Indian cough syrups under scanner after 66 children die in Gambia

Deaths of children in Africa's Gambia, suspected to be due to having consumed contaminated cough syrups, have cast a cloud of doubt over India's pharmacy sector. World Health Organisation on Wednesday said that the deaths of dozens of young children in Gambia from acute kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer. 

The findings, announced by WHO Director-General Tedros Adhanom Ghebreyesus, followed tests on several medicinal syrups suspected of causing 66 child deaths in the West African country.

The World Health Organisation on Wednesday warned that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths. 

The UN agency was conducting an investigation with the Indian regulators and the company that made the syrups, Tedros told reporters.  

According to reports, neither the Health Ministry nor the Drugs Controller General of India commented on the issue. 

The WHO issued a medical product alert asking regulators to remove Maiden Pharma goods from the market. 

The alert covers four products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. 

Lab analysis confirmed "unacceptable" amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, the WHO said.

According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia. It highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.

Also, earlier in July this year, medical officers in Gambia raised an alarm after dozens of children began falling ill with kidney problems. 

A pattern among the deaths was noticed by the authorities. Dozens of patients especially younger than five were falling sick in three to five days after taking locally sold paracetamol syrup. 

Gambia's director of health services, Mustapha Bittaye, said similar problems have been detected in other syrups but that the ministry is awaiting confirmation of the results. He said the number of deaths has tapered off in recent weeks and that the sale of products made by Maiden Pharmaceuticals was banned. 

Gambia's Medicines Control Agency sent a letter on Tuesday to health professionals ordering them to stop selling any of the products listed by WHO. 

According to the website, Maiden Pharmaceuticals manufactures medicines at its facilities in India, which it then sells domestically as well as exporting them to countries in Asia, Africa and Latin America.

(With inputs from PTI)