The past decade has witnessed remarkable growth in pharmaceuticals globally. India has emerged as a global powerhouse, playing a pivotal role in providing affordable and high-quality medicines worldwide. The sector’s compound annual growth has been impressive and its share in the country’s GDP has risen, driven by a range of factors such as a dynamic global Industry, skilled workforce, upgradation of quality systems and a robust local market.
Indian pharma has the potential for greater achievements, propelled by advancements in research and technology. The Pharmaceuticals Secretary, in the recent CII Life Sciences Summit, indicated that India has the potential to grow 3-4 times in value by achieving a shift from a 10 per cent share of Pharma and MedTech in the manufacturing sector in 2020 to a 20 per cent share in 2030, signifying the immense potential of the sector.
As per recent estimates, the Indian pharmaceutical Industry includes a network of 3,000 drug companies and 10,500 manufacturing units. Around 500 API manufacturers are contributing about 8 per cent to the global API Industry. Government initiatives like FDI up to 100 per cent through automatic routes for greenfield pharmaceuticals projects, PLI scheme for KSMs and APIs to boost manufacturing capacity, promotion of medical devices parks, strengthening infrastructure facilities and robust pricing policies are key steps taken in the right direction.
India is now a global force in the Active Ingredients and generics space and a major player in the manufacturing and supply of vaccines. Contract Research and Manufacturing Services (CRAMS) is another driver of growth for the industry. Biological drugs and biosimilars is also a major emerging area of growth.
Challenges and Regulatory Landscape
Amidst the success narrative, challenges persist. Striking a careful balance between generic drug production and investing in research remains a challenge. India faces increased dependence on imports and a dichotomy between fermentation and chemical synthesis-based APIs. There is a need to explore concepts like Accelerated Product Development and Implementation, which are present internationally. A consortium of 2-3 manufacturers could come together to develop the API and later technology can be shared with others.
Regulatory frameworks serve as the bedrock for pharmaceutical integrity and require continuous refinement. Harmonization of regulations, both domestically and internationally, is imperative for streamlining processes and ensuring global compliance. Rigorous adherence to quality standards is non-negotiable for sustaining Indian credibility in the pharma market.
Research & Innovation: Catalysts of Transformation
At the heart of the pharmaceutical renaissance lies a commitment to research and innovation. India’s reputation as a hub for generic drug manufacturing must be complemented by robust and sustained investment in research and development. Collaborative initiatives among Industry stakeholders, academia and research institutions are pivotal in nurturing an environment conducive to groundbreaking drug discovery and technological advancements.
The opportunity of discovering and developing innovative medicines is a very exciting area and offers a large opportunity, albeit with some challenges such as limited access to risk capital, an underdeveloped innovation ecosystem and the challenge of deep science. We do have some natural advantages such as a large patient pool, cost-effective clinical trial infrastructure and a large pool of talent.
A Strategic Roadmap
India’s pharma sector stands at the crossroads of unparalleled growth. Sustained investment in R&D, innovation and strategic collaborations with global partners is imperative in securing a global position. Skill development initiatives and seamless integration of digital technologies will fortify the industry’s resilience and put India on the map of the global healthcare paradigm.
CII Pharma committee envisions a future where India not only retains its status as the ‘pharmacy of the world’ but also becomes a global leader in research and innovation.
CII’s work continues to focus on promoting vertical integration in the supply chain, strengthening domestic manufacturing to reduce import dependency, fostering Industry-academia collaboration, improving market access, improving supply chain issues for combating future global pandemics, addressing regulatory issues at the national and state level, and improving ease of doing business in pharma. Through collaborative efforts, unwavering commitment to excellence and regulatory finesse, the Indian pharma Industry is poised not just to adapt but to script a compelling narrative that resonates globally.
This article was contributed by Mr G V Prasad, Chairman, CII National Committee on Pharmaceuticals and Co-Chairman & MD, Dr Reddy’s Laboratories Ltd. It was first published in CII Communique.
To know more about the sector, download the latest CII Report “Healthcare in India: Poised for a leap”