Indian drug regulator passes buck to Gambia on cough syrup deaths

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By Our Special Correspondent

New Delhi, October 6: Amid the global shock of deaths of over 60 children in Gambia, the National Drug Regulator of India on the basis of the investigation has stated that “it is a usual practice that the importing country tests these imported products on quality parameters, and satisfies itself as to the quality of the products before deciding to release for usage in the country”.

The regulator also stated that the preliminary enquiry revealed that “M/s 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, added the drug regulator.

“The WHO on September 29, informed DCGI, the National Drug Regulator of India, that it 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,” said the regulator in a media statement.

As per the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, 04 samples have been found to contain Diethylene Glycol/ Ethylene Glycol, added the regulator.

“The exact one to one causal relation of death has not yet been provided by WHO to CDSCO.

As a robust National Regulatory Authority, CDSCO has requested WHO to share at the earliest with CDSCO the report on establishment of causal relation to death with the medical products in question,” added the regulator.

It also stated that the State Drug Controller had given licenses to the company only for export of the four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup

“All the four drugs are manufactured only for exports by M/s. Maiden Pharmaceuticals Limited, and they are not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s. Maiden Pharmaceuticals is sold domestically in India,” added the national drug regulator.

However, the claims of the national drug regulator are in contrast to India’s ambitions to be the global pharmacy, for something which was not approved for domestic distribution was allowed to be exported, while attempts are now to wash hands over the deaths of several children.

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