– India is the world’s largest supplier of medicines by volume.
– It has one of the highest numbers of USFDA-approved facilities.
– The focus is on biosimilars, vaccines, and new chemical entities.
India’s pharmaceutical industry has transformed significantly over the past few decades. Once primarily focused on Active Pharmaceutical Ingredient (API) and bulk drug production, it has evolved into a global hub for complex finished dosage forms. Currently, Indian manufacturers are producing biosimilars, vaccines, new chemical entities (NCEs), and new biological entities (NBEs), demonstrating their technical maturity and readiness to meet global healthcare demands.
Advances in medical technology have increased life expectancy and improved patient outcomes, but they have also reshaped disease patterns and heightened the demands on drug development. Lifestyle disorders and chronic conditions necessitate medicines with greater formulation sophistication. Developing complex drugs involves ensuring stability under varied storage conditions, improving bioavailability for poorly soluble drugs, achieving precise release profiles, and creating patient-friendly dosage formats to enhance adherence. These attributes make complex drug formulations a growing focus of innovation.
India is strategically positioned to lead in this area. As the world’s largest supplier of medicines by volume, it boasts one of the highest numbers of USFDA-approved manufacturing facilities. This advantage is complemented by a strong base of scientists, engineers, and pharmaceutical specialists. The combination of talent and regulatory familiarity enables Indian companies to integrate research, development, and manufacturing to deliver high-quality, complex products at scale.
The shift from high-volume generics to high-value, high-barrier products is redefining India’s role in the global pharmaceutical supply chain. Cost advantage is no longer the sole differentiator; expertise in development, manufacturing, and compliance is equally crucial. Innovation hubs in cities like Hyderabad, Bengaluru, and Pune facilitate faster product development through close collaboration between R&D, manufacturing, and regulatory teams.
Government policies supporting R&D funding, skill development, and technology transfer are accelerating progress in complex drug development. With sustained investment, India’s pharmaceutical sector can expand its capabilities in novel delivery systems, biopharmaceuticals, and sustainable manufacturing. The next growth phase will focus on sustained-release technologies, biosimilars meeting stringent quality standards, patient-centric dosage formats, and environmentally responsible manufacturing practices.