According to a government notice issued on Tuesday, after Indian-made cough syrups were linked to the deaths of dozens of children in Gambia and Uzbekistan, the country would require cough syrups to be tested before export.
Beginning June 1, no cough syrups could be exported without a certificate of analysis issued by a government laboratory, according to a government notice dated May 22 and shared by the health ministry on Tuesday.
The $41 billion Indian pharmaceutical industry is one of the world’s largest, but its credibility was harmed when the WHO discovered toxins in cough syrups produced by three Indian companies.
Last year, 70 children in Gambia and 19 children in Uzbekistan died after consuming syrups produced by two of these companies.
“Cough syrup shall be permitted to be exported subject to the export sample being tested and the production of a certificate of analysis,” the trade ministry stated in a notice.
When asked whether cough syrups sold in the domestic market would be tested, the health ministry did not respond immediately.
The notice listed seven federal government laboratories and other state laboratories that were accredited by a national accreditation body as places where samples could be tested.
Toxins were not found in tests conducted in India on cough syrups manufactured by Maiden Pharmaceuticals Ltd and linked to the deaths of children in the Gambia, but many drugs manufactured by Marion Biotech, whose syrups were linked to deaths in Uzbekistan, contained contaminants.
The country is considering a policy shift in its pharmaceutical industry that would include increased testing of cough syrups and drug raw materials. The companies claim they did nothing wrong.
Furthermore, on May 15, this year, the health minister and federal and state regulators convened in Hyderabad, India, “to find a solution to exported cough syrups that killed children,” according to a document from the prime minister’s office.
