India’s Pharma Sector, Opportunities, Challenges, Initiatives

India is known as the “Pharmacy of the World” due to its large-scale production of affordable generic medicines and vaccines, supplying a significant share of global demand, especially to developing countries. Its cost-efficient manufacturing, strong scientific workforce, and wide export network have made it a reliable source of essential drugs worldwide. However, despite this strength, the sector faces important challenges such as limited innovation in new drug development, slow clinical trial approval processes, and continued dependence on imports for key raw materials.

India’s Position in the Global Pharma Market

India’s pharmaceutical sector is one of the largest in the world, driven by scale, affordability, and a strong scientific workforce.

• The Indian pharmaceutical industry ranks 3rd globally in volume and 11th in value. 
• The domestic market is valued at USD 60 billion and is expected to reach USD 130 billion by 2030.
• India supplies nearly 20% of global generic medicines and produces around 60,000 generic brands.
• Pharmaceutical exports reached USD 30.5 billion in 2024-25, with exports to over 190 countries, including highly regulated markets like the US and Europe.
• India is a major supplier of vaccines, meeting a significant share of global demand for DPT, BCG, and measles vaccines. For Example: 
  • Indian manufacturers provide about 60 percent of vaccine supplies to the United Nations International Children’s Emergency Fund (UNICEF), meet 40-70 per cent of global demand for DPT and BCG vaccines, and account for 90 per cent of the World Health Organization’s (WHO) measles vaccine demand. 

This strong global presence reflects India’s role as a reliable supplier of affordable medicines.

India’s Pharma Sector Major Opportunities and Recent Developments

In recent years, India’s Pharma sector is undergoing a significant transformation, driven by policy support, technological advancements, and a strategic shift towards self-reliance and innovation.

• Shift Towards Self-Reliance in APIs: India is reducing its dependence on imports of Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) through Production Linked Incentive (PLI) schemes, which have led to increased domestic capacity and investment.
• Emergence of Indigenous Innovation: The development of Nafithromycin, India’s first indigenously developed antibiotic, demonstrates growing capabilities in original drug discovery, particularly in addressing antimicrobial resistance.
• Adoption of Pharma 4.0 Technologies: The industry is increasingly using AI, digital biology, and data-driven systems to accelerate drug discovery and improve manufacturing efficiency. This is expected to significantly reduce drug development timelines.
• Expansion of Industrial Infrastructure: Bulk drug parks and medical device parks are being developed to provide common infrastructure, reduce costs, and support MSMEs in scaling production.
• Growth in Biologics and Biosimilars: Indian firms are moving beyond traditional generics into high-value segments such as biosimilars and new biological entities, supported by rising demand and patent expiries globally.
• Policy Push for Innovation: Initiatives such as the Biopharma SHAKTI programme aim to build a strong ecosystem for biologics, including research institutions, clinical trial infrastructure, and industry collaboration. Promotion of Research and Innovation (PRIP) scheme supports research projects, industry-academia collaboration, and innovation in pharmaceuticals and medical technology.
• Global Trade Integration: Free trade agreements with regions such as the European Union, the United Kingdom, and New Zealand are expanding market access and improving export competitiveness.
• Improved Access to Medicines: Schemes like Jan Aushadhi are ensuring affordable medicines for citizens while reducing out-of-pocket healthcare expenditure.

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Key Challenges in India’s Pharma Sector

Despite the above mentioned promising opportunities and recent advancements, India’s pharmaceutical sector continues to face several structural and operational challenges that constrain its transition towards innovation-led growth.

• Innovation Deficit: While India is a global leader in generics, it invests relatively less in research and development. High costs and risks discourage firms from developing new drugs, limiting India’s presence in high-value segments.
• Slow Clinical Trial Approval System: One of the biggest bottlenecks is the regulatory delay in approving clinical trials. In India, approvals can take up to two years, whereas countries like the US and China process them much faster. This delay prevents Indian firms from competing in early-stage drug development.
• Over-Centralised Regulatory System: The Central Drugs Standard Control Organisation (CDSCO) relies on a limited number of Subject Expert Committees (SECs), often only one per therapeutic area. These committees are heavily burdened, leading to prolonged review timelines and administrative inefficiency.
• Weak Early-Stage Innovation Ecosystem: India conducts fewer than 40 first-in-human Phase I trials annually, compared to over 800 in the US and 1,000 in China. This indicates a structural weakness in the early stages of drug development, where most breakthrough innovations originate.
• Global Competitive Disadvantage: Due to regulatory delays, Indian firms are unable to keep pace with global competitors. By the time an Indian company begins early trials, Chinese firms may already have advanced data and even secured high-value licensing deals with global companies like Novartis.
• Overdependence on Generic Medicines: Despite being the “pharmacy of the world,” India primarily focuses on generic drugs, which are low-margin and based on existing formulations. In contrast, the real economic value lies in new drug discovery, where India’s presence remains minimal.
• Public Health and Strategic Risks: Failure to develop indigenous drugs may leave India dependent on foreign pharmaceutical companies for critical treatments. This can lead to high costs, limited access, and vulnerability to geopolitical pressures, especially for diseases prevalent in India.
• Pricing Pressures: Government price controls under the National List of Essential Medicines (NLEM) limit profit margins, especially for smaller firms, reducing their ability to invest in advanced technology.
• Skill Gaps in Advanced Technologies: There is a shortage of skilled professionals in areas such as bioinformatics, computational biology, and advanced biologics, which are essential for next-generation drug development.

Way Forward

To address structural bottlenecks in drug development and fully realise its potential as a global pharmaceutical leader, India needs targeted regulatory and institutional reforms.

• Decentralisation of Clinical Trial Approvals: India should shift from a centralised approval system to a decentralised model, allowing multiple institutions to approve early-stage clinical trials, thereby reducing delays.
• Creation of Multiple Subject Expert Committees (SECs): Hospitals, universities, and research institutions should be allowed to establish registered SECs to evaluate and approve clinical trials independently.
• Parallel Processing of Applications: Multiple committees working simultaneously can reduce backlog and significantly speed up the approval process.
• Supervisory Role of CDSCO: CDSCO should act as a regulator and standard-setting body, overseeing and registering committees rather than directly approving every trial.
• Standardised Expert Composition: Each committee should include experts such as a medical doctor, biomedical researcher, pharma expert, and biostatistician to ensure scientific rigor and safety.
• Adoption of Global Best Practices: India can follow models like Australia’s decentralised system, which ensures faster approvals without compromising safety.
• Regulatory Reforms without New Laws: These changes can be implemented through amendments in existing rules, avoiding lengthy legislative procedures.