CDSCO invites public comments on Draft Guidelines for Good Clinical Practices till 12th October 2024

The Central Drugs Standard Control Organization (“CDSCO”) has invited comments/suggestions on draft Guidelines on the Good Clinical Practices (“Draft Guidelines”) till 12^th October 2024. Comments/suggestions may be sent through e-mail to dci@nic.in.

The Draft Guidelines cover the following critical areas:

1. Investigational Pharmaceutical Products
2. Pre-Clinical supporting data
3. Protocols for Clinical Practices
4. Responsibilities of sponsors, investigators, etc.
5. Record keeping
6. Quality Assurances
7. Statistics related to Clinical Studies
8. Disclosures of site specific safety/efficacy data
9. Special Concerns related to the Clinical Study,

(Please note that while the document is dated 12^th September, 2024, it has been made available in the public domain recently)

A Copy of the Circular is linked below for your ease of reference.

Source: Central Drugs Control Standards Organization