Importer & Manufacturer | Source: CDSCO
Published On: 08-07-2026
Enforcement Date: 08 July, 2026
Government Notifies Drugs (Tenth Amendment) Rules, 2026 Bringing High-Alcohol Oral Drug Formulations Under Schedule H1
The Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, introducing stricter regulatory controls for oral drug formulations containing more than 12% v/v ethyl alcohol sold in packs exceeding 30 mL. Such products will now be included under Schedule H1 and excluded from the Schedule K exemption. The amendment will take effect six months after publication in the Official Gazette.
The Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, amending the Drugs Rules, 1945 to strengthen regulatory oversight of oral medicinal formulations containing higher concentrations of alcohol.
Key points include:
- The amendment revises Schedule K by excluding oral formulations containing more than 12% v/v ethyl alcohol packed and sold in bottles exceeding 30 mL from the existing exemption.
- Simultaneously, these products have been added as a new entry under Schedule H1, making them subject to stricter prescription, dispensing, record-keeping, and sale requirements applicable to Schedule H1 drugs.
- The amendment aims to improve monitoring of medicinal products with higher alcohol content and reduce the potential for misuse.
- The revised provisions will come into force six months after publication in the Official Gazette, allowing manufacturers, importers, distributors, and retailers sufficient time to implement the new compliance requirements.
Applicable For: Importer & Manufacturer
Reference Number: CG-DL-E-09072026-274311
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