India Makes Cough Syrup Testing Mandatory Before Exports; DCGI asks laboratories to give top priority to such samples

by trendswire · 25 May 2023

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Image Source: REPRESENTATIVE IMAGE Mandatory cough syrup test before export

New Delhi: India has now made the testing of cough syrups mandatory before export from June 1, following the deaths of 66 and 18 children in The Gambia and Uzbekistan respectively, allegedly due to cough syrups manufactured in the India. The Comptroller General of Drugs of India (DCGI) has ordered government laboratories to test cough syrup samples destined for exports “with the highest priority” and issue reports as soon as possible.

The move is aimed at avoiding unnecessary delays, as the Union Ministry of Commerce issued an order requiring manufacturers of cough syrups to test their stocks at a government laboratory before sending them for export. Cough syrup exporters must present a certificate of analysis issued by a government laboratory before exporting the product, starting June 1, the Foreign Trade General Directorate (DGFT) reported in a notification. The move was taken in response to cases where cough syrups exported by Indian companies raised quality concerns abroad.

‘Give top priority in sample analysis’

On Wednesday, DCGI wrote to Gujarat, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Jammu and Kashmir and Uttarakhand state drug controllers and central laboratories and referred to the notification issued by the Ministry of Commerce and Industries regarding the policy. export of cough syrups.

“State drug controllers are hereby requested to instruct their state-owned NABL laboratories to analyze samples received from cough syrup manufacturers for export purposes with the highest priority and issue the report of the test as soon as possible,” the letter said.

It requested all the central laboratories to give the highest priority in the analysis of the sample received from the manufacturers and issue the report immediately to avoid delays. “All state licensing authorities are requested to send the email IDs of their state NABL-accredited laboratories to this office by return mail,” the letter said.

central government laboratories

The specified central government laboratories include Indian Pharmacopoeial Commission, Regional Drug Testing Laboratory (RDTL – Chandigarh), Central Drug Laboratory (CDL – Kolkata), Central Drug Testing Laboratory (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati) and NABL (National Accreditation Board for Testing and Calibration Laboratories) state government accredited drug testing laboratories.

The Indian pharmaceutical industry is a leading manufacturer and exporter of medical products to the entire world, from highly developed countries to LMICs (low and middle income countries).

‘India is the world’s largest supplier of generic drugs’

India is the world’s largest supplier of generic drugs, supplying more than 50 percent of the world’s demand for various vaccines, about 40 percent of the demand for generics in the US, and about 25 percent of all medicines in the UK. India exported USD 17.6 billion worth of cough syrups in 2022-23 compared to USD 17 billion in 2021-22. Globally, India ranks 3rd in terms of pharmaceutical production by volume and 14th by value.

The industry includes a network of 3,000 pharmaceutical companies and some 10,500 manufacturing units. It facilitates the availability and supply of high-quality, affordable and accessible medicines around the world.

(With PTI inputs)