Indian Made Cough Syrups Kill 66 Children in Gambia; No Alert From India’s Drug Controller Yet

New Delhi: Four medicines made by a Haryana-based firm have caused the death of 66 children in the Gambia due to the contaminants found in them. The World Health Organisation (WHO) announced on October 5 that cough syrups made by Maiden Pharmaceuticals Limited had diethylene glycol and ethylene glycol, which are toxic to human beings.

Addressing a press conference, WHO director-general Tedros Adhanom Ghebreyesus said the four medicines, which were potentially linked to these deaths, caused ‘active kidney injuries’ among children. Ghebreyesus added, “The WHO is conducting enquiries with the company and the regulatory authorities in India.”

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. “To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions,” the WHO said, warning countries across the world in a statement that was issued in addition to the director-general’s response.

“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death,” said the WHO statement.

A collage shows the front labels and the back labels of the four contaminated products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. (Credit: WHO)

It has advised all the countries to remove these products from their markets. WHO has pitched for increased surveillance 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,” the WHO statement said.

The UN health agency also made clear that not one single batch but all batches of these products should be considered harmful – at least until they are analysed by the relevant national regulatory authorities.

There has been no word or advice from India’s Central Drugs Standard Control Organisation (CDSCO) or its head, the Drugs Controller General of India (DCGI), nor has any statement been issued by India’s health ministry. Whether the products were supplied in India or not is not immediately clear. Since the firm is India-based, the chances of them being supplied in India may not be ruled out. The Wire tried reaching DCGI V.G. Somani over the phone to know the status of supply in India, and if any follow-up has been done. However, the call went unanswered.

The Wire has verified that at least one of the products – Promethazine Oral Solution – was procured by the West Bengal government in 2012.

This was not the first instance of children dying due to contaminated cough syrup made by an Indian company. Earlier this year, 14 children died in Himachal Pradesh due to the same contaminants – diethylene glycol. That cough syrup was made by another Indian company. According to Mint, that particular cough syrup failed quality tests 19 times, yet continued to be available in the market till it caused the deaths of 14 children. Even after the deaths, the only action taken against the company was to cancel the license to manufacture the syrup.

The WHO also said that Maiden Pharmaceuticals has failed to provide any satisfactory response to it. “To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” it said.

These products were reported to the WHO to the Gambian authorities in September 2022. The laboratory analysis found the products contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”.

Apart from causing deaths, these contaminants can also cause abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury.

The Wire has reached out to WHO for further comments. The story will be updated when responses are received.