India probes cough syrup linked to death of children in Gambia
The Central Drugs Standard Control Ogranisation has formed a committee to examine the facts pertaining to the cough syrups, the manufacturing license of the company
India’s drugs regulator has ordered an investigation into the alleged contamination of cough syrups produced by Maiden Pharmaceuticals that the World Health Organization has linked to the death of 66 children in the Gambia, the health ministry said on Thursday.
The ministry initiated the inquiry in collaboration with the drug regulator in Haryana, where Maiden’s plant is located, and the state government.
An initial inquiry found that the state regulator licensed the Sonepat-based Maiden to produce Promethazine oral solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup for exports, and the company has exported these products solely to Gambia, the ministry said.
The WHO has, however, warned that the deadly medicines might have found their way to other countries as well.
The samples of these drugs have now been sent to the regional drug testing lab, Chandigarh, by the Central Drugs Standard Control Organisation (CDSCO). Earlier in the day, Haryana health minister Anil Vij said the state regulator had sent drug samples to the Central Drugs Laboratory, Kolkata, for further analysis.
The deaths, if established to be directly linked to the cough syrups, will be a massive blow to the country’s image as a source of cheap generic drugs to the world.
Prime Minister Narendra Modi has often touted India as the “pharmacy to the world” and stressed that India-made drugs and medicines had earned the world’s trust.
While the exports of drugs are more tightly regulated, especially to Western countries, tainted drugs have often found their way to pharmacies and hospitals in India. In 2020, 13 children, all under five years, died after consuming adulterated cough syrup, Cofset, manufactured by Himachal Pradesh-based Digital Vision. The syrup contained a deadly chemical called diethylene glycol. Earlier that year, around 12 children from Ramnagar village in Jammu succumbed after consuming adulterated cough syrup called Coldbest, manufactured by the same company.
The WHO first informed the Drugs Controller General of India on 29 September that it was offering technical assistance to Gambia, where children died because of medicines suspected to be contaminated with diethylene glycol.
According to initial results received by the WHO, out of the 23 samples tested, four were found to contain diethylene glycol or ethylene glycol. However, the certificate of analysis will be made available to WHO soon and will be shared with India, a government official aware of the matter said.
“CDSCO responded to WHO immediately and took up the matter very seriously along with the state drug regulator (Haryana ) to ascertain facts,” the official said, requesting anonymity.
Queries sent to Maiden Pharmaceuticals on Thursday remained unanswered.
It is a practice that the importing country tests these products on quality parameters and satisfies itself before their release for usage in the country.
WHO director-general Dr Tedros Adhanom Ghebreyesus on Wednesday issued an alert against four cough and cold syrups made by Maiden, saying that it might be linked to the deaths of children in the Gambia. “So far, the contaminated products have only been found in Gambia, but the products have been distributed to other countries. WHO recommends all countries detect and remove these products,” Dr Tedros said.
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First Published:7 Oct 2022, 06:35 AM IST
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