New Delhi: Amidst allegations that four drugs manufactured by a Haryana-based pharmaceutical company could be linked to whose death? 66 children In The Gambia, ThePrint learned that the World Health Organization (WHO) notified India’s drug regulator last week, following which Indian authorities launched a detailed investigation.
On Wednesday, the WHO issued an alert against four cough and cold medicines manufactured by Sonepat-based Maiden Pharmaceuticals – Promethazine Oral Solution, Cofexmalin Baby Cough Syrup, Macoff Baby Cough Syrup and Magrip N Cold Syrup. These were identified as “substandard products” which allegedly contained two toxic compounds.
The WHO statement said it was important to remove these products from circulation, and requested “increased monitoring” – including informal/unregulated markets – in countries most likely to be affected. this couple That all batches of these products should be considered unsafe until they can be analyzed by the relevant national regulatory authorities.
According to a health ministry source, the WHO had already alerted the Drugs Controller General of India (DGCI) on September 29 about the possible causal link between drugs and deaths.
This was followed by the Central Drugs Standard Control Organization (CDSCO) – India’s regulatory body Which deals with drugs, cosmetics and pharmaceuticals – came into action. The source said it responded to the WHO within an hour and a half and took up the matter with the state drug controller of Haryana, under whose jurisdiction the Sonepat-based company falls.
According to a health ministry source, a preliminary investigation reveals that Maiden Pharmaceuticals is a licensed manufacturer with permission to manufacture these products, and so far, the company has exported these products only to The Gambia.
It has also been reported that Maiden Pharmaceuticals Not there supplies its medicines in India.
ThePrint reached out to Maiden Pharmaceuticals via telephone. This report will be updated upon receipt of feedback.
toxic compound
A WHO statement released on Wednesday said that a laboratory analysis Samples of each of the four products “confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants”.
“To date, four of these products have been identified in The Gambia, but may be distributed in other countries or regions, through informal markets,” Statement Told.
Ethylene glycol is a Odorless, colourless, flammable and viscous liquid which is used as a raw material in the manufacture of polyester fiber and for antifreeze formulations.
diethylene glycol is also a colorless liquid with a sweet taste, which is used brake fluid – A type of hydraulic fluid used in brakes and clutches in automobiles – and as an industrial solvent.
Both compounds are toxic to humans when consumed, and can prove fatal.
According to the statement, the toxic effects of the compounds can include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status and acute kidney injury that can lead to death.
‘WHO not yet shared test certificates’
The WHO has identified four drugs as follows: substandard product, These are defined as products that fail to meet quality standards or specifications, and are, therefore, “out of specification”.
However, a health ministry source told ThePrint that out of 23 samples tested by WHO, only four were found to contain diethylene glycol or ethylene glycol. The source said that the WHO is yet to share the certificates of these tests with India.
“At the same time, the exact one-to-one causal relationship of death has not yet been provided by the WHO, nor [has it shared] Label or description of products [that would enable] To confirm the identity or source of manufacture of CDSCO products,” the source said.
The source said that CDSCO “Prompt Investigation” has started In conjunction with state regulatory authorities.
“While all necessary steps will be taken in this matter, as a strong national regulatory authority, [the CDSCO has asked] WHO will share the report [establishing a] Cause of death relationship with the concerned medical products, labels/ photos of the products etc., at the earliest,” the source said.
(Edited by Uttara Ramaswamy)
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