The Central Drugs Standard Control Organization (“CDSCO”) has invited comments/suggestions on draft Guidelines on the Good Clinical Practices (“Draft Guidelines”) till 12th October 2024. Comments/suggestions may be sent through e-mail to dci@nic.in.
The Draft Guidelines cover the following critical areas:
- Investigational Pharmaceutical Products
- Pre-Clinical supporting data
- Protocols for Clinical Practices
- Responsibilities of sponsors, investigators, etc.
- Record keeping
- Quality Assurances
- Statistics related to Clinical Studies
- Disclosures of site specific safety/efficacy data
- Special Concerns related to the Clinical Study,
| Pharmaceuticals |
(Please note that while the document is dated 12th 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
