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Informist, Friday, Jul. 10, 2026

NEW DELHI – The Ministry of Health and Family Welfare Friday said it has amended the Drugs Rules, 1945, to require medicinal formulations containing more than 12% volume-by-volume ethyl alcohol in quantities exceeding 30 millilitres to obtain licences and be sold only on prescription. This has been done to prevent misuse of such products.
 

Under the amendment, these formulations will no longer be covered under the licensing exemption available under Schedule K of the Drugs Rules, 1945. Instead, they will require licences under the Drugs and Cosmetics Act, 1940, and will be classified under Schedule H1, which mandates sale only against the prescription of a registered medical practitioner and stricter record-keeping by pharmacies, according to a press release.

The ministry said certain medicinal products, including tinctures of cardamom, ginger, and other aromatic preparations, have been exempt from licensing requirements despite containing ethyl alcohol concentrations of up to 80-90% volume-by-volume. It said these products were susceptible to misuse for intoxication and several state governments had flagged the issue.

"The amendment is expected to strengthen regulatory oversight over those medicinal products containing alcohol, ensuring their supply only through the regulated pharmaceutical supply chain. It will significantly reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use," the press release said.

On Jun. 16, the ministry amended the Drugs Rules, 1945, to remove "syrups" from the list of medicines exempt from prescription requirements, effectively bringing syrup-based formulations, including cough syrups, under prescription-only sale. With this, syrup-based medicines, including cough syrups and other liquid oral formulations, will no longer qualify for over-the-counter sale and will require a prescription from a registered medical practitioner for purchase. The move is expected to affect a wide range of commonly used syrup formulations sold through pharmacies across the country. The notification noted that the draft proposal to amend the rules was published in December 2025.  End
 

Reported by Gunjan Rajput 

Edited by Shubhayan Bhattacharya

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