The Ministry of Health and Family Welfare (MoHFW) on July 09, 2026, issued the Drugs (Tenth Amendment) Rules, 2026 to further amend the Drugs Rules, 1945.
The following amendments have been stated:
• in Schedule K, under the heading Extent and Conditions of Exemptions, against the serial no. 10, after the words “Act and rules thereunder”, the words, figures, symbols, letters and brackets “except for all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.”, shall be inserted;
• in Schedule H1, after the entry “51. Pregabalin”, the following entry shall be inserted, namely: ─
“52. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.”.
They shall come into force after the 6 months of publication of these rules in the Official Gazette.
[Notification No. G.S.R. 607(E)]
