**Summary:**
This circular, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Biological Division on gmhjwy 27, clarifies the submission process for post-approval changes to human vaccines. Further to the memorandum dated 28.10.2013, the circular specifies that applications for certain post-approval changes must be referred to the CDL, Kasauli, with simultaneous submission of the application to CDL Kasauli. These changes include: changes to final product specifications (non-Pharmacopeial); changes to drug substance and drug product shelf life based on stability testing methods different from those used at the time of initial approval; changes to drug substance and drug product testing procedures (non-Pharmacopeial); changes to critical manufacturing processes (e.g., conjugation, inactivation, use of new adjuvant); changes in starting material; and changes mandated by CDSCO or other regulatory bodies. This circular is addressed to the Director of CDL, Kasauli, and all stakeholders via the CDSCO website. Inquiries can be directed to Dr. G.N. Singh, Drugs Controller General India. The file number for this circular is X1102614316BD.
Key Entities Referenced
Directorate General of Health Services: A department under the Ministry of Health and Family Welfare, Government of India.
Central Drugs Standard Control Organization: National Regulatory Authority (NRA) of India, responsible for the regulation of pharmaceuticals and medical devices.
Human Vaccines: Vaccines intended for use in humans.
CDL, Kasauli: Central Drugs Laboratory, Kasauli, a statutory laboratory of the Government of India for quality control of drugs and pharmaceuticals, located in Himachal Pradesh.
Pharmacopeial specifications: Drug specifications as per the pharmacopeia of India.
stability testing method: Method to determine shelf life of drug substance and drug product
Dr. G N. Singh: Drugs Controller General India at the time of publication of the document.
Himachal Pradesh: The state where CDL Kasauli is located.
File No. X-11026/143/16-BD
Directorate General of Health Services
Central Drugs Standard Control Organization
(Biological Division)
Dated: |gmhjwy 27
Circular
Subject:Clarification regarding submission of application for Post Approval
Changes of HumanVaccines -regarding.
In continuation to this office memorandum dated 28.10.2013 for
streamlining the regulatory approvals requiring examination by CDL, Kasauli
and CDSCO, it has been decided that the following post approval changes the
application shall be referred to CDL,Kasuali and the manufacturers shall
simultaneously submit post approval application to CDL Kasauli
il Where there is change in specifications in final product other than
Pharmacopeial specifications.
2: Where there is change in the shelf life of drug substance and drug product
only in case if it is proposed on the basis of stability testing method other
than one used at the time of approval of product.
. Where there is change in the testing procedure of drug substance and
drug product other than Pharmacopeial method.
Where there is change in the critical manufacturing process i.e. change in
the conjugation process, inactivation and use of new adjuvant.
Where there is change in the starting material.
Where there is a specific direction from CDSCO/other regulatory body for
compliance.
(Dr. G/ N. Singh)
Drugs Controller Genfral (India)
To,
The Director, CDL Kasualli.
ii. All Stakeholders through website of CDSCO.