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India is well placed for clinical trials outsourcing: Experts
Our Bureau, Bangalore | Saturday, June 10, 2006, 08:00 Hrs  [IST]

India is much-sought-after for its clinical trails capability going by the interest evinced by global companies, expressed speakers at the Bangalore Bio 2006.

Addressing the topic Clinical Development in India: A Gap Analysis, on the second day of the biotechnology exposition, Dr. Naveen Rao, medical director, MSD Pharmaceuticals said, "We must realize outsourcing is a business phenomenon, though there are business complexities such as cultural and IPR issues. There has been resurgence in Pharmaceutical R&D research. Top US companies have increased new clinical trials by 50 per cent since 2002. During 2003-2005 it rose by 52 per cent. In 2004, leading CRO's managed 23,000 phase 1- IV clinical trials worldwide, monitored more than 1,50,000 clinical investigations and enrolled more than 6,40,000 new subjects."

Stating that cost is not the driving factor for drug companies, Dr. Rao pointed out that pharma companies are look for long term associations, flexibility and timelines adherences. A prevailing trend according to the Tufts Centre for the study of Drug Development 2006 is that 15 percent of the pharma and biotech companies gearing up to offer clinical trial services along with dedicated CROs since 2001.

Elaborating on how to make India more competitive, Dr. Nermeen Varawalla, vice president, Business Development PRA International, UK, said, "Patient Recruitment is critical in clinical trials. India must make all efforts to capture a bigger pie of the global clinical trial market, to be more competitive. It is imperative to find patients in a timely fashion. One third of patients for clinical trials come from North America and another one-third from Western Europe. There still exists a deficit of one-third that can be captured by India."

"India is up against countries such as Korea and China. Regulatory and ethical committee approvals take 12 weeks in India, which is better than China, which take close to nine months, but Korea only takes 30 days. Another factor to consider is that though China is slow on approvals, pharma companies consider the country as a huge future market and are willing to forego the latency period, stated Dr. Varawalla who appreciated the adherence to IPR in the country.

Dr Narges Mahaluxmiwalla, President - Clinical Services and Commercialization, Quintiles India, said, "It is important to dispel myths surrounding Clinical Trials. The most significant areas of Clinical Trials are in the areas of cardiovascular, intestinal diseases and the like. In these areas, the patients are likely to be urban educated Indian who makes an 'informed decision'. It is farfetched to say Indians are being exploited".

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