A crisis with few champions

Antibiotics transformed modern medicine — from safe childbirth to organ transplants — yet their power is slipping away. Antimicrobial resistance (AMR) now kills more than a million people annually worldwide, with India carrying one of the heaviest burdens. Misuse in humans and animals, patchy surveillance, and over-the-counter availability have accelerated resistance in ways public health leaders can barely contain.

What makes this crisis more acute is that Big Pharma has largely abandoned antibiotic discovery, as per the Mint Article in September 2025. Unlike cancer or chronic diseases, antibiotics don’t promise blockbuster revenues: they are taken for short courses, priced low, and restricted by stewardship policies to preserve efficacy. The economics simply don’t add up.

But into this vacuum, Indian companies are stepping in. Orchid Pharma, Wockhardt, and Bugworks Research are reimagining what antibiotic innovation could look like from the Global South. Their progress marks a turning point: India is no longer just the world’s pharmacy for generics, but a serious contender in antibiotic discovery.

Orchid Pharma: From generics to FDA approval

Once a struggling generics player, Orchid Pharma has emerged with one of the most consequential Indian discoveries in decades. Its drug enmetazobactam, a novel β-lactamase inhibitor, has won US FDA approval. This is no small feat: very few antibiotics from India have crossed discovery to regulatory approval in such a direct line.

The science matters. β-lactamase enzymes are among the main drivers of resistance in Gram-negative bacteria, neutralising entire classes of antibiotics. Enmetazobactam restores efficacy to β-lactams, offering physicians a vital new option against some of the world’s most dangerous hospital infections.

For India, this is a reputational leap. Orchid has proven that discovery and global regulatory validation is possible, challenging the notion that Indian pharma can only replicate, not innovate.

Wockhardt: Decades of persistence

Wockhardt is the elder statesman of Indian antibiotic research and development. For decades, as global giants shut down their antimicrobial divisions, Wockhardt continued to invest. Today, that persistence is paying off.

Its lead candidate, Zaynich® (zidebactam + cefepime), has cleared Phase III trials with strong efficacy results. The company has completed a pre-filing meeting with the US FDA and plans to submit applications in the US and Europe.

Beyond Zaynich, Wockhardt has multiple antibiotics in its pipeline, a testament to its long-term commitment. Crucially, it spends a relatively high ~4.6% of revenue on R&D, far above many Indian peers. For a mid-sized company in a difficult therapeutic area, that’s both courageous and risky.

If approved, Zaynich could give Wockhardt a global product in a space where few new entrants exist. However, the real test will be whether stewardship and pricing restrictions enable the company to recoup its investments.

Bugworks: The biotech insurgent

If Orchid represents validation and Wockhardt represents persistence, Bugworks Research represents insurgency. This Bengaluru-based biotech, co-founded by Dr Anand Anandkumar, is attempting what most Indian startups don’t: first-in-class discovery.

Its flagship candidate, BWC0977, a novel broad-spectrum antibiotic, is currently in Phase 1 trials. Unlike larger firms, Bugworks relies on global partnerships, with CARB-X and GARDP committing up to US$20 million in funding and technical support. For a private company with no commercial revenues, this non-dilutive funding is oxygen.

Bugworks’ ambition is to build antibiotics that work both intravenously and orally against WHO-priority Gram-negative pathogens. If it succeeds, it could position India as a cradle of biotech-driven discovery, not just chemistry-based replication.

The ecosystem challenge: Innovation without incentives

The progress is remarkable, but it raises uncomfortable questions. Antibiotics are paradoxical products: society needs them urgently, but must use them sparingly to delay the development of resistance. This “limited demand by design” makes them unattractive for investors and risky for companies.

Without pull incentives — such as subscription models where governments pay for access regardless of volume — most antibiotic developers face financial cliffs even after approvals. This has already led to bankruptcies of antibiotic biotech’s in the US and Europe.

India’s innovators risk the same fate unless policies catch up. Some steps are clear:

• Global pull incentives led by G20 nations, where India now has a seat at the table.
• Domestic procurement guarantees, ensuring companies like Orchid and Wockhardt can sustain production.
• Surveillance and stewardship investments, so new drugs don’t fall victim to misuse.

Data snapshot: Who’s leading and what they spend

*Publicly reported FY24 figures; Bugworks operates on equity and grant funding, not revenue.

Why this matters for India

India has long been the world’s largest manufacturer of generic antibiotics. But being a discoverer, not just a producer, changes the narrative. It creates prestige, strengthens bargaining power in global health, and offers Indian firms a path to higher-margin innovation.

More importantly, it’s about responsibility. With one of the highest burdens of resistant infections, India has both the incentive and the obligation to lead. If Orchid, Wockhardt and Bugworks succeed, they could demonstrate how middle-income countries can fill gaps left by big pharma — not through charity, but through competitive science and global collaboration.