India levels up in solving complex drug formulation challenges

India’s pharmaceutical industry has undergone a remarkable transformation over the last few decades. Once known primarily for API (Active Pharmaceutical Ingredient) and bulk drug production, it has steadily moved up the value chain to become a global hub for complex finished dosage forms. Today, Indian manufacturers are producing biosimilars, vaccines, new chemical entities (NCEs), and new biological entities (NBEs), showcasing technical maturity and readiness to meet evolving global healthcare needs.

Complexity as the new norm

Advances in medical technology have extended life expectancy and improved patient outcomes, but they have also reshaped disease patterns and placed greater demands on drug development. Lifestyle disorders, chronic conditions, and the push for targeted therapies require medicines with greater formulation sophistication.

Developing complex drugs involves more than combining active ingredients. It means ensuring stability under varied storage conditions, improving bioavailability for poorly soluble drugs, achieving precise release profiles, and creating patient-friendly dosage formats to encourage adherence. These attributes make complex drug formulations a growing focus of innovation.

India’s strategic advantages

India is uniquely positioned to lead in this space. As the world’s largest supplier of medicines by volume, it hosts one of the highest numbers of USFDA-approved manufacturing facilities and benefits from a strong base of scientists, engineers, and pharmaceutical specialists.

This combination of talent and regulatory familiarity allows Indian companies to integrate research, development, and manufacturing to deliver high-quality, complex products at scale.

Complex drug development and its challenges

Complex drugs — such as peptides, liposomes, topical extended-release products, injectables, inhalers, biosimilars, and other advanced delivery systems — come with significant technical and regulatory challenges. These range from sophisticated particle engineering and maintaining sterility to device integration and advanced analytical testing. The high barriers to entry make them strategically valuable for companies seeking long-term competitive advantage.

R&D and regulatory integration

The industry’s move into complex formulations is driven by strong R&D capabilities. State-of-the-art development centres staffed by multidisciplinary teams are working on stability enhancement, solubility improvement, extended-release technologies, and targeted delivery systems. These efforts are not only about improving existing drugs but also about addressing unmet medical needs with innovative solutions.

Equally important is integrating regulatory strategy from the start of development. Complex generics and biosimilars face greater scrutiny than traditional generics, requiring detailed characterisation, stability data, bioequivalence or clinical studies, and adherence to global Good Manufacturing Practices. Early regulatory involvement reduces approval risks and speeds time-to-market.

Strengthening global positioning

The shift from high-volume generics to high-value, high-barrier products is redefining India’s position in the global pharmaceutical supply chain. Cost advantage is no longer the only differentiator — expertise in development, manufacturing, and compliance is equally important.

Innovation hubs in cities such as Hyderabad, Bengaluru, and Pune are enabling faster product development through close collaboration between R&D, manufacturing, and regulatory teams.

Policy support and the road ahead

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 and targeted delivery technologies
• Biosimilars and biologics meeting stringent quality standards
• Patient-centric dosage formats
• Environmentally responsible manufacturing practices

Conclusion

India’s evolution from bulk API manufacturing to complex drug formulation is more than an industrial shift — it reflects growing scientific and technical strength. As healthcare challenges become more complex, the ability to develop advanced therapies will be essential.

With its talent pool, infrastructure, and regulatory expertise, India is positioned to be not just the largest supplier by volume but a valued innovation partner in the global pharmaceutical landscape.