Following the deaths of 66 and 18 children in Gambia and Uzbekistan, respectively, reportedly caused by Indian-manufactured cough syrups, India has made the testing of cough syrups before to export mandatory as of June 1. The Drugs Controller General of India (DCGI) has directed that such samples from manufacturers be examined "as soon as possible" and that a test report be issued.
Cough syrup exporters will be required to submit a certificate of analysis issued by a government laboratory before the product can be exported, the Directorate General of Foreign Trade (DGFT) announced on Monday. The move came after reports of quality issues with cough syrups exported by Indian companies in other countries.
The World Health Organisation (WHO) recommended earlier this year that two cough syrups manufactured by the Noida-based company Marion Biotech not be used for children in Uzbekistan.
In December 2022, the Uzbek health ministry stated that 18 children had died in the nation after taking drugs manufactured by an Indian pharmaceutical company.
Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup were among four "contaminated" and "substandard" cough syrups purportedly created by Maiden Pharmaceuticals Limited in Haryana's Sonepat.
This comes months after WHO issued a warning about "contaminated" cough syrups made by the Indian pharmaceutical Maiden Pharma, which have been "potentially linked" to acute renal damage and 66 fatalities among children in Gambia.
"With effect from June 1, 2023, the export of cough syrup shall be permitted subject to export samples being tested and production of a certificate of analysis issued by any of the laboratories...," the notification added.
The country's top drug regulator, DCGI, wrote to state drug controllers in Gujarat, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Jammu and Kashmir, and Uttarakhand, as well as central laboratories, on Wednesday, referring to a notification issued by the Ministry of Commerce and Industries regarding cough syrup export policy.
"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.