable 

nutritional products for infants and children. This expansion, which brings the total investment in the 

plant to US$372m, makes it one of the largest nutritional plants worldwide. The expansion of the plant to 

91,963 square meters (the equivalent of 17 football fields) has boosted the plant's production capacity by 

50% and increased the plant's ability to supply nutrition products to Singapore and to the key markets 

RESEARCH & DEVELOPMENT 

Americas 

US: Brown Rice, Could Reduce Diabetes Risk 

US researchers suggest that eating more brown rice and less white rice, and similarly for other grain 

foods, eating more whole grain and less refined grain, could lower people's risk of developing type 2 

diabetes, because unrefined grains have more nutrients and fiber, which slow the rush of sugar into the 

bloodstream, according to Dr Qi Sun who worked on the study while at Harvard School of Public Health 

(HSPH). 

Hormonal Contraception Options for Men 

Researchers are making progress on studies of hormonal birth control for men -- such as testosteroneblocking 

gels or injections. Researchers have focused on blocking sperm production with use of 

testosterone because it is known to cause sterility in excess amounts. However, other studies have 

examined the use of the synthetic hormone progestin, which is used in female contraceptives. Presently, 

male testosterone pills have been unsuccessful as contraceptives because the body absorbs the hormone 

before it can block sperm production, but researchers have had some success with injectable or topical 

hormones. 

Vitamin C is a cancer fighter 

Vitamin C has been known for its health benefits, but now research is confirming its power as a cancerfighter 

too. The study, led by Margreet Vissers, associate professor at the University of Otago's Free 

Radical Research Group, has come up with the first real evidence of a connection between vitamin C and 

tumour growth. Vissers says, "study results offer a promising intervention to help in the fight against 

cancer at both the level of prevention and cure," Tumours with low vitamin C levels were found to have 

more of a protein called HIF-1 which allows them to thrive in stressful conditions. The findings are 

significant as they show, for the first time, a direct relationship between HIF-1 and low vitamin C levels in 

tumours. 

Damaged heart may be able to repair itself 

An Indian-origin scientist led researchers’ team at the Gladstone Institute, University of California have 

found a way to make damaged heart to repair itself. The revolutionary treatment could be possible after 

the scientists discovered a technique for turning ordinary connective tissue into muscle cells inside the 

heart. It works in a similar way like stem cells, but instead of new cells being grown outside the body and 


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then injected back in, the technique simply makes the cells switch at the point where they are needed. 

When beating muscles cells known as cardiomyocytes - die during an attack, there is no way to reactivate 

them and the surrounding connective tissue known as fibroblasts cannot take over their role. Indianorigin 

scientist team has discovered how to reprogramme fibroblasts into cardiomyocytes. 

Rheumatoid arthritis (RA) is having bias between Rich and Poor countries 

There is significant disparity between 'richer' and 'poorer' countries in terms of access to biological 

treatments for rheumatoid arthritis (RA), according to results from a multinational study across four 

continents presented at EULAR 2010, the Annual Congress of the European League against Rheumatism 

in Rome, Italy. Furthermore, findings from a separate study show that RA patients report the severity of 

their disease in the same way, irrespective of the country where they live. Results of a study assessing 

whether macro-economic differences predict likelihood of treatment with a biologic showed that at the 

start of the study, RA patients in rich countries were three times more likely to have already received a 

biologic than those in poor countries (33% vs. 11.6%). 

Fish Oil Reduces Breast Cancer Risk 

Fish oil have long been credited with health benefits such as boosting brain power, but this is the first 

time they have been linked to a possible reduction in breast cancer cases. In a study involving 35,000 

women, researchers from the Fred Hutchinson Cancer Research Centre in Seattle, found that those who 

regularly took the supplements were 32% less likely to develop the disease. "It may be that the amount of 

omega-3 fatty acids in fish oil supplements are higher than most people would typically get from their 

diet," a lead researcher Emily White was quoted as saying. 

Young single men are oblivious to high blood pressure 

Younger, unmarried men around the world are least likely to be aware of hypertension (high blood 

pressure) and less likely to be receiving treatment. Whereas older women, are most aware of hypertension 

according to Dr. Clara Chow, assistant professor, McMaster University, Hamilton, Canada. The results of 

this study will hopefully help to identify people that may benefit from more targeted blood pressure 

screening and education to improve identification and management of their condition. Treatment rates, 

as a percent of all with hypertension, followed a similar pattern with treatment rates in high-income 

countries being comparable in both urban (48%) and rural (47%). Again, lower rates of treatment were 

seen in rural (23%) areas compared with urban (38%) in low-income countries. 

New York: Invention Enables People with Disabilities Communicate and Steer a Wheelchair 

Unique device based on sniffing inhaling and exhaling through the nose might enable numerous disabled 

people to navigate wheelchairs or communicate with their loved ones. Sniffing technology might even be 

used in the future to create a sort of third hand to assist healthy surgeons or pilots. The new system 

identifies changes in air pressure inside the nostrils and translates these into electrical signals. The device 

was tested on healthy volunteers as well as quadriplegics, and the results showed the method is easily 

mastered. Users were able to navigate a wheelchair around a complex path or play a computer game with 

nearly the speed and accuracy of a mouse or joystick. 

Philadelphia: Video Game Processors Help Lower CT Scan Radiation 

New approach to processing X-ray data could lower by a factor of ten or more the amount of radiation 

patients receive during cone beam CT scans. It plays an essential role in image-guided radiation therapy 

(IGRT) a state-of-the-art cancer treatment. IGRT uses repeated scans during a course of radiation therapy 

to precisely target tumors and minimize radiation damage in surrounding tissue. Though IGRT has 

improved outcomes, the large cumulative radiation dose from the repeated scans has raised concerns 

among physicians and patients. Reducing the total number of X-ray projections and the mAs level per 

projection by tuning down the X-ray generator pulse rate, pulse duration and/or current during a CT scan 

can help minimize patient's exposure to radiation. 


