Published Jun 16, 2026 | 12:06 PM ⚊ Updated Jun 16, 2026 | 12:06 PM
Even commonly used cough syrups will require a prescription from a registered medical practitioner. (Creative Commons)
Synopsis: The Centre has ended the over-the-counter sale exemption for syrup-based medicines, including cough syrups, by amending the Drugs Rules, 1945. Consumers will now require a doctor’s prescription to purchase such medicines. The move follows consultation with the Drugs Technical Advisory Board and comes amid increased scrutiny of cough syrups.
Consumers will now need a doctor’s prescription to buy cough syrups and other syrup-based medicines.
This comes after the Union Ministry of Health and Family Welfare notified an amendment to the Drugs Rules, 1945, removing a key exemption that enabled their over-the-counter (OTC) sale.
The ministry, through the Drugs (Fifth Amendment) Rules, 2026, has amended Schedule K of the Drugs Rules, 1945. The notification states that in Schedule K, “the word ‘Syrups,’ shall be omitted.”
The seemingly minor change has significant implications for consumers and pharmacies, as syrup formulations, including commonly used cough syrups, will no longer enjoy the exemption available under the schedule and will require a prescription from a registered medical practitioner for purchase.
The amendment comes months after the government circulated a draft proposal in December 2025 seeking public comments on the move. In the final notification issued on June 9, the ministry said that “objections and suggestions received from the public on the said draft rules have been considered by the Central Government.”
The notification further noted that the amendment was made after expert consultation, stating that “the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945.”
The rules took immediate effect upon publication in the Official Gazette. “They shall come into force on the date of their publication in the Official Gazette,” the notification said.
The latest move follows growing regulatory scrutiny of cough syrups in India.
In April this year, the National Formulary of India (NFI) 2026 cautioned that cough suppressants have no benefits for children under two years of age and highlighted the risks associated with indiscriminate use of such formulations.
The NFI had also noted that dextromethorphan, one of the most widely used ingredients in cough syrups, has no recommended dose for children under two years and should be used cautiously in children with asthma, liver disease, kidney impairment and atopic conditions.
Public health experts have long raised concerns over self-medication with cough and cold preparations, particularly in children. The government’s decision to withdraw the exemption for syrup formulations is expected to strengthen oversight of their sale and promote more rational use of these medicines.
The Health Ministry said the amendment has been made under powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
(Edited by R Rajesh Kumar.)
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