How can India go from manufacturing medicines to discovering them—Funding is a key

India spends only 0.7 per cent of its GDP on research and development, leaving scientists struggling to turn their discoveries into therapies that can be tested in people | Representative Image

New Delhi: India is often called the ‘pharmacy of the world’ — it exports one-fifth of the world’s generic medicines and meets over half of the global vaccines demand. Yet when it comes to discovering the next breakthrough medicine, India’s contribution remains surprisingly small.

Despite hosting nearly 18 per cent of the world’s population and carrying around 20 per cent of the global disease burden, India accounts for just 1.4 per cent of clinical trials conducted worldwide.

Artificial intelligence and machine learning are reshaping the drug discovery process, helping scientists identify promising therapeutic candidates at an unprecedented pace. While countries race to develop new medicines, India struggles to move beyond manufacturing medicines to discovering new ones.

The paradox is that India already has all the ingredients to accelerate clinical research.

A massive and diverse patient pool has attracted global biotech companies to conduct clinical trials in India. It has internationally trained health care professionals, access to world-class technologies, strong information technology and data management infrastructure, and lower operational costs.

“Diverse populations with more cultures and demographics compared to other regions and patients naive to treatments are some advantages India offers that are difficult to replicate elsewhere,” Alben Sigamani, senior consultant, clinical trials, Karkinos Healthcare Private Limited, Bangalore, told ThePrint.

Pfizer currently has dozens of active clinical trials in India for diseases including multiple sclerosis and prostate cancer. In 2025, Roche, the world’s largest biotech firm, partnered with ten government hospitals through its Advanced Inclusive Research (AIR) Site Alliance programme to expand access to clinical trials among underrepresented populations.

“By equipping leading government hospitals with global-standard clinical trial capabilities, we are helping to bring innovations faster to India. This is a crucial step toward building equitable healthcare and shaping treatments that are relevant for India,” said Sivabalan Sivanesan, country medical director, Roche Pharma India.

However, the majority of these clinical trials are testing drugs conceived and developed primarily in the US and UK.

Research that reflects India’s health needs

India’s clinical research challenge has a core problem — while multinational pharmaceutical companies use India to test out their new medicines, India’s researchers rarely lead the development of those therapies.

Unlike many countries with strong biomedical innovation ecosystems, India has relatively few investigator-led clinical trials—studies initiated and designed by independent researchers, clinicians, or academic institutions to address local scientific and clinical questions.

“There should be greater focus on research and development, not just treatment delivery. For India, this transformation presents both an opportunity and a responsibility,” said Shawn T Joseph, program director, Aster Head and Neck Oncology Network, Kerala cluster, Aster Medcity, Kochi.

Clinical trials are a crucial step in drug development. A potential drug typically spends more than a decade moving from laboratory discovery and animal studies through multiple phases of human testing before regulators approve it for public use. Early-phase trials provide the first evidence of whether a new therapy is safe and effective in people.

“In early-phase work – an important indicator of original drug development — between 1999 and 2022, the WHO-International Clinical Trials Registry Platforms registered 51,755 Phase I clinical trials globally; only 2,260 trials were registered from India,” said Gagandeep Kang, Director, Enterics, Diagnostics, Genomics and Epidemiology, Global Health, at the Gates Foundation. “Of these, only 220 were genuine first-in-human Phase I trials between 2008 and 2022,” she added.

India has both a need and an opportunity to strengthen its clinical research. Much of the medical evidence used worldwide is generated in Western populations, even though genetics, lifestyle, environmental exposures and disease patterns often differ across the country.

“Academic medicine needs strengthening”, said Kang.

This gap has consequences beyond just the scientific discoveries. It decides the kind of diseases that receive the attention of researchers.

In India, diseases like tuberculosis, diabetes, cardiovascular disease, metabolic disorders and respiratory illnesses place a major burden on the healthcare system. Deeper research into these conditions is much needed.

“Head-and-neck cancer, cervical cancer, and GI cancers — which have among the highest burdens in India — are systematically understudied relative to breast and lung, which follow global pharma commercial priorities, not India’s disease burden,” said Kang.

According to Joseph, India participates in a lot of oncology clinical trials, but the vast majority are conceived and led outside the country. The Clinical Trial Registry-India audit found that of the 3,855 academic studies registered over the past decade, roughly one-fourth were postgraduate theses.

“This is the category where genuine investigator-initiated science lives,” said Kang.

Even when promising discoveries emerge from Indian universities and research institutions, they rarely progress beyond publications. Translating scientific discoveries into products requires intellectual property protection, regulatory planning, product development support and funding.

“These should not be absorbed into individual grant budgets,” said Kang.

