December 22, 2007

The rapid growth of Indian clinical trial industry, which is expected to touch US $2 billion in 2010, should be streamlined with adequate regulation and mutual understanding with the foreign clients, say experts.

In a panel discussion on 'Multinational Clinical Trials In India - Opportunities and Challenges' at the 59the IPC conference in Varanasi, experts suggested that the drug regulator should consider adding specific guidelines for pre-clinical studies and related research works, in order to support the momentum of growth of clinical trials in the country.

The ideal approach for the Indian clinical trial industry to grow to the target of US $2 billion should have mutual understanding with the foreign clients to create a win-win situation for both the parties and to allay apprehension from the minds of Indian patients. The government should also create a panel of experts in the field, on the lines of the advisory board in US, to give adequate guidelines to the regulator on clinical trial issues, said Dr Ashok Rakhit, vice president, Clinical Pharmacology, Hoffmann-La Roche Inc, USA, who was chairing the session.

He said that there should be emphasis on patient-safety with adequate priority, so that there would be no apprehension for the patients about the tests conducted. There is an apprehension in the minds of people that the big pharma is using the third world countries as their testing ground. "We know that the rumours on this are completely baseless, but we have to take steps to clear the apprehensions from the common people," he added.

India is going to be the sought-after place for overseas pharma companies in phase III clinical trials, said Dr Susan Abu-Shakra, vice president, Clinical Development, Allegran Inc. She averred that the win-win situation in the clinical trial outsourcing sector would make the Indian patients get treated with drugs cheaply.

The availability of English-learned skilled people, availability of latest technologies and exclusive sites are some of the major strengths of Indian clinical trial sector. The delay in regulatory approvals for drug trials is one of the major difficulties faced by the clients of Indian clinical trial industry. However, the recent experience of the company, which received regulatory approval within six months, shows that the regulatory efforts are also on the way of development, said Dr Susan.

Indian companies should concentrate more on long-term studies rather than looking for quick bucks from short-term trials, commented Prof. Nicholas HG Holford, University of Auckland, New Zealand. Earlier, Dr Satish Bhatia, chief executive, Fortis Clinical Research Centre presented his views on the effects of races, the Caucasian and Indian, in clinical pharmacokinetics. Prof. Harish Padkh, director, B V Patel PERD Centre, Gujarat discussed 'polymorphism and genotype - phenotype correlation of drug response in Indian population', in the symposium.