DCGI prioritises cough syrup tests for export, mandates lab compliance

Effective June 1, cough syrup exporters must present a government laboratory-issued certificate of analysis before exporting the product

Cough syrup
Last year, India-made cough syrups were reportedly associated with the unfortunate deaths of 66 children in Gambia and 18 children in Uzbekistan I Representational pic

Starting June 1, India enforces mandatory testing of cough syrups before export. In response, the Drugs Controller General of India (DCGI) has instructed designated state laboratories to prioritize the examination of samples from manufacturers and promptly issue test reports.

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.

Also Read: Cough syrup exporters need to undertake product testing at govt labs from June 1

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.

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.

Also Read: Uzbekistan cough syrup deaths: Marion Biotech’s licence cancelled by UP authority

“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.

Also Read: Marion Biotech’s license to be cancelled after Uzbek cough syrup deaths: Official

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.