Cough Syrups Made By Maiden Pharma Not Sold In India, Only Exported To Gambia: Centre

The ministry noted samples of the same batch manufactured by Haryana-based Maiden Pharmaceuticals have been sent for testing to a laboratory and the results would "guide further course of action"

Cough syrup being poured onto spoon

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New Delhi: After World Health Organization raised alert over four cough syrups made by an Indian firm linked to the death of children in Gambia, the health ministry on Thursday said the products were made only for exports and not sold in India. “These 04 drugs are not licensed for manufacture and sale in India. In effect, none of these four drugs is sold domestically,” said a release from the union health ministry.

The ministry noted that samples of the same batch manufactured by Haryana-based Maiden Pharmaceuticals for all four drugs have been sent for testing to a laboratory and the results would "guide further course of action as well as bring clarity on the inputs received/to be received from WHO".

The cough and cold syrups, manufactured by Sonipat-based Maiden Pharmaceuticals Ltd, have been blamed for the deaths of more than 60 children from kidney injury in Gambia. The Maiden products for which WHO has issued an alert are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

The regulatory authority Central Drugs Standard Control Organisation has asked the WHO to share its report on "establishment of causal relation to death with the medical products in question" saying it was importing countries that typically test such products before allowing usage in the country.

Anil Vij, the health minister of Haryana, where Maiden has its factories, warned of "strict action if anything is found wrong" after the tests.

Response of pharma company

Naresh Kumar Goyal, director of Maiden Pharmaceuticals Ltd said it heard about the deaths only on Thursday morning and is looking at the details.

"We are trying to find out the situation because it cropped up only today," he said by phone. "We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India," Goyal told news agency Reuters.

WHO findings so far

The WHO on Wednesday said laboratory analysis of four Maiden products had confirmed "unacceptable" amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.

Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products.

WHO Director-General Tedros Adhanom Ghebreyesus said the UN agency was investigating the deaths from acute kidney injuries with India's drug regulator and the drugmaker.

The agency informed the Drugs Controller General of India of the deaths late last month, after which the regulator launched an investigation with state authorities in tandem with the WHO.

Maiden, which launched its operations in November 1990, manufactured and exported the syrup only to the Gambia, the Indian health ministry said. Maiden on its website says it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana, and has recently set up another one.

(With inputs from agency)