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Optical Imaging Could Create Pathway for Radiotracers 

The development of novel multimodality imaging agents and techniques could represent the frontier of 

research in the field of medical imaging science. Optical imaging is a molecular imaging procedure in 

which light-producing molecules designed to attach to specific cells or molecules are injected into the 

bloodstream and then detected by an optical imaging device. It usually requires either excitation by an 

external light source or by a biological process. Cerenkov imaging produces the light from the 

radioactivity, so no external illumination is needed. Combining optical imaging with nuclear medicine 

presents a new path for imaging medical isotopes. It provides optical imaging with an array of approved 

nuclear tracers already in clinical use today, which can be used immediately as opposed to fluorescent 

dyes. 

Multifunctional Nanoparticle Enables New Type of Biological Imaging 

Single cancerous cell has broken free from a tumor and is traveling through the bloodstream to colonize a 

new organ might seem like finding a needle in a haystack. New imaging technique from the University of 

Washington is a first step toward making this possible. UW researchers have developed a multifunctional 

nanoparticle eliminates the background noise, enabling a more precise form of medical imaging essentially 

erasing the haystack, so the needle shines through. Nanoparticles are promising contrast agents for 

ultrasensitive medical imaging. 

Nanoparticles as Destructive Beacons to Zap Tumors 

Group of researchers from Wake Forest University Baptist Medical Center is developing a way to treat 

cancer by using lasers to light up tiny nanoparticles and destroy tumors with the ensuing heat. The 

American Association of Physicists in Medicine (AAPM) in Philadelphia, describe the latest development 

for this technology: iron-containing Multi-Walled Carbon Nanotubes (MWCNTs) -- threads of hollow 

carbon that are 10 thousand times thinner than a human hair. In laboratory experiments, the team 

showed that by using an MRI scanner, team could image these particles in living tissue, watch as team 

approached a tumor, zap them with a laser, and destroy the tumor in the process. 

New 3-D Imaging Techniques for Improved Lung Cancer Drug Development 

Advanced imaging technologies to improve the development of effective drugs to treat lung cancer are 

the focus of the current special issue of Optics. Research featured in the special focus issue on Imaging in 

Diagnosis and Treatment of Lung Cancer outlines standardized approaches to measure and compare 

tumor size, as well as to validate the accuracy of such measurements under defined settings. The 

appropriate validation of these tools is a critical new area of research as important new applications for 

these tools are being explored in pharmaceutical drug development. 

Surgeons Find New Way to Shield Vision during Radiation for Eye Cancer 

Eye cancer patients face an unenviable dilemma. Patients enter treatment knowing that their surgeon's 

strategy to kill the deadly tumor with radiation may also sacrifice their eyesight. UCLA researchers have 

discovered a commonly used substance called silicon oil shields the eye and appears to protect vision in 

patients undergoing radiation therapy for ocular melanoma. Surgeons treat ocular melanoma by stitching 

a gold plaque containing radioactive seeds to the white of the eye and removing it a few days later. While 

radiation kills the cancer cells, it also causes irreversible injury to the optic nerve fibers and macula, the 

section of the retina responsible for central vision. 

Europe 

Another ray of hope for Arthritis Sufferers 

Anti-arthritic drugs can cause side effects and surgery can be expensive, however there is hope from a 

natural product liquid glucosamine and chondroitin sulfates. Some excellent results with an approach 

based on a combination of the two supplements have been reported by many doctors from Europe and 

Asia. Glucosamine is a nutrient-rich formula for connective tissue and joints. It helps regenerate 

connective tissue, and may help prevent cartilage breakdown. According to Dr. Jason Theodosakis, a 

medical doctor the study results showing the benefits to arthritis sufferers from liquid glucosamine. Most 

people, taking glucosamine report their arthritic symptoms diminished quickly, from a few days to a few 

weeks. 


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London: One Injection could stop people dying of severe bleeding from accidents & injuries 

In the recent study Roberts and colleagues of Epidemiology dept at the London School of Hygiene and 

Tropical Medicine (LSHTM) indicated that early administration of tranexamic acid (TXA, a drug that 

reduces clot breakdown) to patients with severe, bleeding injuries saves lives with no evidence of side 

effects from unwanted clotting. For this study, researchers were only enrolled patients who had 

significant bleeding, or were at risk of significant bleeding and the injury had happened within the last few 

hours. They suggest using the widely available and easily administered off-patent drug, which is 

manufactured by a number of different companies, in cheaper cost, could save tens of thousands of lives 

every year worldwide. 

New Therapeutic Route For Rare Dent”s Disease in Kidney 

Dr Jonathan Lippiat, Scientists from the University of Leeds have discovered the mechanisms of a 

protein known to play an active part in the inherited kidney disorder, Dent's disease. The findings provide 

a new focus for future therapies for the disease, for which there is currently no cure. Dent's disease is an 

extremely rare illness caused by a genetic mutation on the X chromosome. Affecting mostly men, its main 

symptom is kidney stones often followed by a deterioration of kidney function and in many cases chronic 

kidney failure. 

London: Sleeping Sickness Offers Insight into Human Cells 

Sleeping sickness is a potentially fatal condition which affects up to 70,000 people in sub-Saharan Africa, 

and millions more are at risk from the disease caused by parasite. Professor Keith Matthews and his team 

from the University of Edinburgh found that when the parasite is swallowed by a fly, a reaction is 

triggered in a particular part of the parasites' cells. This causes a change in the activity of enzymes stored 

there, allowing the parasite to rapidly adapt its body to survive in the fly's gut. The part of the parasite 

cell associated with this response has a corresponding part in human cells. Because of this, researchers say 

their study could also point towards greater understanding of human genetic disorders linked to cell 

defects. These include Zellweger syndrome, a rare neurological condition that causes infant death. 

