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India–EU FTA has the potential to be a game changer for pharma & med-tech: Dr Sujit Paul
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Nandita Vijayasimha, Bengaluru
February 02 , 2026
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The India–EU FTA has the potential to be a game changer for Indian pharma and medtech companies. By improving market access, enhancing regulatory cooperation, and fostering innovation partnerships, the agreement can elevate India’s position as a trusted global healthcare manufacturing and innovation hub delivering benefits not only for industry, but also for patients across both regions, said Dr Sujit Paul, Group CEO, Zota Healthcare.
This FTA presents a crucial opportunity for India through which its pharmaceutical and medical technology industries can establish their presence in one of the world's most advanced and valuable healthcare markets, he added.
The European Union functions as a major global pharmaceutical market. The FTA will enable Indian pharmaceutical companies which currently supply trustworthy generic medicines and biosimilars and vaccines to expand their business operations through the elimination of tariff and non-tariff trade restrictions. Indian exporters will gain better price competitiveness and higher profit margins through the upcoming decrease in customs duties which affects pharmaceutical formulations and active pharmaceutical ingredients (APIs) and medical devices, Dr Paul told Pharmabiz.
Beyond tariffs, the primary advantage will come from enhanced regulatory collaboration between the two parties. The alignment of Good Manufacturing Practices (GMP) standards together with mutual acceptance of quality certifications and inspection results will enable companies to achieve better operational efficiency through reduced costs and shorter timeframes needed for regulatory approvals, he said.
The medtech sector stands to benefit equally. India has become a rapidly expanding centre for affordable medical devices and diagnostic equipment and digital health technologies. This approach will drive revenue growth while motivating Indian manufacturers to invest in design excellence and quality control systems and regulatory science development.
The protection of intellectual property (IP) rights presents a vital aspect of the situation. The protection of intellectual property rights should protect both innovation incentives and public health requirements, but a balanced system will allow Indian and European enterprises to share technologies and conduct joint research and develop shared projects between their organizations
The FTA will bring major benefits to Indian MSMEs which operate in the pharmaceutical and medical technology sectors. The combination of better market access and steady regulatory processes will decrease entry hurdles for smaller businesses which want to join European supply chains. This approach supports India’s intention to boost its domestic production capacities through the ‘Make in India’” and ‘Atmanirbhar Bharat’ programs while increasing export-driven development, said Dr Paul.
Stronger healthcare trade between India and the European Union strengthens supply chain security for both nations. The pandemic established supply network weaknesses which affected global access to pharmaceutical and medical device products. The FTA enables both regions to establish multiple manufacturing and sourcing partnerships which will create reliable and transparent supply chains that do not rely on particular regions, he said.
Indian businesses need to enhance their quality control systems and develop their regulatory knowledge while implementing worldwide standard approaches to drug safety monitoring and market tracking and environmental practices. The government needs to provide export support through capacity development initiatives and regulatory assistance programs, said Dr Paul.
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