The amendment also shifts these products to Schedule H1 of the Drugs Rules, which mandates sale against prescription
| Photo Credit:
EXTREME-PHOTOGRAPHER
In an effort to prevent the misuse of medicinal products with high alcohol content, the Union Health Ministry has done away with an existing exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol. From now on, these products will also be sold only on a doctor’s prescription, the Ministry said.All formulations containing more than 12 per cent ethyl alcohol, in quantities exceeding 30 ml, would no longer be covered under the exemption provided to them under Schedule K, a note from the Health Ministry said. Consequently, such products will be required to obtain the requisite licences under the Drugs and Cosmetics Act, 1940. Homeopathy medicines already have a governance structure in place, a Ministry representative said.“Certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945. Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80–90%, making them susceptible to misuse for intoxication. References were also received from certain State Governments in this regard,” the Ministry said, explaining the rationale behind the regulation.The amendment also shifts these products to Schedule H1 of the Drugs Rules, 1945, which mandates sale against the prescription of a registered medical practitioner and stricter record-keeping, the note added.“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,” it said.Published on July 10, 2026
