16 June,2026 01:37 PM IST | New Delhi | mid-day online correspondent
Representational Image. Pic/Pixabay
The Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, withdrawing a regulatory exemption that previously allowed the sale of cough syrups in villages with populations of less than 1,000 without certain retail licensing requirements.
According to the Ministry of Health and Family Welfare, the change has been notified through the Drugs (Fifth Amendment) Rules, 2026, which came into effect upon publication in the Official Gazette on June 9, 2026. The amendment removes the word "Syrups" from Entry 7 under Serial No. 13 of Schedule K of the Drugs Rules, 1945.
Schedule K provides exemptions from specific provisions of the Drugs and Cosmetics Act, 1940, and related rules for certain categories of drugs. Before the amendment, the provision allowed cough syrups to be sold in smaller villages without requiring compliance with some retail sale licensing norms.
With the removal of the exemption, cough syrups can now be sold and dispensed only through duly licensed pharmacies, irrespective of the population of the village. The Ministry said the move is aimed at strengthening oversight of syrup-based formulations and ensuring compliance with existing regulatory standards.
The amendment means that manufacturers, distributors and retailers involved in the supply chain of cough syrups will be required to adhere strictly to the licensing and regulatory provisions prescribed under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
The Ministry stated that the measure is intended to improve regulatory control over the distribution of cough syrups and align the exemption framework with current public health and safety requirements.
The Ministry of Health and Family Welfare noted that the amendment follows a consultation process initiated through draft rules published on December 30, 2025. The draft notification invited objections and suggestions from stakeholders for a period of 30 days, as required under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
According to the notification, copies of the draft rules were made available to the public on December 30, 2025, and comments received during the consultation period were subsequently examined by the Central Government before the final rules were notified.
The amendment was also undertaken after consultation with the Drugs Technical Advisory Board, the statutory body that advises the government on technical matters related to drug regulation.
The Ministry said the revised framework is expected to promote more responsible distribution and sale of cough syrups across the country. By requiring sales through licensed pharmacies, authorities aim to strengthen accountability in the supply chain and ensure that drug distribution remains subject to appropriate regulatory oversight.
Officials said the amendment forms part of ongoing efforts to update regulatory provisions in line with evolving public health priorities and to ensure uniform compliance with drug control regulations across urban and rural areas.
