INDIA —In response to tragic incidents in Gambia and Uzbekistan, where Indian-manufactured cough syrups were allegedly linked to the deaths of numerous children, India has taken decisive action to ensure the safety and quality of its pharmaceutical exports.
Under the revised export policy order issued by the Directorate General of Foreign Trade (DGFT) under the commerce ministry, these new regulations will come into effect on June 1.
To expedite the process and avoid unnecessary delays, the Union Ministry of Commerce has issued an order requiring cough syrup manufacturers to have their stocks tested at government laboratories before exporting.
Furthermore, exporters will be obligated to present a certificate of analysis from a government laboratory, certifying the safety and quality of the product.
However, it remains unclear whether similar testing measures will be implemented for the domestic market, as the health ministry has yet to respond to queries from journalists.
This proactive approach comes in the wake of concerns raised by international authorities, such as the World Health Organization (WHO), which detected toxins in cough syrups manufactured by three Indian companies.
Disturbingly, two of these companies’ syrups were implicated in the deaths of 70 children in Gambia and 19 in Uzbekistan in the previous year.
The reputation of India’s pharmaceutical industry, valued at US$41 billion and one of the largest globally, suffered a blow due to these incidents.
As a result, the government is now considering a comprehensive overhaul of its pharmaceutical industry policies, with a focus on strengthening testing procedures and monitoring raw materials.
The directive to prioritize testing and issue prompt reports has been communicated to all federal government laboratories and drug regulators in major production states.
The government has identified several accredited laboratories, including the Indian Pharmacopoeia Commission and various Central and State Drugs Testing Laboratories, where manufacturers can conduct the necessary tests.
India’s pharmaceutical industry plays a vital role as a major manufacturer and exporter of medical products worldwide, catering to both highly developed countries and low- to middle-income countries (LMICs).
As the largest provider of generic drugs globally, India supplies over 50% of the global demand for vaccines, about 40% of generic demand in the US, and approximately 25% of all medicine in the UK.
In the 2022-23 fiscal year, India exported cough syrups worth US$17.6 billion, further solidifying its position as a key player in the global pharmaceutical market.
With a vast network of 3,000 drug companies and 10,500 manufacturing units, India’s pharmaceutical industry ensures the availability and affordability of high-quality medicines worldwide.
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