**Policy Summary:**
This circular, dated May 26, 2017, issued by the Drugs Controller General of India (Dr. G.N. Singh), addresses the acknowledgment process for Level III Post-Approval Changes and Annual Notifications related to Biological products, Vaccines, and rDNA products. The policy clarifies that Level III post-approval changes should be notified to CDSCO HQ with complete details and do not require separate prior approval, except in cases involving changes to shelf life. For imported products, these changes must also be notified and acknowledged by the National Regulatory Authority (NRA) of the country of origin. This circular aims to streamline the approval process as per the existing Guidance document for Industry. The circular has been distributed to all stakeholders of Vaccine and rDNA product manufacturers and importers, Zonal/Sub-Zonal offices of the Biological Division of CDSCO, the Director of CDL, Kasauli, and has been published on the CDSCO website.
Key Entities Referenced
Level III Post approval changes: Refers to a category of modifications made to biological products, vaccines, and rDNA products after their initial approval.
Biological products: A category of products regulated by the CDSCO, including vaccines and rDNA products.
Vaccines: A specific type of biological product that is subject to the guidelines outlined in the circular.
rDNA: Refers to Recombinant DNA products, a category of biological products.
CDSCO HQ: Central Drugs Standard Control Organisation Headquarters, the main office to which Level III post-approval changes must be notified.
Dr. G N. Singh: The Drugs Controller General of India at the time of the circular's issuance.
Drugs Controller General India: The title of Dr. G.N. Singh, head of CDSCO.
CDL, Kasauli, Himachal Pradesh: Central Drugs Laboratory, a laboratory located in Kasauli, Himachal Pradesh.
Dated: 26.05.2017
CIRCULAR
Subject: Acknowledgement for Level -III Post approval changes (Annual
Notifications) of Biological products (Vaccines & r-DNA) - Regarding.
In order to streamline the approval process of Level -III Post approval changes
(Annual Notifications) of Biological products (Vaccines & r-DNA) as per the Guidance
document for Industry, it is to clarify that, Level-III post-approval changes needs to be
notified to CDSCO (HQ) with complete details and does not require separate prior
approval, except for cases of change in shelf life. In case of imported products, such
changes also needs to be notified and acknowledged by NRA of country of origin.
(Dr. G/ N. Singh)
Drugs Controller General (India)
Copy To:
1. All Stakeholder of Vaccine and r-DNA product manufacturers and importers.
2. Zonal/Sub-Zonal offices / Biological Division of CDSCO.
3. Director, CDL, Kasauli.
4. CDSCO Web site.