Limited funding to take a drug from bench to bedside

A major reason that Indian research rarely goes out of the laboratory is the lack of sustained funding. Researchers have a difficult time securing funding to turn their discoveries into therapies that can be tested in people.

India spends only about 0.7 per cent of its GDP on research and development, substantially less than many leading research economies. While some funding is available for basic research, support for proof-of-concept studies, prototype development and early clinical validation remains limited.

An audit of cancer trials registered in the Clinical Trials Registry-India between 2007 and 2017 found that around 48.9 per cent were sponsored by pharmaceutical companies, while only about 32% received government support.

“Less than 1 per cent of testing will reach the next stage. Do we have the appetite for this type of investment?” said Deepak Saini, professor, developmental biology and genetics, Indian Institute of Science (IISc), Bangalore. Saini is the convenor of BHARAT, a multi-centre research initiative aimed at creating India’s first large-scale, population-specific database to better understand biological ageing patterns.

India-based biotechnology startups trying to develop first-in-class therapies face similar challenges. The country now hosts more than 10,000 biotech startups, many of which are less than a decade old and remain in the early stages of development.

The Government of India has introduced several initiatives to strengthen the innovation ecosystem. To support its goal of building a $300-billion bioeconomy by 2030, the Department of Biotechnology and BIRAC have established the country’s first Biofoundry Network across eight academic institutions and created 11 advanced biomanufacturing facilities nationwide.

The government’s goal is to  help researchers, startups and industries scale technologies from the laboratory to commercial production. BIRAC also supports early-stage innovation through programmes such as the Biotechnology Ignition Grant (BIG).

“We are an early-stage company, and funding is available to some extent for this stage. But Cost of development, like machinery and reagents, is substantial, which creates a high upfront cost for most startups in the discovery space,” said Lalit Pai, CEO and Director of Bangalore-based biotech startup NKure Therapeutics.

While venture investment in Indian biotechnology has increased, access to long-term financing remains difficult.

“The government could help by creating policies which encourage private companies to invest in or fund research more aggressively,” Pai said.

Mismatched goals hinder collaborations

Funding alone is not enough. Translating discoveries into therapies requires close collaboration between academic institutions, hospitals and industry. In India, these often operate in silos. Academic institutions prioritise publications and scientific recognition, while industry focuses on intellectual property, commercialisation and speed.

“Academia has largely focused on fundamental research, which makes collaboration with industry more difficult,” said Pai.

Hospitals face a different hurdle. While many private and government hospitals have the infrastructure and clinical expertise to conduct research, there are no incentives for carrying out investigator-led research.

“Private hospital systems have the patients and the clinical skills, but the incentives and protected time are lacking, as in many cases, is the research infrastructure. Until hospital accreditation standards require research activity, private hospitals will continue to treat investigator-led research as a cost centre rather than a strategic asset. But they will do pharma trials, since those bring in funding,” said Kang.

Rebuilding trust in clinical research

Once infrastructure, funding, and partnerships are built, there is another challenge that remains—public participation. Obtaining meaningful data from clinical trials requires public trust. Although India has a large population and substantial healthcare needs, clinical trial participation per million people remains much lower than in the US.

“Lack of transparency is a major reason why people are sceptical about these trials. Also, most of them are conducted by international players, and that is looked at with guarded eyes,” said Saini.

Growing concerns about transparency, suppression of negative results and reports of unethical clinical research prompted the Indian Council of Medical Research to establish the Clinical Trials Registry–India in 2007.

Public concerns deepened following the suspension of HPV vaccine trials in 2010 after the deaths of seven participating girls. Subsequent investigations found that the deaths were unrelated to the vaccine but identified serious ethical lapses, including deficiencies in informed consent and participant monitoring.

The controversy prompted the Supreme Court of India to intervene in 2013, leading to major regulatory reforms. While these measures strengthened participant protections, they also created delays and uncertainty that temporarily reduced India’s attractiveness as a destination for clinical research.

Further reforms, including the New Drugs Clinical Trials (NDCT) Rules, 2019, sought to streamline approvals while maintaining safeguards. These regulations are overseen by the Central Drugs Standard Control Organisation (CDSCO).

Public health experts argue that rebuilding confidence requires more than stronger regulations. It also requires greater public awareness about ongoing clinical trials, how they contribute to medical research, and the potential benefits they can bring to individual and public health.

“Truly informed consent has to be a process that engages participants through the clinical trial life cycle and ensures that information is shared, understood, and free from coercion,” Anant Bhan, ethics and global health researcher, told ThePrint.

Despite these challenges, decent advances in vaccines, biologics and indigenous CAR-T therapies suggest that India has the scientific capability to become a stronger force in medical innovation.

“Translating this scientific strength into global leadership in clinical research will require addressing key structural bottlenecks,” said Joseph.

(Edited by Janaki Pande)