Prima facie the four cough syrups that have been linked to the death of 66 children in the Gambia were not being sold in India, say sources from the drug controller’s office. This comes after the Central Drugs Standard Control Organisation (CDSCO) initiated a probe into Delhi-based Maiden Pharmaceuticals following World Health Organisation’s report linking the deaths of scores of Gambian children to consumption of the company’s cold and cough syrups.
The four cough syrups Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup were sold only in the Gambia, sources said, but only further investigation will conclude this.
Meanwhile, the Drugs Controller General of India (DCGI) has asked the WHO to provide the certificate of analysis, on the basis of which the report linking the deaths to the cough syrups was made. Maiden Pharmaceuticals that is under investigation has indicated that it might recall the products following the government direction.
The medicines were made in Maiden’s Sonepat facility. Haryana's state drugs controller, which is the concerned state drug control authority, has also stepped in to investigate.
The deaths, WHO said, occurred due to acute kidney injuries, which are linked to Maiden Pharma’s contaminated cough and cold syrups. Tentative results of four samples received by WHO of the 23 samples tested were found to contain “unacceptable” amounts of Diethylene Glycol/Ethylene Glycol, which can be toxic and lead to acute kidney injury.
Sources said that the WHO has said that the certificate of analysis will be made available to them shortly, after which it will share the certificate with the CDSCO.
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