Centre mandates prescription for cough syrups, ends over-the-counter sale

The Central Government has amended the Drugs Rules, 1945, to remove cough syrups and other syrup-based medicines from Schedule K, ending their over-the-counter sale. The decision, notified recently, mandates that all such formulations, including those containing codeine, can now be sold only on prescription from a registered medical practitioner.

This regulatory change comes in the wake of multiple tragic incidents linked to contaminated cough syrups. In October 2025, over 20 children died in Madhya Pradesh and Rajasthan after consuming locally procured cough syrups. Earlier, between December 2019 and January 2020, similar fatalities were reported in Jammu and Kashmir. Internationally, India-manufactured cough syrups have been implicated in the deaths of more than 140 children in Africa and Central Asia since 2022.

Previously, under Entry 13 of Schedule K, certain cough syrup formulations were exempted from prescription-only sale, allowing them to be dispensed through outlets other than licensed pharmacies, including general stores in villages with a population of less than 1,000. This exemption, aimed at improving access in underserved areas, inadvertently created gaps in regulatory oversight and encouraged self-medication, sometimes with fatal consequences.

Investigations into the October 2025 incident found that the cough syrup Coldrif, sold in Madhya Pradesh, contained diethylene glycol and ethylene glycol in concentrations far exceeding permissible limits. These industrial solvents, when ingested, can cause acute kidney failure and death. The Central Drugs Standard Control Organization subsequently intensified surveillance and recommended the removal of cough syrups from Schedule K.

Schedule K of the Drugs Rules lists categories of drugs exempted from certain provisions of the law. Originally intended to facilitate access in remote and rural areas where pharmacies are scarce, the exemptions have been criticised for being exploited by unscrupulous manufacturers and retailers. The cough syrup exemption under Entry 13 allowed sale by non-pharmacists, often without any documentation or quality checks, creating a parallel unregulated market.

The deaths in Africa—in The Gambia, Uzbekistan, and Cameroon—were traced to Indian-made syrups contaminated with diethylene glycol, prompting the World Health Organization to issue global alerts. These incidents tarnished India's reputation as a major pharmaceutical exporter and led to increased scrutiny by international regulators. The domestic tragedies further underscored the urgency of reform.

Medical associations, including the Indian Academy of Paediatrics, had long advocated for stricter regulation, noting that codeine-based cough syrups were often abused for their sedative effects. The new rule is expected to curb such misuse. However, some healthcare workers in rural areas have expressed concern about reduced access to essential medicines, suggesting that the government must simultaneously strengthen public health infrastructure to ensure that prescriptions are genuinely required and that affordable medicines remain available.

The amended rule now places all syrup-based medicines, irrespective of their composition, under the same dispensation as other prescription drugs. Retailers must verify prescriptions and maintain proper records. The move is expected to curb irrational use, prevent accidental poisonings, and ensure that quality-assured products reach consumers through regulated channels.

The government has also advised state drug controllers to conduct regular inspections and enforce compliance. The health ministry has announced a campaign to educate consumers about the dangers of self-medication and the importance of consulting a doctor. The amendment is part of a series of recent measures, including mandatory barcoding of top-selling drugs and tightened manufacturing standards, aimed at restoring faith in India's drug safety framework.

In the long term, the move is expected to align India's drug distribution practices with global norms and reduce the incidence of preventable fatalities caused by unregulated medicines. Legal experts note that the amendment will need robust enforcement, particularly in smaller towns and villages, to be effective. The government has indicated that periodic reviews will be conducted to assess the impact on public health access.