Regulate,not ban, clinical trial of drugs

Published: 02nd October 2013 07:12 AM  |   Last Updated: 02nd October 2013 07:12 AM   |  A+A-

The Supreme Court cannot be faulted for adopting a tough stance on clinical trial of new medicines. In its latest order, the apex court has stayed the approval granted to 162 applications for clinical trials. The court’s intervention has come in the wake of charges that the medical companies do not adhere to the norms for such trials. The government has been given two weeks to inform the court about how it proposes to regulate the pharmaceutical companies. This should be seen against the backdrop of the affidavit submitted by the government, according to which 2,644 persons died during trials of 475 drugs between 2005 and 2012. Out of them, 80 died as a result of reaction to the new medicines.

Over the years, India has emerged as a major centre for clinical trial of new medicines. Pharmaceutical firms in the West have been finding it difficult to conduct clinical trial of drugs as the laws have become strict there. Besides, they have to pay huge compensation in case those on whom the drugs are tested suffer even mildly. In India, there is very little awareness among the general public about the norms that govern clinical trials. Since a majority of the poor people in India cannot afford medicines, they are considered better guinea pigs than those who have been dependent on drugs. Also, the companies have to spend only a pittance as compensation.

If the government fails to convince the apex court about the steps it has taken to enforce the norms for clinical trials, the danger of it extending the ban on clinical trial cannot be ruled out. Needless to say, that will not be in the interest of medical science and the Indian pharmaceutical industry. India has emerged as one of the largest producers of drugs, cheaper than those produced by their western counterparts. Clinical trials of new medicines are a must before they can be marketed. If there is a blanket ban, the Indian pharmaceutical industry will lose its ability to develop new drugs.


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