India’s drug regulator has asked the state drug controllers to instruct their government-run laboratories to analyse samples of cough syrups that have to be exported “on top priority” and issue test reports at the earliest in order to avoid delays.

The Directorate General of Foreign Trade (DGFT) on Monday made it mandatory for exporters of cough syrups to get them tested at government laboratories before they are shipped.

According to the notification, beginning June 1, cough syrup exporters will have to produce the certificate of analysis (CoA) issued by the government testing laboratory to be able to export. In a letter dated May 24, the Drugs Controller General of India has asked the state drug controllers “to give instructions to their state-owned NABL-accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export purpose on top priority and issue the report at the earliest”.

“It is further requested to all central laboratories to give top priority in analysing the samples received from the manufacturers and issue the report immediately in order to avoid delays…,” it said. According to the DGFT notification, the CoA can be obtained from government laboratories, including the India Pharmacopoeia Commission in Ghaziabad, and the central drug laboratories (CDL) in Kolkata, Chennai, Mumbai and Hyderabad.

Other than this, the certificates can also be taken from regional laboratories, including RDTL Chandigarh and 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 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 Gambia in 2022 was associated with case fatality rates of more than 80%,” it said.