The ministry of health and family welfare has published draft rules for the amendment to the Dugs and Cosmetic Rules, 1945 along with the draft guidelines for deciding financial compensation in cases of drug trial-related deaths.
The Drugs and Cosmetic Rules (4th amendment) mainly aim at regulating the Ethics Committees (ECs) by adding section 122-DD and Schedule Y-1 to the original rules.
On the other hand, the draft guidelines published by the Central Drugs Standard Control Organization (CDSCO) seek to determine the quantum of financial compensation to be paid in case of “clinical trial related injury or death”.
The ministry 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 respectively from the dates of publication.
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.
An EC is an important, though much abused, institution in the drug-trial process. It is responsible for reviewing the drug trial protocol, for determining the suitability of investigators, ruling out any conflict of interest, ensuring the informed consent of the trial subjects and protection of the rights, safety and well-being of human subjects.
The rules define the scope and composition of the ECs and require detailed record maintenance and regular inspection of the ECs by competent authorities.
Financial Compensation
The CDSCO's draft guidelines for financial compensation seek to fill a major gap in the existing Drugs and Cosmetic Act 1940, which does not contain any provision for financial compensation in cases of drug trial-related injuries and deaths.
At present, financial compensation is not mandated by law and is only 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.
While deaths related to drug trials have been on the rise, compensation figures have remained abysmal. Between 2007 and 2011, drug trials caused 2,193 deaths. However, compensation was paid only in 22 cases.
The CDSCO's draft guidelines propose the calculation of financial compensation 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.
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.
The compensation to the “healthy” category would be higher on account of the `loss of dependency' to the family of the victims. On the other hand, 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.
The guidelines would apply to all cases of clinical trials covered under the Drugs & Cosmetics Act.
The Clinical Trial Victims Association (CTVA) of Madhya Pradesh has raised objections to the guidelines for compensation, calling them pro-business as opposed to pro-people.
“The most major flaw is that the guidelines have left children and non-earning members of the family outside the ambit of compensation. Secondly, the income parameter is problematic as most of the drug-trial victims are poor,” Anand Rai, medical rights activist and founder of CTVA, told The Hindu .
“Also, the decision regarding the quantum of compensation cannot be left to the Ethics committee or the Principal investigator but has to be judged by a party without any conflict of interest,” said Dr. Rai.
