India investigates fake drugs that killed children in Gambia

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By Omar Bah

The Indian Government has formed a four-member panel to examine the detailed report shared by the World Health Organisation on 69 children’s deaths in The Gambia reportedly after using Indian-made medicines.

On October 5, the director general of the World Health Organisation issued a medical product alert for contaminated medicines linked to Acute Kidney Injury, AKI, which has been killing children in The Gambia. Tedros Ghebreyesus, in a media briefing, said the four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India.

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According to the Indian government officials, the investigating the committee will examine and analyse adverse event reports, causal relationship, and all related details shared by WHO.

“After examining the details, the committee will suitably advise and recommend the Drug Controller General of India (DCGI) about further course of action. The committee may co-opt any other technical expert as deemed necessary,” an official source told IANS.

The committee will be chaired by Dr Y.K Gupta, Vice Chairperson, Standing National Committee on Medicines. The other members are Dr Pragya D. Yadav, NIV, ICMR, Pune, Dr Arti Bahl, Division of Epidemiology, NCDC, New Delhi, and A.K. Pradhan, JDC(I), CDSCO.

The WHO has informed that as per the tentative results received by it, out of the 23 samples of the products under reference which were tested, four samples have been found to contain Diethylene Glycol/Ethylene Glycol.

However, the global health body has not yet made available the certificate of analysis only saying that it  will be made available in the near future. “The exact one to one causal relation of death has not yet been provided by the WHO to the Central Drugs Standard Control Organisation (CDSCO) although it has requested the global health body twice in this regard,” Indian government sources told IANS.

An initial investigation launched by the CDSCO revealed that Maiden Pharmaceutical Ltd, is a manufacturer licensed by the State Drug Controller for products such as Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and MaGrip and Cold Syrup under reference, and holds manufacturing permission for these products for export only. The company has manufactured and exported these products only to The Gambia.

Meanwhile, the CDSCO and State Drug Controller Haryana have stopped all the manufacturing activities of Maiden Pharmaceuticals Ltd at Sonepat on October 11 on grounds of deficiencies found on local inspection.