Health ministry seeks public feedback on amendments to drug trial rules

The Hindu A protest against unethical clinical trial in Bhopal. A file photo: A. M. Faruqui.

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.

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Health ministry seeks public feedback on amendments to drug trial rules