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  4. India's drug regulator initiates probe after WHO flags four cough syrups linked to deaths in Gambia

India's drug regulator initiates probe after WHO flags four cough syrups linked to deaths in Gambia

India's drug regulator has already taken up an urgent investigation into the matter with regulatory authorities in Haryana, based on the available information, sources have said.

Vani Mehrotra Edited By: Vani Mehrotra @vani_mehrotra New Delhi Published on: October 06, 2022 11:45 IST
cough syrup, WHO, Indian made cough syrup, Gambia children death
Image Source : PTI/REPRESENTATIVE Drug regulator initiates probe after WHO links children deaths in Gambia to cough syrup made in India

Highlights

  • WHO termed the four cough syrups as "contaminated" and "substandard"
  • The syrups in question were produced by Maiden Pharmaceuticals Ltd based in Haryana's Sonipat
  • WHO said the syrups could be the reason for the deaths in the West African nation

India's drug regulator said it has initiated a probe after the World Health Organisation (WHO) issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said.

Shooting out a warning, the health body on Wednesday said four "contaminated" and "substandard" cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonipat could be the reason for the deaths in the West African nation.

The sources said 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 Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.

"Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana. 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.

WHO's warning against four Indian cough syrups

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

It highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines that 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 of 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.

"The company has manufactured and exported these products only to The Gambia so far," the source said.

It is a practice that the importing country tests the products for quality before sanctioning their usage there.

As per the tentative results received by WHO out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. 

It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India.

"At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products," the official source stated.

(With inputs from PTI)

Also Read | WHO Regional Committee meet concludes, member countries vow to strengthen health systems

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