Pharmaceutical Reviews Year: 2008 Vol: 6 Issue: 1 ISSN: School of Pharmacy and Technology Management, NMiMS University, Mumbai

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Britton Gilbert
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1 Dayanidhi B, Amol S School of Pharmacy and Technology Management, NMiMS University, Mumbai The US$65-billion (in 2005), global R&D pie is expected to grow to US$l00-billion by If India secures even a small share of this, it could grow 2-billion business. Thus, pharmaceutical R&D, whether outsourcing or indigenous, is likely to emerge as a multibillion dollar industry, including contract research and manufacturing, clinical trials, etc. Indian clinical trials market in 2006 was US$ 140million and is growing at a CAGR of 40% for the last 3 years. India is fast emerging as a favoured destination for clinical trials outsourcing, in view of the country's advantages like large pool of patients, faster patient recruitment, well trained English speaking physicians and IPR (Intellectual property rights) protection, besides lower labour costs. Over 100 pharmaceutical companies, including big multinationals such as Pfizer and Merck, are currently outsourcing clinical trials in the country. Also, there is an increased awareness regarding ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) guidelines for conduct of clinical research. Besides, India's inherent advantage in IT skills helped in outsourcing of high-end activities like data management. The new drug discovery is a complex process. It involves screening of around 10,000 compounds over a period of 8-10 years before a new drug discovery is successful. It also involves huge investment to the tune of almost US$1-billion. The major cost in the drug discovery process is the clinical trials [1,2]. India is uniquely placed to undertake clinical trials, due to the following reasons: 1.Very large population base available; 2.Diverse ethnic groups available; 3.Well equipped hospitals;

2 4.The law, including on ethics, is in place; 5.The expertise has been developed; and 6.Most importantly, the cost is substantially lower than in the West. In spite of the above, out of the global clinical market US$50-billion, India's share is as yet only US$100-million. Phase I trials This stage involves introduction of a new drug into healthy humans, to determine the metabolic and pharmacological actions of the drug, its side-effects and effectiveness. The trial evaluates drug metabolism, structure activity relationships and the mechanism of action in human. The number of subjects is typically from 20 to 50. Phase II trials These are controlled clinical studies for obtaining preliminary data on the effectiveness of the drug for subjects with the disease. The objective is to determine the short-term side-effects and risks of using the drug. The number of subjects runs into several hundreds. Phase III trials This phase of the trial is carried out with the aim of gathering additional information about the effectiveness and safety of the drug. It provides a basis for extrapolating the results to the general population and putting that information on the label. The number of subjects ranges from several hundreds to several thousands. If the cost of new drug discovery is to be reduced, it is imperative that clinical trials are carried out effectively at a lower cost. This is where India is uniquely placed. Indian clinical scenario 80 Indian hospitals are presently involved in clinical trials. This figure is likely to go up to 14,000 and will mean an involvement of 5 lakhs doctors, 7 lakhs bed's, 17,000 medical graduates in 160 medical colleges.

3 While India has many advantages for carrying out the clinical trial work meeting the stringent requirements of the west, there is competition from other countries (Table 2), As can be seen, while India is rated high for its available patient pool, it scores average in comfort level of sponsors. In spite of competition, India is still cost competitive (Table 3). New drug discovery is a complex process, involving screening of 10,000 compounds over a 8-10 year period and costs about US$1-billion before a new drug is successfully inducted into the market. The major cost in drug discovery are in the Phase I, II & III clinical trials and India is uniquely placed in carrying them out due to various advantages, including substantial lower cost. Cost-savings are a significant draw card for many pharmaceutical companies when deciding to outsource clinical research to countries in emerging markets such as India. In the last 10 years, skyrocketing costs of R&D have led to a growth explosion in the clinical services industry as pharma companies scramble to cut costs [2,3]. CROs in India 1.Clinigene 2.Dr Reddy's Laboratories Limited 3.GlaxoSmithKline 4.Lupin Limited 5.Novartis 6.Pfizer Limited 7.Ranbaxy Laboratories Limited 8.Torrent Pharmaceuticals Limited

4 9.Vimta Labs Limited 10.Zydus Cadila 11. Asian Clinical Trials Limited 12.Bioserve Clinical Research Pvt. Ltd. 13.Clininvent Research Pvt. Ltd. 14.Clintec International 15. Eli Lilly and Company (India) Pvt. Ltd 16.Igate Clinical Research International 17.Intas Pharmaceuticals 18.Johnson& Johnson, India 19.Lambda Therapeutic Research Ltd 20.Lotus Labs Pvt. Ltd. 21.Matrix Laboratories Ltd. 22.Merck Limited 23.Novo Nordisk India Private Ltd. 24.Pharmanet 25.Quintiles Research (India) Private Limited 26.Reliance Clinical Research Services 27.Roche India Ltd.

