The Union health ministry has amended the Drugs Rules, 1945, removing cough syrups from Schedule K, which covers drugs that can be sold over the counter without a prescription. According to a gazette notification issued on Tuesday, the change means cough syrups can now be distributed, dispensed, and sold only through licensed pharmacies that comply with the Drugs and Cosmetics Act, 1940. Earlier, the provision had allowed cough syrups to be sold in villages with fewer than 1,000 residents without a retail drug license. The ministry said the amendment was undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements. Manufacturers, distributors, and rural retailers are expected to ensure immediate compliance with the updated licensing standards. A government official said unlicensed village shops lacked the administrative oversight to track product batches or handle recalls, creating blind spots where counterfeit, expired, or substandard syrups could be sold to rural families. Licensed pharmacies ensure better supply-chain tracking, proper storage, and adherence to safety standards. Over-the-counter products are medications consumers can legally purchase off the shelf without a prescription, such as paracetamol, antacid gels, and cold pills. Mint reported on 19 November 2025 that the Centre was considering stricter controls on cough syrup sales after at least 22 children died in Madhya Pradesh's Chhindwara district following consumption of contaminated syrups. Experts welcomed the move but stressed that its real impact will depend on strict enforcement at the dispensing level and public awareness.