Why Indian pharma must think beyond generics

This article is authored by NK Ganguly, former director general, ICMR.

As the global pharmaceutical landscape undergoes rapid change with advances in novel drug discovery, smarter manufacturing, and shifting trade policies, India is uniquely positioned to lead this transformation. Our pharmaceutical sector, often called the pharmacy of the world, has earned its global reputation. Today, India supplies 20% of global generics and meets over 60% of the world’s vaccine demand, exporting to more than 200 countries.

Pharma(Pixabay/Representative)

Yet, even as we celebrate these strengths, it is clear that the next phase of growth will not be driven by volume alone. To remain globally competitive and meet the complex health needs of the future, India must move up the value chain—towards biosimilars, novel biologics, precision medicine, and region-specific innovation.

This evolution is not a break from our generics’ legacy but a natural extension of it. The same scientific talent, manufacturing capability, and regulatory maturity that powered the generics boom can now be redirected to build a high-value, innovation-driven pharmaceutical ecosystem. In fact, India is already making meaningful progress in this direction. The development of an indigenous mRNA vaccine platform during the Covid-19 pandemic and Zydus’ breakthrough with Saroglitazar, the first NCE developed and commercialised by an Indian company are important milestones.

To succeed at scale, India must build stronger infrastructure not just for discovery, but for translating scientific leads into approved products. A good innovation pipeline starts with a strong foundation in basic research and lead generation. But that is only the first step. We now need to focus on converting these leads into next-in-class innovations—products that refine, improve, and differentiate themselves from global first-in-class breakthroughs. 

India’s generics advantage, while still formidable, is facing increasing pressure. Countries such as Bangladesh, Vietnam, Taiwan, and South Korea are rapidly upgrading their pharmaceutical capabilities, backed by infrastructure investments, regulatory reforms, and skilled talent. Several African and Latin American nations are also building local manufacturing hubs to reduce import dependency, narrowing India’s traditional export strongholds.

Simultaneously, developed markets like the US are re-evaluating supply chains to reduce dependence on imports. Tariffs which are likely to be announced on select pharmaceutical products, could significantly impact Indian exports—particularly given our continuing reliance on China for 45–50% of active pharmaceutical ingredients. While schemes like the Production Linked Incentive (PLI) are beginning to address this gap, further scale-up of domestic API production and green chemistry alternatives remains a priority.

Despite these external pressures, India’s generics industry continues to deliver on affordability and access. Our patent laws, including provisions like pre-grant opposition and strict patentability criteria, have enabled the timely launch of generics such as Dapagliflozin combinations and Trastuzumab SC, offering life-saving alternatives to millions. These safeguards ensure that the global pursuit of profit does not come at the cost of public health.

Even as the global terrain shifts, India must also look inward. Our most compelling case for innovation lies within our own borders. The country faces a growing burden of non-communicable diseases (NCDs) diabetes, cardiovascular diseases, obesity, and cancer—all of which demand a new class of therapies: targeted biologics, gene therapies, and precision interventions.

However, current treatment options for such diseases are often prohibitively expensive. A single course of a GLP-1 agonist for diabetes or targeted cancer therapy can cost thousands of dollars. Without affordable domestic alternatives, a large section of the Indian population risks being excluded from life-saving care.

To realise this opportunity, India must invest in the core capabilities that drive pharmaceutical innovation. We need to strengthen drug discovery platforms such as high-throughput screening, multi-omics research, and advanced fermentation technologies. Equally vital is the expansion of preclinical infrastructure—transgenic animal models, knockout studies—as well as a robust, decentralised clinical trial ecosystem.

Reducing API dependence on China must go hand in hand with scaling up local manufacturing and supporting the development of drug parks. As of 2024, India has around 500 API producers, but many still rely on imported intermediates. 

At the institutional level, agencies like BIRAC, DBT, and NMITLI need greater resourcing and more agile operations. Encouraging university-based innovation by allowing faculty to launch spin-offs, relaxing tax norms for biotech entrepreneurs, and supporting translational research will open new pathways. Countries like Switzerland and Sweden offer useful models, where academia and industry operate as seamless innovation partners.

It is equally important to bring the finance ministry into the fold, so that fiscal tools and R&D incentives are aligned with national health and industrial priorities.

India’s pharmaceutical industry has already demonstrated that it can scale for the world. The next challenge is to innovate for the world—starting with our own unmet needs.

This is not a choice between generics and innovation, but a call to integrate the two. Our generics legacy gives us a strong foundation. By coupling that with long-term investment in research, faster regulatory approvals, manufacturing resilience, and institutional reform, we can emerge not just as a reliable supplier of essential medicines, but as a pioneer of affordable, world-class therapeutics.

This article is authored by NK Ganguly, former director general, ICMR.