New Delhi: The Centre has tightened regulations governing the sale of oral medicines containing high levels of ethyl alcohol, bringing them under the stricter Schedule H1 category to prevent misuse for intoxication.

Under a notification issued by the Union Ministry of Health, formulations containing more than 12 percent v/v (volume by volume) ethyl alcohol in quantities exceeding 30 mL will no longer enjoy the exemption available under Schedule K of the Drugs Rules, 1945. These medicines will now require a valid licence for sale under the Drugs and Cosmetics Act, 1940, and can be dispensed only against a doctor’s prescription.

The amendment also requires pharmacies to maintain detailed records of every sale, including the patient’s and prescribing doctor’s details, in line with Schedule H1 provisions that apply to medicines with a higher risk of misuse.

“The amendment is expected to strengthen regulatory oversight over those medicinal products containing alcohol, ensuring their supply only through the regulated pharmaceutical supply chain,” the ministry said.

The government said the decision follows reports from several states highlighting the diversion of alcohol-containing medicinal products for non-medical consumption. While ethyl alcohol is commonly used in pharmaceutical formulations as a solvent and preservative, some products exempted under Schedule K contain significantly higher concentrations of alcohol.

According to the notification, certain tinctures and alcohol-based herbal extracts, including preparations of cardamom, ginger and other aromatic substances, contain as much as 80 to 90 percent ethyl alcohol, making them vulnerable to misuse.

Until now, these formulations were exempt from several licensing and sale requirements under Schedule K, which covers specific categories of medicines intended to improve access to healthcare.

Officials said the latest amendment aligns the regulation of these medicines with safeguards already in place for other systems of medicine. Under Rule 161 of the Drugs Rules, Ayurvedic, Siddha and Unani syrups can contain up to 16 percent alcohol, while Rule 106B, introduced in 1994, restricts the sale of homeopathic medicines containing more than 12 percent alcohol in bottles larger than 30 mL, except for supplies to hospitals and dispensaries in packs of up to 100 mL.

The revised rules extend similar controls to high-alcohol medicinal formulations that were previously exempt, with the aim of ensuring their use remains limited to legitimate medical purposes.

BI Bureau