The Central Government has tightened regulations for medicinal formulations with high alcohol content, introducing stricter licensing and prescription requirements to reduce the risk of misuse for intoxication.
The Ministry of Health and Family Welfare announced on July 10, 2026, that the Drugs Rules, 1945, have been amended to strengthen regulatory oversight of high-alcohol drug formulations.
Under the amended rules, formulations containing more than 12% volume by volume (v/v) ethyl alcohol in quantities exceeding 30 millilitres will no longer be covered by the existing exemption under Schedule K. These formulations will be required to obtain licenses under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.milliliters
The affected products have also been included under Schedule H1 of the Drugs Rules, 1945. As a result, they can be sold only against the prescription of a Registered Medical Practitioner and will be subject to stricter record-keeping requirements.
The government said certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, had been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945.
However, some of these formulations contain high concentrations of ethyl alcohol. According to the Health Ministry, alcohol levels in certain cases can reach 80% to 90% v/v, making the products susceptible to misuse for intoxication.
The ministry said it had also received references from certain state governments regarding such misuse.
The matter was examined by the Drugs Technical Advisory Board, or DTAB, which recommended tighter regulation of these formulations. Based on the DTAB’s recommendations, the government amended the Drugs Rules, 1945.
Schedule K of the Drugs Rules, 1945, provides specified exemptions from certain regulatory requirements for particular categories of drugs, subject to prescribed conditions.
The official government announcement identifies the affected category using two thresholds:
more than 12% v/v ethyl alcohol; and
quantities exceeding 30 mL.
The Health Ministry specifically referred to certain medicinal products that had benefited from Schedule K exemptions, including tinctures of cardamom, ginger and other aromatic preparations.
However, the official announcement does not provide a comprehensive brand-wise list of affected medicines.
The Health Ministry said the amendments are intended to strengthen regulatory oversight and prevent the misuse of medicinal products with high alcohol content.
According to the government, the revised framework is aimed at reducing the possibility of diversion and misuse while ensuring that such medicines remain available for legitimate therapeutic use.
Sakshi Phaugat, M.Pharm (Pharmacology), shared her perspective during an ongoing discussion on MedBound Hub. She said:
I think this is a positive step. Medicines with a high potential for misuse should be dispensed under proper medical supervision. At the same time, it’s important that genuine patients don’t face unnecessary delays in accessing treatment. The success of this regulation will depend on effective implementation and patient awareness.
By removing the relevant Schedule K exemption and bringing the affected formulations under Schedule H1, the government has tightened licensing, sale and dispensing controls for high-alcohol medicinal formulations.
(Rh/ARC/MSM)