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November 12, 2015.
With pharmaceutical research in the country declining in recent years, India’s Central Drugs Standard Control Organization (CDSCO) is instigating measures to promote more clinical research on the subcontinent, Zachary Brennan of the Regulatory Affairs Professionals Society (RAPS) reports.
CDSCO approved 19 trials in the first four months of 2015, which compares to 76 trials approved in the first five months of 2014 and 24 over the same timeframe in 2013.
As of this week, CDSCO says that 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
The DCGI also says 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 DCGI has also agreed to 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, [will need] to be recorded in writing.”
Review Committee on Genetic Manipulation
It has also been decided 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.
For more, see the RAPS report here.