The Union health ministry has proposed an amendment to the Drugs Rules, 1945, to remove cough syrups from Schedule K, effectively ending their over-the-counter sale in rural areas and making them available only on a doctor’s prescription. The draft rules will be considered after 30 days from the date of publication in the Official Gazette, during which objections and suggestions from stakeholders will be invited.
The proposal follows a recommendation made last month by the Drugs Consultative Committee (DCC), the apex advisory body responsible for ensuring uniform enforcement of drug laws across India. The decision was taken during a DCC meeting chaired by Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi.
Currently, Entry 13 of Schedule K exempts certain household remedies—including aspirin, paracetamol tablets, antacids, balms, gripe water and cough syrups—from licensing requirements, allowing unlicensed pharmacists in villages with populations of less than 1,000 to sell them. The DCC approved the deletion of this exemption for cough syrups, citing public health and safety concerns.
The move is expected to curb the sale of cough syrups without prescription and prevent unlicensed shops from engaging in illegal practices. It also comes in the wake of serious safety incidents linked to contaminated medicines. In October, more than 20 children in Madhya Pradesh reportedly died after consuming cough syrup contaminated with toxic levels of diethylene glycol (DEG). Similar incidents were reported globally in 2022, when the World Health Organisation linked DEG-contaminated cough syrups manufactured in India to child deaths in Gambia.
Health officials said removing cough syrups from Schedule K would ensure stricter regulatory oversight and limit access to these medicines without medical supervision. The ministry has already advised medical practitioners not to prescribe cough and cold medicines to children below two years of age and noted that such medicines are not recommended for children under five. For older children, use should be based on careful clinical evaluation, close monitoring, and strict adherence to dosage guidelines.
The DCC also raised concerns over the use of propylene glycol, a high-risk solvent commonly used in oral liquid formulations. The Central Drugs Standard Control Organisation (CDSCO) informed the committee that multiple cases of DEG and ethylene glycol (EG) contamination have been linked to poor-quality propylene glycol used in syrups, particularly paediatric formulations.
In response, the DCC has directed the CDSCO to consult stakeholders to assess the extent of formulations using high-risk solvents and explore safer alternative excipients. The committee emphasised the urgent need to take stock of such formulations to reduce toxicity risks and strengthen drug safety standards.
