New Delhi: The Health Ministry of India has revised drug regulations to ban the sale of syrups, including cough syrups, without a valid doctor’s prescription.
The change is intended to strengthen regulatory control over syrup-based medicines and improve patient safety.
The amendment was introduced through the Drugs (Fifth Amendment) Rules, 2026, and took effect immediately upon publication in the official gazette. Under the revised rules, the term “syrups” has been removed from Item 7 of Schedule K under the Drugs Rules, 1945, which previously exempted certain categories of medicines from specific provisions related to manufacturing, sale, and distribution.
The decision follows a draft notification issued in December last year that invited feedback from stakeholders. After reviewing public comments and consulting the Drugs Technical Advisory Board (DTAB), the government’s top technical body on drug-related matters, the amendment was finalised.
The move comes amid heightened concerns over the quality and safety of cough syrups and other liquid medicines, particularly after reports linked contaminated formulations to child deaths in several countries. Officials believe the new rules will improve oversight, traceability, and quality control by requiring stricter compliance from manufacturers and sellers.
