'Contaminated' Indian medicines linked to deaths of 66 children in Gambia: WHO

Tribune News Service

Aditi Tandon

New Delhi, October 5

The World Health Organization on Wednesday issued a medical product alert for four “contaminated” Indian pediatric medicines, manufactured by a firm in Haryana’s Sonepat, saying these drugs identified in Gambia had been potentially linked with acute kidney injuries and 66 deaths among children in the west African country.

The medicines in question are cough and cold syrups produced by Maiden Pharmaceuticals Limited, Sonepat in India.

WHO said laboratory analysis of samples of each of the four products confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

“To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients.” the WHO alerted.

The Health Ministry here said it had already launched investigations into the matter and asked WHO to provide the report establishing the link between the medicines in question and the stated mortality.

The report is awaited, the ministry added.

Top government sources also said that the Central Drugs Standard Control Organisation, the apex drug regulator, had on September 29 received the related intimation from the WHO and immediately launched a probe.

“As per the tentative results received by WHO, out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/Ethylene Glycol as indicated.  It has also been informed by WHO that the certificate of analysis will be made available to it in near future and the world body will share it with India. The exact one to one causal relation of death has not yet been provided by WHO, nor have the details of labels and products been shared by WHO with the CDSCO enabling it to confirm the identity and the source of the manufacturing of the products,” official sources said.

They said while 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.

WHO Director-General Tedros Adhanom Ghebreyesus, meanwhile, said while the “contaminated” products have so far only been detected in Gambia only, these may have been distributed to other countries and must be recalled.

India, meanwhile, told WHO that from the preliminary inquiry, it is made out that Maiden Pharmaceutical Limited, Sonepat, Haryana, is a manufacturer licensed by the State Drug Controller for the products under reference, and holds manufacturing permission for these products.

“The company has manufactured and exported these products only to Gambia so far. It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country,” government sources said.

PRODUCTS IN QUESTION

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

RISKS

Contaminants Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

WHO ADVICE

It is important to detect and remove these substandard products from circulation to prevent harm to patients. WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised.

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