Regulatory Focus™ > News Articles > India’s CDSCO Offers Four New Updates to Promote Clinical Research

India’s CDSCO Offers Four New Updates to Promote Clinical Research

Posted 10 November 2015 | By Zachary Brennan 

India’s CDSCO Offers Four New Updates to Promote Clinical Research

India’s Central Drugs Standard Control Organization (CDSCO) issued four new circulars on Tuesday that all seek to help promote clinical research on the subcontinent.

The new circulars come as pharmaceutical research in India has been on the decline in recent years. CDSCO approved 19 trials through the first four months of 2015, which compares with 76 trials approved through the first five months of 2014, and 24 approved over the same time in 2013.

Academic Research

Following meetings on issues around clinical trials in August and October, both of which were conducted under the chairmanship of India’s Secretary of Health and Family Welfare, CDSCO says that as of Tuesday, researchers will no longer need the permission of the Drug Controller General of India (DCGI) for “academic/research purposes that are non-regulatory in nature.”

The new rule is set to apply for trials that have been approved by an ethics committee but are not intended for the marketing of a new drug.

The ethics committee is still required to inform the DCGI of the study and the DCGI will have 30 days to object to the decision to not seek its approval.

Adding Trial Sites, Investigators

In addition, the DCGI is saying that ethics committees can also approve requests for new clinical trial sites and new investigators to be added to a clinical trial without CDSCO’s approval as long as the ethics committees conduct “due diligence.”

The ethics committees would still have to inform the DCGI of the changes, and the DCGI would be able to object to any such additions or deletions of sites or investigators.

Preclinical/Toxicology Studies

The DCGI also signed off on a third circular that would eliminate the need for repetitive pre-clinical/toxicological animal studies for drugs that are “already approved outside India.”

CDSCO notes, “Such studies are not required to be repeated while approving their proposal for import/manufacture in India unless there were specific concerns. The concerns, however, needed [sic] to be recorded in writing.”

Review Committee on Genetic Manipulation

Meanwhile, it was also decided at these two meetings that applicants “for r-DNA derived drugs like insulin, monoclonal antibody, etc.,” can submit parallel applications to the Review Committee on Genetic Manipulation and the DCGI when seeking approval to conduct a trial.

“However, DCGI shall complete the scrutiny of application and issue permission,” the circular says.

Requirement of permission for conduct of trials for academic/research purposes

Requirement of NOC from DCGI for addition of new clinical trial site or investigator

Removing the practice of repetition of preclinical/toxicological studies

Review Committee on Genetic Manipulation


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