Drug regulator flags testing lapses at pharma firms after cough syrups deaths

Toxic cough syrup linked to 17 deaths, all under 5 years of age

New Delhi: Some Indian pharmaceutical firms failed to follow rules that every batch of medicinal ingredients is tested, the country's drug regulator said on Wednesday, after deaths in the past month of 17 children linked to toxic cough syrups.

An advisory by the drugs controller general of India, Rajeev Raghuvanshi, said the regulator carried out checks at some factories and found serious lapses. In the advisory dated October 7 and posted on a government website on Wednesday, Raghuvanshi did not name any companies or the number of companies that were found to have flouted norms, but said the inspections had been carried out at firms whose drugs had earlier been found to be of "not of standard quality".

By law, Indian drugmakers have to test each batch of raw material and the final product, apart from keeping records. Exports of cough syrups require another layer of tests at government-mandated labs since 2023 following the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon linked to Indian syrups.

Despite the stricter rules and inspections since the overseas deaths, at least 17 children under the age of 5 have died in India in the past month after consuming cough medicine that contained 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. Reuters could not contact Sresan chief G. Ranganathan, whose office and factory in the southern state of Tamil Nadu were shut and his phone switched off. 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. It did not identify the companies.

"The manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products," Raghuvanshi said.

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'.

In checks between October 3 and 5, state and federal inspectors identified unspecified deficiencies at the companies and ordered an immediate halt to all production and distribution. No one responded to calls made to Shape and Rednex offices.

Reuters could not ascertain if the two companies had also exported medicines. State officials did not respond to requests for comment.

"As a precautionary measure, 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. "Action will be taken based on those reports."

Diethylene glycol or ethylene glycol toxins were found in Indian-made cough syrups that killed the children in Gambia, Uzbekistan and Cameroon since 2022, and another 12 children in India in 2019, damaging the image of the world's third-biggest drug-manufacturing country by volume.

India's pharmaceutical industry, which is exceeded in size only by the US and China, is valued at $50 billion. More than half of its value comes from exports, according to government data, with costs of manufacturing in India up to 35% less than the US and Europe.

India supplies 40% of generic medicines used in the United States, 25% of all those used in Britain, and more than 90% of all medicines in many African nations, according to health authorities.