Beetroot Juice Lowers Blood Pressure 

The nitrate content of beetroot juice can lower blood pressure levels, says a study. The researchers of 

Queen Mary University of London found lowering of blood pressure (BP) within 24 hours in people who 

took nitrate tablets and people who drank beetroot juice. It is a welcome news for people with high BP as 

they can now use a 'natural' approach to reduce the risk of cardiovascular disease (including stroke and 

heart attacks) the world's biggest killer. The investigation was able to demonstrate that the nitrate found 

in beetroot juice had beneficial effects upon cardiovascular health by increasing the levels of the nitricoxide 

in blood. 

Sweden: No Treatment May Be Suitable Option for Low Risk Prostate Cancer 

Dr Pär Stattin, and his team from Department of Surgical and Perioperative Science at Umea University, 

Sweden found that only a small minority of men diagnosed with low risk early stage prostate cancer die 

from the disease if not treated and suggest that surveillance as opposed to treatment may be a suitable 

option for such patients. Treatment of localized, low risk prostate cancer is a controversial issue because 

while some experts advocate treatment such as surgery or radiotherapy, others say the risks of treatment 

outweigh the benefits and that surveillance or "watchful waiting" is a better option. 

Belgium: Listening MP3 players at high volume indicates danger 

The new study was conducted by researchers of Ghent University, Belgium which reveals that overstimulation 

of hair cells within the ear occurs even at varying volume levels for short periods of time. 

Listening to music at high volume causes temporary changes in hearing sensitivity which may lead to 

long-term harm, study indicates. The new study follows previous warnings from doctors that using MP3 

players at high volumes with earphones that fit into the ear canal could lead to loss of hearing. The 

primary damage is concentrated on the outer hair cells, which are more vulnerable to acoustic overstimulation 

than inner hair cells. Considering the reduction in hearing sensitivity after listening to a 

portable media player, these devices are potentially harmful, study reported. 


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Asia-Pacific 

India; Daiichi Sakyo and Ranbaxy creates new NDDR entity Daiichi Sankyo India Pvt Ltd 

Daiichi Sankyo Company and Ranbaxy Laboratories has been transferred to Daiichi Sankyo India Pharma 

Pvt Ltd as part of the strategy to strengthen the global Research and Development (R&D) structure of 

the Daiichi Sankyo Group. By incorporating NDDR into the global Research function, the Group would 

benefit from more efficient global R&D to achieve quicker results. The new organization, Daiichi Sankyo 

Life Science Research Centre in India (RCI), based in Gurgaon, will play a key role in the Group’s global 

Drug Discovery Research especially in the area of low molecular weight infectious and inflammatory 

disease treatments. It will also continue to support the programs of dengue and tuberculosis that NDDR 

was working on in alliance with the Department of Biotechnology. 

India: Diabetes the Leading Cause of Kidney Failure 

According to the recent study the research team have the collective data on kidney failure indicated that 

diabetes is the number one cause of kidney failure. In the US, more than 40% of the new cases of endstage 

renal disease (ESRD) are reporting each year. People with ESRD require regular dialysis or a kidney 

transplant to stay alive. Almost 25% of patients suffering from diabetes will get kidney problems. 

Scientists know that high levels of blood sugar and hypertension (high blood pressure) increase the risk of 

people with diabetes developing ESRD. 

Australia: Risk of intake alcohol during pregnancy needs more understanding 

Ms Jennifer Powers, statistician at the University of Newcastle, NSW, and co-authors analysed data 

collected by the Australian Longitudinal Study on Women's Health from women aged 22-33 years who 

were pregnant before October 2001, when guidelines recommended zero alcohol, or who were first 

pregnant after October 2001, recommended low alcohol intake They found that women's alcohol intake 

prior to pregnancy was the strongest determinant of alcohol intake during pregnancy, whereas for low 

alcohol intake or abstinence had little effect. Women who drank moderate or high amounts of alcohol 

before pregnancy were 1.5 times less likely to drink low amounts of alcohol during pregnancy. 

India: New superbug may spread due to medical tourism 

According to the scientists, a new superbug could spread from India due to medical tourism. They say 

that there are almost no drugs to treat it. Researchers said that they had found a new gene called New 

Delhi metallo-beta-lactamase, or NDM-1, in patients in South Asia and in Britain. NDM-1 is a different 

type of gene that makes bacteria highly resistant to almost all antibiotics including the powerful 

carbapenems. India is currently a destination for affordable healthcare. Medical tourism and international 

travel in general, resistance to these types of bacteria has the potential to spread around the world very, 

very quickly. And there is nothing in the (drug development) pipeline to tackle it. 

India: Single-shot insulin for diabetes patients developed 

Indian scientists have developed single-shot insulin, Supramolecular Insulin Assembly-II (SIA-II) which 

can help diabetes patients control blood sugar levels for about two months. According to scientists, 

National Immunology Institute (NII), New Delhi, SIA-II is said to have tremendous therapeutic potential 

and is expected to constitute a new way of treatment for diabetes patients around the world. A single shot 

of SIA-II would continuously release just above basal levels of insulin into blood in a sustained manner, 

curbing the increase in glucose levels after meals. It also does not cause severe hypoglycaemia in the 

morning, a dreadful condition faced by diabetics. Patient has to now take only a single shot of insulin to 

keep sugar levels under control for over a month. 

Australia: Sweet drinks help to reduce stress at work 

Sweet drinks such as sugary tea help to reduce stress at work, and make people less likely to be aggressive 

or argumentative. According to a study, the energy boost provided by the sugar enables the brain to 

maintain control over its impulses, meaning people can prevent themselves from reacting spontaneously 

when under stress. Consuming a sweetened beverage on the commute home following a stressful day 

could reduce aggression toward family members or fellow drivers. Glucose is required by the brain to 

enable "executive functioning", which included the ability to restrain one's impulses, the researchers from 

the University of New South Wales and Queensland University announced. 


