The stalled path of drug discovery scene in India

Drug discovery is a complex and multidisciplinary scientific process, requiring collaboration among experts from various fields. Bringing a new drug to market typically requires over a decade of intensive research and development, along with substantial financial investment.

Despite the adoption of advanced strategies and technologies, approximately 90 per cent of clinical drug development efforts ultimately fail. Nevertheless, the global drug discovery market continues to experience significant growth and innovation. According to the SkyQuest (2024), this growth is fuelled by the rising prevalence of diseases, rapid technological advancements, and increasing demand for personalized medicine.

Valued at US$ 73.31 billion in 2023, the market is expected to grow from US$ 81.18 billion in 2024 to US$ 170.26 billion by 2032, registering a compound annual growth rate (CAGR) of 9.7 per cent during the forecast period (2025–2032).

The Government of India has introduced the National Policy on Research and Development and Innovation in the Pharma-MedTech Sector (PRIP), along with a corresponding scheme to promote research and innovation within the sector.

Under PRIP, India is taking comprehensive measures to promote research and development (R&D) in pharmaceuticals and medical devices. The aim is to foster a robust ecosystem for innovation, enabling the country to emerge as a global leader in drug discovery and the development of cutting-edge medical technologies.

As Dr. V. K. Paul, Member (Health) of NITI (National Institution for Transforming India) Aayog, emphasized, there is a pressing need to strengthen collaboration between academia, public institutions, and the private sector in drug developmental research.

To address these challenges and rejuvenate innovation in the pharmaceutical and medical technology sectors, it has been proposed to establish the Indian Council of Pharmaceuticals and Med-Tech Research and Development.

This body has been designed to serve as a platform to facilitate and promote synergy among industry, academia, and research institutions across various departments, while also fostering both domestic and international collaboration in R&D within the Pharma and Med-Tech sectors.

In August 2023, the PRIP proposed a budget outlay of `5,000 crore to transform the Indian pharmaceutical sector from a cost-driven model to one driven by innovation. The aim of the scheme is to promote industry-academia linkage for R&D in priority areas and to inculcate the culture of quality research and nurture our pool of scientists.

This scheme is also intended to promote research in pharmaceutical sector by encouraging research in six priority areas like new chemical entities, complex generics including biosimilars, medical devices, stem cell therapy, orphan drugs, anti-microbial resistance etc., wherein financial assistance will be provided for the Industries, MSME (Micro, Small and Medium Enterprises), SME (Small and Medium Enterprises), Startups working with government institutes and for both in- house and academic research. The scheme also aims to strengthen industry-academia linkages
by fostering collaboration between the private sector and government institutions.

Industry-academic collaborations
This issue has been discussed extensively, and several steps have already been taken to address it. However, the expected outcomes are yet to materialize. Even today, the achievements of most premier academic institutions are still largely measured by the number of publications and patents granted. A patent that cannot be translated into a commercially viable product loses much of its value.

The credibility of an academic research institution should also be evaluated based on its collaborative research efforts with industry. When an industry approaches an academic institution, the latter must shed the preconceived notion that “industries are merely money sacs”—a perception that might apply to a few large pharmaceutical companies, but certainly not across the board. Another major challenge faced by academic institutions in research is data reproducibility.

While discussions on data integrity and the retraction of scientific publications are beyond the scope of this article, it is important to acknowledge that data integrity and reproducibility are key factors contributing to the quality and credibility of research. However, it is pertinent to highlight that, as reported in Nature India (August 2025), a study analysing over 13,500 life science retractions across the past four decades ranks India third globally, with retractions primarily due to ethical breaches and flawed data.

Most research facilities in academic institutions procure equipment using funds from various government agencies. Typically, the equipment is calibrated or validated at the time of installation, but subsequent validation is rarely performed due to financial constraints. This raises serious concerns, as data generated from non-validated equipment cannot be considered reliable.

To address this, researchers should include the cost of equipment validation—preferably for at least three years—in their project proposals. Furthermore, academic institutions should adopt clear policies on data ownership and accountability to ensure data quality and integrity.

To bridge the gap between research and real-world application, government funding agencies could consider mandating partnerships with private organizations as a prerequisite for awarding grants to applied research projects. Such a move would not only encourage relevance but also enhance the chances of successful commercialization.

Investors
In our country, attracting investors for drug development remains a significant challenge, unlike in many other nations where the ecosystem is more supportive. To address this gap, the Government of India could explore mechanisms to encourage pharma and allied industries to allocate a portion of their income toward drug development initiatives. This could be incentivized through tax rebates, financial credits, or other policy-driven benefits. Such measures would not only stimulate private sector participation but also help accelerate innovation and reduce dependence on external markets for critical drugs.

Current status of drug discovery research in India
While India continues to hold its position as the global leader in generic medicine production, China has significantly ramped up its investment in innovation-driven drug discovery and development, aiming to surpass India in this domain.

The Government of India has launched several ambitious initiatives to promote drug discovery, such as the Biomedical Research and Innovation Platform for Pharma (BRIPP). One of the aims of the BRIPP is the development of research infrastructure, particularly in building a world class research atmosphere at NIPERs (National Institute of Pharmaceutical Education and Research), and other institutes and help in creating talent pool of qualified trained students.

While acknowledging the NIPERS contribution to pharma sector in our country, building R&D infrastructure in Government sectors like NIPER alone will not help a greater extent of drug discovery. Government must also take steps to boost infrastructure in pharma industries who are active in drug discovery. Similarly, India should streamline clinical trial approval process and reduce regulatory timelines. While India is home to almost 17 per cent of the world’s population and 20 per cent of its disease burden, it has one of the lowest clinical trial densities in the world.

The Central Drugs Standard Control Organization (CDSCO) has implemented significant improvements in its guidelines, tightening regulations whenever necessary. These changes have ensured that clinical trial units in India comply with regulatory standards and maintain high-quality practices in the conduct of trials. In comparison, the regulatory approval process in the United States is notably faster, with the FDA typically completing its review within 30 calendar days of receiving the original Investigational New Drug (IND) application.

At present, pharmaceutical companies and Contract Research Organizations (CROs) often prefer private hospitals, as the protocol approval process through ethics committees in Government institutions is perceived to be more cumbersome.  The Government may consider encouraging government medical college hospitals to participate more actively in clinical trials.

It is disappointing to note that a majority of the major pharmaceutical companies that were once active in drug discovery research now appear to be losing interest in this domain. Some have even completely shut down their drug discovery programs. A few continue minimal research efforts, largely for the sake of reputation and to bolster the global marketing of their generic portfolios.

This decline in interest stems from several discouraging factors: the prolonged timelines required to identify a promising drug candidate, the high probability of failure during clinical trials, and the enormous financial investment needed to advance a molecule to the clinical development stage. These challenges have made drug discovery a high-risk endeavour, prompting many companies to shift their focus toward less risky and more immediately profitable areas such as generics and biosimilars.

One potential way to promote drug discovery in India is by offering targeted incentives at various stages of the drug development process. Many startups and small research organizations face significant financial constraints that hinder the progress of their drug discovery programs. For such entities, support can be extended in the form of grants, with the condition that, upon successful commercialization of the drug, the country derives a measurable benefit.