Govt ends OTC exemption for cough syrups

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.

The provision had allowed cough syrups to be sold in villages with fewer than 1,000 residents without a retail drug license.

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, 1940, according to a gazette notification issued on Tuesday.

“The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements,” the health ministry said in a statement.

Manufacturers, distributors, and rural retailers are expected to ensure immediate compliance with the updated licensing standards.

“Unlicensed local village shops lacked the administrative oversight to track product batches or handle recalls, creating blind spots where counterfeit, expired, or substandard syrup formulations could be sold freely to unsuspecting rural families, said a government official on the condition of anonymity.

The official added that these liquid formulations are handled by verified, licensed pharmacies, which also ensure better supply-chain tracking, proper storage conditions, and strict adherence to safety standards nationwide.

Tighter regulation

Removing Schedule K exemption is an excellent public health step because it curtails unmonitored over-the-counter misuse in rural areas. However, the real impact will depend entirely on how strictly this licensing mandate is enforced, said Dr. Dhiren Gupta, pediatric co-director at the division of intensive care, Sir Ganga Ram Hospital in New Delhi.

Over-the-counter products are medications that consumers can legally and safely purchase off the shelf without a prescription. These products include pain relievers like paracetamol, basic antacid gels for digestive burns, and standard multi-symptom cold pills.

“The pharmaceutical product should be dispensed under the supervision of a licensed pharmacist…This is a highly welcome move by the government that will significantly elevate patient safety standards across India,” said Sudarshan Jain, secretary general at Indian Pharmaceutical Alliance (IPA), representing 23 pharmaceutical companies such as Sun Pharmaceutical Industries Ltd, Cipla Ltd, and Mankind Pharma Ltd, among others.

Mint reported on 19 November 2025 that the Centre was considering stricter controls on the retail sale of cough syrups, especially in rural areas, after at least 22 children died in Madhya Pradesh's Chhindwara district following the consumption of contaminated syrups.

“India has faced challenges with self-medication across several drug categories, particularly antibiotics. While regulations provide an important framework, their impact depends largely on effective enforcement at the dispensing level and awareness among the public,” said Dr Shandip Kumar Sinha, director of pediatric surgery and pediatric urology at Medanta-The Medicity in Gurugram.