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South Africa 

Poor MDR-TB knowledge among nurses 

South Africa has one of the highest rates of multidrug-resistant tuberculosis (MDR-TB). The study 

results presented at South African TB Conference, recently, found that only about 19% of the 16 health 

facilities surveyed in rural and urban areas of Limpopo and KwaZulu-Natal provinces had nurses with 

formal training in MDR-TB management. It also has found that many nurses have not been trained to 

handle this deadly, difficult-to-treat strain of the disease. Nurses who had been trained to handle MDR- 

TB demonstrated similar levels of knowledge as those who were untrained. Inadequate understanding of 

the disease led to poorly recorded patient histories and failure to follow up on people who had been in 

close contact with MDR-TB patients, such as household members. 

GOVERNMENT REGULATIONS 

Americas 

Vision 2020 Biopharma Strategy calls for simplification of regulatory mechanism 

The Vision 2020 Biopharma Strategy has detailed the measures for the industry and the Government to 

work towards making India one of the five toppers in the sector and grab 10% of the expected US$319 

billion global market by 2020, from the current share of 1.4%t in the US$137 billion market at present. It 

has also set a target of churning out at least 10 biopharma products by 2020 in the domestic sector and 

two of them in the global arena. 

FDA Advisory Panel Unanimously Endorses Five-Day Emergency Contraceptive 

FDA's Reproductive Health Drugs Advisory Committee voted unanimously to recommend that the 

agency approve the emergency contraceptive ulipristal acetate (UPA), evidence shows it is safe and 

effective for preventing most pregnancies for up to 120 hours after sex. UPA is manufactured by Parisbased 

HRA Pharma and sold in 22 European countries as ellaOne. After FDA approval, ella would be 

available by prescription only. The research studies have found ella to be more effective over a longer 

period of time than Plan B, an emergency contraceptive product currently available in the market. 

US: Hospitals work to reduce wait times 

Hospitals are working to reduce emergency room wait times and then advertising the results. "St. Joseph 

Medical Center [in Towson, Md.] posts the anticipated wait time on its website. Harbor Hospital in South 

Baltimore has put up billboards and handed out brochures door-to-door to tell residents about its 'quick' 

emergency room experience. Hospitals in Arizona, Florida, Illinois, Iowa, Maine, Michigan and Tennessee 

are texting and e-mailing potential patients, posting real-time waits on billboards and taking other steps to 

tout their speedy service. Some hospitals are changing because they view the emergency room as a 'front 

door' to the hospital and a link to future - and more lucrative - business such as elective surgery. 

South Africa 

Govt commitment to reduce maternal and child mortality 

Statement by President on behalf of the African Union on Maternal Health, Newborn and Child Health 

for the Achievement of the Millennium Development Goals African Union Member States recognize the 

urgent need for accelerated action and increased support for building stronger national health systems in 

order to further scale-up and leverage the gains being made in expanding service delivery to achieve their 

Universal Access targets, while at the same time, speeding up progress on maternal and child health. The 

heavy burden placed by HIV, tuberculosis and malaria on the health of women and children underscores 

the inextricable linkages between efforts to reduce child mortality and to improve maternal health and the 

fight against the pandemics. 


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NEW PRODUCT LAUNCHES 

Asia-Pacific 

India: Nasal Spray Swine Flu Vaccine Nasovac Launched 

India has launched its first painless swine flu vaccine called Nasovac recently. This ready-to-use vaccine 

has been developed by the scientists at Serum Institute of India (SII), Pune. The public’s fear at the 

height of the pandemic was a challenge for India’s healthcare sector. Right from the time the institute has 

started work on the vaccine, it was clear that apart from developing indigenous capability for tackling 

pandemics, institute wanted to provide a painless prevention option for the masses. Institute has 

capabilities, in collaboration with global healthcare agencies, to respond with affordable preventive 

vaccines for pandemic healthcare emergencies anywhere around the world. 

OTHERS 

DoP to organise convention on biopharma 

Recognizing the potential of biopharma’s role in healthcare of the future, the Department of 

Pharmaceuticals (DoP) is organizing a one-day 'National Convention on Biopharma' with participation 

from Department of Biotechnology (DBT) in partnership with Federation of Indian Chambers of 

Commerce and Industry (FICCI) with the support of Association of Biotechnology Led Enterprises. The 

objective of the convention is to bring stakeholders and the Government together to discuss where 

industry needs facilitation and the support of the government to bridge the gaps for making the Indian 

biopharmaceutical industry live up to its identified and acknowledged potential of a leader. The 

convention is significant as India is gaining momentum in positioning itself as significant player in the 

global biopharmaceutical industry. 

Importance of Gene in Breast Cancer Prognosis Isolated 

Oregon Health & Science University Knight Cancer Institute researchers found the GRB7 gene drives an 

aggressive form of breast cancer and acts independently of the HER-2 gene, known to be a stimulator of 

breast cancer growth. Isolating the role of this gene ultimately help fine-tune a patient's treatment and 

enable physicians to provide a more accurate prognosis. Levels of GRB7, or growth factor receptor 

bound protein seven, are important on their own as a marker for aggressive breast cancer. Patients whose 

breast cancer tumors tested positive for high levels of HER-2, the protein human epidermal growth 

factor receptor-2, tended to have a more aggressive form of the disease than patients whose tumors did 

not have elevated levels of this protein. 


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Product Focus – LIPITOR 

LIPITOR 

Introduction 

Lipitor, generic name Atorvastatin is an oral prescription drug manufactured and marketed by Pfizer 

drug. This drug helps in lowering the level of cholesterol in the blood and the triglyceride levels. Lipitor 

(Atorvastatin) approved by the FDA in 1996, belongs to a class of drugs referred to as statins which 

prevent the production of cholesterol by the liver by blocking the enzyme, HMGCoA reductase 

responsible for making cholesterol. Lipitor not only retards the progression but may even reverse 

coronary artery disease. Its effectiveness on high blood concentrations of triglycerides can be considered 

as a means to curtail coronary artery disease. 

