Coldrif deaths in MP: Drug regulator flags lapses at testing of ingredients by pharma companies

In connection with the death of children being linked to cough syrup containing toxins, India’s drug regulator, Central Drugs Standard Control Organisation (CDSCO) has said that the pharmaceutical firms failed to follow rules that every batch of pharmaceutical ingredients is tested.

Madhya Pradesh Deputy Chief Minister Rajendra Shukla has said that 20 children have died so far after drinking a contaminated cough syrup, while five are under treatment for kidney failure.

The World Health Organisation (WHO) has said it has sought clarification from the government on whether Coldrif cough syrup that is being linked to the deaths has been exported to other countries. It will also assess the need for a Global Medical Products Alert on Coldrif syrup once it receives official confirmation from the government.

In a letter dated October 7 to the states, CDSCO said, “This Directorate has time to time emphasized the critical importance of testing of raw materials, including the excipients before its use in the manufacturing of pharmaceutical formulations. There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to the quality of these cough syrups.”

The letter signed by Drug Controller General, Dr Rajeev Singh Raghvanshi said inspections were carried out at the facilities whose drugs were previously declared as ‘Not of Standard Quality’.

“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 said.

He emphasised that according to Drugs Rules, the licensee should in his own laboratory or in any laboratory approved by the licensing authority test each raw material used by him for the manufacturing of medicines and also each batch of the final product. The manufacturers are also mandated to keep a record of the tests being carried out at the laboratories.

Coldrif Syrup is manufactured by Sresan Pharmaceutical Manufacturer.

“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,” CDSCO said.