No More Over-the-Counter Cough Syrups: Centre Makes Doctor’s Prescription Mandatory

SRINAGAR: In a major move to strengthen drug safety regulations in India, the Central Government has made a doctor’s prescription mandatory for the purchase of medicinal syrups, including commonly used cough syrups, under the amended Drugs Rules, 1945.The new rule effectively ends the over-the-counter sale of syrup-based medicines, requiring pharmacies across the country to dispense these products only on the prescription of a registered medical practitioner.The decision comes in the wake of growing concerns over the safety of liquid medicines after contaminated cough syrups were linked to the deaths of several children in Madhya Pradesh and Rajasthan, prompting calls for stricter monitoring and regulatory safeguards.According to a notification issued on June 9, 2026, the Centre amended the Drugs Rules, 1945 by removing “Syrups” from the exemption list under Schedule K. The amendment, notified as the Drugs (Fifth Amendment) Rules, 2026, came into force immediately upon publication in the Official Gazette.With the exemption withdrawn, medicinal syrups can no longer be sold without medical authorisation. The move is expected to impact routine pharmacy purchases and bring tighter control over the distribution and use of liquid formulations.Officials said the amendment aims to enhance patient safety, improve oversight of syrup-based medicines, and prevent misuse while ensuring stricter compliance within the pharmaceutical sector.