New Delhi, June 16: The central government has taken significant steps to enhance public health safety by amending the Drugs Rules of 1945. Selling cough syrup without a prescription from a doctor is now illegal, particularly in small villages with populations under 1,000.
The Ministry of Health and Family Welfare announced this amendment through Gazette Notification GSR 927 (E). The term “syrup” has been removed from Entry 13 of Schedule ‘C’ of the Drugs Rules, 1945.
Previously, there were exemptions for selling cough medicine in villages with populations below 1,000, where a retail sales license was not required. This led to easy access to these medications. However, this exemption has now been completely revoked.
Post-amendment, the sale and distribution of cough syrup will only be legal through licensed pharmacies under the Drugs and Cosmetics Act of 1940 and the Drugs Rules of 1945. Even in small villages, these medications cannot be sold without a license.
According to the ministry, this move aims to strengthen regulatory oversight over the manufacturing and sale of cough syrup. It will promote responsible distribution of medications and ensure better compliance with regulatory standards across the country.
The health ministry has issued a stern warning to all manufacturers, distributors, and retailers of cough medicines to strictly adhere to the new regulations. Legal action will be taken against any violations. This amendment was notified in December 2025 and is now considered enforceable nationwide.
This initiative will also ensure the quality and safety of medications in rural areas, particularly concerning cough syrups given to children. Consumers will now need a valid prescription from a registered doctor to purchase such medications.
Leave a Comment