“The committee will examining and analysing adverse event reports, causal relationship, and all related details shared by WHO. After examining, 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 WHO had issued an alert on four India-made cough and cold syrups “potentially linked with acute kidney injuries and 66 deaths among children in Gambia”.
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. It has informed that the same will be made available in 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, sources told IANS.
After the CDSCO launched a detailed investigation to ascertain the facts, the preliminary enquiry has revealed that Maiden Pharmaceutical Ltd, Sonepat, Haryana is a manufacturer licensed by the State Drug Controller for products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, 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, 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.
