Centre makes doctor’s prescription mandatory for cough syrups, ending OTC sale nationwide

Cough syrups will now require a doctor's prescription as the Centre has removed them from a decades-old exemption. This move, following concerns over contaminated syrups, brings all formulations under regular regulatory oversight. The change aims to enhance accountability and public health safety in the distribution of these commonly used medicines.

New Delhi: The government has barred over-the-counter sale of cough syrups across the country with immediate effect, mandating that the medicines be dispensed only on a doctor's prescription and through licensed pharmacies amid safety concerns. The government has amended the Drugs Rules, 1945, removing syrup-based medicines from the list of drugs exempted under Schedule K from certain provisions governing manufacture, sale and distribution.Even in small villages with a population of less than 1,000, where certain remedies including cough syrups were allowed to be sold without retail sale licences so far, now only duly licensed pharmacies can dispense cough syrups.The exemption was given under entry number 13 of Schedule K of the Drugs and Cosmetics Act, 1945 to household remedies including Aspirin tablets, paracetamol tablets, analgesic balms, antacid preparations, gripe water for use of infants and cough syrups.131780985"In view of the recent incidents due to contaminated cough syrup, it is proposed that the exemption provided for the sale of syrups for cough may be deleted," a government document read. ET has seen a copy of the document. The move is widely seen as part of a broader crackdown on misuse of cough syrups, several variants of which have come under scanner in recent years for being abused as intoxicants, particularly among the youth.Regulatory authorities have flagged repeated instances of codeine-based cough syrups being sold without prescriptions, often in bulk quantities, raising serious public health concerns. The All India Organisation of Chemists and Druggists (AIOCD) on Tuesday welcomed the government's move, calling it a positive step toward responsible medicine distribution and closing regulatory loopholes. The AIOCD president has urged the government to undertake a comprehensive review of Schedule K in consultation with stakeholders including regulators, healthcare professionals, pharmacists, and patient groups to prevent misuse, ensure a level field, and safeguard public health.The organisation has also issued an advisory to its member associations nationwide to strictly comply with statutory provisions governing medicine sales, particularly for cough syrups and other prescription medicines. The removal of syrups from the exempted list marks a notable shift in the regulatory framework that had remained largely unchanged for decades.

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 WithdrawnThe 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 SafetyAccording 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.Also Watch: Maharashtra FDA Suspends 1,696 Medical Store Licences In Crackdown On Cough Syrup Sales Without PrescriptionDoctors Welcome DecisionWelcoming 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.To get details on exclusive and budget-friendly property deals in Mumbai & surrounding regions, do visit: https://budgetproperties.in/

New Delhi: The Union Health Ministry on Tuesday revised drug regulations to prohibit the over-the-counter sale of syrup-based medicines, including cough syrups, making a valid doctor's prescription compulsory for their purchase.Centre amends drug rulesThe change follows the Centre's amendment to the Drugs Rules, 1945, through the Drugs (Fifth Amendment) Rules, 2026, which were notified in the Official Gazette on June 9. As part of the amendment, the term "Syrups" has been removed from item number (7) under serial number 13 of Schedule K of the Drugs Rules, 1945, according to an NDTV report.Move follows safety concernsThe decision comes months after contaminated cough syrups were linked to the deaths of children in Madhya Pradesh and Rajasthan, sparking fresh concerns over the safety and regulation of widely used liquid medicines. The incidents also renewed demands for stricter oversight and more rigorous quality checks on the production and sale of syrup-based formulations.Special Task Force Seizes 23,000+ Fake Cough Syrup Bottles Worth ₹50 Lakh From Bhopal HideoutEarlier in October 2025, ⁠Sresan Pharmaceutical-made Coldrif syrup was linked to the deaths of 24 children.The notification, issued on June 9, 2026, was published after the government reviewed suggestions and objections received from the public on a draft proposal released in December last year.Prescription now mandatoryOne of the key reasons behind the decision is the concern over misuse and unsupervised consumption of cough syrups and other medicinal syrups. Health authorities have been working to promote the proper usage of these medicines, especially among children.With the amendment now effective, pharmacies across India will have to comply with the revised rules governing the sale of syrups and related formulations.

A new regulation from the Union Ministry of Health and Family Welfare now requires a doctor's prescription for purchasing cough syrups and other syrup medicines. This change, effective immediately, removes these medications from over-the-counter availability. The amendment to the Drugs Rules, 1945, was finalized after considering public and stakeholder feedback.

The Ministry of Health has amended the Drugs Rules, 2026, removing ‘syrups’ from OTC sale, requiring doctors' prescriptions instead. This follows concerns over contaminated cough syrups linked to child fatalities in Madhya Pradesh, Rajasthan.