Prescription Mandatory for Cough Syrups Under New Drug Rules

The Center has made the permitted uses and sale regulations on syrups (which included cough syrups) stricter through new amendments to the Drugs Rules, 1945.

Government Amends Drug Regulations

Under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the Central Government, with the assistance of the Drugs Technical Advisory Board, has published an amendment to the Drugs Rules, 1945. 

According to the new Drugs Rules, a medicine has to be used only upon prescription of a Registered Medical Practitioner for the word "Syrups" has been taken out from a list of drugs mentioned in Schedule K of the Drugs Rules, which lists drugs sold over the counter without a doctor's prescription.

Doctor's Prescription Needed for Cough Syrups

Customers would now be required to obtain a prescription from a registered medical practitioner to buy cough syrup, which has been available in the Indian markets in retail stores for many years. This amendment will have a direct impact on purchases like cough syrups. 

This is after months after contaminated cough syrups were responsible for the deaths of numerous children in states like Madhya Pradesh and Rajasthan.

Advisory Board Reviewed Changes

The amendment follows a draft notification issued on December 29, 2025, which invited comments and objections from all and it has now taken those into account to notify the final Drugs rules 1945. The health ministry says all comments that have been received in the regard have been carefully examined. 

The amendment has been made after obtaining advice from the Drugs Technical Advisory Board, which is the highest technical committee for drugs regulation in the country.