New Delhi: Oral medicines containing more than 12 percent ethyl alcohol will now be subject to tighter regulation, and will have to be sold with a doctor’s prescription following concerns over their misuse for intoxication.
In a notification issued Friday, the Union Ministry of Health amended the Drugs Rules, 1945, removing the long-standing exemption for such medicines under Schedule K, which includes specific classes of drugs (like over-the-counter painkillers and basic ointments) that are exempt from certain strict licensing and sales provisions to improve healthcare accessibility.
Formulations containing more than 12 percent v/v (volume by volume) ethyl alcohol in quantities exceeding 30 mL will now need licences to sell under the Drugs and Cosmetics Act, 1940, and will fall under ‘Schedule H1’—a special category meant to curb abuse of habit-forming medications.
Schedule H1 status means pharmacies can sell these drugs only against a valid prescription, and must maintain a strict log of the patient’s and prescriber’s details.
“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.
Why has the govt changed the rules?
Many medicinal formulations use ethyl alcohol as a solvent to extract active ingredients from herbs and plants, or preserve the medicine. These were exempt from certain licensing requirements as long as they fell under Schedule K of the drugs rules. The government said some of these formulations contain very high concentrations of alcohol and have increasingly been diverted for non-medical use.
According to the notification, some products covered by the earlier exemption—including tinctures, or alcohol-based herbal extracts, of cardamom, ginger and other aromatic preparations—contain as much as 80-90 percent ethyl alcohol, making them especially vulnerable to misuse.
The Centre said references received from several state governments highlighted repeated instances of such products being diverted for intoxication, prompting the review.
Ministry sources said similar safeguards already exist for traditional systems of medicine.
Under Rule 161 of the Drugs Rules, Ayurvedic, Siddha and Unani syrups can contain up to 16 per cent alcohol. Rule 106B, introduced in 1994, restricts the sale of homeopathic medicines containing more than 12 per cent alcohol in bottles larger than 30 mL, except when supplied to hospitals and dispensaries in packs of up to 100 mL.
Officials said the latest amendment extends a similar regulatory approach to the high-alcohol medicinal formulations that were previously exempt under Schedule K.
(Edited by Niyati Kothiyal)