New Delhi: In a major step to curb the misuse of medicines for intoxication, the Central Government has tightened regulations governing the sale of certain alcohol-containing medicines by amending the Drugs Rules, 1945. Under the revised provisions, cough syrups and other oral medicines containing more than 12 per cent ethyl alcohol will no longer be available over the counter and can only be sold on the prescription of a registered medical practitioner.
The government has brought these medicines under the Schedule H1 category, strengthening controls on their sale and distribution. The move is aimed at preventing the growing misuse of alcohol-based medicinal formulations for recreational intoxication while ensuring their availability for genuine medical purposes.
The revised rules apply to oral medicines containing more than 12 per cent ethyl alcohol that are marketed in bottles exceeding 30 millilitres. Retail chemists will now be permitted to dispense such medicines only against a valid doctor’s prescription.
In addition to prescription-only sales, the government has imposed stricter record-keeping requirements on pharmacies. Medical stores will be required to maintain a separate register documenting the sale of these medicines, including details of the prescription and the quantity dispensed. The measure is intended to improve traceability and strengthen monitoring of medicines susceptible to misuse.
Officials said the amendments are part of the Centre’s broader efforts to prevent the abuse of pharmaceutical products while promoting responsible dispensing practices. By bringing high alcohol-content medicinal formulations under the Schedule H1 category, authorities expect to reduce unauthorised access and enhance regulatory oversight of their distribution.
The latest changes to the Drugs Rules, 1945, are expected to strengthen safeguards against substance abuse and ensure that medicines with a higher potential for misuse are dispensed only under appropriate medical supervision.
