The Union health ministry on Tuesday amended drug regulations to end the over-the-counter sale of syrup-based medicines, including cough syrups, making a doctor's prescription mandatory for their purchase.
Amendment Details
The change comes under the Drugs (Fifth Amendment) Rules, 2026, notified by the health ministry on June 9 and brought into effect through an amendment to the Drugs Rules, 1945.
Key Changes
Under the revised rules, the word "syrups" has been removed from Schedule K, which lists categories of medicines exempt from certain provisions of the Drugs and Cosmetics Act, 1940. As a result, syrup formulations will no longer enjoy those exemptions and will be subject to stricter regulatory requirements.
Impact on Consumers
The move means consumers will have to produce a valid prescription to purchase cough syrups and other syrup-based medicines that were previously available without one.
Consultation Process
The amendment follows a draft notification issued on December 29, 2025, through which the government had invited suggestions and objections from stakeholders and the public. According to the notification, all comments received during the consultation process were examined before the final rules were notified.
Regulatory Framework
The Drugs Rules, 1945, framed under the Drugs and Cosmetics Act, regulate the manufacture, sale and distribution of medicines in India. The health ministry said the amendment was made after consultation with the Drugs Technical Advisory Board, the country's apex technical body on drug regulation.
Rationale Behind the Amendment
Officials said the latest amendment is aimed at strengthening oversight of syrup-based medicines by bringing them under the applicable regulatory framework. This step is expected to curb misuse and ensure safer dispensing of these medications.