How cholesterol causes heart problems 

High cholesterol builds up in the walls of arteries. Over time, 

this build up causes "hardening of the arteries" so that arteries 

become narrowed and blood flow to the heart is slowed down 

or blocked. Blood carries oxygen to the heart, and if enough 

blood and oxygen cannot reach heart, a person may suffer chest 

pain. If the blood supply to a portion of the heart is completely 

cut off by a blockage, the result is a heart attack. 

Drug Information 

Brand Name Lipitor 

Major Manufacturer DRL, Ranbaxy 

Drug Name Atorvastatin 

Therapeutic segment Cardiovascular 

Source: Cygnus Research 

Mechanism of action 

Lipitor prevents the production of cholesterol by the liver by blocking the 

enzyme that makes cholesterol, HMG-CoA reductase. Lipitor lowers total blood 

cholesterol as well as LDL cholesterol levels. LDL cholesterol is believed to be 

the "bad" cholesterol that is primarily responsible for the development of 

coronary artery disease. Lowering LDL cholesterol levels retards progression 

and may even reverse coronary artery disease. Unlike other statin drugs, 

Atorvastatin has the ability to reduce the concentration of triglycerides in the 

blood. High blood concentrations of triglycerides also have been associated with 

coronary artery disease. 

Side effects 

‣ Constipation 

‣ Diarrhoea 

‣ Fatigue 

‣ Gas 

‣ Heartburn 

‣ Headache 

Side effects 

Lipitor is generally well-tolerated, and side effects are rare. Minor side effects include constipation, 

diarrhoea, fatigue, gas, heartburn, and headache. Atorvastatin should be used with caution in patients with 

alcohol related or other liver diseases. Muscle problems may occur and it could further lead to kidney 

failure. Caution is needed while taking Lipitor with other medications such as cyclosporine 

(Sandimmune), gemfibrozil (Lopid), erythromycin and nicotinic acid as the risk of muscle break down is 

higher. 

Drug interaction 

‣ Use Lipitor after judging all possibilities of drug interaction 

‣ Consult the physician and inform about all the prescription and non-prescription drugs that are 

undertaken includes vitamins, minerals, and herbal products 

‣ Avoid Lipitor at the time of antifungal medication such as itraconazole (Sporanox), fluconazole 

(Diflucan), or ketoconazole (Nizoral) 

‣ Avoid Lipitor if the person is using hormonal birth control (pills, patches, or implants) 

‣ Consult the physician if the person is using any of the drugs like cyclosporine (Sandimmune, Neoral); 

gemfibrozil (Lopid), clofibrate (Atromid-S), or fenofibrate (Tricor); niacin (Nicolar, Nicobid, Slo- 

Niacin, others); erythromycin (E-Mycin, E.E.S., Ery-Tab, others) or clarithromycin (Biaxin); 

cholestyramine (Questran) or colestipol (Colestid) 


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Storage 

Lipitor tablets should be stored below or at room temperature. The best condition for storage is at 15- 

30°C (59-86°F). 

Dosage 

Atorvastatin is prescribed once daily. Starting doses are 10mg to 

40mg. daily. 

Precautions 

‣ Precautions should be taken to guard against obscure 

possibilities if the person is affected by chronic muscular 

disease, have blood disorder, drink alcoholic beverages or is 

expecting a major surgery 

‣ Inform the physician if the person is affected by liver disease 

‣ Lipitor has been enlisted in the FDA pregnancy category X. This means that Lipitor is known to 

cause birth defects if it is taken during pregnancy. Therefore, Lipitor is not recommended to be taken 

if you are pregnant or contemplating pregnancy during treatment 

‣ Grapefruit and grapefruit juice may interact with Lipitor leading to potentially dangerous effects 

‣ It is not known whether Lipitor passes into breast milk. Therefore, consult the physician to stop 

using this drug 

‣ This drug is not recommended for use in 

children 

Market Scenario 

Lipitor is considered the best selling 

pharmaceutical drug that heals cholesterol all over 

the world. Lipitor, the world’s best selling 

medicine, whose sales remained relatively steady 

in 2009-10 despite ferocious branded and 

unbranded competition. Lipitor is first among 

Molecule Brand Manufacturer 

Atorvastatin Lipitor Pfizer 

Simvastatin Zocor Merck 

Lovastatin Mevacor Merck 

Pravastatin Pravachol Bristol-Myers Squibb 

Fluvastatin Lescol Novartis 

Rosuvastatin Crestor Astra-Zeneca 

Source: lipitorcare.com; Cygnus Research 

cholesterol-reducing medicines and backed by more than 400 ongoing and completed clinical studies, as 

well as over 15m patient-years of experience. 

Sales Scenario 

Lipitor is likely to retain patent protection 

until late 2011.The drug faces tough 

competition from other generics in its 

class, such as simvastatin, the generic 

version of Merck’s Zocor. Corey 

Goodman, hired by the company in 2007 

to run a new biotech unit in South San 

Francisco, is leaving Pfizer. This looks to 

be related to the Wyeth deal.Pfizer will 

oversee the company’s biologics R&D 

work after the merger. According to IMS 

Health, worldwide, cholesterol-lowering 

12.9 

12.8 

12.7 

Lipitor Sales 

drugs accounted for US$52.4 billion in 

12.6 

sales for 2009-10. Lipitor is world’s highest 

2006-07 2007-08 2008-09 

revenue-generating drug, being 

manufactured by Pfizer. Lipitor 

Source: Company Source; Cygnus Research 

maintained its highest position among the blockbusters with net sales of US$13 during 2009-10 as against 

US$12.9 in the 2008-09. 

