Deadly Dose of Negligence

At least 20 children from Madhya Pradesh and Rajasthan have died in recent weeks after consuming a contaminated cough syrup that was prescribed for the common cold and cough. This has sparked growing public outrage and demands for accountability. It was later found that the Coldrif syrup, manufactured by the Tamil Nadu-based Sresan Pharmaceuticals and administered to children, contains 48.6 per cent diethylene glycol (DEG), against the WHO acceptable standard of 0.10 per cent. DEG is a toxic industrial solvent used in the making of paints, ink and brake fluids, and is known to cause kidney failure.

Following the tragic fallout, the Ministry of Health and Family Welfare has sought strict compliance with the Revised Schedule M by all drug manufacturers and directed all States/UTs to ensure the rational use of cough syrups, particularly among children, enhance surveillance, and strengthen inter-state coordination for early reporting and joint action. Sresan Pharmaceuticals has been sealed, and a Special Investigation Team has been constituted to investigate the deaths of the children, while the Tamil Nadu Drugs Control Department has issued a show-cause notice to the private firm. Several states have banned the syrup, and a paediatrician who reportedly recommended the cough syrup to children in Madhya Pradesh has been arrested, but many questions over accountability remain unanswered.

This is not an isolated case. Drugs made in India have come under scrutiny over safety concerns on several occasions in the past. In 2019, at least a dozen children in Jammu and Kashmir died after consuming a cough syrup manufactured by a Himachal Pradesh-based pharmaceutical company. Indian-made cough syrups have been linked to the deaths of more than 100 children in Gambia, Uzbekistan and Cameroon. All these scandals have one thing in common — cough syrups made in India with diethylene glycol (DEG) beyond permissible limits.

Much damage has been inflicted on the country’s reputation as one of the world’s largest producers of pharmaceuticals, and the “Pharmacy of the World” title it has earned for its role in providing affordable generic drugs has suffered significantly. Despite global condemnation and public outcry, India has failed to take punitive action to ensure quality. It speaks of systemic regulatory collapse. While the Drugs and Cosmetics Act of 1940 gives the Centre the power to regulate the manufacture, quality, sale and distribution of drugs in the country, public health is a state subject under the federal constitution, giving state governments a significant role in health regulations, including licensing. This often leads to gaps in the distribution of powers and responsibilities among the regulatory bodies. For instance, the Central Drugs Standard Control Organisation (CDSCO) has recommended the cancellation of the manufacturing licence for Sresan Pharmaceuticals, which is associated with the recent deaths, but the final decision rests with the state drug controller. This loophole in the drug regulatory framework needs urgent attention, and swift action should be taken against non-compliant manufacturers to disrupt the current pattern and restore public trust.