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P.T. Jyothi Datta

New Delhi , Sept. 23

EVEN as pharmaceutical giants such as the Pfizers, Lillys and Novartis' wait in the wings to benefit from the gradually evolving environment for clinical trials in India - there still prevails an underlying apprehension on whether the country is ready to take on this challenge of drug trials sponsored by pharma companies or Government agencies.

Are pharmaceutical companies transparent enough in their processes of drug development and is the regulatory framework strong enough to protect the patient from being used as a "guinea pig"?

"The concern regarding patients becoming `guinea pigs' is a valid one. But, if a drug is not tested adequately before it is put out into the market, then the whole general population becomes a guinea pig. One should conduct drug studies in a controlled population, the challenge lies in bringing good research techniques to the existing processes," points out Ms Cathy White, Global CEO, Neeman Medical International (NMI), a US-based multinational study conduct organisation and a wholly-owned subsidiary of Max India.

"Clinical trials are not new in India, only the processes being brought to it are global. All the drugs taken till date have been tested on western guinea pigs. When floodgates are being opened in India, the overall principle should be to protect the human subject at the centre of the procedure. Informed consent is important and when patients are not educated, one relies on the individual's robust common sense. But a trial does not commence till the person is clear about what he or she is getting into. The regulatory framework needs to be strengthened to generate reliable, valid data," observes Mr Vijai Kumar, President and CEO of NMI.

India is poised for entry into the global arena of clinical trials, points out Mr Kenneth A. Getz, President and CEO of Thomson Centrewatch, a forum that brings together researchers and industry.

"In terms of infrastructure readiness (for clinical trials), India is poised to grow rapidly - not merely because India can deliver at a fraction of the total cost. It is true that the global pharma industry is looking to manage its cost, but that is only part of the reason. In the broader spectrum, patients have been ready and now the country too is ready in terms of regulatory framework and compliance, which is why companies like Pfizer, Novartis and Lilly are evincing interest in India."

Further, with every clinical trial gone awry, the regulatory procedure has been tightened. As a result, the number of "self-referred" patients who go in for clinical trials in the US have gone up to 65 per cent, from about 30 per cent a decade ago!

NMI's Ms White adds, "One of the major pitfalls that needs to be avoided is the tendency to cut corners in delivering quality."

Though the US accounts for 50,000 of the total 80,000 clinical trials done per year, NMI's Mr Vijai Kumar points out that India too holds a trump card in terms of trained medical professionals, English as a business language, data outsourcing management facilities and the availability of `treatment-naïve' (not overly medicated) individuals.

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