India requires government lab tests before exporting cough syrup. Last year, syrups produced by two Indian businesses were implicated in the deaths of 19 children in Uzbekistan and 70 children in The Gambia.
Following reports linking Indian-made cough syrups to the deaths of numerous children in The Gambia and Uzbekistan, India announced that testing will be required before cough syrups are shipped.
With effect from June 1, all cough syrups must have a certificate of analysis from a government laboratory before being exported, the government announced in a notification distributed by the health ministry on Tuesday.
One of the largest in the world, India’s $41 billion pharmaceutical sector has had its reputation damaged when the World Health Organisation (WHO) discovered toxins in cough syrups produced by three Indian companies.
Last year, syrups produced by two of these businesses were implicated in the deaths of 19 children in Uzbekistan and 70 in The Gambia.
The notice from the trade ministry stated, “Cough syrup shall be permitted to be exported subject to the export sample being tested and presentation of certificate of analysis.
A question regarding whether testing would be necessary for cough syrups marketed on the domestic market was not immediately answered by the health ministry.
In addition to several state laboratories accredited by a national accreditation authority, the notice listed seven federal government laboratories where samples might be sent for testing.
However, pollutants were found in numerous medications made by Marion Biotech, whose cough syrups were linked to deaths in Uzbekistan. Maiden Pharmaceuticals Ltd. cough syrups were tested in India and were associated to the deaths of children in The Gambia, but no poisons were discovered.
India was reportedly considering altering its pharmaceutical sector policies last week, including increasing testing of cough syrups and medicinal raw materials. This was according to Reuters news agency. The businesses dispute any wrongdoing.
A brainstorming conference was also conducted earlier this year in the southern city of Hyderabad by the health minister, federal and state regulators, and others “to find a solution to exported cough syrups that killed children,” according to a May 15 memo from the prime minister’s office.
