364 Violations Found At Pharma Company Behind 'Killer' Cough Syrup: Sources

The pharmaceutical company, Sresan Pharma, at the centre of the cough syrup tragedy that has claimed over a dozen children's lives in Madhya Pradesh was found to be supplying the cough syrup without testing it, said a top source.

At least 20 children had died in Chhindwara after consuming the cough syrup that was found to contain a highly poisonous substance beyond permissible limits.

Ranganathan Govindan owns Sresan Pharma that manufactures the Coldrif syrup. Govindan and his wife had been on the run since the tragedy came to light. He was caught in Chennai around 1:30 am on Thursday.

An investigation revealed 364 violations at the company's Tamil Nadu plant, including 38 serious ones, said sources.

All products of Sresan company, which received the licence to operate in 2011, have been banned, said a source.

This licence, which was renewed in 2016, was given by the Tamil Nadu FDA and the Central Drugs Standard Control Organisation (CDSCO) was not involved in it, meaning the centre was not aware of it.

Now, the CDSCO is going to investigate thousands of cough syrup manufacturing companies across the country. A complete list of companies, said sources, has been sought from all states.

Sources said the CDSCO will make public test reports of all cough syrups in the next one month.

The CDSCO has directed all state and union territory drug controllers to intensify inspections, ensure manufacturers test every batch before release, and verify that raw materials are sourced only from approved and reliable vendors.

Sources within CDSCO said that a joint inspection by central and state drug regulators in Madhya Pradesh recently examined 19 syrup samples, of which three failed quality tests for diethylene glycol (DEG) namely: Respifresh, Relife, and Coldrif were found to contain DEG. 

All six samples tested by CDSCO were clear, but the Tamil Nadu FDA detected DEG in the same batch later that evening. The Madhya Pradesh FDA subsequently confirmed the same finding.

The deaths in Rajasthan were not caused by the cough syrup, said sources, adding that the real causes of death were found to be acute respiratory syndrome and Japanese encephalitis.

Several states have tightened controls: Kerala has banned the sale of cough syrups to children under 12 without a doctor's prescription, while the Indian Pharmacists Association has urged chemists nationwide to stop dispensing cough syrups to infants under two.