The World Health Organisation (WHO) on Wednesday, October 5 flagged four "contaminated" and "substandard" cough syrups made by an Indian company, while warning that they could be linked to the deaths of 66 children in the West African nation of Gambia.
The medicines made by New Delhi-based Maiden Pharmaceuticals, which have been largely utilised for paediatric purposes, are believed to contain chemicals that are toxic and potentially fatal, the WHO said, as per PTI.
But is this the first time such a mishap has occurred with regard to a 'Made in India' medicine? Today’s FAQ will answer some of your questions about the same.
How did it all begin?
A spike in cases of acute kidney injury among children under the age of five was observed in late July in the West African nation, as reported by Reuters. A number of patients apparently began to report kidney problems three to five days after taking a paracetamol syrup that was sold locally, the report said. Inability to pass urine, fever and vomiting were some of the symptoms that children suffered from.
As per the nation’s Health Ministry figures, by early August, 28 children had died with a fatality rate of nearly 90 per cent, as reported by Reuters. The death tally increased in the following months.
How was the link with the Indian-made medicine established?
Samples of the medicines that the children ingested were sent to toxicology labs for further testing. The laboratory analysis found the products contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” as stated in media reports.
WHO's Director-General Tedros Adhanom Ghebreyesus, while addressing a press conference on Wednesday, stated that the cough syrups made by Maiden Pharmaceuticals contained diethylene glycol and ethylene glycol, which are toxic to human beings. The four products are namely, Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The organisation further advised all countries to remove the aforementioned products from their markets.
Is this the first time an Indian-made medicine has caused deaths?
Several such cases have been reported in India itself. In Jammu and Kashmir, 17 children died in 2020 after consuming a different brand of contaminated cough syrup, however, with the same diethylene glycol. Similarly, 14 children died in Himachal Pradesh this year due to the same contaminants — diethylene glycol. Reports pointed out that the culprit in this case — the particular cough syrup — failed the required quality tests 19 times. However, it was still available for purchase in the market.
How are medicines approved in India?
The Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) of India. It holds the prime responsibility for approval of new drugs, clinical trials in the country, laying down the standards for drugs, control over the quality of imported drugs and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bringing about uniformity in the enforcement of the Drugs and Cosmetics Act.
Further, CDSCO, along with state regulators, is jointly responsible for the grant of licenses for certain specialised categories of critical drugs such as blood and blood products, IV fluids, vaccines and sera.
However, WHO, in its statement, noted that the concerned manufacturer has not provided guarantees to WHO on the safety and quality of these products. Meanwhile, no statement has been issued by the Indian Health Ministry or the CDSCO yet in this regard.
