Centre forms four-member expert team to probe WHO claims on Sonepat-based firm
New Delhi, October 12: The Central Government on Wednesday constituted a four-member expert committee to investigate the report sent by the World Health Organisation (WHO) on the deaths of 66 children in Gambia by consumption of cough syrups from Sonepat-based company Maiden Pharmaceuticals Limited, official sources informed.
"Government is alert and formed a committee. Production of cough syrups by Maiden Pharmaceuticals Ltd has been suspended, and a lab report is awaited. Four-member expert committee has been formed to investigate the report sent by WHO," official sources said.
A committee including technical experts Dr YK Gupta, Vice Chairperson, Standing National Committee on Medicines (chair); Dr Pragya Yadav, ICMR -NIV, Pune; Dr Arti Bahl, Division of epidemiology, NCDC, New Delhi and AK Pradhan, JDC(I), CDSCO has been constituted.
According to sources, Atlanta-based Atlantic Pharmaceuticals Company Ltd, which is authorised to export medicines to Gambia, bought combined syrups bottles from Maiden Pharmaceuticals Limited.
"From the preliminary inquiry of Central Drugs Standard Control Organisation (CDSCO), it has been made out that Maiden Pharmaceuticals Ltd is a manufacturer licensed by the State Drug Controller for the product's 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 sources added.
The company has manufactured and exported these products only to Gambia.
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"It is a usual practice that the importing country tests such imported medicines on quality parameters, and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country. In the present case, it is yet not clear whether these medicines were tested in Gambia before release," the sources stated.
According to the tentative results received by WHO, four samples of the 23 samples of products under reference that were tested contained Diethylene Glycol or Ethylene Glycol.
"WHO has not yet made available a certificate of analysis. It has informed that the same will be made available in near future," the sources stated.
According to the top officials, WHO has not delivered the exact "one-to-one causal relation of death" to CDSCO, despite the fact that CDSCO has requested WHO twice in this regard.
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-PTC News
