New rule for export of cough syrup: Testing at govt labs mandatory from this date

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 direction has come after quality concerns were raised globally for cough syrups exported by Indian firms.

“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 said 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, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops. Before that, 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.

The Indian pharmaceutical industry is a prominent manufacturer and exporter of medical products to the entire globe; ranging from highly developed countries to the LMIC (low and middle income countries)..

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..

The industry includes a network of 3,000 drug companies and about 10,500 manufacturing units. It facilitates the availability and supply of high-quality, affordable and accessible medicines around the world. India enjoys an important position in the global pharmaceuticals sector.

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