The Central government has introduced stricter regulations for the sale of medicinal syrups, including cough syrups, making a doctor’s prescription mandatory for their purchase from pharmacies.
The decision follows recent incidents in Madhya Pradesh and Rajasthan, where contaminated cough syrups were allegedly linked to the deaths of several children, triggering concerns over the quality control and monitoring of liquid medicines sold across the country.
The revised rules were notified through an amendment to the Drugs Rules, 1945, issued on June 9 after the government reviewed public feedback on draft proposals circulated in December last year.
Under the amendment, the word “Syrups” has been removed from a category listed in Schedule K of the Drugs Rules. This change effectively ends the over-the-counter sale of such medicines and places them under tighter regulatory supervision.
According to the notification, the amendment has been introduced by the Central government under powers granted by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
The notification states that the revised provisions, titled the Drugs (Fifth Amendment) Rules, 2026, came into effect from the date of publication in the Official Gazette.
As a result of the new rules, consumers will now have to produce a valid prescription from a registered medical practitioner to purchase cough syrups and similar liquid medicines from pharmacies.
The move is expected to impact the routine sale of commonly used syrups that were earlier easily available without medical authorisation.
The government said draft amendments proposing the changes were first published on December 30, 2025, inviting suggestions and objections from the public before the rules were finalised.
The notification was issued by Harsh Mangla, Joint Secretary in the Department of Health and Family Welfare.
With the amendment now operational, pharmacies and medical stores across India will be required to comply with the updated prescription norms for syrup-based medicines.
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