Notification No.: G.S.R. 607(E) dated July 08, 2026
Applicable Act/Rule: Drugs Rules, 1945 (under the Drugs and Cosmetics Act, 1940)
Applicable Section/Rule: Schedule K (Serial No. 10) and Schedule H1
Effective Date: January 09, 2027
The notification is issued by the Ministry of Health and Family Welfare (Department of Health and Family Welfare) in exercise of powers under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940. A draft of the rules was earlier published on October 16, 2025 inviting objections and suggestions; no objections or suggestions were received from the public. The Drugs Rules, 1945 were last amended on July 2, 2026.
The rules are titled Drugs (Tenth Amendment) Rules, 2026. They apply to manufacturers and sellers of oral pharmaceutical formulations. In Schedule K, against serial no. 10, an exception is inserted excluding all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol), packed and sold in packings or bottles of more than 30 millilitres, from the stated exemption. In Schedule H1, a new entry (52) is inserted covering all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 millilitres.
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