The Union Ministry of Health and Family Welfare has notified the Drugs (Fifth Amendment) Rules, 2026, effectively ending the over-the-counter sale of all syrups, including cough syrups, by removing the category from the exemptions available under Schedule K of the Drugs Rules, 1945.
With the amendment, consumers will now be required to produce a valid prescription from a registered medical practitioner to purchase syrup formulations, marking a significant tightening of the country’s drug regulatory framework.
The notification, issued on June 9, 2026, removes the word “Syrups” from item (7) under serial number 13 of Schedule K, which lists classes of drugs exempt from certain provisions of the Drugs and Cosmetics Act and the Drugs Rules. The amendment comes into force immediately upon its publication in the Official Gazette.

