Prescription Required: Cough Syrups Removed from Over-the-Counter Access

The Indian government has announced that cough syrups will no longer be sold over the counter, requiring a doctor's prescription for purchase. This decision follows amendments to the Drugs Rules, 1945, reflecting increased regulatory measures aimed to ensure responsible use and oversight of such medications.

The Union Ministry of Health and Family Welfare has issued a pivotal notification that removes syrup medicines, including cough syrups, from over-the-counter availability, effective immediately. This regulatory change means consumers must now present a doctor’s prescription to acquire these medications.

The modification arises as part of the Drugs (Fifth Amendment) Rules, 2026, recently published in the Official Gazette. Specifically, the word 'Syrups' has been stricken from item number (7) under serial number 13 of Schedule K of the Drugs Rules, 1945. This amendment mandates that these medicines adhere to the applicable regulatory framework.

This policy adjustment follows a draft notification issued in December 2025, which solicited feedback from the public and stakeholders. After evaluating all received comments, the government, in collaboration with the Drugs Technical Advisory Board, finalized the rules. The updated regulations intend to enhance the oversight of medicinal use in India.