Ban Product List by Indian FDA

File No. 4-01/2023-DC (Misc. 3)
Government of India
Directorate General of Health Services Central Drugs Standard Control Organization
(FDC Division)

FDA Bhawan, Kotla Road
New Delhi-110002
Dated: 11 April 2025

To,
All State/ UT’s Drugs Controllers
Subject: Manufacturing and marketing of unapproved FDC’s – regarding.

Sir/Madam,
With reference to the letter issued by this office vide F.No. 4-01/2013-DC (Misc13-PSC) dated 15.01.2013, wherein concerns were raised regarding the grant of manufacturing licenses for sale of the Fixed Dose Combination (FDC) drugs that fall under the definition of a “New Drug” in the country without due approval from Drugs Controller General (India). The same concern has been raised from time to time and multiple letters have been issued to the respective SLA’s that granted permission for manufacturing & marketing of unapproved FDC’s. The recent such letter was issued on 28.02.2025.

With reference to the above subject, it has come to the notice of this Directorate that certain Fixed Dose Combination (FDC) drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy as per the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940. This poses a serious risk to public health and safety.

The approval of such unapproved FDC’s compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation. Upon issuance of show cause notices to the manufacturers, they have stated that these licenses were granted by the respective Drug Licensing Authorities and have not violated any Rules. This has resulted in a lack of uniform enforcement of the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940 across the country.

In view of the above, all the State and Union Territory Drug Controllers are requested to review their approval process for such FDC’s and ensure strict compliance of the provisions of the Act and Rules. Public health and safety must remain the top priority.

A list of unapproved FDC’s which were earlier licensed by State/ Union Territory Drug Controllers for manufacture, sale, and distribution without evaluation of safety & efficacy by CDSCO and later on cancelled by Drug Licensing Authorities (SLAs) or voluntarily surrendered by manufacturers following the issuance of show cause notices is annexed for reference.