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Controversial syrup was only sent to Gambia, says Regulators

 

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Controversial syrup was only sent to Gambia, says Regulators

It has come to notice that controversial syrups exported by India based Maiden Pharmaceutical are linked to the death of 66 children in Gambia. Regulators informed that the company has manufactured and exported these products only to Gambia.

World Health Organization (WHO) on 29.09.2022 informed DCGI, the National Drug Regulator of India, that WHO is currently providing technical assistance and advice to Gambia, where children have died and where a contributing factor, is suspected to be the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol.

In some of the samples, it was claimed to have been confirmed by further analysis conducted by WHO.

CDSCO took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical Limited, Sonepat is located.


Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with the State Drugs Controller, Haryana.

From the preliminary enquiry of CDSCO, it has been made out 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