The centre has formed a four-member panel to analysis and examine the detailed report shared by the World Health Organisation on 66 children’s deaths in Gambia.
“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 DCGI about further course of action. The Committee may co-opt any other technical expert as deemed necessary”, said the ministry.
The WHO on Wednesday 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 in the panel will include 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 WHO, out of the 23 samples of the products under reference which were tested, 4 samples have been found to contain Diethylene Glycol/ Ethylene Glycol. However, the global health body has not yet made available 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 WHO to CDSCO although CDSCO has requested WHO twice in this regard.
After the CDSCO launched a detailed investigation to ascertain the facts, the preliminary enquiry has revealed that Maiden Pharmaceutical Limited, Sonepat, Haryana is a manufacturer licensed by the State Drug Controller for the 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 Gambia.
Meanwhile, the CDSCO and State Drug Controller Haryana have stopped all the manufacturing activities of M/s. Maiden Pharmaceuticals Limited at Sonepat on grounds of deficencies found in local inspection.