Cough syrup exporters need to undertake product testing at govt labs from June 1

Cough syrup exporters need to undertake product testing at govt labs from June 1

The Directorate General of Foreign Trade (DGFT) on Monday made it mandatory for the exporters to cough syrups to get them tested at the government laboratory before they are exported. According to the notification the exporters will have to also produce the certificate of analysis (CoA) from the government laboratory to be able to export cough syrups effective June 1.

The CoA can be obtained from various government laboratories including the India Pharmacopoeia Commission, Ghaziabad, Central Drug Laboratories (CDL) at Kolkata, Chennai, Mumbai and Hyderabad, Other than this, the certificates can also be taken from regional laboratories including RDTL Chandigarh, Guwahati, and any NABL accredited state drugs testing laboratory.

“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 production of CoA issued by any of the laboratories with effect from June 1, 2023,” the notification said.

The intervention by the DGFT follows past incidents where India-made cough syrups imported into Gambia were allegedly found to be contaminated with diethylene glycol (DEG) and ethylene glycol (EG) resulting in Acute Kidney Injury (AKI) cluster among children.

An investigation led by the United States Center for Disease Control and Prevention and Gambian scientists in March “strongly suggested” that medications contaminated with DEG or EG imported into the Gambia led to this AKI cluster among children.

“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%,” it said.

The WHO had on October 5 last year announced that the deaths of dozens of children in Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups made by an Indian drug manufacturer-Maiden pharmaceuticals Ltd.The ‘Morbidity and Mortality weekly report’ published by the CDC, reached its conclusions by reviewing the medical records of 52 (67%) of the 78 identified patients with suspected AKI.

A similar incident came to light in March where the state drug controller of UP cancelled the licence of Noida-based Marion Biotech which manufactured alleged contaminated cough syrup linked to the death of 18 children in Uzbekistan.

(With inputs from health)