New regulations mandate prescriptions for cough syrups and all medicinal syrups in India, aiming to enhance safety following tragic incidents.
Medicinal syrups, including those used for treating coughs, will now require a doctor’s prescription for purchase in India. This policy change was formalised in a government notification issued on June 16, 2026. Previously, over-the-counter sales of these syrups were permissible.
The amendment to the Drugs Rules, 1945, by the Ministry of Health and Family Welfare comes after concerning incidents involving cough syrups contaminated with industrial solvents. Notably, 24 children died in Madhya Pradesh in September due to such adulterated products. Additionally, since 2022, cough syrups exported from India have been associated with the deaths of over 140 children in regions including Africa and Central Asia.
The latest notification also instructs the removal of the term ‘syrups’ from the list of items exempted from certain regulations outlined by the Drugs and Cosmetics Act, 1940. This amendment clarifies that while medicinal syrups will necessitate a prescription, cough lozenges, pills, and tablets remain available without one.
This policy adjustment follows a draft notification released in December 2025, which sought feedback from various stakeholders and the public. The government stated it has incorporated all comments received before finalising the new rules. The objective of these changes is to improve regulations and ensure the safety of medicinal products across the country.
