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Regulatory update on India clinical research approval timelines

Wednesday, February 5, 2014

Dr. Renu Razdan, vice president, ACRO India, and also chief operating officer, CRO Max Neeman Medical International, said he welcomes the new timelines and guidelines set up by the Drug Controller General of India [DCGI] for approval of clinical trials.

The drug regulatory authority in India has provided written confirmation to the pharmaceutical industry and investigators that clinical trial approval will be given within 180 days of submission of a clinical trial application, provided all submitted documents are complete. Also, clinical trial protocol amendments will be approved within 60 days, if consultation of NDAC is not required. The notification was issued Jan. 24.

In another step to make clinical trials transparent and safe, the Drug Controller General of India [DCGI] made it compulsory in November to obtain not just written informed consent from trial participants, but also present audio and visual recording of the informed consent process for each new patient.

Clarity also has been brought on the much debated issue of medical management and financial compensation paid to patients during clinical trials. Recent guidelines state a trial participant must be medically managed only when the injury to that participant is deemed trial related, and compensation need not be paid for injury or death due to unrelated causes.

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