India Makes Cough Syrup Testing Mandatory For Exports

India has now made the testing of cough syrups before export mandatory from June 1, following the deaths of 66 and 18 children in Gambia and Uzbekistan respectively allegedly due to Indian-made cough syrups. 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.

Cough syrup-related controversies

Earlier this year, the World Health Organisation (WHO) recommended that two cough syrups manufactured by the Noida-based company Marion Biotech should not be used for children in Uzbekistan.

Back in December 2022, the health ministry of Uzbekistan claimed that as many as 18 children have lost their lives in the country after consuming medicines manufactured by the Indian pharmaceutical company.

Previously WHO claimed that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited in Haryana's Sonepat included Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. 

This comes months after WHO issued an alert for the "contaminated" cough syrups manufactured by the Indian drugmaker, Maiden Pharma, that have been "potentially linked" with acute kidney injuries and 66 deaths among children in Gambia.

"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 regulaor, 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 accreditated 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 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.

(With inputs from PTI)