Centre tightens cough syrup sales rules, ends exemption for small villages

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 1000 without certain retail licensing requirementsAccording 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 ldquoSyrupsrdquo from Entry 7 under Serial No 13 of Schedule K of the Drugs Rules 1945Schedule 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 normsSales to Be Restricted to Licensed PharmaciesWith 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 syrupbased formulations and ensuring compliance with existing regulatory standardsThe 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 1945The 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 requirementsDraft Rules Were Opened for Public ConsultationThe 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 1940According 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 notifiedThe 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 regulationFocus on Public Health and ComplianceThe 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 oversightOfficials 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