Child deaths in Gambia linked to Maiden Pharma's cough syrups; CDSCO initiates probe

The Central Drugs Standard Control Organisation has initiated an investigation into Delhi-based Maiden Pharmaceuticals after the World Health Organisation linked the deaths of nearly 66 children in Gambia to consumption of the company’s cold and cough syrups. The WHO said that the deaths of these Gambian children from acute kidney injuries may be linked to the contaminated cough and cold syrups made by Maiden Pharma. 

The CSDCO has taken up the matter with concerned state regulatory authorities and launched a detailed investigation on the basis of the information shared by WHO, according to government sources. The preliminary enquiry reveals that Maiden manufactured and exported these products only to Gambia so far. 

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 informed that the certificate of analysis will be made available to the organisation shortly, and it will then share that with the Indian government. Sources confirmed that WHO has been requested to share at the earliest with CDSCO the report on establishment of causal relation to death with the medical products in question, photographs of labels and products etc,which is now awaited.

In July, medical officers in Gambia raised an alarm after dozens of children began falling ill with kidney problems. A pattern quickly emerged: patients younger than five were falling ill three to five days after taking a locally sold paracetamol syrup.

Similar problems have been detected in other syrups too, said Gambia's director of health services, Mustapha Bittaye. The sale of products made by Maiden Pharmaceuticals was banned by the country.

Maiden Pharmaceuticals that manufactures medicines at its facilities in India, also sells domestically along with exporting them to countries in Asia, Africa and Latin America, according to its website.

Also read: Rash of child deaths in Gambia linked to cough syrups made in India: WHO

Also read: WHO issues alert against 4 cough syrups made by India's Maiden Pharmaceuticals