India's Pharma Sector: Aiming For Value Leadership
The Indian pharmaceutical industry has emerged as a global powerhouse, playing a pivotal role in shaping worldwide health outcomes. Throughout the COVID-19 pandemic, it demonstrated its unwavering commitment to manufacturing, ensuring a seamless supply of high-quality medicines to over 150 countries. Today, India stands as the third-largest pharmaceutical producer globally in terms of volume and ranks 14th in overall value. With two-thirds of the sector”s global value residing in innovation, India has a unique opportunity to evolve into a life sciences innovation hub, with a projected market growth to $120-130 billion by 2030 and a staggering $400-450 billion by 2047.
However, to fully realise this potential, India”s pharmaceutical industry must make crucial advancements. Unlike its global counterparts that allocate approximately 20-25% of their revenues to research and development (R&D), Indian pharmaceutical companies spend only around 8% on the same. Recognising this gap, the government has introduced a ₹5,000 crore fund under the Promotion of Research & Innovation Scheme. This fund aims to establish centers of excellence and promote research within the private sector, a necessary step to elevate the industry”s global competitiveness.
To achieve these goals, India must fortify its regulatory framework. Currently, the regulatory landscape for the Indian pharma industry is intricate, leading to protracted approval processes. Simplifying these procedures is essential to expedite the journey from the laboratory to the market, promote sustainable growth, and foster innovation. Recent amendments to the New Drugs and Clinical Trial Rules (2023) exemplify India”s commitment to ethical research practices and innovation. These revisions underscore patient safety and encourage alternative research methods, aligning Indian practices with global trends.
Quality assurance is another vital aspect where India can excel. Harmonising its regulations with global standards, such as ICH/PIC(s), will establish India as a global quality benchmark. The introduction of the New Drugs, Medical Devices, and Cosmetics Bill, 2022, signifies India”s commitment to quality, emphasising safety, effectiveness, and compliance with international standards. This alignment will enhance trust in Indian producers globally, fostering international collaborations that are crucial for the industry”s advancement.
India”s pharmaceutical market, characterised by intense competition, offers some of the world”s lowest-priced medicines. However, regulations should prioritise affordability, accessibility, and cost viability. An enabling pricing ecosystem plays a role in attracting investments, encouraging innovation, and ensuring high-quality medicines.
To unleash the full potential of the pharmaceutical sector, India should transition from “Make in India” to “Discover and Make in India for the world.” The industry”s knowledge-driven nature and strategic importance should be harnessed with stable, predictable, and coherent policies. This transition from volume to value leadership hinges on a robust regulatory ecosystem that prioritises patient-centricity while maintaining the delicate balance between access, affordability, and innovation.
Collaboration among key stakeholders, including the government, regulators, industry, and academia, will be instrumental in realising this vision. Meeting the unmet healthcare needs of patients globally will not only have a positive impact on the nation”s economy but also cement India”s position as a global pharmaceutical leader.
