CDSCO requests WHO to share its report on establishment of causal relation to death with Maiden Pharma’s cough syrup

The Central Drugs Standard Control Organization (CDSCO) has requested the World Health Organization (WHO) to share with it the report on establishment of causal relation to death with the Maiden Pharma’s cough syrup in Gambia.

The WHO, on 29th September, 2022, had informed DCGI, 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 (in some of the samples, it was claimed to have been confirmed by further analysis conducted by WHO).

CDSCO then, had taken up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharma, Sonepat, Haryana, 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 Pharma 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.

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 the importing country decides to release such products for usage in the country.

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

State Drug Controller had given licenses to the said company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Further, all these four drugs manufactured only for exports by Maiden Pharma are not licensed for manufacture and sale in India. In effect, none of these four drugs is sold domestically in India.

The samples (controlled samples of the same batch manufactured by Maiden Pharma for all the four drugs in question) have been taken and sent for testing to Regional Drug Testing Lab, Chandigarh, by CDSCO, the results of which will guide further course of action as well as bring clarity on the inputs received/to be received from WHO.