Saturday, July 9, 2011

Transnational pharma companies conduct clinical trials in India for monetary gains

Syed Akbar
Hyderabad: Transnational pharma companies have been carrying out clinical trials in India knowing well that Indian clinical trials are not recognised by many developed nations including the United States of America. Clinical trials, when successful, are redone in developed nations for approval of drugs. In case of failed results, the pharma companies abandon the drug trials.
This, in other words, means transnational pharma firms view India as a natural laboratory for testing of new drugs and vaccines. With no monetary compensation component for volunteers in India, the companies prefer the country for all the three phases of human trials, which involve both healthy people and patients.
As the rush for clinical trials (CT) gained momentum in the last three years, the CT industry in India is now worth Rs 5000 crore. It was just Rs 800 crore three years ago. According to World Health Organisation news bulletin, India along with Pakistan and Bangladesh has emerged as the world's preferred destinations for clinical trials.
Though the reasons cited, for India emerging as a major attraction for clinical trials, are its highly qualified technical workforce and low costs, pharma companies actually prefer the country for patient availability and a "friendly drug-control system." It is this friendly drug control system that frequently puts economically disadvantaged groups to high risks of complications associated with new drug tests.
The WHO bulletin points out that while it is "good news for India’s economy, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and the uneven application of requirements for informed consent and proper ethics review".
According to the FDA, less than 25 per cent of drugs introduced in the last 10 years have been breakthrough drugs. About 75 per cent of the new drugs have had only a marginal benefit or no benefit as ‘add on’ drugs.
"Only trials conducted in the randomised controlled trials setting have a proven value in determining whether or not the drug in question is effective (the best form of evidence). But very few trials in India are done in the randomised setting," regrets senior oncologist Dr P Raghuram.
Health researchers point out that most trials in India are undertaken without compensation mechanisms in place. Although the Indian Council of Medical Research has strict guidelines relating to compensation mechanism in case of injury or death of the patient in question participating in the trial, very few trials in India have robust insurance cover.
They demand that research must be part and parcel of medical curriculum in MBBS and postgraduate training in all medical colleges in the country. Doctors, who have not published widely in peer reviewed journals, must not be allowed to participate in clinical trials.

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