The Union Government has so far done little except express ‘concern’ over clinical trial of drugs being conducted illegally across the country, because if the Government had cracked the whip on such practices, the Supreme Court would not have had to issue a notice to it recently, seeking an explanation on the matter.
It is not that the Union Ministry of Health has been unaware of the fact that several drug manufacturers have been indulging in the illegal practice; Union Minister for Health Ghulam Nabi Azad has admitted that “sometimes” drug manufacturing companies do not adhere to the guidelines laid down by the Drugs Controller General of India. Whether it is “sometimes” or more often than that, is not the issue. What is important is that illegal clinical trials are taking place without the Government acting against them in an adequate manner.
The indifference of the Health Ministry has been such that these clinical trials take place in the open. The Ministry’s argument that such trials are essential before the drugs are made commercially available in the market is an attempt to obfuscate the issue. Nobody is contesting the need for clinical trials, but when they are conducted without following the procedures laid down by law and on people like women (even those who are pregnant) and children who have no understanding of what they are being subjected to, or on the mentally-ill who are not even in a position to make an informed choice, the practice cannot be allowed to go unchallenged.
The public interest litigation filled by a Non-Government Organisation, Swasthya Adhikar Manch, in response to which the Supreme Court has issued the notice to the Government, details such cases of illegal clinical trials by multinational pharmaceutical companies. It is to be remembered that, besides being unethical because the consent of those subjected to the trial is taken — if at all — in a spurious fashion, these clinical trials are loaded with health-related risks.
Because the trials are done on people who are not equipped to challenge the big firms, the companies get away even if those subjected to the trials suffer from health complications as a result of such experiments. The NGO has also made the shocking claim that in many cases, the multinational corporations have been using contract research organisations to do the clinical trials.
What the Government has not done, and should now do, is two-fold: One, it must use the existing mechanism through the Drugs Controller General of India and the Medical Council of India to identify and take action against the pharmaceutical companies that have indulged in the illegal activity. And two, it should without any further delay revisit the existing provisions in the law that control clinical trials and plug the loopholes in them.
