New Delhi, June 16 (IANS). Taking important steps to strengthen the health protection of the general public, the Central Government has amended the Drugs Rules, 1945. It is now illegal to sell cough syrup without a license in small villages (with population less than 1000). Also, now cough syrup will not be available without doctor’s prescription.
The Ministry of Health and Family Welfare has notified this amendment through Gazette Notification GSR 927 (E). Under this notification, the word ‘syrup’ has been removed from entry number 13 of Schedule ‘A’ of the Drugs Rules, 1945.
Earlier, some relaxation was given on the sale of cough medicine (syrup) in villages with population less than 1000. There was no need for retail sales license in these areas, due to which these medicines were easily sold. Now this exemption has been completely abolished.
After the amendment, sale and distribution of cough syrup will now be legal only through pharmacies licensed under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. Now these medicines will not be sold without license even in small villages.
According to the ministry, this step has been taken to strengthen the regulatory oversight on the process of manufacturing and selling cough syrup. This will promote responsible distribution of medicines and ensure better compliance with regulatory standards across the country.
The Health Ministry issued a strict warning to all manufacturers, distributors and retailers of cough medicines to strictly follow the new rules. Legal action will be taken against any kind of negligence. This amendment was notified in December 2025 and will now be considered applicable to the entire country.
This step will ensure the quality and safety of medicines, especially cough syrups given to children, even in rural areas.
Now consumers will need a valid prescription from a registered doctor to buy such medicine.
–IANS
SCH/DKP
