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Informist, Tuesday, Jun. 16, 2026

NEW DELHI – The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, removing "syrups" from the list of medicines exempt from prescription requirements, effectively bringing syrup-based formulations, including cough syrups, under prescription-only sale.

In a notification issued on Jun. 9 and published in the Official Gazette, the ministry notified the Drugs (Fifth Amendment) Rules, 2026. The amendment came into force upon its publication. Under the revised rules, the word "syrups" has been omitted from Schedule K of the Drugs Rules, 1945. Schedule K lists certain classes of drugs that are exempt from specific provisions relating to manufacture, sale and distribution, allowing them to be sold over the counter without a prescription. The amendment modifies serial number 13, item 7 of Schedule K, where "syrups" was previously included among products eligible for over-the-counter sale.

With this, syrup-based medicines, including cough syrups and other liquid oral formulations, will no longer qualify for over-the-counter sale and will require a prescription from a registered medical practitioner for purchase. The move is expected to affect a wide range of commonly used syrup formulations sold through pharmacies across the country. The notification noted that the draft proposal to amend the rules was published in December 2025.  End

Reported by Gunjan Rajput 

Edited by Avishek Dutta

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