2026.06.23 G.S.R. 509(E)_ Draft notification regarding simplification of the process for obtaining test licences for import of drugs under Form 11 of the Drugs Rules, 1945

The draft notification G.S.R. 509(E), dated 23 June 2026, proposes amendments to the Drugs Rules, 1945 to streamline the import of drugs used for analytical and non-clinical testing. Under the proposal, applicants importing eligible drugs would submit an online Form 12 as a prior intimation to the Central Licensing Authority and may proceed with import upon receiving acknowledgment of such intimation.   The simplified procedure would not apply to sex hormones, cytotoxic drugs, beta-lactam products, biologics containing live microorganisms, narcotic drugs, or psychotropic substances. Consequential amendments are proposed in Rules 33, 34, 35 and Schedule A to recognize acknowledgments of prior intimation alongside licences. The draft has been published for stakeholder comments and objections within 30 days of publication in the Gazette.