The Ministry of Ayush on July 24, 2026, issued the Drugs (Eleventh Amendment) Rules, 2026 to further amend the Drugs Rules, 1945.
The following has been amended:
• In rule 154, after sub-rule (3), the following sub-rule has been inserted, namely: - (4) A licence issued under sub-rule (1) shall remain valid perpetually.
• In rule 154A, after sub-rule (4), the following sub-rule has been inserted, namely: - (5) A licence issued under sub-rule (1) shall remain valid perpetually.
• The rules 156 and 156A has been omitted.
• In the rule 157, - (i) in sub-rule (1 C), for the proviso, the following provisos has been substituted, namely: - “Provided that, this sub-rule shall not be applicable, for extract based single plant-ingredient of Ayurvedic, Siddha, Sowa-Rigpa or Unani formulation licensed or to be licensed as patent or proprietary medicine as defined under sub-clause (i) of clause (h) of section 3 of the Act, till one year from the commencement of the Drugs (Eleventh mendment) Rules, 2026: Provided further that, such extract based single plant-ingredient of Ayurvedic, Siddha, Sowa-Rigpa or Unani formulations shall be named with prefix or suffix with any expression specific to the licencee.”
Please refer to the document attached below for more details.
[G.S.R. 657(E).]
