Medicines with over 12% alcohol can no longer be sold without prescription: Govt
- On Friday, the Union Health Ministry announced that medicinal formulations containing more than 12% ethyl alcohol in quantities exceeding 30 mL no longer enjoy licensing exemptions under the Drugs Rules, effective immediately.
- Officials flagged that certain formulations contain ethyl alcohol concentrations up to 80-90%, making them susceptible to misuse for intoxication. State governments previously raised these concerns regarding the products.
- Manufacturers must now obtain proper licenses under the Drugs and Cosmetics Act, 1940, with products moved to Schedule H1, requiring sale only against a registered medical practitioner's prescription.
- The Drugs Technical Advisory Board and the Drugs Consultative Committee had examined the proposal earlier, with a draft notification regarding the 12% and 30 mL threshold circulated for public comment in October 2025.
- Regulatory changes aim to significantly reduce diversion and misuse while ensuring continued availability for legitimate therapeutic purposes, strengthening the Ministry's public health framework.
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Medicines with over 12% alcohol can no longer be sold without prescription: Govt
In a new regulatory change, medications with alcohol content exceeding twelve percent will require a prescription from a doctor. This decision treats these products like standard prescription drugs, compelling manufacturers to obtain the necessary licenses. Furthermore, pharmacies are now tasked with rigorous record-keeping to mitigate potential abuse and ensure that genuine medical use is preserved under enhanced scrutiny.
High-Alcohol Cough Syrups Now Need Doctor's Prescription as Centre Tightens Rules | 📰 LatestLY
The Union Ministry of Health and Family Welfare has issued a gazette notification strictly banning the over-the-counter (OTC) sale of all oral medicinal formulations containing more than 12% ethyl alcohol by volume when sold in bottles larger than 30 ml. 📰 High-Alcohol Cough Syrups Now Need Doctor's Prescription as Centre Tightens Rules.
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