Make unethical drug trials a punishable offence, say experts

Current laws do not fix penalty if such practices are found

By Ankur Paliwal
Published: Tuesday 27 September 2011

Public health experts have called for criminal prosecution of people found involved in unethical clinical drug trials.

Schedule Y of the Drugs and Cosmetics Act, which govern clinical trials in India do not impose any penalty if such unethical practices are found. The demand for imposing criminal penalty was raised by Brinda Karat, member of Rajya Sabha at a two-day consultation organised by Sama, The Centre for Studies in Ethics and Rights, and other non-profit health organisations in New Delhi on September 26.

Reffering to the recent unethical clinical trials conducted on tribal women by Axis Clinical Laboratory in Guntur District of Hyderabad where no criminal action was taken against either the sponsor company, Contract Research Organisations (CRO) or the ethical committee of the company Karat said, “In the name of action, only the trial was discontinued.” But is that enough to fix accountability? she asked, adding that in none of the unethical drug trials uncovered in the past any stringent punishment has been imposed on the liable party.

Experts call for criminal prosecution in cases of unthical trials
The current schedule Y of Drugs and Cosmetics Act which govern clinical trials in India do not fix any kind of penalty if such unethical practices are caught
In none of the unethical drug trials uncovered in the past any stringent punishment has been imposed on the liable party

The experts also stressed on the need of an independent body to examine all cases of serious health hazards and deaths during the course of a trial. “We rely on the sponsor companies for this data. In many cases they say that the death was not trial related,” saysAmar Jesani, founding member of Indian Journal of Medical Ethics. For example, of the total 671 deaths which occurred in 2010, only 22 were said to be trial-related by the sponsor company. “How do you trust this data?” he asks. To make matters worse, there are no guidelines on how the amount of compensation in case of trial-related injury would be decided and who would decide it. “Because of this, it is left to the discretion of the ethics committee or the sponsor company to decide,” says C M Gulhati, editor of Monthely Index of Medical Specialities.

The companies take advantage of this, explains Gulhati with an example. Of the 22 trial-related deaths, three were due to trials conducted by Pfizer. After much hue and cry and pressure from the office of the Drug Controller General of India, Pfizer paid a compensation ranging between Rs 1,50,000 and Rs 2,25,000. The same company paid a compensation of Rs 84 lakh to each kin of the victims in Nigeria. “Such huge variations are found due to the lack of proper regulations which makes the life of an Indian cheap. It is huge money saved for the company and gives them all the more reasons to outsource trials to India,” he adds.

L C Goyal, additional secretary, in the Union ministry of health, who was also part of the consultation said the ministry is seriously looking into the matters of ¬transparency and accountability in clinical research. “The law needs to be strengthened to fix accountability and take care of the rights and safety of the research participants in the clinical trials,” says Goyal. The long-pending Biomedical Research on Human Participants Bill 2007 is being revised for the same. The Bill is expected to be made available for public comments by December.

The ministry has also set aside a budget of Rs 5,000 crore in the 12 th Five Year Plan to improve resource and capacity of the Drug Controller General of India office at the Centre and at the state levels.

The final recommendations of the meeting will be presented to the health ministry, the office of Drug Controller General of India and other accountable and implementing bodies to make important policy changes.

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