India’s pharmaceutical market for the fiscal year 2023-24 is valued at $50 billion, comprising $23.5 billion in domestic consumption and $26.5 billion in exports. The Indian pharmaceutical industry is the third largest globally by volume and ranks 14th in production value, reflecting its significant role on the global stage.
The sector encompasses a diverse range of products, including generic drugs, bulk drugs, vaccines, biosimilars, biologics, and over-the-counter medicines. According to the National Accounts Statistics 2024, issued by the Ministry of Statistics and Programme Implementation, the total output of the pharmaceutical, medicinal, and botanical products industry in FY 2022-23 was ₹4,56,246 crore at constant prices, with a value addition of ₹1,75,583 crore. During the same period, the industry employed approximately 9,25,811 individuals.
The Department of Pharmaceuticals has established seven National Institutes of Pharmaceutical Education & Research (NIPERs), recognised as institutions of national importance. These institutes provide postgraduate and doctoral education while conducting advanced research in specialised areas of pharmaceuticals.
In August 2023, the department introduced the “National Policy on Research & Development and Innovation in Pharma-MedTech Sector in India.” This policy aims to foster an innovation-driven ecosystem for pharmaceuticals and medical devices, focusing on drug discovery and the development of cutting-edge medical technologies. It sets forth three key objectives:
- Establishing a regulatory framework to support innovation and product development.
- Offering fiscal and non-fiscal incentives to encourage private and public investment in research.
- Creating a robust ecosystem for cross-sectoral research, supported by institutional frameworks.
The policy is part of a broader initiative, including the ₹5,000 crore Scheme for Promotion of Research & Innovation in Pharma Sector (PRIP), which will run from 2023-24 to 2027-28. This scheme includes two components: establishing Centres of Excellence (CoEs) in the seven NIPERs and providing financial support for research projects in six priority areas.
The New Drugs and Clinical Trials Rules, 2019, introduced measures to expedite clinical trials and drug approvals. These include time-bound application processing, accelerated approval for drugs addressing unmet needs, and provisions for pre- and post-submission discussions. The rules aim to streamline research and manufacturing processes while maintaining safety and quality standards.
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For exports, drugs must comply with both Indian regulations and the requirements of importing countries, ensuring international standards are met.
While there are no sector-specific initiatives for the pharmaceutical industry’s intellectual property regime, several reforms have been implemented to streamline intellectual property rules. These include expedited patent examination for startups, small entities, and educational institutions, fee rebates, and digitisation of the application process. Additionally, the Startups Intellectual Property Protection (SIPP) scheme has been extended to 2026, providing financial and procedural support to innovators.
This information was shared by the Minister of State for Chemicals and Fertilisers, Anupriya Patel, in a written reply to a query in the Rajya Sabha.
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