NEW DELHI: From June 1, all cough syrup exporters will have to undertake mandatory testing of their products at specified government laboratories before getting permission for the outbound shipments.
The direction comes after three alerts issued by the World Health Organisation (WHO), in seven months, on contaminated India-made cough syrups.
"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 Directorate General of Foreign Trade (DGFT) said in a notification on Monday.
The earmarked 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 quality check of the cough syrups has been taken after India's image as the "pharmacy of the world" took a knock following the WHO alerts on contaminated cough syrups.
For this, the Ministry of Health and Family Welfare would partner with the state governments and the exporters.
Officials believe this measure would help re-emphasise India's commitment to assuring the quality of various exported pharmaceutical products. They added that necessary steps are being taken to ensure the smooth implementation of this testing requirement.
India exported cough syrups worth $17.6 billion in 2022-23 against $17 billion in 2021-22.
India-made cough syrups were allegedly linked to the deaths of 70 children in the Gambia and 18 children in Uzbekistan last year.
In April, WHO again raised an alert over contaminated India-made cough syrup sold in the Marshall Islands and Micronesia. But it was not just cough syrups.
Earlier this year, an India-manufactured eye drop was linked to an outbreak of highly resistant bacterial infections in the U.S.
The Centers for Disease Control and Prevention (CDC), which is the national public health agency of the US, had linked the eye drops manufactured by Chennai-based pharma company Global Pharma Healthcare to the likelihood of a highly drug-resistant bacteria gaining a foothold in the U.S.
India is the largest provider of generic drugs globally, supplying over 50 per cent of the global demand for vaccines, about 40 per cent of generic demand in the US, and about 25 per cent of all medicine in the UK.
Globally, India ranks third in 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, accessible medicines worldwide.
Similarly, over 80 per cent of the antiretroviral drugs used globally to combat AIDS are supplied by Indian pharmaceutical firms.