New Cough Syrup Export Guidelines: Stringent Quality Checks And CoA Verification From June 1, Says DGFT

The directive has been issued in response to quality concerns raised globally surrounding cough syrups exported by Indian companies.

New Delhi: Starting from June 1, cough syrup exporters will be required to conduct testing of their products at designated government laboratories before getting permission for outbound shipments. This directive has been issued in response to quality concerns raised globally surrounding cough syrups exported by Indian companies.

“The export of cough syrup shall be permitted to be exported subject to export samples being tested and production of 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 on Monday.

The specified central government labs include Indian 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.

Explaining further, an official told PTI that to re-emphasize India's commitment towards assuring the quality of various pharmaceutical products exported from India, the central government has decided to initiate a process of a pre-quality check of the cough syrup formulations being exported.

“The finished goods (cough syrup in this case) are to be tested at laboratories before being permitted for export,” the official said, adding that necessary steps are being taken to ensure the smooth implementation of this testing requirement, and MoHFW would partner with the state governments and the exporters to ensure smooth implementation of this notification.

In February, Global Pharma Healthcare, a company based in Tamil Nadu, recalled its complete batch of eye drops.

Prior to this, India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in Gambia and Uzbekistan, respectively, last year.

India exported cough syrups worth USD 17.6 billion in 2022-23 as against USD 17 billion in 2021-22.

India is the largest provider of generic drugs globally, supplying over 50 per cent of global demand for various vaccines, about 40 per cent of generic demand in the US, and about 25 per cent of all medicine in the UK.

Globally, India ranks third in terms of pharmaceutical production by volume and 14th by value.

Presently over 80 per cent of the antiretroviral drugs used globally to combat AIDS are supplied by Indian pharmaceutical firms.