In a significant tightening of drug-sale regulations, the Union Ministry of Health and Family Welfare has made it mandatory for consumers to present a valid doctor's prescription to purchase cough syrups across India.
The decision follows a gazette notification issued on June 9, which removes the term "syrup" from the Schedule K list under the Drugs and Cosmetics Act, 1945. Medicines included under Schedule K are exempt from prescription requirements and can be sold over the counter.
With the latest amendment, pharmacies will no longer be permitted to sell cough syrups without a prescription issued by a registered medical practitioner.
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According to officials familiar with the matter, the move is aimed at strengthening regulatory oversight following a series of contamination-related incidents linked to cough syrups manufactured in India.
Move follows safety concerns and child death cases
A senior Health Ministry official said the proposal had first been placed in the public domain through a draft notification issued in December last year.
"A draft notification in this regard was issued in December last year, and all stakeholders were given a chance to go through it. Since there was no objection made by the parties concerned, the ministry finally notified it," the official said.
Union Ministry of Health and Family Welfare issues notification which brings into effect that all 'Syrups', including cough syrups will no longer be available over the counter. A prescription by a doctor will be required for the purchase of 'Syrups'. pic.twitter.com/SaszQvHH1C
— Press Trust of India (@PTI_News) June 16, 2026
The decision comes after several high-profile investigations involving contaminated cough syrups allegedly linked to child fatalities in India and other countries.
Last year, at least 22 children, mostly in Rajasthan, reportedly died after consuming a contaminated cough syrup. Investigations found the medicine contained diethylene glycol (DEG), a toxic industrial solvent commonly used in antifreeze and brake fluids.
Laboratory analysis reportedly detected DEG levels far exceeding the permissible limit of 0.1 per cent. Medical experts warn that ingestion of DEG can lead to severe kidney damage, neurological complications and, in extreme cases, death.
Regulatory scrutiny intensifies
India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has been reviewing multiple measures to improve quality control and compliance standards within the pharmaceutical sector.
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The issue gained international attention after India-manufactured cough syrups were linked to child deaths in countries including The Gambia and Uzbekistan. A separate contamination-related case was also reported in Cameroon.
Health officials believe the prescription-only requirement will help ensure greater monitoring of cough syrup usage while strengthening accountability throughout the supply chain.
The latest notification marks one of the most significant regulatory changes affecting commonly used medicines in recent years and is expected to impact pharmacies, manufacturers and consumers across the country.
FAQs
Do I now need a prescription to buy cough syrup in India?
Yes. Under the new Health Ministry notification, cough syrups can only be purchased with a valid prescription issued by a registered medical practitioner.
Why has the government banned over-the-counter sale of cough syrups?
The move follows concerns over contamination-related incidents, including cases where toxic substances were allegedly found in cough syrups linked to child deaths in India and several other countries.
