WHO calls India-made cough syrup deaths in Gambia a ’very serious issue’
- WHO said that India needs to harmonize operations between central and state-level drug regulators
The World Health Organization's chief scientist Dr Soumya Swaminathan said the death of children in Gambia, potentially linked to four Indian-made cough syrups, was a serious issue.
While speaking with media on the sidelines of the annual general meeting of the Developing Countries Vaccine Manufacturers Network (DCVMN), the WHO chief scientist said, "Certainly, the government is in touch with WHO as WHO actually provided the report based on the investigation which was done to prove that it was because of the diethylene glycol contamination. It is a very serious issue and it has to be taken very seriously".
Swaminathan asserted that India needs to harmonize operations between central and state-level drug regulators.
"There are no mechanisms where regulators of different states can actually work together, do the inspections on each other's products," and added, "For India to remain a leader in generic medicines and vaccines space, it is important to prove that it has a strong regulatory system".
Early this month, 69 children died in the Gambia, a tiny country in West Africa, and the WHO proclaimed that Indian-made cough syrup was a reason behind deaths.
WHO Director-General Tedros Adhanom Ghebreyesus said, “WHO has issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked to acute kidney injuries and deaths among children."
The four medicines are cough and cold syrups produced in India, said the WHO statement.
Subsequently, the Indian government formed a panel to examine the details and adverse event reports received from the WHO. The government's action had come after the Haryana government ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals as "many contraventions" were found during an inspection.
The WHO had warned that four cough and cold remedies manufactured by Maiden Pharmaceuticals could cause acute kidney injury in children in Gambia. The WHO investigators had already found "unacceptable" levels of diethylene glycol and ethylene glycol, which can be toxic, in four products made by the New Delhi-based firm.
Maiden Pharmaceuticals director Naresh Goyal has reportedly denied the deaths were caused by cough syrups produced at his company.
"The deaths have been due to paracetamol syrup and not due to our cough syrups," he said.
However, the government panel later observed that the clinical information shared by the WHO was inadequate to determine the aetiology.
Rutendo Kuwana from the WHO on October 13 had written to the DCGI seeking to know the progress with the investigation of the manufacturer of the four cough syrups. In an email response, Drugs Controller General of India (DCGI) V G Somani "The clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the aetiology."
Meanwhile, Gambian police have linked children's deaths to Maiden Pharmaceuticals. The police report did not name Maiden directly but listed the company's same four products that were mentioned by the WHO: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
The cough syrups had been approved for export only to the Gambia, India says, although the WHO says they may have gone elsewhere through informal markets.
Recently, Indonesia said it would investigate cases of acute kidney injury which has caused the deaths of more than 20 children in its capital Jakarta this year, but that there was no connection with the cases in Gambia.
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First Published:21 Oct 2022, 06:17 AM IST
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