India to introduce new drug safety law after child deaths linked to toxic cough syrup

Centre is set to overhaul the country’s drug monitoring framework following recent child deaths linked to contaminated cough syrup in Madhya Pradesh.

Officials said a new law will grant statutory powers to the Central Drugs Standard Control Organisation (CDSCO) to regulate the manufacture, distribution, and sale of drugs, medical devices, and cosmetics.

The proposed “Drugs, Medical Devices, and Cosmetics Act 2025” will replace the existing 1940 legislation and align India’s regulations with international standards. Sources said the law aims to enhance transparency and accountability across the entire supply chain, from production to marketing.

Under the new framework, CDSCO will have the authority to take swift action against spurious or substandard drugs. Licensing procedures will be fully digitised, laboratory capacities expanded, and coordination with state regulators strengthened, officials added.

In recent years, several states, including Madhya Pradesh, Haryana, Jammu and Kashmir, and Tamil Nadu, have reported child deaths linked to contaminated cough syrups. Following the latest deaths in Madhya Pradesh, the World Health Organization (WHO) issued a health advisory warning against three specific syrups: Coldrif, Respifresh TR, and ReLife.

The government said the new measures aim to make India’s drug safety system more stringent, ensuring public health is better protected against unsafe medications.