PerspectivesAre you interested in submitting a Perspective Article? Be sure to read The Science Advisory Board's Editorial Guides for Perspective Articles. Click here. India's Pharmaceutical Sector by Ketan Desai, M.D., Ph.D. Not too many folks consider India when thinking of pharmaceutical services. That is changing. The pharmaceutical service sector was somewhat late to the outsourcing party compared to the IT sector, but it is expanding quite well. According to research firm Frost & Sullivan, the pharmaceutical outsourcing business in India will grow to around $7B by 2013. A report by Value Notes forecasts a growth of 23.6% annually for the industry up to 2010. Currently, India conducts about 1.5% of the global clinical trials. This could rise to 5% by end of 2008 and 15% by 2011. Outsourced pharmaceutical manufacturing activity in India is expected to cross $1B by 2010 (Motilal Oswal Report). The pharmaceutical services include those related to pre-clinical services, manufacturing, radiology reviews and clinical trials. There are too many companies to enumerate here, so a select few are mentioned. Pre-clinical: Services offered here include screening, lead optimization, toxicology, ADME (absorption, distribution, metabolism, and excretion) and pre-clinical pharmacology. Some companies in this sector include Aurigene Sciences, Advinus, and GVK Biosciences. GVK is part of the larger GVK conglomerate, Advinus is part of the Tata group, and Aurigene is an independent subsidiary of the Dr Reddy's Laboratories. The parent of the last is listed in the US NYSE: RDY. The biggest advantage here is cost, which can be up to one-third the US cost. Good Laboratory Practice standards are increasingly being used, and several US pharmaceutical giants have entered into collaborations with these outfits. One disadvantage is the lack of monkey studies (to avoid offending religious sentiments). Manufacturing: India has the most FDA approved pharmaceutical manufacturing sites outside USA (75). Services include the manufacture of active pharmaceutical ingredients [API] or finished dose products. Some companies in this space include Nicholas Piramal, Jubilant Organosys and Dishman. The advantages include cost and the immense expertise of Indian companies in chemistry. With India having signed the patent law, intellectual property is not so much of a concern. The FDA has audited some of these companies and Good Manufacturing Practices is not an issue. Radiology: Services in this sector include radiology reviews of studies conducted throughout the world. Studies in rheumatology, oncology, and neurology are specially suited since the primary or secondary endpoints are often radiologic. IMC Radiology, based in Pennsylvania and Hyderabad, is one such company that has read films for phase II and III oncology and rheumatology trials. The advantage includes low cost, high quality due to dedicated services (try finding a radiologist in the US who will be willing to give up practice to only read films for trials), and rapid turn around time (24 – 48 hours). The FDA has "audited" IMCR through radiology charters. Clinical Trials: This is the largest segment. It includes everything from recruitment, site management and clinical monitoring to data management. Many US companies have branches in India, including PPD Pharmaco (Nasdaq: PPDI) and Quintiles. Indian companies include Siro Clinpharm, Vimta and Lotus Labs. One has to be careful in picking the right company – some are very good, while others (not among those listed above) leave much to be desired. The biggest advantages of conducting trials in India include availability of patients, cost, standard of care (in urban centers) and use of English language (again, in urban centers). Generally, recruitment is two to three times faster than in the US, and costs about half to a third. The biggest disadvantages include the Indian regulatory authorities (they are overworked and understaffed), making sure that physicians truly understand how important it is to follow the protocol (in other words, Good Clinical Practice training), and import-export regulations of test materials. If anyone is interested, a full list of companies will be provided on request. This excerpt is from a larger article published by Ketan Desai, M.D., Ph.D. at Seekingalpha.com ### << Previous Next >> [ View All Perspectives ] |
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