US$bn 

Statins used for the 

Treatment of Cholestrol 

‣ Lovastatin (Mevacor) 

‣ Simvastatin (Zocor) 

‣ Pravastatin (Pravachol) 

‣ Fluvastatin (Lescol) 

‣ Cerivastatin (Baycol) 

‣ Atorvastatin (Lipitor 


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Competition from the generic side 

Lipitor most serious competition comes in the form of generic cholesterol reducers that do not have 

Lipitor molecular structure. Overcoming the price advantages of these generic cardiovascular medicines 

starts with the basic message that there is no generic form of Lipitor, and that Lipitor benefits are worth 

its price. Pfizer continues to leverage the Lipitor clinical program as well as patient and physician 

education programs. The company is also building novel partnerships with payers to keep Lipitor 

accessible and demonstrating, through clinical and real world data, that Lipitor can help patients avoid 

more costly and invasive disease interventions. 

Indian Scenario 

Top ten firms in India compete for Lipitor generic. Dr Reddy’s Labs (DRL), Nicholas, Ranbaxy, Cipla, 

Cadila, Intas Pharma and other medium players produce generic version of Lipitor. Lipitor faces tough 

competition in India. Atocor, Atrova, Stator, Strovas, Atrolip and Lipcor are the famous brands in Indian 

market. 

Outlook 

The prevalence of cardiovascular diseases is increasing world over. Global cardiovascular market is valued 

at US$137 billion, and every year 17m deaths are registered due to this disease. According to estimations, 

by the end of 2030, the loss is expected to rise to 17.9m which is 940% more than the loss estimated in 

the USA. Changing food and lifestyle, high cholesterol foods, and lack of required nutrition will be the 

major factors leading to health problems. Lipitor will be the number one brand having high volume of 

sales in the world. By 2010, generic Atorvastatin will come out, and it is expected that it would be 90% 

cheaper. Sales growth may show 2-3% improvement in future, there is stiff competition. US will be the 

major market for sales. Sales is expected to increase in Asian countries with gradual rise in heart diseases. 

In Indian markets, Lipitor will face tight competition as more number of players have their generic 

version. With increasing cardiovascular risks in India, generic version of Lipitor will bring more revenues 

to Indian firms. 


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Stock Scan 

105 

Relative Market Cap Performance 

100 

BSE Sensex 

Piramal 

Cipla 

95 

16/06/10 

17/06/10 

18/06/10 

21/06/10 

22/06/10 

23/06/10 

24/06/10 

25/06/10 

28/06/10 

29/06/10 

30/06/10 

01/07/10 

02/07/10 

05/07/10 

06/07/10 

07/07/10 

08/07/10 

09/07/10 

12/07/10 

13/07/10 

14/07/10 

15/07/10 

125 

Relative Market Cap Performance 

BSE Sensex 

SHASUN 

AUROBINDO 

110 

95 

16/06/10 

17/06/10 

18/06/10 

21/06/10 

22/06/10 

23/06/10 

24/06/10 

25/06/10 

28/06/10 

29/06/10 

30/06/10 

01/07/10 

02/07/10 

05/07/10 

06/07/10 

07/07/10 

08/07/10 

09/07/10 

12/07/10 

13/07/10 

14/07/10 

15/07/10 

Source: BSE India; Cygnus Research; 

SENSEX 

16-22 June,2010 23-29 June ,2010 30-07 July ,2010 08-15 July,2010 

Sensex gained 286 Due to Profit Global cues and fall 

points during the booking and market in the banking and 

week and ended at pressures sensex steel stocks are the 

17749.69 points. decline by 1% key reasons for 

Engineering and during the week. sensex to decline by 

construction, Oil With the decline of 1% and ended at 

& Gas stocks 221.85 points and 17,471.03 points by 

helped the sensex recorded 

loosing 229.87 points. 

to end on positive 17,534.09 points. 

node gaining 2%. 

Cipla The company 

share price 

increase by 0.76% 

from Rs333.90 to 

Rs336.45. 

The company share 

price increase by 

0.40% from 

Rs339.15 

Rs340.50 

to 


price decrease by 

0.84% from Rs337.75 

to Rs334.90. 

During the week 

Sensex rose by 1% 

Banking, auto and 

IT stocks helped by 

286 and ended at 

17,909.46 points. 



3.38% from Rs339 

to Rs327.55.. 


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Piramal The company 

share price 



Rs491.25. 

Shasun The company 

share price 



Rs77.20 

Aurobindo The company 

share price 



Rs867.15. 



1.22% from 

Rs490.65 to 

Rs484.65. 



1.15% from Rs82.50 

to Rs83.45. 



2.71% from 

Rs871.75 to 

Rs895.40. 



4.39% from Rs479.50 

to Rs500.55. 



2.12% from Rs87.15 

to Rs89. 



0.36% from Rs910.55 

to Rs913.85. 



1.50% from 

Rs499.80 to 

Rs507.30. 



0.06% from 

Rs87.10 to Rs87.05. 



5.38% from 

Rs919.05 to 

Rs968.50 


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Regulatory Issues 

INTERNATIONAL 

Obama Healthcare Reform Bill and its Impact on the US Healthcare Market 

President Obama signed the health reform into law to address the inefficiencies of the existing healthcare 

structure and to decrease the number of uninsured people in the US. The health reform bill outlines 

several provisions such as universal health coverage, cost containment, increase in insurance market 

competition, excise tax on medical device manufacturers, and lower drug costs for Medicaid and 

Medicare. Thus, the provisions in the health reforms directly impact the US healthcare industry and its 

stakeholders 

US FDA Proposes to Withdraw Low Blood Pressure Drug Midodrine 

The US Food and Drug Administration proposed to withdraw approval of the drug midodrine 

hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, due to required 

post-approval studies which verify the clinical benefit of the drug have not been done. Patients who 

currently take this medication should not stop taking it and should consult their health care professional 

about other treatment options. 

