India's top drug regulator has admitted to widespread lapses in pharmaceutical manufacturing after the deaths of at least 20 children in Madhya Pradesh were linked to contaminated cough syrup. The children died over the past month after consuming Coldrif syrup, which was found to contain toxic diethylene glycol (DEG) at levels nearly 500 times the permissible limit.
In a 7 October advisory, drugs controller general of India, Rajeev Raghuvanshi, said inspections at several factories revealed that many companies were not testing every batch of raw materials and finished products, as required under Indian drug laws. The Central Drugs Standard Control Organisation (CDSCO) urged states to step up inspections and verify that all materials come from approved vendors.
Inspections at the Tamil Nadu plant of Sresan Pharmaceuticals, which produces Coldrif, found rusted machinery and unsafe practices, with over 350 manufacturing lapses recorded. Samples from the factory tested positive for DEG, though those collected in Madhya Pradesh did not, raising questions about distribution and oversight. The owner, 75-year-old S Ranganathan, was arrested in Chennai and taken into custody by Madhya Pradesh police.
A test report declared the syrup “not of standard quality”, revealing it contained 48.6 per cent by volume of diethylene glycol, a toxic industrial solvent found in antifreeze and cosmetics. DEG can cause vomiting, abdominal pain and acute kidney failure, which the World Health Organization warns can be fatal. The doctor who prescribed the medicine has also been arrested, and a criminal case registered against the manufacturer.
The formulation has been banned in eight Indian states and territories. The WHO has sought urgent assurances from India on whether the contaminated syrup was exported, following a series of similar incidents. In 2022, tainted syrups were linked to 70 child deaths in Gambia and 18 in Uzbekistan, while at least 12 children died in Jammu in 2019-2020 after allegedly consuming a locally made cough syrup.
