Indian pharmaceutical firms failed to follow rules that every batch of medicinal ingredients is tested, the country's drug regulator said on Wednesday, following the deaths of 17 children aged under five linked to toxic cough syrups.
An advisory by the drugs controller general of India, Rajeev Raghuvanshi, said the regulator had carried out checks at factories and found serious lapses.
In the advisory dated October 7 and posted on a government website, Raghuvanshi did not name any companies or the number of them that were found to have flouted rules, but said the inspections had been carried out at firms whose drugs had earlier been found to be below standard quality.
By law, Indian drugmakers must test each batch of raw materials and the final product. Exports of cough syrups have required another layer of tests at government-mandated laboratories since 2023 following the deaths of over 140 children in Gambia, Uzbekistan and Cameroon linked to Indian syrups.
17 children died after consuming cough medicine
At least 17 children have died in India in the past month after consuming cough medicine containing toxic diethylene glycol in quantities nearly 500 times the permissible limit, officials say.
The medicine, Coldrif Syrup made by Sresan Pharmaceutical Manufacturer, was only sold locally.
The World Health Organization told Reuters it was seeking clarification from New Delhi on whether a cough syrup linked to the deaths has been exported to other countries.
The WHO said it will assess the need for a Global Medical Products Alert on Coldrif syrup once it receives official confirmation from Indian authorities.
The UN health agency is continuing to advise against the use of cough and cold medicines for children.
Reuters could not contact Sresan chief G. Ranganathan, whose office and factory in the southern state of Tamil Nadu were shut. Police are investigating the company for manslaughter, sales of the syrup have been banned, and central authorities have recommended cancelling Sresan's manufacturing licence.
The health ministry said on Sunday authorities were carrying out inspections across 19 other manufacturing units in six states.
Samples not of standard quality
Two of the inspected companies were Shape Pharma and Rednex Pharmaceuticals, based in the key pharmaceutical manufacturing hub of Gujarat. State authorities said on Tuesday that samples of cough syrups produced by the companies had been found to be "not of standard quality".
State and federal inspectors identified unspecified deficiencies and ordered an immediate halt to all production and distribution. Shape and Rednex did not respond to requests for comment.
"Three additional cough syrup samples were taken from Shape Pharma and eleven from Rednex Pharmaceuticals have been sent to government laboratories for further testing," Gujarat state Health Minister Rishikesh Patel said in a statement.
India's Telangana state advised the public on Wednesday to immediately stop using the cough syrups Relife and Respifresh TR manufactured by Shape and Rednex respectively.
Ethylene or diethylene glycol toxins were found in Indian-made cough syrups that killed children in Gambia, Uzbekistan and Cameroon since 2022, and 12 children in India in 2019, damaging the image of the world's third-biggest drug-manufacturing country by volume.
India's pharmaceutical industry, exceeded in size only by the U.S. and China, is valued at $50 billion. More than half of its value comes from exports.
India supplies 40% of generic medicines used in the U.S., and more than 90% of all medicines in many African nations.
