New Delhi: The Center has constituted a four-member panel to probe a detailed report shared by the World Health Organisation, that 66 children have died in The Gambia after allegedly using Indian-made drugs.
“The committee will examine and analyze the adverse event report, causal link, and all relevant details shared by WHO. After investigation, the committee will make suitable advice and recommendations to the Drug Controller General of India (DCGI) regarding further course of action. The committee may co-opt another technical expert if deemed necessary, an official source told IANS.
The WHO had issued an alert on four India-made cough and cold syrups “potentially linked to serious kidney injuries and 66 deaths in children in The Gambia”.
The committee will be headed by Dr. YK Gupta, Vice Chairman, Standing National Committee on Medicines. The other members are Dr. Pragya D. Yadav, NIV, ICMR, Pune, Dr. Aarti Behl, Department of Epidemiology, NCDC, New Delhi, and AK Pradhan, JDC (I), CDSCO.
The WHO has informed that as per the provisional results obtained by it, out of the 23 samples that were tested, four samples have been found to contain diethylene glycol/ethylene glycol.
However, the global health body is yet to provide a certificate of analysis. It has informed that it will be made available in the near future. Sources told IANS that the exact one-to-one causal relationship of death has not yet been provided by the WHO to the Central Drugs Standard Control Organization (CDSCO), though it has made two requests to the global health body in this regard.
After CDSCO initiated a detailed investigation to find out the facts, preliminary investigation has revealed that Maiden Pharmaceutical Ltd., Sonipat, Haryana State Drug Controller has been involved in the production of Promethazine Oral Solution BP, Cofexanaline Baby Cough Syrup, Macof Baby Cough Syrup products. is a licensed manufacturer. , and MaGrip n 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, CDSCO and State Drug Controller Haryana have stopped all manufacturing activities of Maiden Pharmaceuticals Limited in Sonepat on October 11 on the basis of deficiencies found in the local inspection.