2024: A year of building on a foundation for sustainable growth in India’s pharma sector

The Indian pharma industry is a knowledge-driven sector and a key driver for the nation’s economy. The industry is estimated to be US$58 billion, with equal contribution from exports and domestic market. India is the manufacturing hub of the world with 20% contribution to global generics sales. 2024 has been a year of building on robust foundation with sustainable growth and thrust on simplifying regulations and harmonisation with global standards.

The Production Linked Incentive (PLI) schemes aimed at self-reliance and making global champions from India have started seeing dividends with the launch of green-field projects for the production of Penicillin G and Clavulanic acid among others. This is important for healthcare security and facilitating diversified supply chain.

Quality is a fundamental license to operate in the pharma sector. The implementation of revised Schedule M, the key quality manufacturing standards in India, will strengthen the quality landscape. The government’s support, including technological assistance and awareness programs, has been playing a vital role to move forward the quality agenda. Furthermore, India hosted the International Conference of Drug Regulatory Authorities (ICDRA) that brought together regulatory authorities from WHO Member States to strengthen collaboration and develop international consensus on regulatory priorities.

Innovation will continue to be a major focus going forward. The government is expected to soon announce the operational details of the Promotion of Research & Innovation Programme that will spur innovation. Leading companies are increasing their focus on specialty portfolios, diversifying into higher-value drugs. Discovery products such as Nafithromycin and Saroglitazar should propel the wave of research from India. Committees for streamlining regulatory reforms have been set up that will help create an enabling ecosystem for R&D.

Additionally, the industry is set to make notable progress in cutting-edge areas such as CAR-T cell therapy, mRNA vaccines, and the development of complex molecules, which hold immense potential for driving future growth. The patent expiries of blockbuster biologics by 2025 present a significant growth avenue in the global biosimilars market.

Additionally, India’s Contract Development and Manufacturing Organisations (CDMOs) are emerging as preferred partners for biologics manufacturing, driven by their cost advantages, robust regulatory compliance, and technical expertise. To capitalise on these opportunities, the industry will continue to focus on building a strong innovation pipeline, enhancing regulatory compliance, and expanding global market. 

Indian pharma market is expected to move up to US$ 120-130 Billion by 2030 from current size of US$58 Billion. Initiatives in terms of quality, innovation and wider global reach, will help India’s pharmaceutical sector to realise its true potential. Given the conducive policies and the advantage of demographic and digital talent, India will play a pivotal role in advancing global health for all in the years to come

—The author, Sudarshan Jain, is Secretary General, Indian Pharmaceutical Alliance. The views are personal.