Govt contemplating key changes in rules for clinical trials

October 28, 2012

The Union Government is pondering to bring major changes in the Drugs & Cosmetics Act, 1940, and its Rules, to address the problem of inadequate monitoring of clinical trials in the country. As per the proposed changes:

Mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and the ethics committee, within 24 hours of occurrence.
DGCI will form a committee of experts to analyze the report of the Investigator, the sponsor, and the ethics committee, to arrive at the exact cause of the injury or death, and to recommend the exact quantum of compensation in case of trial-related injury or deaths within 3 months.
Mandatory for the sponsor to provide medical care to the person who suffers injury during trial, for as long as required.
Specific provision in the Rules for payment of compensation to the affected persons/their nominees, for trial-related injuries and deaths.
Modifications in the Informed Consent Form to capture qualifications, occupation, annual income, and address of the person concerned.

What are the existing procedures regarding SAEs?

As per the current procedure, Investigator reports all Serious Adverse Events (SAEs) to the sponsor and the company within 24 hours and to the ethics committee in 7 days. The sponsor then forwards the information to the DCGI and some other investigators within 14 days. It is the institutional ethics committee or the independent ethics committee that arrived on the cause of the injury or death, and declares compensation accordingly.

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