Center forms committee to investigate WHO details on 66 child deaths in Gambia

New Delhi: The Center has formed a four-member panel to examine the detailed report shared by the World Health Organization on 66 infant deaths in The Gambia, reportedly after the use of Indian-made drugs.

“The commission will investigate and analyze adverse event reports, causal relationships and any related details shared by WHO. Upon investigation, the commission will properly advise and recommend the Drug Controller General of India (DCGI) on further steps. other technical expert if deemed necessary, an official source told IANS.

The WHO had issued a warning for four Indian-made cough and cold syrups “possibly linked to acute kidney injury and 66 deaths among children in The Gambia”.

The committee will be chaired by Dr. YK Gupta, Vice-Chairman of the Standing National Committee on Medicines. The other members are Dr. Pragya D. Yadav, NIV, ICMR, Pune, Dr. Arti Bahl, Department of Epidemiology, NCDC, New Delhi, and AK Pradhan, JDC(I), CDSCO.

The WHO has informed that according to the preliminary results it has received, of the 23 samples of the products under investigation that were tested, four samples contained diethylene glycol/ethylene glycol.

However, the Global Health Authority has not yet made the Certificate of Analysis available. It has announced that the same will be made available in the near future. The exact one-to-one causation of death has not yet been provided by WHO to the Central Drugs Standard Control Organization (CDSCO), although it has twice requested the global health authority in this regard, sources told IANS.

After the CDSCO launched a detailed investigation to establish the facts, the preliminary investigation found that Maiden Pharmaceutical Ltd, Sonepat, Haryana is a manufacturer under license from the State Drug Controller for products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and MaGrip n Cold Syrup by reference, and is authorized to manufacture these products for export only. The company has only produced and exported these products to The Gambia.

Meanwhile, the CDSCO and State Drug Controller Haryana halted all manufacturing activities of Maiden Pharmaceuticals Ltd in Sonepat on October 11 due to deficiencies found by local inspection.

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