5 28.Sanofi-Aventis (Aventis Pharma Limited) 29.Siro Clinpharm Pvt Ltd 30.SRL Ranbaxy 31.Sristek 32.Synchron Research Pvt. Ltd Table 1: Success Rate in New Drug Discovery Activity Drug screening Preclinical testing Phase I Phase II Phase III Market launch Probability of success High risk of failure Low risk of failure Number of candidates Probability % 8% 79% 58% 57% --- of entering next phase Source: R. Vipranarayanan & Dr. A.K. Mukerkee; Chronicle Pharmabiz

6 Table 2: How India Fares in Global Clinical Research Country Population (Available patent pool) Comfort level of sponsors Intellectual property/regulation Cost Attractiveness India China Eastern Europe US Ratings: 1 = Low; 2 = Medium; 3 = High; Source: 2005 study by US consultancy Proximare. Source: Business Week Source: Pharmabiz, Cygnus Research Table 3: Cost Competitiveness of Indian R&D Phase US Costs Indian Costs Phase I US$ 20 million <50% of US cost Phase II US$ 50 million <60% of US cost Phase III US$ 100 million <60% of US cost Source: Pharmabiz, Cygnus Research

7 Table 4: Drug Discovery Pipeline of Indian Pharma sector Company Pre-clinical Phase I Phase II Ranbaxy Dr Reddy's Wockhardt Nicholas Piramal Lupin Orchid Torrent Glenmark Dabur Total Source: India Brand Equity Foundation The average cost of running a US-based clinical trial per patient is $5,404 for Phase I, $6,538 for Phase II and $7,635 for Phase III clinical trials. According to an analysis last year by Rabo India Finance, conducting a clinical trial in a lower-cost destination such as India, for example, can cost up to 60 per cent less than in the US. However, while quickly gaining momentum, India 's much hyped clinical research industry is still yet to really take off. A report by analysts at McKinsey estimated that clinical research in India will be a $l billion ( 800,000million) industry by 2010, although many analysts expect it will be closer to half that. To make India a preferred destination for drug testing finance minister has proposed to exempt

8 clinic trial of new drugs from service tax in the Budget for the year Also, total exemption from service tax is being provided to technical testing and analysis for testing of new drugs, vaccines and herbal remedies, on human participants by a CRG (Clinical Reference Group) approved to conduct clinical trials by the Drugs Controller General of India. It is a well-known fact that the world is looking at India as a clinical trial destination of choice. However, is India capable of handling large, complex clinical trials? India must pay immediate attention to handle large clinical trial projects effectively and to sustain a steady growth in the clinical trials market. There is a large influx of clinical trials from across the globe heading towards India. Major pharmaceutical companies and global Contract Research Organizations (CROs) are expanding staff and business activity in India. In this situation, it is mandatory for India to tackle issues to sustain in the industry keep other competing countries at edge. A recently held conference on Clinical Research and Development in India held by the Institute of Clinical Research in association with DST, has highlighted following issues for the Indian attention. Infrastructure: Creating large-scale exclusive clinical trial facilities in India are a must. There is a need for hospitals to create special beds for clinical trials. Research institutions and pharmaceutical companies should establish clinical trial centers that do not overlap with the existing R&D facilities. Manpower: There is an acute manpower attrition in India. Qualified and experienced clinical trial investigators are the need of the hour. Experienced investigators who can take decisions in adverse situations have to be strengthened. According to an estimate it presently requires about 4,000 experienced Principals Investigators for major trials. There is a requirement for experienced nurses, biostatisticians, researchers and coordinators in every clinical trial, and India must train the manpower available in these areas to suit clinical trial evaluation. India has a crunch in auditors, who can audit the effectiveness of a clinical trial.

9 Data Management: Effective data collection, storage and maintenance need to be strategically adapted in India. Electronic data storage and analysis need could help streamline some cumbersome process and would also save significant time. Regulatory Compliance and Ethical Issues: Although, the Indian Government has revised the ethical guidelines for clinical trials in 2007, CROs mllst practice and follow the guidelines diligently. A number of such isslles are bogging down on clinical trials industry in India. It is essential for the government to work in coordination with CROs, regulatory bodies and patients to help India gain the earmark as the best destination for clinical trials [1-3]. References: 1.Chemical weekly, April 17, 2007, p Budget Speech, Conference on Clinical Research and Development in India, April 14-15, 2007, Bangalore.

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