India’s drug regulator has said several pharmaceutical firms had failed to follow rules that every batch of medicinal ingredients is tested, following the deaths of 20 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. The drug controller has not, however, revealed the names of the errant firms.
Reuters reported on Wednesday that the World Health Organisation (WHO) has asked India whether the cough syrup that has caused the deaths was exported
as well.
Over the past month, at least 20 children have died in Madhya Pradesh’s Chhindwara district after receiving Coldrif cough syrup. Rajasthan’s Opposition leader Tika Ram Jully has claimed that four children died in his state after consuming medicine containing dextromethorphan, which is not recommended for paediatric use.
Several states, including Tamil Nadu, Madhya Pradesh, Rajasthan, Kerala, Maharashtra, Uttarakhand, Uttar Pradesh, Punjab and Himachal Pradesh, have this month banned Coldrif and/or cough syrups containing dextromethorphan.
Telangana has issued an alert calling for the withdrawal of Coldrif stocks of the SR-13 batch, in which contamination with the toxic industrial solvent diethylene glycol has been found.
In a letter to drug controllers of all states and Union Territories on Tuesday, DCG (India) Raghuvanshi said: “Further during the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed in the reports that 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.”
The letter cited Drugs Rules 74 (c) and 78 (c) (ii), which mandates that drug manufacturers “test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product”.
The letter added: “All the State/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc. Further, it shall also be ensured that the manufacturers have a robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only.”
Sohanlal Valmik, Congress MLA from Parasia in Madhya Pradesh, where most of the deceased children are from, told The Telegraph: “Pharma companies are clearly experimenting on children of backward districts. We have to take the agitation route, going to court is the last resort. We will hold regular protests against what these companies are doing and expose them.”
Reuters quoted unnamed WHO sources as saying that they had asked India if Coldrif had been exported. The report said: “The WHO said it would 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.”
Ethylene or diethylene glycol toxins found in Indian-made cough syrups have killed over 140 children in Gambia, Uzbekistan and Cameroon since 2022, and marred India’s credibility as the world’s third-largest drug maker, which supplies 40 per cent of generic medicines in the US and more than 90 per cent of all medicines in many African countries.
Reuters added: “The health ministry said on Sunday authorities were carrying out inspections across 19 other manufacturing units in six states.... 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’.”