Govt. amends rules to strengthen regulation of drug formulations with high alcohol content
Aimed at strengthening regulatory oversight and preventing misuse of medicinal products with high alcohol content, the Union Health Ministry has now removed the existing exemption
Aimed at strengthening regulatory oversight and preventing misuse of medicinal products with high alcohol content, the Union Health Ministry has now removed the existing exemption from licensing requirements for formulations containing ethyl alcohol. In a release issued on Friday (July 10, 2026), the Ministry said that 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.
Susceptible to misuse “Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80-90% v/v, making them susceptible to misuse for intoxication. References were also received from certain State governments in this regard,” the Ministry said. The government has mandated that all formulations containing more than 12% v/v ethyl alcohol, in quantities exceeding 30 ml, shall no longer be covered under the exemption provided to them under Schedule K.
Consequently, such products will be required to obtain the requisite licences under the Drugs and Cosmetics Act, 1940. 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. Regulation in supply chain The amendment is expected to strengthen regulatory oversight over those medicinal products containing alcohol, ensuring their availability 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 initiative is in line with the government’s continued efforts to strengthen the regulatory framework for drugs, promote the rational and responsible use of medicinal products and safeguard public health,” noted the release.
The BriefWire