
The samples of cough syrup that were linked to the deaths of children in Gambia were found to be complying with the required specifications, India told World Health Organisation on Thursday, adding, that Indian pharmaceutical company Maiden Pharma fulfilled the required safety criteria.
The Drugs Controller General of India said thatWHO drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country's pharmaceutical products across the globe.
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As a matter of precaution, Indian health authorities had directed and subsequently implemented a production haltat Maiden Pharmaceuticals' manufacturing plant, after a WHO statement, now deemed 'premature', drew a link between the deaths of 69 children in Gambia with consumption of cough syrup made by New Delhi-headquartered company.
What did WHO allege?
In a letter to the WHO dated December 13, India's drugs controller general, V.G. Somani, said that tests on samples of Maiden Pharma's products "have been found to be complying with specifications" and showed the samples were not contaminated with ethylene glycol and diethylene glycol.
Gambia's Medicines Control Agency is yet to pinpoint the exact cause of deaths. The primary medical reports cited by Gambia's police said that 69 children died of "acute kidney injury".
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The WHO's statement in October, linking the deaths to the cough syrup manufactured in India, caused "irreparable damage" to the country's supply chain of pharmaceutical products, Somani said in the Dec. 13 letter, addressed to Roderigo Gaspar, director, regulation and prequalification, at WHO.
The DCGI said India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in the quality control of drugs and cosmetics.
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