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Ethical & Regulatory Issues in Conducting Clinical Trials in India

Amendment to Drug Trials Rules

In recent years, India has made a name for itself in the international pharmaceutical arena as a preferred destination for leading global companies to conduct clinical trials and there exists a basic regulatory regime governing the conduct of clinical trials. In due course of time, adequate knowledge of good clinical practice (GCP) requirements along with ethical concerns have resulted in a need of stringent regulatory requirements.

Recently, the ministry of health and family welfare has published draft rules for the amendment to the Drugs and Cosmetic Rules, 1945 along with the draft guidelines for deciding financial compensation in cases of drug trial-related deaths. By the look of it, The Drugs and Cosmetic Rules (4th amendment) are primarily aimed at regulating the Ethics Committees (ECs) by adding section 122-DD and Schedule Y-1 to the original rules. The draft Drugs and Cosmetic Rules (4th amendment) propose to make the registration of Ethics Committees mandatory and lay down detailed guidelines and requirements for the registration process.

The government of India has sought public feedback on both the draft rules (notified on July 17, 2010) and the draft guidelines (published on August 03, 2012) within 45 and 30 days from the dates of their respective publication.

In brief, the draft guidelines for financial compensation are aimed at providing a crucial amendment in the existing Drugs and Cosmetic Act 1940, which, at present, does not contain any provision for financial compensation in cases of drug trial-related injuries and deaths. As per present guidelines, financial compensation is not mandated by law and is merely mentioned as a Good Clinical Practice (GCP) in para 2.4.7 of the Indian Council of Medical Research’s GCP Guidelines for Clinical Trials in India.

As per the proposed draft guidelines, the financial compensation will be calculated through a mathematical formula using four predetermined parameters, namely-age of the deceased; income of the deceased; seriousness and severity of the disease; and percentage of permanent disability. Additionally, the guidelines propose two categories of victims-those who were healthy at the time of participation in a drug trial and those who were suffering from a disease prior to participation. Accordingly, the compensation to the “healthy” category would be higher on account of the `loss of dependency’ to the family of the victims. In contrast, for the “diseased” category, the compensation amount would be a fraction of the amount for healthy people and would depend on seriousness and severity of the disease.

As per a recent news report, as many as 2,031 people in India have died because of the clinical drug trials they were subjected to in the past four years. Only 22 of them have been compensated. What’s more, no action has been taken so far against any pharma company, ethics committee that oversees clinical trials or contract research organisation that conducts the trials, which have been found guilty of unethical practices. The information became public during the hearing of a Right To Information (RTI) petition by the Central Information Commission on June 29. This is the first time that the office of the Drugs Controller General of India (DCGI) has admitted to not paying compensation  for any of the deaths that have occurred so far except in 2010-2011. Similar issues were raised in an article in the Washington Post, published earlier this year.

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