US FDA Issues CMC Draft Rules for New NDAs & ANDAs 

US Department of Health and Human Services, Food and Drug Administration Centre for Drug 

Evaluation and Research (CDER) has issued a draft guidance on chemistry, manufacturing and controls 

(CMC) which calls for post approval manufacturing changes to drug applicants on the types of changes 

that are to be included in annual submissions. According to the draft guidance, the number of CMC 

manufacturing supplements for new and abbreviated new drug applications (NDAs and ANDAs) has 

increased greatly over the past few years 

NATIONAL 

India Set to Formulate Policy on Antibiotics Use 

India is set to have a policy on the rational use of antibiotics. Policy comes even as the recent super bug 

study on antibiotic resistance attracts hi-decibel reactions, the latest being from drug-maker Wyeth, one of 

the funding agencies. In three months, the country is expected to put in place a policy regarding the use 

of antibiotics. Irrational use of antibiotics has resulted in strains of bacteria increasingly becoming 

resistant to antibiotics thus requiring newer, stronger generations of antibiotics to quell an illness. 

Compulsory Licensing of Patented Drugs under Study 

Compulsory Licensing (CL) allows governments to license third parties (that is, parties other than the 

patent holders) to produce and market a patented product or process without the consent of patent 

owners. This power is contained in the law on intellectual property and is WTO-compatible. Commerce 

minister had drawn attention to the acquisition of pharma companies by foreign multinationals and the 

resultant concerns on its impact on low-cost medicines. Minister need to strike a balance between the 

interest of inventors and those of consumers; the imperative of providing affordable healthcare assumes a 

different dimension. 

New Guidance for Issuing Marketing Approval for Medical Devices 

The medical devices industry in the country has set of draft regulatory guidance issued by the Drug 

Controller General of India (DCGI) to extend standard procedures for issuing marketing approval for 

medical devices will prove to be a good beginning to address the issues in medical devices industry, 

though some of them only ease the procedures for the importers. The Association of Indian Medical 

Devices Industry (AIMED), an umbrella organisation of the domestic medical devices industry in the 

country, expressed its relief on finally getting the first piece of regulatory guidance for medical devices 

segment. 


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Govt Constitutes National Apex Committee for Monitoring Stem Cell Research 

Union health ministry has finally constituted the much awaited National Apex Committee for Stem Cell 

Research and Therapy (NAC-SCRT) for effectively reviewing and monitoring the stem cell research in 

the country. The Indian Council for Medical Research (ICMR) will act as the secretariat for the NAC. 

Senior Scientist at the ICMR Dr Vijay Kumar will be the member secretary of the NAC while another 

senior scientist at ICMR Dr Geeta Jotwani will represent ICMR in the NAC. 

Centre to Amend Drugs & Cosmetics Act to Bring Sowa-Rigpa Medicines under Ambit 

The Centre is planning to amend the Drugs and Cosmetics Act and Rules to bring the Sowa-Rigpa 

medicines under its ambit on the pattern of other Ayurveda, Siddha and Unani drugs, once the system is 

legally recognised. Currently, the health ministry is looking to get the Indian Medicine Central Council 

(Amendment) Bill 2010 passed to formally accord the legal status to the traditional Sowa-Rigpa system 

which is popular in the Himalayan regions. 

Regulators Toughen Stand on APIS Quality 

The presence of pharmaceutical impurities in the active pharmaceutical ingredients (APIs) even in small 

amounts can influence the efficacy and safety of a product, impurity profiling is now getting more critical 

attention than any other time from regulatory authorities. The European Directorate for the Quality of 

Medicines (EDQM) is keept a strict vigil on API manufacturers around the world. It had suspended and 

withdrawn six additional certificates of suitability. 

. 


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Upcoming Events 

1. Event Healthcare Facilities Symposium & Expo 

Date Sep 14-16, 2010. 

Venue Navy Pier Chicago, United States Of America. 

Highlights It is the longest-running conference and exhibition dedicated to the 

improvement of the overall health and welfare of patients and successful 

business outcomes through the design element. 

Contact 

Details 

JD Events LLC5520, Park Avenue, Suite, Trumbull, United States Of America 

Tel:+(1)-(203)-3716322 

2. Event Medifest South Africa 

Date Sep 24-26, 2010. 

Venue Cape Town International Convention Centre (CTICC) Cape Town, Western 

Cape, South Africa. 

Highlights It will provide huge opportunities for establishing profitable business 

relationship and a change to interact with others in the area of business and 

trade. It will prove to be a perfect platform to capture wider alternative of nation 

wide customers and suppliers and meet them face-to-face. 

Contact 

Details 

Vantage Trade Fairs (P) Limited, 23/21A, IInd Floor, East Patel Nagar, 

New Delhi - 110 008, India. 

Tel: +(91)-(11)-30580444; Fax: +(91)-(11)-30581000. 

3. Event World Dental Show 

Date Oct 29-31, 2010 

Venue MMRDA Exhibition Centre Mumbai, Maharashtra, India 

Highlights 

The ever growing demand for the latest dental procedures from people across 

the country and the status of the country as one of the best and most affordable 

oral healthcare destinations add flavour to the Show 

Contact 

Details 

Indian Dental Association; Bombay Mutual Terrace, 2nd Floor, 534, 

Sandhurst Bridge, Opera House, Mumbai - 400 007, India. 

Tel: +(91)-(22)-43434545 

4. Event IndiaMART Famdent Show Hyderabad 

Date Nov 26-28, 2010. 

Venue Hyderabad International Convention Centre, Hyderabad, Andhra Pradesh, 

India. 

Highlights It is a most comprehensive useful and cost effective exhibition for dental sector 

in India. The event will showcase the latest innovation and equipments 

technology for dental industry. 

