India :New draft guidance of clinical trials and new drug approvals

India’s Central drugs standard control organisation (CDSCO) has issued new draft guidance of clinical trials and new drug approvals that pave the way for potential electronic submissions.

The document covers the requirements for approval of trials, new drugs and details the CDSCO’s review process under Rule 122A, 122B, 122DA,122DAA,122E and Schedule-Y of the Drugs and Cosmetics Rule.

The organisation said that: “This guidance will help the industry to submit the required documents in a more realistic manner, which in turn will also help reviewer of CDSCO to review such application in systematic manner.

“It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the preparation of electronic submissions, which may happen in the near future at CDSCO.”

The issuance of the new document, which covers the differing requirements for clinical trials for drugs discovered in India compared with those discovered elsewhere, follows just a month or so after the CDSCO updated its rules on adverse events during studies.

Guidance for new drug approval.pdf (642.9 KB)

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