Mumbai, June 16: In a significant move to strengthen drug safety and curb misuse, the Central Government has made it mandatory for consumers to produce a valid doctor’s prescription to purchase cough syrups and other medicinal syrups.
The decision effectively ends the over-the-counter (OTC) sale of these medicines across the country, including in rural areas where certain exemptions were previously available.
The Union Health Ministry issued a notification on June 15 amending the Drugs Rules, 1945, and removing syrup-based medicines from Schedule K, which permitted the sale of certain medicines without a prescription under relaxed conditions.
Consequently, cough syrups and other medicinal syrups can now be dispensed only against a prescription issued by a registered medical practitioner. However, tablets, pills and lozenges continue to remain under the exemption list.
Schedule K Exemption Withdrawn
The move follows a proposal floated by the Health Ministry earlier this year. In January 2026, The Free Press Journal had reported that the Centre was considering removing cough syrups from Schedule K to end their OTC sale, particularly in rural areas where such products were widely available without medical supervision.
Under the earlier provisions, certain cough syrups were classified as household remedies and could be sold by vendors holding restricted retail licences.
The exemption was primarily intended for villages and small towns with populations below 1,000 and limited access to pharmacies. As a result, cough syrups were often available OTC not only at chemist shops but also through non-pharmaceutical retail outlets in these areas.
The proposal stemmed from a recommendation made by the Drugs Consultative Committee (DCC), a statutory body under the Central Drugs Standard Control Organisation (CDSCO), in December 2025.
The committee had recommended stricter controls on cough syrup sales to curb misuse and ensure uniform implementation of drug regulations across the country.
Move Aims To Improve Drug Safety
According to officials, the decision is expected to curb indiscriminate sales, prevent unauthorised outlets from stocking and selling cough syrups, and reduce self-medication. Authorities believe the measure will ensure that such medicines are used only under proper medical supervision.
The regulatory tightening comes amid growing concerns over medicine safety. In October last year, more than 24 children in Madhya Pradesh reportedly died after consuming cough syrup contaminated with toxic levels of diethylene glycol (DEG).
Similar incidents attracted global attention in 2022 when the World Health Organisation linked DEG-contaminated cough syrups manufactured in India to child deaths in Gambia.
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Doctors Welcome Decision
Welcoming the move, Dr Manjusha Agarwal, Consultant – Internal Medicine, Gleneagles Hospital Mumbai, said the decision would help improve patient safety and encourage responsible use of medicines.
“Self-medication with cough syrups can mask underlying illnesses ranging from allergies to pneumonia, delaying timely diagnosis and treatment. Many cough syrups can also cause side effects, drug interactions and, in some cases, dependency. Persistent cough, fever, breathlessness, chest pain or blood in sputum should always be evaluated by a doctor,” she said.
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