Regulator launches pan-India crackdown on cough syrup makers after child deaths

In the wake of children’s deaths allegedly caused by the consumption of contaminated cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has launched a pan-India drive to test, inspect and audit cough syrup manufacturers. The CDSCO has also directed all states and union territories to submit a list of cough syrup manufacturing companies for auditing.

Sources said no state has so far fully complied with the Corrective and Preventive Action (CAPA) guidelines introduced to ensure safety and maintain standards in pharmaceutical products.

In Madhya Pradesh, two more children died of kidney infections allegedly linked to the consumption of contaminated cough syrup, bringing the toll to 22.

Meanwhile, the CDSCO has informed the World Health Organisation that cough syrups Coldrif, RespifreshTR and ReLife were recalled and manufacturers ordered to stop their production, though none of the products were exported from India, sources said.

So far, 18 state drug control authorities have onboarded the Online National Drugs Licensing System (ONDLS), aimed at streamlining drug licensing and regulatory compliance. More states are expected to join. Sources said, “Once states adopt the ONDLS fully, firms such as Sresan Pharmaceuticals, which previously escaped the Centre’s radar, will be caught if their licences are up for renewal.”

Government officials said Tamil Nadu-based Sresan Pharmaceuticals, manufacturer of Coldrif cough syrup, was issued a manufacturing licence by the state government in 2011, renewed in 2016. However, Central authorities were not informed.

An official said, “The firm was not in the Centre’s radar. It is a small company. The state audit recorded 364 violations, of which 38 were critical.”

Nineteen samples of cough syrups were tested — 13 by the Madhya Pradesh Government and six by the CDSCO.

An official said, “We analysed six samples, all of which were found clean. Of the 13 tested by the state government, three were initially found toxin-free.”

Testing by Tamil Nadu revealed that the Coldrif sample contained 48.6 per cent Diethylene Glycol (DEG).

The official added, “Once the Madhya Pradesh Government learnt that Coldrif was the most consumed cough syrup and the manufacturer was based in Tamil Nadu, they requested the state government to conduct tests and site inspections.”

The CDSCO has asked the Tamil Nadu government to initiate criminal proceedings against Sresan Pharmaceuticals.