Government ends OTC exemption for cough syrups | Today’s news
The Union Health Ministry amended the Drugs Rules of 1945 and removed cough syrups from Schedule K, which includes drugs that can be sold freely without a prescription.
This provision allowed cough syrups to be sold in villages with fewer than 1,000 inhabitants without a retail drug licence.
The change means cough syrups can now be distributed, dispensed and sold in these rural areas only through licensed pharmacies that comply with the Drugs and Cosmetics Act of 1940, according to a notice issued on Tuesday.
“The amendment was made to strengthen regulatory oversight of syrup formulations and align the exemption framework with current public health and safety requirements,” the Department of Health said in a statement.
Manufacturers, distributors and rural retailers are expected to ensure immediate compliance with the updated licensing standards.
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“Unlicensed local village shops lacked administrative oversight to track product batches or handle recalls, creating blind spots where counterfeit, expired or substandard syrup formulations could be freely sold to unsuspecting rural families,” a government official said on condition of anonymity.
The official added that these liquid formulations are handled by verified, licensed pharmacies, which also ensure better supply chain monitoring, proper storage conditions and strict adherence to safety norms across the country.
Tighter regulation
Eliminating the Schedule K exemption is an excellent public health step because it limits unmonitored over-the-counter abuse in rural areas. However, the actual impact will depend entirely on how strictly this licensing mandate is enforced, said Dr. Dhiren Gupta, Pediatric Co-Director, Division of Intensive Care, Sir Ganga Rama Hospital, New Delhi.
Read also | Health Ministry probe finds no contamination in MP cough syrups, issues advisory
Over-the-counter products are drugs that consumers can legally and safely buy over the counter without a prescription. These products include painkillers such as paracetamol, basic antacid gels for heartburn and standard cold pills with many symptoms.
“The pharmaceutical product should be dispensed under the supervision of a licensed pharmacist… This is a very welcome move by the government that will significantly raise patient safety standards across India,” said Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents 23 pharmaceutical companies including Sun Pharmaceutical Industries Ltd, Cipla Ltd and Mankind Pharma Ltd, among others.
Mint reported on 19 November 2025 that the Center was considering stricter controls on the retail sale of cough syrups, especially in rural areas, after at least 22 children died in Chhindwara district of Madhya Pradesh after consuming contaminated syrups.
“India has faced self-medication issues across several drug categories, particularly antibiotics. While regulations provide an important framework, their impact largely depends on effective enforcement at the dispensing level and public awareness,” said Dr. Shandip Kumar Sinha, director of pediatric surgery and pediatric urology at Medanta-The Medicity in Gurugram.