India’s drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), has launched an investigation into the deaths of at least 66 children in The Gambia that the World Health Organization (WHO) said may be linked to a cough syrup made by Haryana-based Maiden Pharmaceuticals.
Samples from the same batch manufactured by Maiden for all the four drugs have been sent for testing to the Regional Drug Testing Lab, Chandigarh, the results of which would guide the further course of action.
The health ministry said Maiden was not licensed for manufacture and sale in India, and none of these four drugs were sold domestically.
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The WHO warned people not to use the four syrups: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The agency said in an alert that the laboratory analysis of samples of each of the four products confirmed they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in Gambia, but may have been distributed, through informal markets to other countries or regions, it said. WHO director general Tedros Adhanom Ghebreyesus tweeted that the agency was conducting further investigations with the company and regulatory authorities in India.
The ministry said WHO had informed DCGI, the national drug regulator of India, on September 29, and alerted it about the death of children in Gambia and the suspected cause of the deaths was the use of medicines that may have been contaminated with diethylene glycol or ethylene glycol. As per the tentative results received by WHO, out of the 23 samples of the products which were tested, four samples have been found to contain diethylene glycol/ ethylene glycol.
CDSCO had taken up the matter with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located, and a detailed investigation was launched in collaboration with the State Drugs Controller, Haryana. A preliminary inquiry of CDSCO said Maiden Pharmaceutical was the manufacturer of Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup and had manufacturing permission for these products for export only. The company has manufactured and exported these products only to Gambia.
CDSCO has requested WHO to share the certificate of analysis with CDSCO and the report on the establishment of causal relation to death with the medical products in question.