Gambia cough syrup deaths: Pharma firm production stopped, Centre forms committee

The state government action comes nearly a week after the WHO raised an alert that four cough syrups manufactured by the Sonepat company might have killed 66 children in Gambia.

Confirming the development, Haryana Health Minister Anil Vij said that 12 shortcomings were found during the inspections at the pharma unit. Inspections at the plant were conducted on October 1, 3, 6, and 11.

The committee set up by Union MoH&FW comprises Vice-Chairperson of the Standing National Committee on Medicines Dr YK Gupta, Senior Scientist from National Institute of Virology-Pune Dr Pragya Yadav, Additional Director and Head of Epidemiology at National Centre for Disease Control Dr Arti Bahl, and Central Drugs Standards Control Organisation officer A K Pradhan.

“In view of the seriousness of contraventions observed during the investigation and its potential risk to quality, safety, and efficacy of drugs being produced, all the manufacturing activities of the firm is being stopped with immediate effect…till further order in public interest, without prejudice to further action in the matter,” the order by state and Central drug control officers stated.

“During the investigations…it was observed that the firm has been manufacturing and testing drugs without adhering to and in contravention of the various good manufacturing practices … the firm has not maintained and not produced complete records of manufacturing and testing as required under the Drugs and Cosmetics Act,” the order stated.

Sources said among the shortcomings found were missing batch numbers, and dates of manufacturing/ expiry on the invoices for the solvent — propylene glycol.

Experts pointed out that use of non-pharmaceutical grade propylene glycol can lead to di-ethylene glycol and ethylene glycol contamination, which are toxic for humans. The company also failed to test the solvent, propylene glycol, for these known contaminants, according to persons in the know of the matter.

Following the WHO alert, the Haryana government had sent samples of the four cough syrups manufactured by the company to the Central Drugs Laboratory (CDL), Kolkata. “The report is awaited and further action shall be taken accordingly. But, in the joint inspection conducted by the teams of the central and state drugs department, 12 flaws were found. Thus, we have decided that the production at this pharmaceutical company should be stopped. A notice has been issued to the company,” Vij said.

“A senior official of the Centre’s Department of Pharmaceuticals also spoke with Haryana’s Additional Chief Secretary (Health) in the matter. The cough syrups manufactured by the pharmaceutical company were approved for export. It is not available for sale or marketing within the country. We shall be able to arrive at a conclusion once we get the report of CDL,” the minister had said.

(With inputs from ENS Chandigarh)