In a notice issued on Tuesday, the central government has now made tests mandatory for cough syrups before they are exported. The notice comes after Indian-made cough syrups were linked to the deaths of dozens of children in Gambia and Uzbekistan.
According to the notice according to a notification issued on Monday by the Directorate General of Foreign Trade (DGFT), and shared by the Health Ministry on Tuesday, any cough syrup must have a certificate of analysis issued by a government laboratory before it is exported, effective June 1.
The CoA would be issued by the Indian Pharmacopoeia Commission, Ghaziabad, CDL Kolkata, CDTL Chennai, CDTL Mumbai, CDTL Hyderabad, RDTL Chandigarh, RDTL Guwahati, and any NABL-accredited state drugs testing laboratories.
Earlier this month, the Central Drugs Standard Control Organisation (CDSCO) proposed the examination of cough syrups in government laboratories before they are exported to other countries.
In April this year, the World Health Organisation (WHO) flagged contaminated cough syrups made by Punjab-based QP Pharmachem Ltd, that were found in Marshall Islands and Micronesia. Reportedly, the cough syrups were marketed by Hyderabad-based Trillium Pharma.
Last year, the global health agency found toxins in cough syrups made by three Indian companies. Cough syrups made by two of these companies were linked to the deaths of 70 children in Gambia and 19 in Uzbekistan last year.
However, it is still not clear whether testing would be required for cough syrups sold in the domestic market.
“Cough syrup shall be permitted to be exported subject to the export sample being tested and production of certificate of analysis,” said the notice issued by the trade ministry.
Indian tests of cough syrups made by Maiden Pharmaceuticals Ltd, 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, as per a report by Reuters.
