India's Active Pharmaceutical Ingredients (API) industry stands at a pivotal moment, shaped by evolving global supply chain dynamics and an intensified push for self-reliance. HRV Pharma' Director for Americas, Sreenivas Varma, shares crucial insights on this transformation.
The Strategic Shift Towards Self-Reliance
Traditionally dependent on imports, particularly from China, India has made remarkable progress in strengthening domestic API manufacturing capabilities. The Production Linked Incentive (PLI) scheme has catalyzed significant investments in critical APIs and key starting materials (KSMs).
"The PLI scheme has spurred investments in critical APIs and key starting materials, reducing our dependence on imports. This is a very strategic initiative because APIs are the lifeline of the pharma sector, and India supplies nearly 20% of the global API needs."
Sreenivas Varma, Director, Americas, HRV Pharma
Overcoming Industry Challenges
Despite significant advancement, the industry faces considerable obstacles including raw material costs, environmental regulations, and compliance requirements. However, companies embracing innovative process technologies, sustainability practices, and high-value API segments are positioning themselves for success.
Key Transformation Areas
The API industry in India is undergoing transformation across multiple dimensions:
- Backward Integration: Reducing import dependence through domestic production of intermediates and KSMs
- High-Value Segments: Moving towards niche, high-margin APIs including orphan drugs and rare disease treatments
- Regulatory Excellence: Enhanced compliance with US FDA, EMA, and WHO standards
- Sustainability Focus: Adopting green chemistry and environmentally friendly manufacturing processes
- Digital Innovation: Implementing virtual API supply chain models and technology-enabled sourcing
Market Evolution: From Commodity to Specialty
The market is transitioning from commodity APIs to specialized, high-margin segments. Key growth areas include:
- Orphan and rare disease APIs
- Personalized medicine applications
- High-value peptides and biosimilars
- Oncology APIs with growing global demand
HRV Pharma's Leadership Position
HRV Pharma maintains a robust 450+ product portfolio spanning oncology, rare diseases, and veterinary APIs. The company has filed 10 DMFs and 5 CEPs within nine months, targeting 100+ USDMFs/CEPs by 2028.
As India's API landscape continues evolving, HRV Pharma leads in global market expansion, regulatory excellence, and sustainable growth initiatives.
Source: Pharmabiz Industry Coverage
