India's central drug control authority has launched an investigation in Haryana after the WHO issued a public warning that cough syrups manufactured by an Indian company based there could potentially be linked to the deaths of at least 66 children in The Gambia.
"While all required steps will be taken, as a robust regulatory authority, WHO has been requested to share with CDSCO (Central Drugs Standard Control Organisation) the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," an official source told PTI said in New Delhi.
The World Health Organisation on Wednesday warned that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation, according to a PTI report from Geneva.
The United Nations health agency, however, has not yet shared details of labels and products with the Central Drugs Standard Control Organisation (CDSCO), which would enable it to confirm the identity and source of manufacturing of the products, official sources said.
According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.
It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.
The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority. Further, a detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
"From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana, is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products.
"The company has manufactured and exported these products only to The Gambia so far," the source said.
It is a practice that the importing country tests the products for quality before sanctioning their usage there.
According to the tentative results received by the WHO, four out of the 23 samples tested have been found to contain either Diethylene Glycol/Ethylene Glycol. WHO has also informed India that it will share the certificate of analysis soon.
"At the same time, the exact one to one causal relation of the deaths has not yet been provided by the WHO, nor have the details of labels or products been shared with CDSCO, which would enable it to confirm the identity and source of the manufacturing of the products," the source added.
'Beyond heart-breaking'
WHO Director-General Tedros Adhanom Ghebreyesus told reporters Wednesday, "The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited in India. WHO is conducting further investigation with the company and regulatory authorities in India," he said, adding that the loss of young lives due to the products is "beyond heart-breaking for their families".
"The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The manufacturer of these products is Maiden Pharmaceuticals Limited, Haryana, India, and to date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," WHO said.
The WHO chief said while the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO has recommended all countries detect and remove these products from circulation to prevent further harm to patients.
Four substandard products
The WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. WHO said substandard medical products are the products that fail to meet either their quality standards or specifications. Therefore, they are "out of specification", the health body said.
Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. Outlining the risks associated with the products, WHO said diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
Many toxic effects
"Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death," it said.
All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death, it added.
PTI