In recent years, the global pharmaceutical landscape has witnessed growing momentum toward self-reliance in Active Pharmaceutical Ingredient (API) manufacturing, particularly amid rising tariff pressures and disrupted global supply chains. India, with its robust pharma legacy, is well-positioned to lead this shift, but realising this potential requires a strategic and multi-pronged approach.

To begin with, strengthening local manufacturing is key. While India has already made significant strides in API production, scaling this further is essential to reduce dependence on imports. A strong and consistent manufacturing base will not only enhance supply chain resilience but also ensure long-term sustainability and cost efficiency.

The Production Linked Incentive (PLI) scheme continues to play a pivotal role in strengthening India’s position in API manufacturing. This phase represents a significant opportunity for companies to align with the government’s vision of self-reliance. Companies that have proactively embraced the scheme are now well-positioned to gain early-mover advantage in this evolving ecosystem.

The government’s role in this transformation is crucial. Initiatives such as the PLI scheme are commendable steps toward incentivising domestic API manufacturing. However, support must go beyond financial incentives. Streamlining regulatory processes and ensuring faster approvals remain pressing needs. Regulatory delays can hinder production timelines and deter new entrants from the market. A simplified and responsive framework will give the industry the confidence and clarity it needs to grow.

Additionally, with the United States set to begin imposing tariffs onimported medicines from August 2025, India has a golden opportunityto step up and fill global supply gaps—especially for regulated markets.

Moreover, supportive policies that foster a conducive business environment can accelerate this journey. Whether it’s easing compliance burdens, ensuring access to affordable utilities, or enabling ease of doing business, policy support must be holistic and consistent across the board.

Innovation and R&D are other powerful levers that can shift the equation in India’s favour. Focused investments in research can reduce production costs, improve process efficiencies, and enable manufacturers to scale operations sustainably. When coupled

with backwards integration, this can offer a significant competitive edge, ensuring cost advantages, stable raw material supply, and enhanced control over quality and timelines.

It’s also important to recognise that API manufacturing is capital-intensive and infrastructure heavy. Setting up and running facilities requires considerable investment and high-grade infrastructure, including uninterrupted power and water supplies, efficient waste management systems, and transportation networks. Here too, the government must step in to build and upgrade pharma-friendly infrastructure that supports large-scale, compliant, and sustainable manufacturing.

With a focused approach that encompasses stronger local manufacturing, supportive government policies, streamlined regulations, innovation-driven R&D, and infrastructure development, India is well-positioned to lead the global shift toward API self-reliance. Embracing these measures will not only strengthen India’s pharmaceutical ecosystem but also secure its position as a leading force in the global active pharmaceutical ingredient (API) market.

Ms. Shivani Wagh, Joint Managing Director, Supriya Lifescience Ltd.