India to require tests of cough syrups for export

India will mandate tests for cough syrups before they are exported, according to a government notice on Tuesday, after Indian-made cough syrups were linked to the deaths of dozens of children in Gambia and Uzbekistan.

Any cough syrup must have a certificate of analysis issued by a government laboratory before it is exported, effective June 1, the government said in a notice dated May 22 and shared by the health ministry on Tuesday.

India’s $41bn pharmaceutical industry is one of the biggest in the world, but its reputation was shaken after the World Health Organisation (WHO) found toxins in cough syrups made by three Indian companies.

Syrups made by two of them were linked to the deaths of 70 children in Gambia and 19 in Uzbekistan last year.

“Cough syrup shall be permitted to be exported subject to the export sample being tested and production of certificate of analysis,” the notice issued by the trade ministry reads.

The health ministry did not immediately respond to a query on whether testing would be required for cough syrups sold in the domestic market.

The notice identified seven federal government laboratories where samples could be sent for testing, in addition to other state laboratories certified by a national accreditation body.

Indian tests of cough syrups made by Maiden Pharmaceuticals, linked to the deaths of children in Gambia, found no toxins but contaminants were detected in many drugs made by Marion Biotech, whose syrups were linked to deaths in Uzbekistan.

The companies deny any wrongdoing.

The health minister and federal and state regulators also met in the southern city of Hyderabad earlier this year “to find a solution to exported cough syrups that killed children”, according a document from the prime minister's office, dated May 15.

Reuters