Gambian cough syrup deaths: Health ministry forms four member panel

Maiden Pharmaceuticals

India's health ministry has constituted a four-member panel under Dr. Y K Gupta, vice chairman of the standing national committee on medicines, and three others to investigate the deaths of 66 Gambian kids purportedly due to adulterated cough syrups supplied by a local manufacturer.

Announcing the constitution of the panel, top sources in the health ministry said on October 12 that the Central Drugs and State Drug Controller Haryana have stopped all the manufacturing activities at the Sonepat Unit of Maiden Pharmaceuticals, the drugmaker in the dock for supplying spurious drugs.

The sources said that the newly formed panel will, after examining and analyzing adverse event reports, causal relationship,s and all related details shared by the World Health Organization, advise and recommend DCGI about the further course of action.

Stressing that the state drug controller had given licenses to the company only for the export of four cough syrups, against which the WHO has issued an international drug alert on October 5, government sources said that the world health agency has not made available a certificate of analysis.

"It has informed that the same will be made available in near future," sources also said.

Sources also insisted that the exact one-to-one causal relation of death has not yet been provided by the WHO to CDSCO although the regulator has requested the agency twice.

The ministry has said that the results of the controlled samples of the same batch- that had been supplied to Gambia- is expected on October 14 by the Regional Drug Testing Lab, Chandigarh.

The CDSCO and state drug regulators have stopped manufacturing activities at the pharma firm's Sonepat unit on grounds of deficiencies found in the local inspection, the government has said.

It has however added that exact penal actions and charges against the company can be determined only after receiving the sample reports.