Contact 

Details 

Famdent Events, 102, Sapphire Court, 7, Azad Nagar, 

Behind Apna Bazar, J. P. Road, Andheri West, Mumbai - 400 053, India. 

Tel: + (91)-(22)-65049697; Fax: + (91)-(22)-26742425. 

5. Event Hospital Infrastructure India 

Date Dec -07-09, 2010 

Venue Bombay Exhibition Centre(BEC), Mumbai, Maharashtra, India 

Highlights 

Contact 

Details 

This exhibition will be the sole platform where Investors, Planners, Builders, 

Contractors, Architects and Designers will meet senior managers and 

commissioners of healthcare facilities in India. 

Informa India ; A 202 Business Square, Solitaire Corporate Park, 

Andheri Kurla Road, Chakal, Andheri (East), Mumbai, India. 

Tel:+(91)-(22)-40203300 


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6. Event Medifest India 

Date Dec 10-12, 2010 

Venue Pragati Maidan, New Delhi, Delhi, India 

Highlights 

It is an International Trade Fair and a unique opportunity for all related to 

medicine and healthcare field to reach new horizons of effective cooperation 

and discuss vital issues that stand presently in front of medical and healthcare 

industry. The scope of healthcare market along with the exclusivity of this fair 

will be putting every attendee on a leading edge. 

Vantage Trade Fairs (P) Limited 

Contact 

23/21A, IInd Floor, East Patel Nagar, New Delhi, India. 

Details 

Tel:+(91)-(11)-30580444; Fax:+(91)-(11)-30581000 

7. Event Clinical Trials International Summit 

Date Sep 01-02, 2010 

Venue Shanghai Marriott Hotel Hongqiao, Shanghai, China. 

Highlights 

The focus of the event will be on: Current Status & Trend of Global Clinical 

Trial Outsourcing, Development Trends of China Biomedical R&D Model. 

Jfps Group Unit 2007-2010, 20th Floor, 

Contact 

Tower 1 Kerry Everbright City, Shanghai, China 

Details 

Tel:+(86)-(21)-51720000; Fax:+(86)-(21)-51720099 

8. Event International Contract Services Expo-India 

Date Dec 01 – 03, 2010. 

Venue Bombay Exhibition Centre(BEC) Mumbai, India 

Highlights 

It is the only truly global exhibition where you can meet, mix, mingle, and do 

business with worldwide pharmaceutical outsourcing customers, potential 

clients, decision makers and journalists. 

Contact 

Details 

UBM India Pvt. Ltd, Sagar Tech Plaza A, 615-617 6th Floor, Andheri Kurla 

Road Saki Naka Junction, Andheri East, Mumbai, India. 

Tel:+(91)-(22)-66122648; Fax:+(91)-(22)-66122626 

9. Event P-Mec India 

Date Dec 01 – 03, 2010. 

Venue Bombay Exhibition Centre(BEC) Mumbai, India. 

Highlights 

Contact 

Details 

It will provide the opportunity to showcase their latest accomplishments in 

pharmaceutical machinery and equipment. It will be held alongside the ICSE 

and CPhI events, offering complete coverage of all developments in the 

pharmaceutical world. 

UBM India Pvt. Ltd., Sagar Tech Plaza A, 615-617 6th Floor, Andheri Kurla 

Road Saki Naka Junction, Andheri East, Mumbai, India. 

Tel:+(91)-(22)-66122648; Fax:+(91)-(22)-66122626 

10. Event Pharmaceutical Expo 

Date Dec 17 – 19, 2010. 

Venue Manipal University Manipal, India 

Highlights 

Contact 

Details 

It is most prestigious annual event of Indian Pharmaceutical Industry. It is an 

opportunity for the companies in the pharma sector including machinery & 

technology to showcase their capabilities & services. 

Federation of Indian Chambers of Commerce & Industry, 

Federation House, 1, Tansen Marg, New Delhi, India 

Tel:+(91)-(11)-23738760; Fax:+(91)-(11)-23320714 


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11. Event BioPharm America 

Date Sep 15-17, 2010 

Venue TBA Boston, United States Of America 

Highlights 

It is the sole international exhibition in Massachusetts that focuses on 

biomedicine and medical industry. It will offer great opportunity to meet all the 

professionals under one roof. It will showcase latest innovation products and 

equipments for related industry. 

Contact 

Details 

E.B.D. Group, Inc., 2032 Corte del Nogal, Suite, Carlsbad, USA 

Tel:+(1)-(760)-9300500; Fax:+(1)-(760)-9300520 

12. Event Pharma CI Conference & Exhibition 

Date Sep 21-22, 2010. 

Venue Parsippany Hilton Parsippany, United States Of America. 

Highlights 

It is the largest and best gathering of senior level pharma, biotech, medical 

device, and diagnostic executives in competitive/business intelligence. It is one 

of the highly specialized event which will offer unique insight and expertise of 

pharma world. It will offer wide enormous networking opportunities to connect 

with pioneers of pharma industry. 

Pharma Ci Conference, 70 East 12th Street Suite 8/C, 

Contact 

New York, United States Of America 

Details 

Tel:+(1)-(212)-2287974 

13. Event P-Mec India 

Date Dec 01-03, 2010 

Venue Bombay Exhibition Centre(BEC), Mumbai, Maharashtra, India 

Highlights 

It is the exhibition for the supplier of quality equipment and machinery for 

pharmaceutical manufacturing industry. The event will provide the opportunity 

to showcase their latest accomplishments in pharmaceutical machinery and 

equipment. It will offer complete coverage of all developments in the 

pharmaceutical word. 

Contact 

Details 

UBM India Pvt. Ltd. 

A-615, Sagar Tech Plaza, Saki Naka Junction, Mumbai, India. 

Tel:+(91)-(22)-66122600; Fax:+(91)-(22)-66122626 


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PHARMA PROFESSIONAL - Indian Pharmaceutical Association

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