The World Health Organisation has issued an alert about an Indian made cough syrup after 66 children died in The Gambia.
Indian authorities are investigating after the WHO said the medicine could be causing potentially fatal kidney damage.
Health Ministry staff in India told Reuters that an "urgent investigation in the matter has been already taken up".
They added that "all required steps" would be taken in the probe but they were still awaiting a report establishing "causal relation to death with the medical products in question".
On Wednesday, the WHO revealed that laboratory analysis of cough syrup made by New Delhi based company Maiden Pharmaceuticals.
WHO Director-General Tedros Adhanom Ghebreyesus said an investigation was underway into the deaths of the children from acute kidney injuries in the west African nation.
He confirmed the products they were investigating as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
WHO testing found that all the syrups contained "unacceptable amounts" diethylene glycol and ethylene glycol, both of which can cause potentially fatal kidney failure.
So far, the products have only been identified as being exported to The Gambia but could have been distributed through informal channels in other markets.
The UN agency added: "All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulation Authorities."
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Blow to 'pharmacy of the world'
The deaths of 66 children is a serious blow to India's efforts to cast itself as the "pharmacy of the world".
India manufactures a third of the world's medicines and provides most of the drugs bought by African countries.
Maiden says on its website it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana state, and has recently set up another one.
It has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets, and exports to countries in Asia, Africa and Latin America.
Sky News has emailed Maiden Pharmaceuticals for comment.