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India's strong process chemistry expertise, globally audited plants power specialty pharma leadership: Jeevan Kasara
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Nandita Vijayasimha, Bengaluru
August 03 , 2026
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India's emergence as a global specialty pharma powerhouse is anchored in its process chemistry expertise, globally audited manufacturing facilities, and proven ability to deliver complex, high-value medicines at scale. Consistent investment in scientific talent, regulatory compliance, and advanced manufacturing with the Union government’s production linked incentive (PLI) scheme have enabled companies to move beyond generic drugs into specialty therapeutic segments such as oncology, cardiology, and nephrology, said Jeevan Kasara, chairman of the board, Steris Healthcare.
“Our qualified-competent workforce is driving the transition from generic formulations to speciality pharmaceuticals. Researchers, process chemists, and manufacturing professionals are developing complex therapies that address challenging disease areas. This transformation is evident in oncology, cardiology, and nephrology therapeutic segments with significant unmet medical needs, complex treatment pathways, and high research and development costs,” he added.
The advantage India has in specialty drugs lies in its production prowess with the highest globally certified pharma operations. There is a major thrust to develop capabilities in complex formulations, liposomal drug delivery systems for cancer therapies, modified-release cardiovascular drugs, and highly accurate injection formulations for nephrology and dialysis-related needs. The changeover to specialty APIs is just as relevant. Domestic manufacturing of APIs for complex formulations is not only cheaper but is also less risky in terms of sourcing for finished formulations manufacturers, Kasara told Pharmabiz.
In recent years, R&D investments into specialty pharmaceuticals have risen substantially, especially biosimilars. Companies have not just successfully manufactured and marketed their own biosimilars of monoclonal antibodies for cancer and auto-immune treatment but have providing these high quality medications substantially reduced costs compared to originator companies.
In cardiology, Indian pharma has manufactured complex generics and drug-eluting stent ingredients along with sustained release medications for hypertension and heart failure.
Nephrology too is becoming an area of increasing interest in terms of erythropoiesis-stimulating agents and other dialysis drugs. These are indicative of a new dimension of the Indian pharmaceutical production chain, said Kasara.
Policies like the PLI offer incentives to invest in just those specialty areas where India is trying to develop capabilities. These policy tailwinds, along with the increasing global need to diversify supply chains and reduce dependence on certain geographies, will help India become an attractive and viable specialist partner in regulated regions of North America, Europe, and emerging markets. Specialty pharmaceuticals export opportunities are becoming more robust with stringent regulations, cost competitiveness, and production capability without compromising on quality, he noted.
Now to become a realistic and compelling partner as a global specialty pharma partner cannot happen merely by virtue of lofty ambitions. It requires consistent investments in R&D infrastructure, ongoing building up of regulatory capabilities, talent development in specialty pharma sciences, and increased collaboration between industries and academia. The imminent trend is India is not just supplying the world with high quality, cost-effective generics, but is evolving itself with the capacity to manufacture advanced and innovative specialty drugs, said Kasara.
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