Emergence As Healthcare Leader

By Dr. D.K. Giri

(Prof. of Practice, Institute of Management Bhubaneshwar)

India saved a large part of the world in the pandemic. During Covid-19, it shipped 300m vaccine doses to 100 plus countries under ‘Vaccine Maitri’ (Vaccine Friendship). The Global South called it a lifeline. That was potential made real at the time of a health crisis. But the potential is not leadership. It is actualising the potential and creating scope for further action and support.

A NITI Aayog report puts it bluntly: India is one of the world’s largest suppliers of generic medicines and vaccines. Yet, our global export share in pharmaceuticals and APIs remains just 2.8 per cent. We are the world’s pharmacy, but we own a corner shop, not the mall. To illustrate this comment, India occupies number one position in the world in generic drugs by volume, but has 20 per cent of global share; in vaccine production, it’s number one with a global share of 60 per cent; pharma exports by value (2025) amounted to 28.5b USD, but the global share is just 2.8 per cent; API production puts India at number three in the world, but global share just 8 per cent.

The 2.8 per cent share in pharma exports is both our drawback as well as a runway for greater accomplishment. Keep in mind, global pharma market was 1.6T USD in 2025, biologics alone 450b USD. The context and scope for health intervention is increasing globally: ageing West, rising South, disasters and pandemic lurking. (at the time of writing Venezuela has been struck by a massive earthquake). The question is not if India can lead, it is how and how fast, given the potentials existing in India.

The potentials consist of three main pillars. One, the Manufacturing Muscle: 650+ USFDA-approved plants — highest outside America; 10,500 manufacturing units at the cost 30-40% lower than West. This is a strategic pillar, not just an industry. Two, Generic Dominance: Our comparative advantage is formulations — retail medicaments, ARVs, TB drugs. It is the case that, when Africa needs HIV drugs or Brazil needs insulin, the Purchase Order lands in Hyderabad. We built trust the hard way: affordable, reliable and accessible. Three, Supply Chain Integration: Serum, Cipla, Biocon, Dr. Reddy’s — Indian firms are now empanelled in WHO, UNICEF, Global Alliance for Vaccines and Immunisation (GAVI) supply chains. Covid taught the world: if Africa sneezes, India rolls out paracetamol.

The pitfalls which hold back emergence of India as a leader in healthcare, are largely structural, and to some extent, circumstantial. The latter is mainly shifting of global pharma to high-value segments – biologics, mRNA, cell and gene therapy, immunologicals, patents, 80 per cent margins, brutal regulators. In these areas, India’s export regime is thin. The structural drawbacks comprise the following:

API Dependence: 70% of APIs and 90% of key starting materials are procured from China. One Galwan type incident and Lagos loses HIV drugs. Production Linked Incentives (PLI) covers 53 APIs, but we’re 5-7 years from security. Second, Regulatory Trust Deficit: Indian firms got 42 USFDA import alerts in 2023-25 vs 12 for EU. The Gambia cough syrup deaths in 2022 did to “Made in India” what Maggi did to noodles — one tragedy, global memory. Third, R&D Gap: India spends 0.7 per cent of pharma sales on R&D compared to global spending of 8-10 per cent. India is perceived great at process innovation but poor at product innovation. There are zero Indian-origin drugs with $1B global sales.

How does India make-up these drawbacks? Obviously, it calls for a shift in strategy from one geographical area to another. In Africa, India needs to move from exploring the market to becoming a manufacturing partner. Africa is not just a buyer. It’s 1.4B people, 25 per cent of global disease burden, 2 per cent of drugs made locally. It imports $16B pharma yearly — 80 per cent from India and China.

Second, stop selling, start co-producing. Vaccine Maitri 2.0 = Technology Maitri: Serum + Aspen South Africa already do fill-finish. Scale it. India should set up 5 vaccine hubs in Kenya, Nigeria, Rwanda, Senegal, and Egypt. Transfer mRNA, not just vials. Third, ARVs & Malaria: 70 per cent of Africa’s Antiretrovirals (ARVs) are Indian. Shift from export to JV plants. Fourth, use AfCFTA – African Continental Free Trade Area – if made in Ghana, sell duty-free to 54 nations.

Fifth, climate-proof drugs: Africa needs drugs that survive 45°C, patchy power. India’s frugal R&D edge: heat-stable insulin, vaccines without -80°C. We should sell resilience, not just molecules. Sixth, regulatory bridge: push for African Medicines Agency with CDSCO – Central Drugs Standard Control Organisation as mentor. If approved in India, fast-track in Africa. This is health without borders.

In Latin America, Middle East, South Asia, the following shift is necessary. Latin America: $50B market. Brazil demands local trials. Set up clinical trial hubs in São Paulo; target oncology biosimilars — 40 per cent cheaper than Roche.  Middle East wants halal-certified, USFDA-grade material. GCC is $20B import market. Let us use CEPA with UAE as gateway. Nearer home, in South Asia, our lab is BIMSTEC health pact — one approval in India is equal to auto-clear in Dhaka, Colombo, and Kathmandu. If we can’t integrate here, we can’t lead anywhere.

It is important to crack the high-value West. Focus on regulatory harmony: join ICH, PIC/S. Hire ex-FDA inspectors for pre-audits. Trust is the new API. Let us bet on Biosimilars: $300B market. Build 10 Bio-VIP Parks — assured power, single window, shared bioreactors. PLI 2.0 for platforms: mRNA, MAbs, CAR-T and so on. Secure intellectual property + Diaspora support. License, acquire, co-develop, Biocon-Viatris model. Use 300K Indian-origin scientists in Boston/Basel as bridgeheads. This should amount to invented with India.

Finally, fix the home game. Revisit API Atmanirbharta: Fermentation parks, 10-year tax holiday. Emphasise on national security, not commerce. One Regulator: Merge CDSCO/State FDAs into Indian Medical Products Authority. Fix 180-day timelines. Conduct trials reform: 20 per cent of global disease, 2 per cent of trials. Secure digital consent, fast ethics, insurance backstop. Brand India Pharma: QR code on every strip. Track from Baddi to Bamako. After Gambia, trust must be scanned.

The leadership test is reflected in Prime Minister Modi’s statement at G20 health summit, 2023: “India’s vision is One Earth, One Health. During Covid, we saw that when India grows, the world benefits.” This was endorsed by WHO Director-General Dr. Tedros who added during Vaccine Maitri: “India’s capacity to produce vaccines at scale has been critical for global equity. The world needs India’s continued leadership.” The scope is awaiting, New Delhi needs to grab it with both hands. — INFA