India's drug regulator allows concurrent applications for genetic-related trials


Applications for clinical trials on genetic candidates in India can be sent at the same time to the Drug Controller General of India and the Review Committee on Genetic Manipulation under the Department of Biotechnology as part of an effort to streamline the process.

In a circular, the Drug Controller General of India, or DCGI, said the joint filing was approved at a meeting earlier this month, though it will have the final word on approval.

"It was decided in the meeting that the applicant may submit parallel application to RCGM (Review Committee on Genetic Manipulation) and DCGI seeking approval to conduct (a) clinical trial," DCGI chief G.N. Singh said in the notice.

However (the) DCGI shall complete the scrutiny of (the) application and issue permission, only after RCGM clearance was received."

The RCGM is charged under law with reviewing the safety and ethics of recombinant DNA projects and activities in India that involve genetically engineered organisms, as well as setting guidelines, and previously had the first look at any applications.

According to the Regulatory Affairs Professionals Society, the change could shorten the path to clinical trial regulatory clearances for insulin or monoclonal antibody (mAb) candidates.

In July, the DCGI tweaked biosimilar approval guidelines and narrowed the scope to issue waivers required to run Phase III trials and rely on clinical references to biologic drugs not marketed yet in the country as part of an effort to get a better handle on data used to support such work.

- here's the notice (PDF)
- and a story from RAPS

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India tweaks biosimilar guidelines to narrow waivers in clinical trials