The Central Drugs Standard Control Organization (CDSCO) is the primary body which regulates medical devices, drugs, cosmetics, in vitro diagnostics in the Indian subcontinent. This body is also responsible for the monitoring and approval of clinical trials and research in the country. Early this year, several amendments were made the the clinical trial approval process including the requirement to video-record the consent process from patient. These new amendments have provided stringent measures for clinical trial approvals. From 76 trials being approved in Q1/Q2 of 2014, merely 19 trials were approved in Q1/Q2 of 2015.
Recently the Indian regulatory authorities issued notices to encourage clinical research in the country. The key points of this circular are:
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Academic Research:
Trials which are for academic/ research purposes and not intended for new drug marketing do not require the permission of the Drug Controller General of India (DCGI). The ethics committee must still inform the DCGI and the DCGI would have 30 days to object to the decision to not seek its approval.
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Adding Trial Sites, Investigators:
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.
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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.”
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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.
For more information on clinical trials in India, click here.
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