Unethical clinical trials may invite painful penalty

NEW DELHI: The government plans to amend the Drugs & Cosmetics Act to slap up to 10 years’ imprisonment and cancellation of licence for

violating norms for testing drugs on humans in India, a government official said.

“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 India, framed by ICMR, have been approved by the ministries of law and health. The move is intended to improve the country’s image in this area, which has been sullied by some cases of alleged unethical and sub-standard practices.

India has become a hub for clinical trials of drugs with a clinical research market estimated at $389 million, which is forecast to touch $1 billion by 2010.

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.

India does not allow Phase 1 trials, or initial experimentation on human subjects after a drug is found effective on laboratory animals, for molecules developed abroad. This prevents Indians from being the initial guinea pigs for foreign drug companies.

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 India.

So far, India has established only voluntary guidelines for testing experimental drugs on humans. Drugmakers as well as companies which do such experiments for a fee may choose to register themselves with the ICMR or with the World Health Organisation (WHO). But this is not yet mandatory.