The Long Road to a New Medicine: Making Drug Approvals Work for Bharat@2047

India’s next leap in healthcare innovation depends on building a system that empowers discovery, safeguards ethics and restores trust in innovation.

India aspires to be among the world’s foremost knowledge economies by 2047, marking a century of independence. To achieve that vision, science and innovation must become central pillars of development, and healthcare will be one of the most critical frontiers. India already enjoys global recognition as the “pharmacy of the world,” exporting affordable generic medicines and vaccines to more than a hundred countries. Yet, the process of getting a new drug approved within the country remains far from smooth. It is long, expensive, and complicated—discouraging many innovators who might otherwise have contributed to the nation’s scientific self-reliance. If India truly wishes to be a leader in healthcare innovation by 2047, its regulatory system must evolve to encourage discovery, not just duplication.

The approval of a new drug is one of the most rigorous and demanding processes in terms of science and ethics in any modern nation. In India, it is governed by the Drugs and Cosmetics Act of 1940 and the New Drugs and Clinical Trials Rules of 2019, and overseen by the Central Drugs Standard Control Organization (CDSCO). Every new molecule must pass through preclinical testing, three phases of clinical trials, and a comprehensive regulatory review before it can be sold to patients. These steps are essential for ensuring safety and efficacy, but they also demand time, money, and a high tolerance for risk.

Prohibitive costs

For the first company that dares to introduce a new drug in India, the cost of this journey can be enormous. A single clinical trial may cost anywhere between eight and twenty-six crore rupees, depending on its design and size. When combined with the costs of research, compliance, and documentation, the total expenditure to bring a new molecule from concept to clinic can run into hundreds of crores. For many domestic firms, this is a prohibitive barrier, especially when returns are uncertain. Yet, the moment this pioneering company completes the process, its competitors can enter the same market by conducting only a bioequivalence study—a far simpler and much cheaper test that costs barely two or three lakh rupees. Bioequivalence tests are designed to show that two formulations of the same active ingredient release the drug into the bloodstream at a similar rate and extent under standardized conditions. The result is an approval system that inadvertently penalises the pioneer and rewards the imitator.

This imbalance has consequences that go beyond economics. Innovation depends on the willingness to take risks. A company that invests in novel drug development bears scientific uncertainty, ethical obligations, and regulatory scrutiny. It takes responsibility for patient safety, post-marketing surveillance, and long-term pharmacovigilance. Beyond money, the first sponsor also signs up for pharmacovigilance obligations and long-tail responsibilities that later entrants largely avoid at the outset. If competitors can later rely on the same data without bearing the same burden, the incentive to innovate weakens. Over time, such a system promotes caution instead of creativity and dependence instead of discovery. In a nation that aims to build Atmanirbhar Bharat in science and technology, this contradiction strikes at the heart of India’s ambition to be both self-reliant and globally competitive.

The Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, has recognized this challenge and initiated a consultation to design a fairer, research-friendly framework. The proposal aims to correct the asymmetry between the first applicant, who undertakes the full course of trials, and the subsequent applicants, who currently benefit from the pioneer’s investment. It seeks to reward genuine innovation without compromising the safety or affordability that Indian regulations have always emphasized. This is a significant step toward aligning India’s drug approval system with its long-term vision for Bharat@2047 — a nation where scientific enterprise and public good advance together.

Systemic bottlenecks

A modern, balanced regulatory framework must also address systemic bottlenecks that delay progress. India’s drug approval process still requires parallel clearances from multiple bodies—state authorities, ethics committees, and the CDSCO—each operating in its own silo. The absence of digital integration means that the same dossier may be reviewed multiple times by different entities, leading to duplication of effort and wasted time. The country has barely 250 accredited clinical trial sites, far too few for its population size and disease diversity. Training programs for investigators and data managers remain limited, while public perception of clinical trials continues to be shaped by earlier controversies. What India needs is a transparent, technology-driven, and ethically robust system that connects all stakeholders and inspires public trust.

There are lessons to be learned from other nations. The United States grants data exclusivity for a fixed period—five years for small molecules and twelve years for biologics—during which competitors cannot rely on the original applicant’s data. The European Union follows an “8+2+1” model, ensuring that innovators enjoy eight years of data protection and two years of market exclusivity, with an additional year for new therapeutic indications. China, once known for bureaucratic inertia, has reformed its system by introducing conditional approvals and priority reviews for innovative drugs. India does not currently offer formal data exclusivity for small molecules. Introducing a limited, time-bound protection—say, three to five years—would reward first movers without undermining the affordability of medicines that has made India a global healthcare provider.

Digitalization could further transform the process. A single electronic docket that tracks every application from ethics approval to final clearance would eliminate redundancy and reduce decision times. A dynamic public portal, fully integrated with the Clinical Trials Registry of India (CTRI), could make protocols, approvals, and trial outcomes accessible in real time. Greater transparency would not only increase accountability but also strengthen India’s global credibility as a responsible regulator. Training and certifying clinical research professionals, expanding trial infrastructure, and encouraging public–private partnerships could collectively accelerate the pace of safe innovation.

The global clinical research market is expanding rapidly, and India’s share (currently about 1.5 billion dollars) is projected to grow fivefold by the end of this decade. To capture this opportunity, India must combine its traditional strengths in manufacturing and cost efficiency with a modern regulatory framework that values originality and integrity. The CDSCO’s initiative is a move in the right direction, but it must be accompanied by policy coherence, inter-agency coordination, and investment in capacity building.

The broader question is philosophical: how does a nation value courage in science? The courage to be first, to test the untested, and to bear the weight of uncertainty is the essence of innovation. When the system rewards this courage fairly, discovery flourishes. When it punishes it, progress stagnates. Bharat@2047 will not be defined merely by how many medicines we make but by how many we create. India’s new drug approval system must begin not just with policy change but with restoring trust in science, regulation and the integrity of innovation itself.

Every new medicine represents not just chemistry but years of research, sleepless nights, and human hope. Simplifying the path to approval without compromising safety is not a bureaucratic shortcut; it is a commitment to national health and scientific integrity. If India wishes to transform from the pharmacy of the world to the laboratory of the world by 2047, this transformation must begin with trust—for science, for industry, and above all, for the people of Bharat.

(The writer is former Director, Agharkar Research Institute (under Ministry of Science and Technology, Govt. of India), Pune and a Distinguished Visiting Professor, Indian Institute of Technology Bombay, Mumbai. Views personal.)