Clinical trial sites to have adequate infrastructure, facilities and documented procedures
.jpg "Reena Yadav’s son developed mental illness after he was made to participate in a drug trial in Indore, Madhya Pradesh (Photo: Aparna Pallavi)")
The Central government has finally introduced a draft proposing the monitoring and regulation of clinical trials in the country. The provision for monitoring by the Quality Council of India was first suggested by Ranjit Roy Chaudhury committee a few months back.
The expert committee that was set up by the Government, in February 2014, to formulate policy guidelines for approval of new drugs has proposed major changes in the existing guidelines for clinical drug trials. The committee, headed by Ranjit Roy Choudhury, advisor to department of health and family welfare, has recommended that clinical drug trials should be held only at centres which are accredited for the purpose.
In the draft, the Centre has proposed accreditation as mandatory condition for all clinical trials. The new standards, as a draft, were placed in public domain on February 3.
As per the new standards, clinical trial sites shall have adequate infrastructure, facilities, documented procedures and oversight mechanism to support clinical trial conduct as per applicable rules and regulations ensuring trial intergrity and protection of subject rights, safety and wellbeing.
In case of any violation, these standards would consider all parties—including investigators, ethics committee members and even hospitals—as accountable.
Experts have been pointing towards the weak regulatory framework for conducting clinical trials. It has to be seen how the new standards influence current practices. The standards include documentation for patient safety and protection, informed consent, review of consent, declaration of payments, conflict of interest, monitoring, minimum number of meetings and a few other factors.
Implementation of law has also been a major contention till now. However, it is believed that with these new guidelines, more effective compliance can be assured.
Procedure for review of application of CT and new drugs
Ethical guidelines for biomedical research on human participants
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