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 cough medicine containing toxic diethylene glycol in quantities nearly 500 times the permissible limit, officials said. The deaths were all linked to the Coldrif medicine, banned after a test confirmed the presence of the chemical.
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 the Indian drug laws.
The Central Drugs Standard Control Organisation (CDSCO), India’s national regulatory body for cosmetics, pharmaceuticals and medical devices, urged states to step up inspections and verify that all materials come from approved vendors.
“It has been observed that manufacturers are not carrying out testing of each batch for verification of compliance with the prescribed standards before using them in manufacture and also in finished products,” the regulator said.
At a plant belonging to Sresan Pharmaceuticals in India’s Tamil Nadu state, rusted machinery and unsafe practices were reported by Indian media outlets. The company produces the Coldrif syrup. Samples from the factory tested positive for toxic diethylene glycol, though those collected in Madhya Pradesh did not, raising questions about distribution and oversight, according to NDTV.
The inspection, carried out by the Tamil Nadu Drugs Control Department, found over 350 lapses in the manufacturing process, India Today reported.
S Ranganathan, 75, owner of the Tamil Nadu-based pharmaceutical company, was arrested in Chennai on Wednesday and taken into custody by Madhya Pradesh police, according to The Hindustan Times.
The syrup has been linked to the deaths of at least 20 children in Madhya Pradesh and Rajasthan. Authorities confirmed that Coldrif syrup contained diethylene glycol (DEG), a toxic industrial chemical that can be deadly even in small amounts.
A test report found the cough syrup to be “not of standard quality”, revealing it contained 48.6 per cent by volume of diethylene glycol, the toxic industrial solvent.
The report concluded that the sample was “adulterated”, noting that the presence of diethylene glycol rendered the medicine “injurious to health”.
DEG, a chemical found in products like antifreeze, cosmetics, and lubricants, can trigger symptoms ranging from vomiting and abdominal pain to acute kidney failure, which the World Health Organization warns can be fatal.
“The doctor who wrote the prescription has been arrested,” Rajendra Shukla, deputy chief minister of Madhya Pradesh, earlier told ANI, adding that a criminal case had been registered against the manufacturer.
Authorities have since banned the formulation in eight Indian states and territories – Tamil Nadu, Madhya Pradesh, Kerala, Karnataka, Punjab, Himachal Pradesh, Uttar Pradesh and Puducherry.
The World Health Organization has also sought urgent assurances from India following the deaths of the children linked to contaminated cough syrup. The WHO told Reuters it was seeking clarification from the Indian government on whether the cough syrup involved in the deaths has been exported to other countries.
This marks the latest in a troubling series of child deaths linked to Indian-made cough syrups. In 2022, tainted formulations were linked to the deaths of 70 children in Gambia and 18 in Uzbekistan.
Earlier, between December 2019 and January 2020, at least 12 children under five died in Jammu, in Indian-administered Kashmir, after allegedly consuming a locally made cough syrup – with activists warning the true toll may have been higher.
India has also struggled with the misuse of cough syrups containing codeine, a mild opioid capable of inducing euphoria and dependence at high doses, and deemed unsafe for young children.
Sresan Pharmaceuticals has not issued a public statement, did not respond to queries from Reuters, and could not immediately be reached for comment by The Independent.
