The Union ministry of health and family welfare (MoHFW) has amended the Drugs Rules, 1945, removing a long-standing exemption that allowed cough syrups and certain other syrup formulations to be sold in small villages without compliance with specific retail licensing requirements.
The amendment effectively ends the exemption that previously permitted the sale of such medicines in villages with populations below 1,000 under Schedule K of the Drugs Rules.
According to the ministry, the change has been introduced to strengthen regulatory oversight of syrup-based medicines and align the exemption framework with current public health and safety requirements.
Under the revised framework, cough syrups covered by the amendment can now be sold only through duly licensed pharmacies operating in accordance with the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
The ministry said the measure is expected to promote responsible distribution and sale of medicinal syrups while ensuring greater compliance with regulatory standards across the country.
Manufacturers, distributors and retailers dealing in cough syrups have been advised to ensure strict adherence to all applicable licensing and regulatory requirements.
Under the amendment, the word 'syrups' has been omitted from item (7) under serial number 13 of Schedule K of the Drugs Rules, 1945. Schedule K provides exemptions from certain provisions of the Drugs and Cosmetics Act and related rules for specified categories of drugs.
The notification follows the publication of draft rules in December 2025. The government said objections and suggestions received from stakeholders and the public were examined before the final amendment was notified after consultation with the Drugs Technical Advisory Board.
The move comes amid heightened scrutiny of syrup-based medicines in recent years following concerns over quality standards, misuse and the need for stronger supply-chain controls. By bringing cough syrup sales in previously exempted rural areas under the licensed pharmacy network, the government aims to improve accountability and monitoring of distribution channels.
According to the ministry, consumers purchasing cough syrups covered under the revised framework will now be required to obtain them through authorised and regulated channels.
However, legal and pharmaceutical experts have clarified that the amendment does not create a blanket nationwide prescription-only requirement for all cough syrups or syrup-based medicines. Rather, it removes a specific exemption that had allowed certain syrup formulations to be sold in villages with populations below 1,000 without the usual retail licensing requirements.
The principal impact of the amendment is, therefore, on the licensing and regulation of sales channels in small villages, rather than the classification of all cough syrups as prescription-only medicines.
Even so, medicines that already fall under prescription drug categories will continue to require a valid prescription from a registered medical practitioner, irrespective of where they are sold.
Officials said the revised framework will strengthen safeguards around the distribution and sale of medicinal syrups while ensuring more uniform regulatory standards across urban and rural markets.
The ministry added that the amendment is aimed at improving accountability, patient safety and compliance with drug regulations throughout the supply chain.
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