SRINAGAR: The Centre has tightened regulations governing the sale of medicinal syrups, including cough syrups, by making a doctor’s prescription mandatory for their purchase under a fresh amendment to the Drugs Rules, 1945.
The move effectively ends the over-the-counter sale of syrup-based medicines and places them under stricter regulatory oversight. Pharmacies across the country will now be required to dispense such medicines only against a valid prescription issued by a registered medical practitioner.
The amendment comes months after contaminated cough syrups were linked to the deaths of children in Madhya Pradesh and Rajasthan, triggering concerns over the safety of liquid medicines and prompting demands for stronger regulatory safeguards.
According to a notification issued on June 9, 2026, the Central Government has amended the Drugs Rules, 1945 by removing the word “Syrups” from Item 7 under the “Class of Drugs” category in Schedule K. The amendment was made under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
The notification, titled the Drugs (Fifth Amendment) Rules, 2026, states that the revised rules came into force from the date of their publication in the Official Gazette.
Officials said the amendment was finalised after considering objections and suggestions received from the public following the publication of draft rules on December 30, 2025.
With the exemption withdrawn, medicinal syrups, including commonly used cough preparations, can no longer be sold without medical authorisation. The change is expected to affect routine purchases of a wide range of liquid formulations that were previously available directly from pharmacies.
The government said the measure is aimed at strengthening oversight of syrup formulations and ensuring greater safeguards in their distribution and use.
