India Tightens Rules on High-Alcohol Medicines to Curb Misuse

The Union Health Ministry has amended the Drugs Rules, 1945 to remove the exemption from licensing for medicinal formulations containing high concentrations of ethyl alcohol. The move, announced on July 10, 2026, is aimed at strengthening regulatory oversight and preventing the misuse of such products for intoxication.

Previously, certain medicinal products—including tinctures of cardamom, ginger, and other aromatic preparations—were exempted from licensing requirements under Schedule K of the Drugs Rules. However, many of these formulations contain alcohol levels as high as 80-90% by volume, making them susceptible to diversion and recreational use.

According to a ministry release, state governments had flagged concerns about the misuse of these products. In response, the central government has now mandated that all formulations containing more than 12% ethyl alcohol in quantities exceeding 30 ml must obtain a licence under the Drugs and Cosmetics Act, 1940. Additionally, these products have been moved to Schedule H1, which requires sale only against a prescription from a registered medical practitioner and stricter record-keeping.

The amendment is expected to tighten control over the supply chain, ensuring that such medicinal alcohol products are only available through regulated pharmaceutical channels. The ministry stated that the change will reduce the potential for diversion and misuse while maintaining access for legitimate therapeutic purposes.

“This initiative is in line with the government’s continued efforts to strengthen the regulatory framework for drugs, promote rational and responsible use of medicinal products, and safeguard public health,” the release noted.

The revised rules apply to a range of formulations, including certain tinctures and aromatic preparations that were previously unlicensed. The government believes that the prescription requirement and enhanced record-keeping will act as a deterrent against abuse.

Public health experts have welcomed the move, noting that high-alcohol medicinal products have been a loophole for those seeking to bypass alcohol sales regulations. The change brings India’s drug rules in line with global best practices for controlling substances with abuse potential.

The Health Ministry has directed all state drug controllers to enforce the amended rules promptly. Manufacturers and sellers of the affected products must now apply for licences and comply with Schedule H1 requirements, including maintaining records of sale and dispensing.