With raids and show-cause notice, govt plans mega crackdown on cough syrup maker under WHO lens over Gambia deaths

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Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) has launched a probe following World Health Organisation’s alert against four cough and cold syrups manufactured by New Delhi-based Maiden Pharmaceuticals over the death of children in The Gambia. 

According to a News18 report, multiple meetings are going on at CDSCO over the matter and a show-cause notice to the company is likely to be sent. 

“A thorough investigation has been ordered into the matter which will begin with the raids on the manufacturing sites and random sample checks across India. All samples picked so far have already been sent to the lab for testing,” a government official was quoted by News18 as saying. 

Meanwhile, Gambia has launched an urgent door-to-door campaign to remove cough and cold syrups blamed for the deaths of children from kidney injury in the tiny West African country.

Speaking to The Associated Press, the Director of Health Dr. Mustapha Bittaye confirmed the wave of child deaths from acute kidney injury, sending shockwaves across the country of 2.4 million people and around the world.

The World Health Organisation (WHO) on Wednesday warned that four “contaminated” and “substandard” cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana’s Sonepat could be the reason for the deaths of 66 children in the West African nation.

PTI quoted sources saying that the exact “one-to-one causal relation of death” has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the CDSCO, enabling it to confirm the identity or source of the manufacturing of the products. 

“While all required steps will be taken, as a robust regulatory authority, the WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc,” the sources said.

According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.

It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.

The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority.

A detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.

From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products.

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