Cough Syrup Exporters Require to undertake Testing at Govt Labs For Outbound Shipments

From June 1, cough syrup exporters will need to test their products at specific government laboratories before obtaining approval for outbound shipments. The shift in the trajectory came after after India-made cough syrups that were connected to dozens of deaths in the Gambia and Uzbekistan in 2002, the decision to implement quality checks before export was made.

The Directorate General of Foreign Trade (DGFT) stated in a notification on Monday, “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 NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments are included among the specified central government labs, along with the Pharmacopoeia Commission, regional drug testing labs (RDTL – Chandigarh), central drugs labs (CDL – Kolkata), central drug testing labs (CDTL – Chennai Hyderabad, Mumbai), and RDTL (Guwahati).

The syrups, produced by the Indian company Maiden Pharmaceuticals Ltd., were found to contain the deadly toxins ethylene glycol (EG) and diethylene glycol (DEG), which are also found in brake fluid. Unreliable actors may substitute these ingredients for propylene glycol (PG), a crucial component of syrupy medicines.

Global Pharma Healthcare, based in Tamil Nadu, recalled its entire batch of eye drops in February.  In 2022–2023, India exported cough syrups worth US$17.6 billion, up from US$17 billion in the 2021–2022 period.

The LMIC (low and middle-income countries) and highly developed nations alike purchase medical products from the Indian pharmaceutical industry, which is a significant global manufacturer and exporter of pharmaceuticals. India is the world’s largest supplier of generic drugs, meeting more than 50% of the demand for various vaccines globally, about 40% of generic drug demand in the US, and about 25% of all medicine demand in the UK.

India is the third-largest pharmaceutical producer in the world by volume and the fourteenth-largest by value. There are about 10,500 manufacturing facilities and a network of 3,000 pharmaceutical companies in this sector. It makes it easier for high-quality, reasonably priced, and easily accessible medicines to be supplied and made available globally. India holds a significant position in the world’s pharmaceutical industry.

Currently, Indian pharmaceutical companies provide over 80% of the antiretroviral drugs used to combat AIDS worldwide.