Centre mandates prescription for syrup-based medicines

In a significant move the government has tightened the sale of cough syrups, making it mandatory for chemists to dispense syrup-based medicines only against a valid doctor’s prescription.

The Centre has amended the Drugs Rules, 1945, removing syrups from the list of exempted drug categories under Schedule K which covers drugs exempt from certain provisions governing manufacture, sale and distribution signalling a clampdown on the over-the-counter sale of syrup-based medicines.

The amendment comes amid growing regulatory attention on cough and oral liquid medicines following safety concerns.


“The Drugs (Fifth Amendment) Rules, 2026, which come into force immediately upon publication in the Official Gazette, effectively prohibit chemists from selling syrups, including widely used cough syrups, without a valid prescription,” said the notification.

The amendment follows a draft notification issued by the Ministry of Health and Family Welfare in December 2025 inviting public feedback. After reviewing objections and suggestions the Central Government, in consultation with the Drugs Technical Advisory Board (DTAB) cleared the change.