India’s drug regulator has ordered an investigation into alleged contamination of cough syrups made by Maiden Pharmaceuticals that the World Health Organization has linked to the deaths of 66 children in Gambia, the health ministry said on Thursday. The ministry has launched an investigation in collaboration with the drug regulator in Haryana, where Maiden’s plant is located, and the state government.
An initial investigation found that the state regulator granted a license to Sonepat-based Maiden to manufacture Promethazine BP oral solution, Kofexnalin infant cough syrup, MaKoff children’s cough syrup and MaGrip n cold syrup and the company was exporting these products exclusively to The Gambia, the ministry said.
However, the WHO warned that the deadly drugs may have found their way to other countries as well. The samples of these drugs have now been sent to the Regional Drug Testing Laboratory, Chandigarh, Central Drugs Standard Control Organization (CDSCO). Earlier in the day, Haryana Health Minister Anil Vij said the state regulator had sent drug samples to the Central Drugs Laboratory in Kolkata for further analysis.
If the deaths are proven to be directly linked to the cough syrups, it will be a huge blow to the country’s image as a source of cheap generic drugs for the world. Prime Minister Narendra Modi has often hailed India as the “pharmacy to the world” and emphasized that Indian drugs and medicines have earned the world’s trust.
While the export of drugs is more strictly regulated, especially to Western countries, contaminated drugs have often found their way into pharmacies and hospitals in India. In 2020, 13 children, all under the age of five, died after consuming counterfeit Cofset cough syrup 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 to their injuries after consuming a fake cough syrup called Coldbest manufactured by the same company. On September 29, the WHO first informed India’s drug controller general that it was offering technical assistance to The Gambia, where children have died from drugs suspected of being contaminated with diethylene glycol.
According to the first results received by the WHO, of the 23 samples tested, four were found to contain diethylene glycol or ethylene glycol. However, the certificate of analysis will soon be made available to the WHO and will be shared with India, a government official aware of the matter said. “CDSCO immediately responded to WHO and took the matter very seriously along with the state drug regulator (Haryana) to ascertain the facts,” said the official, requesting anonymity.
WHO Director-General Dr Tedros Adhanom Ghebreyesus on Wednesday issued a warning against four cough and cold syrups made by Maiden, saying it may be linked to the deaths of children in The Gambia. “So far, the contaminated products have only been found in The Gambia, but the products have been distributed to other countries. WHO recommends that all countries detect and eliminate these products,” said Dr Tedros.
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