Government Mandates Licenses for Medicines with Over 12% Alcohol

The Centre has withdrawn the licensing exemption for certain medicinal formulations containing more than 12% v/v ethyl alcohol, as per a PIB report.  

Under the amended Drugs Rules, 1945, products containing over 12% alcohol in quantities above 30 mL will no longer qualify for exemption under Schedule K. Manufacturers of these medicines will now be required to obtain licences under the Drugs and Cosmetics Act, 1940. 

Prescription Requirement Introduced 

The amended rules also place these formulations under Schedule H1 of the Drugs Rules, 1945. This means they can only be sold against the prescription of a registered medical practitioner.  

Pharmacies will be required to maintain records of sales, as is already mandated for medicines listed under Schedule H1. 

Why the Rules Have Changed? 

According to the Ministry of Health and Family Welfare, some medicinal preparations covered under Schedule K contained ethyl alcohol levels of up to 80-90% v/v.  

These included certain tinctures prepared using ingredients such as cardamom, ginger and other aromatic substances. The ministry said such products were found to be susceptible to misuse for intoxication. Similar concerns had also been raised by a number of state governments. 

The proposal was examined by the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC). A draft notification setting the 12% alcohol threshold and 30 mL limit was issued for public comments in October 2025 before the amendments were finalised. 

Existing Limits Continue 

The amendment does not change the alcohol limits prescribed for other categories of medicines. Under Rule 161 of the Drugs Rules, Ayurvedic, Siddha and Unani syrups are permitted to contain up to 16% alcohol.  

Rule 106B allows homoeopathic medicines to contain up to 12% alcohol. 

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Conclusion 

Medicinal products containing more than 12% ethyl alcohol and exceeding 30 mL will now be regulated under stricter licensing and prescription requirements. The amendment also brings these products under Schedule H1 of the Drugs Rules, 1945. 

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