Cough syrup deaths: Drug regulator flags lapses in testing raw material

India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has said pharmaceutical firms failed to comply with the rule requiring every batch of pharmaceutical ingredients to be tested. This comes after 20 children under the age of five reportedly died in Madhya Pradesh from consuming toxic cough syrups.

Meanwhile, the World Health Organisation (WHO) said it has sought clarification from the Indian government on whether Coldrif cough syrup — the product linked to the fatalities — has been exported to other countries. The WHO added that it will assess the need to issue a Global Medical Products Alert on Coldrif once it receives official confirmation from the government.

Plant sealed, MP SIT visits pharma unit, office

A pharma unit producing a now banned cough syrup allegedly linked to the death of children in Madhya Pradesh is in the dock with the plant being sealed by the Tamil Nadu Government and a police team from MP visiting the facility as part of its probe into the fatalities.

In a letter dated October 7 to all states, the CDSCO said, “This Directorate has from time to time emphasised the critical importance of testing raw materials, including excipients, before their use in the manufacture 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 their quality.”

The letter, signed by Drug Controller General Dr Rajeev Singh Raghuvanshi, noted that inspections were conducted at facilities whose drugs had previously been declared “Not of Standard Quality”.

“During the inspections carried out at the manufacturing facilities and the investigations of drugs declared as Not of Standard Quality, it was observed that manufacturers are not testing each batch of excipients, inactive and active pharmaceutical ingredients to verify compliance with prescribed standards before using them in formulations or in the finished products,” the letter stated.

Dr Raghuvanshi emphasised that under the drugs rules, licensees must test every raw material used in the manufacture of medicines and every batch of the final product — either in their own laboratories or in those approved by the licensing authority. Manufacturers are also required to maintain records of all such tests.

The Coldrif syrup linked to the deaths is manufactured by Sresan Pharmaceutical.

“All state and UT drug controllers are requested to take measures to ensure testing before the manufacture and release of any batch to the market by monitoring during inspections and sensitising manufacturers through circulars, etc. Further, it must be ensured that manufacturers have a robust vendor qualification system in place and source raw materials, including excipients, only from reliable and approved vendors,” the CDSCO said.