A draft of these rules was published vide G.S.R. 52(E) dated January 22, 2026. Copies were made available to the public on January 27, 2026. No objections or suggestions were received. The Central Government, after consultation with the Drugs Technical Advisory Board, has made the following amendments to the Drugs Rules, 1945. The principal rules were last amended vide G.S.R. 377(E) dated May 13, 2026.

Schedule B (See Rules 7 and 48) and Schedule B(1) (See Rule 163F) of the Drugs Rules, 1945 are substituted in their entirety. Both revised schedules carry a note that the prescribed fees shall automatically increase by 5% annually.

The revised Schedule B specifies fees for test or analysis by Central Drugs Laboratories or State Drugs Laboratories. It is structured in three parts.

Part-A covers fees for drugs tests and assays, comprising:

(1) tests requiring use of animals, ranging from ₹1000 to ₹25,000;

(2) microbiological tests and assays, ranging from ₹500 to ₹5000;

(3) identification tests, ranging from ₹150 to ₹900;

(4) physical tests, ranging from ₹100 to ₹2500;

(5) assays, ranging from ₹250 to ₹1500; and

(6) other miscellaneous tests at ₹300–1500.

Part-B covers fees for sera and vaccines, comprising 89 entries for sterility, potency, identity, biochemical testing and other parameters for individual vaccine and antiserum categories, ranging from ₹300 to ₹45,000.

Part-C covers fees for Homeopathic/Herbal medicines, covering identification, limit, assay and chromatographic tests, ranging from ₹200 to ₹500. For tests not listed in the Schedule, charges shall be determined by the Director or Government Analyst of the Laboratory or institute.

The revised Schedule B(1) specifies fees for test or analysis by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) or the Government Analyst, covering 25 categories of tests applicable to Ayurvedic, Unani, Siddha and Homoeopathic medicines, ranging from ₹100 to ₹25,000. Sample testing charges under Schedule B(1) shall be determined or revised by the Director, Pharmacopoeia Commission for Indian Medicine and Homoeopathy or Government Analyst of its Central Laboratory, in consultation with the Ministry of AYUSH.