Why cough syrup exporters will have to undertake product testing
The Directorate General of Foreign Trade (DGFT) of the Ministry of Commerce and Industry (MCI) has made it mandatory for exporters of cough syrups to get their products tested at government laboratories before they are shipped. According to a notification on Monday, exporters must also produce the certificate of analysis (CoA) from a government laboratory to export cough syrups from June 1 onward.
Why does this story matter?
This move from the DGFT comes after Indian-made cough syrups imported into the Gambia were reportedly found to be contaminated with ethylene glycol (EG) and diethylene glycol (DEG), resulting in an acute kidney injury (AKI) cluster among children who consumed them. In March, a probe "strongly suggested" that medications contaminated with DEG/EG led to this AKI cluster.
Here's where to obtain certificate of analysis
According to the news outlet Economic Times, the CoA can be obtained from numerous government laboratories, including the India Pharmacopoeia Commission, Ghaziabad, and the Central Drug Laboratories (CDL) in Chennai, Kolkata, Hyderabad, and Mumbai. Furthermore, certificates can be collected from regional laboratories, including RDTL Guwahati, Chandigarh, and any National Accreditation Board for Testing and Calibration Laboratories-accredited state drugs testing laboratory.
Official order by DGFT
Government official reveals another reason behind DGFT's move
"The export of cough syrup shall be permitted to be exported subject to export samples being tested and production of a certificate of analysis issued by any of the laboratories, with effect from June 1, 2023," the DGFT stated in a release. This move is to re-emphasize India's commitment toward assuring the quality of various pharmaceutical products, PTI quoted a government official as saying.
Recent allegations against Indian-made syrups
In March, a probe led by Gambian scientists and the United States (US) Center for Disease Control and Prevention (CDC) claimed that drugs contaminated with EG/DEG imported into the country led to the AKI cluster among kids. "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 alleged.
Similar incidents involving Indian syrups
Last October, the World Health Organization (WHO) reported that the deaths of numerous children in Gambia from acute kidney injuries might be due to contaminated cold and cough syrups manufactured by an Indian drug manufacturer, Maiden Pharmaceuticals Limited. In another similar incident, the Uttar Pradesh drug controller canceled the license of Marion Biotech in March after the deaths of 18 children in Uzbekistan.
Know about Indian pharmaceutical industry's global influence
Notably, the Indian pharmaceutical industry is a prominent exporter and manufacturer of medical products worldwide, ranging from highly developed nations to low-and middle-income nations. More significantly, India is also ranked third in the world when it comes to pharmaceutical production by volume and is ranked 14th in terms of its worldwide valuation.
