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Shardul Nautiyal, Mumbai April 25 , 2025
Amid evolving global trade dynamics and geopolitical shifts, the Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) underscores the increasing significance of Indian pharmaceutical companies and MSMEs in shaping the future of global healthcare. Dharmesh Kharwar, joint secretary of FPME and director of NGB Laboratories Pvt Ltd, highlighted the industry’s collaborative push to register generics and biosimilars in key international export markets.

Kharwar highlighted that Indian companies, particularly MSMEs, are increasingly adopting a collaborative model to bridge gaps in the global pharmaceutical market. He noted that the approach is pivotal in meeting the growing demand for affordable and quality medicines worldwide, including in low and middle income countries.

"Indian pharma companies are realising that in order to fulfill certain healthcare gaps, they need to participate in various expos and forums to develop innovative products and therapies. Our core competency lies in product development, and ensuring these products are manufactured at the appropriate sites, meeting regulatory requirements in multiple countries where they can be registered," said Kharwar.

FPME, with over 300 members, plays a crucial role in supporting Indian pharma companies in their efforts to enter global markets. According to Kharwar, FPME members have a well-established presence in over 100 countries, making a significant impact on the global pharmaceutical landscape.

"Our products have reached virtually every country in the world. Recently, we listed 195 countries or territories where FPME members have made an impact, and we also identified the regulatory authorities in these markets. This underscores the widespread reach of our members who provide medicines not only to high income countries but to every corner of the globe whenever they are needed," he added.

The role of FPME members in supplying medicines to the world was further emphasized, with Kharwar referring to merchant exporters as the "real pharmacy of the world." He explained that their focus is not just on high income markets but on making quality medicines accessible across all regions, especially in countries with limited access to essential healthcare products.

"FPME members are bringing the best of Indian medicines to the world, whether in vials or container loads. We are committed to training and building capacity within our network to ensure that Indian medicines continue to meet global standards," said Kharwar.

At the summit, FPME also presented innovative approaches to overcoming challenges faced by pharmaceutical companies in regulatory processes. "We focus on providing an accessible methodology for filing products in global markets with an economical process. Our workshops addressed the challenges of GMP inspections, ensuring that fees are not forfeited due to failed inspections at manufacturing plants, whether for API or formulations," Kharwar explained.

In response to the growing global demand for biosimilars, Kharwar expressed confidence that Indian pharma MSMEs have a significant opportunity to replicate the success they achieved with small molecules decades ago. "We received an enthusiastic response on our innovative model for developing biosimilars. Several countries are eager to source these products from India, and this represents a unique opportunity for Indian companies, particularly MSMEs, to make their mark in this rapidly expanding segment of the global pharmaceutical market."

“FPME's focus remains on bringing Indian products to the global stage, using genuine data and compliant, cost-effective solutions. By nurturing capacity building and fostering collaboration, FPME and its members are poised to continue making a substantial impact on global healthcare access, particularly in under-served regions,” he said.

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