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The Centre has tightened regulations governing the sale of cough syrups and other syrup-based medicines by making a doctor’s prescription mandatory for purchase.
The decision follows amendments to the Drugs Rules, 1945, aimed at strengthening oversight of medicine distribution across the country.
The government notified the Drugs (Fifth Amendment) Rules, 2026, and removed the term ‘syrups’ from the list of exempted medicines under Schedule K.
The amendment increases scrutiny over the manufacture, sale and supply of syrup formulations.
Schedule K outlines categories of medicines exempt from certain legal provisions relating to manufacturing and retail distribution.
Authorities originally introduced these exemptions to improve accessibility to specific medicines under defined conditions.
Before the amendment, retailers could sell cough syrups in villages with populations below 1,000 without complying with certain retail licensing requirements.
The revised framework removes this exemption and places cough syrups under stricter regulatory control.
Under the new provisions, licensed pharmacies must dispense cough syrups in accordance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Consumers will now need a valid prescription issued by a registered medical practitioner before purchasing such medicines.
The Health Ministry stated that the amendment aligns existing exemptions with present-day public health and safety requirements.
Officials believe the measure will encourage responsible distribution practices and improve compliance with regulatory standards nationwide.
The Ministry directed manufacturers, distributors and retailers to strictly follow all licensing and legal requirements for syrup-based medicines.
The revised rules will improve patient safety, boost accountability and strengthen monitoring across the pharmaceutical supply chain.
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