The government on Monday issued a notification barring over-the-counter sale of cough syrups, making a doctors’ prescription mandatory for their purchase after amending the Drugs Rules, 1945.
The move follows a series of alerts issued by the World Health Organisation (WHO) over the death of more than 20 children on account of complications linked to Coldrif cough syrup, manufactured by Tamil Nadu-based Sresan Pharmaceuticals. WHO has earlier too issued global health alerts on India-made cough syrups.
The Central Government has notified the Drugs (Fifth Amendment) Rules, 2026, introducing a change to the Drugs Rules, 1945 by removing the word ‘syrups’ from a specified category under Schedule K which previously granted exemption to syrups.
This category exempts some medicines from stringent manufacturing, distribution and sales requirements related regulatory provisions of the Drugs Act, 1940.
The exemption allows tye defined set of medicines—listed in Schedule K of the Drugs Rules 1945 — to be sold without a formal sales licence (as required under Form 20-A of the parent Act) in villages with a population of not more than 1,000 people, provided there is no licensed dealer nearby.
Exempt drug category includes what the rules describe as “household remedies” including aspirin and paracetamol tablets and analgesic balms. The government’s latest notification drops the word “syrup” from the listing under the above category which currently reads “syrups, lozenges, pills and tablets for cough.”
The amendment comes into force with its publication in the Official Gazette.
The notification issued by the Ministry of Health and Family Welfare says the amendment follows consideration of objections and suggestions received from the public on draft rules published in December 2025.
The government stated that all feedback received during the consultation process was examined before the final rules were notified.
The amendment has been made under the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board.
Under the revised provisions, the word Syrups has been omitted from item number (7) against serial number 13 in Schedule K of the Drugs Rules, 1945.
What is Schedule K
Schedule K lists certain categories of drugs that are exempt from some provisions of the Drugs and Cosmetics Rules relating to manufacturing, sale, stocking and distribution, subject to specified conditions. The schedule primarily covers medicines supplied through government institutions, charitable dispensaries, educational institutions, first-aid boxes and other specified channels. Changes in Schedule K can affect the regulatory treatment and compliance requirements applicable to the listed categories of drugs.
