New Delhi: Cough syrup exporters will have to undertake testing of their products at specified government laboratories from June 1 before getting permission for the outbound shipments. The decision to implement quality checks before export was introduced after India-made cough syrups were linked to dozens of deaths in Gambia and Uzbekistan in 2002.
“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 Directorate General of Foreign Trade (DGFT) said in a notification.
The specified central government labs are Pharmacopoeia Commission, regional drug testing lab (RDTL – Chandigarh), central drugs lab (CDL – Kolkata), central drug testing lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments.
The World Health Organization said last year the syrups, made by Indian manufacturer Maiden Pharmaceuticals Ltd, contained lethal toxins ethylene glycol (EG) and diethylene glycol (DEG) – used in car brake fluid. These ingredients can be used by unscrupulous actors as a substitute for propylene glycol (PG), which is a key base of syrupy medicines.
In February, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops.
India exported cough syrups worth USD 17.6 billion in 2022-23 as against USD 17 billion in 2021-22.