India says samples taken from pharma firm linked to Gambia deaths meet required standards

MUMBAI (Reuters) -India has told the World Health Organization that samples taken from Indian pharmaceutical company Maiden Pharma, whose products were linked to the deaths of children in Gambia, have been found to comply with required specifications.

Indian health authorities announced a production halt at Maiden Pharmaceuticals’ factory in Sonepat in northern India in October after a WHO report said the company’s cough and cold syrups might be linked to the deaths of 69 children in Gambia.

In a letter to the WHO dated Dec. 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.

The Indian health ministry released a copy of the letter to reporters on Thursday.

The WHO did not immediately respond to a request for comment. The U.N. agency had said in October that its investigators had found “unacceptable” levels of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, in the products manufactured by Maiden Pharma.

Gambian police said in October that they were investigating if the deaths of 69 children from acute kidney injury were linked to four cough syrups made in India and imported into the West African country.

Gambia’s Medicines Control Agency, a national regulatory body, later said it had not yet pinpointed the exact cause of the deaths.

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.

(Reporting by Shilpa Jamkhandikar in Mumbai; Editing by Krishna N. Das and Susan Fenton)