In 1821, US secretary of state John Quincy Adams proclaimed, “We are the well-wishers of freedom of all, but the champions only of our own.” America defied Adams with its considerable contributions to global prosperity over the next two centuries.
Yet, recent proposals to restrict foreign access to frontier artificial intelligence (AI) models and the US Food and Drug Administration (FDA) faced with demands to disregard clinical-trial data from China and India would advise caution. This new world makes a re-imagination of India’s science ecosystem imperative.
Science has gone beyond laboratories, journals and patents. It is a source of national power, economic competitiveness, health security and mass prosperity. Nations that lead in AI, semiconductors, clean energy, biotechnology, medicines and defence technology will shape the future, while those that only consume them will live by rules written elsewhere.
Anxiety over India’s science ecosystem, already high as countries weaponize their technology, is amplified by China’s performance. India and China had the same per capita GDP in 1990, but China is now five times ours at $12,500; both discovered almost no original medicine till 2000, but now China accounts for a third of global new molecule licensing.
We had the same intellectual property receipts in 2005, but China now 13 times as many. China’s GDP growth and innovation are linked; science produces the technology that produces prosperity.
The Indian pharmaceutical industry’s capabilities (producing 50% of the world’s medicines) and challenges (capturing only 6% of the world’s medicine revenues) offer important lessons.
It made medicines globally affordable by integrating chemistry, entrepreneurship and regulation across five phases; Pharma 1.0 leveraged the 1970 Patents Act for formulations; Pharma 2.0 harnessed the Hatch-Waxman Act to take generics global; Pharma 3.0 moved into complex generics; Pharma 4.0, now underway, launches new drugs in India before taking them global and spends 8% of revenue on R&D—lower than the Western pharma average of 15% but far higher than India Inc’s 1%.
Pharma 5.0, the future, will require shifting from making medicines to imagining them. This is Indian pharma’s defining challenge; only 10 of the 5,000-plus drugs launched globally over the last decade came from India.
Science eventually becomes technology; Crick and Watson’s discovery of the DNA structure enabled today’s vaccines and Planck’s Quantum Theory underlies today’s digital technologies; Einstein’s relativity keeps the global positioning system accurate. The five vectors needed to re-imagine Indian pharma are a microcosm of our broader science, innovation and technology ecosystem.
The first is regulation. China broke ahead in new drug development by re-imagining regulatory approval pathways, which take almost a year in India. We need a regulatory path that is predictable, ethical, risk-based and fast. Speed need not be reckless, just as delays do not assure safety. A modern innovation ecosystem requires clear timelines for clinical approvals, data reviews, post-marketing surveillance and global development pathways.
The second is universities. Nobel Laureate Julius Axelrod’s government-funded research on neurotransmitters led to the development of selective serotonin re-uptake inhibitor drugs.
Professor Judith Wurtman at MIT linked them to the treatment of pre-menstrual disorders, leading to patents, licensing and commercialization. MIT licensed this work to Interneuron Pharmaceuticals, which licensed it to Eli Lilly, which in turn got FDA approval for a new use of fluoxetine and developed the global blockbuster antidepressant Sertraline.
For some of the world’s top universities to be in India we need technology-transfer offices, a bias for licensing, royalty-sharing rules, PhDs of practice, shared facilities and a thicker skin among policymakers faced with outspoken academics.
The third is capital—both finance and talent. Drug discovery is like portfolio finance; we need to underwrite uncertainty. Indian pharma firms must raise R&D spending from 8% to 12% and start innovating through financial innovation in partnership with venture capital, philanthropy, private equity and the government, while convincing market investors about the upside of short-term costs.
They must also raise R&D intensity by bringing back our scientific diaspora, hiring experienced global talent and building overseas research centres.
The fourth is collaboration. Discovery is a team sport. Companies don’t do chemistry, biology, clinical development, regulation, data science, manufacturing and commercialization equally well. The sector must collaborate with policymakers, universities, startups, global firms, Japan and China.
The fifth is procurement. Innovation policy must aim to create early markets, not just fund labs. Stanford has been called the Cold War University and Silicon Valley the Arsenal of Democracy because of public funding for defence research and clear government purchase prospects.
Indian innovators need predictable public procurement, reimbursement and inclusion in treatment guidelines. India cannot ask scientists to pursue discoveries and then make it impossible to adopt these for healthcare.
The frontier of science is endless, and as the world changes, India needn’t be at its periphery.
The authors are, respectively, managing director, Lupin, and author of ‘Made in India.’