Mandatory testing of cough syrup before exports, DCGI asks labs to prioritise such samples

With India making testing of cough syrups before export mandatory from June 1, the Drugs Controller General of India (DCGI) has asked specified state laboratories to examine such samples from manufacturers on "top priority and issue the test report at the earliest".

Cough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before the product is exported, effective June 1, the Directorate General of Foreign Trade (DGFT) said in a notification on Monday.

The move came amid instances of quality concerns being raised abroad on 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 a certificate of analysis issued by any of the laboratories..., with effect from June 1, 2023," the notification stated.

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

"State Drug Controllers are hereby requested to give instructions to your state-owned NABL accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export purpose on top priority and issue the test report at the earliest," the letter stated.

It requested all central laboratories to give top priority in analyse the sample received from the manufacturers and issue the report immediately in order to avoid delays.

"It is requested to all state licensing authorities to forward the e-mail Ids of their NABL accredited laboratories of their state to this office by return mail," the letter stated.

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.

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.

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.

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.