Product Testing Deemed Mandatory for Exporters of Cough Syrup

From June 1, cough syrup exporters will need to perform tests on the goods they sell at specific government laboratories prior to obtaining approval for outgoing deliveries. 

Cough syrup manufacturers are now required by the Directorate General of Foreign Trade (DGFT) to have their products examined at a government lab prior to being sent abroad. From June 1, exporters must also present the certificate of analysis (CoA) from the government lab in order to ship out cough syrups.

The official notice 

“The export of cough syrup under ITC (HS) codes falling under the heading 3004 shall be permitted subject to the export sample being tested and the production of CoA issued by any of the laboratories with effect from June 1, 2023,” the notification said.

Preferred place for testing 

Several government laboratories, notably the India Pharmacopoeia Commission in Ghaziabad, the Central Drug Laboratories (CDL) in Kolkata, Chennai, Mumbai, and Hyderabad, offer the CoA. In addition to this, state drug testing laboratories recognised by the NABL as well as regional labs like RDTL Chandigarh, Guwahati, and others can provide the certificates.

The WHO stated on October 5 of last year that there may be a connection between tainted cough and cold syrups produced by an Indian pharmaceutical company, Maiden Pharmaceuticals Ltd., and the acute kidney damage that caused the deaths of hundreds of children in the Gambia.

“A large cluster of acute kidney injury cases affecting children in The Gambia in 2022 was associated with case fatality rates of more than 80%,” an investigation by Gambian doctors with US scientists said.


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