Unethical clinical trials may invite painful penalty
“The new set of guidelines would ensure that those who do not follow the norms approved by the Drug Controller General of India (DCGI) for conducting clinical trials on humans are brought to book and punished,” Dr Vishwa Mohan Katoch, secretary in the department of health research and director general of the Indian Council of Medical Research (ICMR), told ET.
The move comes in the wake of the drug regulator’s failure to take action against several companies even after finding gaps in their clinical trials during audits, due to the absence of legal provisions.
The proposed guidelines for conducting clinical trials of experimental drugs in
Having a tough, credible regulatory set-up is crucial to enable the growth of this industry while protecting the rights of Indians who volunteer to become test subjects.
Recently, DCGI conducted the first audit of a clinical trial for Wyeth’s advanced pneumonia vaccine after an infant’s death was reported during the trial last October. It turned out that the child had been administered not the experimental vaccine but an already licensed, widely distributed vaccine in the double-blind study.
But the child should not have been enrolled in the study at all on account of a cardiac condition it suffered from, the drug regulator’s audit had found.
However, in the absence of legal provisions, the regulator is still weighing future action in this case.
In another incident last year, 49 children died during clinical trials at the country’s premier medical institution All India Institute of Medical Sciences. Later, a high-level committee found that none of the drugs had been tested on healthy children and rather they were suffering from high-risk illnesses and were also in a serious condition.
“Even as the DCGI prescribes certain protocols while allowing any company to conduct clinical trial, it does not have statutory powers to punish companies that do not follow these guidelines or violate any norms,” said a health ministry official who asked not to be named.
The most important part of these guidelines is that the person undergoing the experiment is informed about the risks involved while giving consent. The norms also specify the eligibility of a human subject to participate in the experiment.
The health ministry now plans to bring in a separate provision in the Drugs and Cosmetics Act to deal with offenders to check unethical human experiments in
So far,
The government relaxed earlier laws to allow clinical trials of drugs developed in foreign countries and now Indians are treated as guinea pigs to promote clinical research organisations who are sub-contractors of foreign multinationals, he said. “In this background, if the government wants to safeguard public interest, this is bolting the door after the horse has run away,” Mr Sengupta said.
Experts also say very few pathology laboratories in