Sonipat: The Central Drugs Standard Control Organisation (CDSCO) has taken up a probe against Haryana-based pharmaceutical company 'Maiden Pharmaceuticals Limited' after the World Health Organization issued an alert for four "contaminated" medicines manufactured by the company that has been "potentially linked" with acute kidney injuries and 66 deaths among children in The Gambia.
News agency ANI while quoting CDSCO sources reported that an “urgent investigation” into the matter has been taken up with the State Regulatory Authorities after receiving communication from WHO based on the available information. “While all required steps will be taken in the matter, as a robust National Regulatory Authority, WHO has been requested to share at the earliest with CDSCO the report on the establishment of causal relation to death with the medical products in question, photographs of labels/ products, etc. which is awaited," sources said.
The CDSCO also took up the matter with the concerned State Regulatory Authority in Haryana, under whose jurisdiction the drug manufacturing unit is located even as a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana. Sources said that a preliminary inquiry has revealed that Maiden Pharmaceutical Limited, Sonipat, Haryana is a manufacturer licensed by the State Drug Controller for the products under reference, and holds manufacturing permission for these products.
The company has manufactured and exported these products only to The Gambia so far. "It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country," said a source and explained the quality parameter needs to be followed by the country that imports these products
