India Amended Cosmetic Manufacture and Sale License Validity and Verification

Takehome:

India has amended the "Drugs and Cosmetics Rules 1945" that stipulated the validity provisions for drugs and cosmetics manufacturing license and relevant manufacturing premises inspection measures.

Ministry of Health and Family Welfare of India amended the Notification No. G.S.R 1337 (E) from "Drugs and Cosmetics Rules 1945", stipulating that manufacturing license for drugs and cosmetics and approval of drugs/cosmetics testing laboratories shall remain valid if the licensee deposits license retention fee before the expiry date of every succeeding five years from the date of issue, or the license will be suspended or cancelled by the authority.

The amendment also stipulated that before granting the license, the State Licensing Authority shall launch cosmetic manufacturing premises inspection jointly with the Central and State Drugs Inspectors. Inspectors should verify the compliance of manufacturing premises with the license requirement every three years or as needed as per risk based approach.

Further, to ensure smoothly processing applications for manufacturing license, one should follow:

1. The application should be submitted by the manufacturers to the respective State Licensing Authority;
2. The State Licensing Authority should fix a date for joint inspection of the manufacturing premises in coordination with the respective Zonal/Sub Zonal offices of CDSCO at least seven days beforehand;
3. In case that inspectors from CDSCO Zonal/Sub-Zonal offices is not available on the fixed day, the inspector from CDSCO (HQ) will be deputed for the joint inspection;
4. Proper coordination between the State Licensing Authorities, CDSCO HQ and Zonal/Sub-Zonal offices should be ensured for timely inspection and processing of the application;
5. In case of deficiency in the application, the joint inspection team may verify such documents during the inspection and record them in the report.