India is the pharmacy of the world — third-largest drug producer by volume, the planet’s biggest vaccine maker. Yet it buys 70–80 per cent of the advanced enzymes its own factories run on, mostly from Europe and China. As engineered biocatalysts move from the margins of drug manufacturing to its centre, closing that gap has become the quiet test of whether “self-reliance” means anything at all.
Every tablet has a hidden history of chemistry, and increasingly that chemistry is done not by metal catalysts and harsh solvents but by enzymes — the biological machines that living cells use to build and break molecules. In pharmaceutical manufacturing these biocatalysts have moved, in barely a decade, from a behind-the-scenes convenience to a strategic technology. The reason is arithmetic. Enzyme-based routes can cut the number of steps in a synthesis by 20 to 50 per cent, lift yields, slash solvent use and waste, and deliver the exquisite precision that complex modern drugs demand — stereoselectivity, the ability to make just the mirror-image form of a molecule the body can use, often exceeding 99 per cent.
The textbook case is Merck’s diabetes blockbuster sitagliptin. In 2006 the company faced a costly, wasteful chemical route built around an expensive rhodium catalyst. The fix came not from better metallurgy but from biology: a single engineered transaminase enzyme replaced the metal step, improving yield by roughly 10 to 13 per cent, cutting waste sharply, and eliminating the precious-metal catalyst altogether. It proved enzymes could not merely compete with synthetic chemistry but beat it at industrial scale. Two decades on, that logic is reshaping how the world’s medicines are made — and it exposes a specific, awkward weakness in India’s position.
The adoption is now broad rather than exceptional. Industry reviews describe biocatalysis maturing from a niche tool into a central component of small-molecule drug production, with ketoreductases reducing ketones to chiral alcohols, transaminases building amines, and enzymes such as P450 monooxygenases and halogenases performing late-stage modifications that classical chemistry finds all but impossible. Of nearly 4,000 known enzymes, only about 200 are used commercially — a measure of the headroom. Each new enzyme brought to industrial readiness adds a new reaction to the manufacturing repertoire, and whoever can engineer them holds a widening advantage.
Pharmacy of the world, tenant of its tools
India’s pharmaceutical strength is real and hard-won. It is the third-largest drug producer by volume, the largest vaccine maker on earth, and the dominant global supplier of generics and antibiotics. It has a sizeable enzyme ecosystem too — well over 100 companies, an industry directory listing 131 suppliers as of May 2026, and a domestic enzymes market worth about $440 million in 2023 and growing near 8 per cent a year.
But that base is lopsided. India makes bulk quantities of conventional, workhorse enzymes — lipases, proteases, amylases — competently and at scale. What it does not make, in any meaningful quantity, are the high-performance pharmaceutical biocatalysts the new medicine depends on: the transaminases, ketoreductases, glycosyltransferases, alcohol dehydrogenases and bespoke engineered enzymes used in advanced API synthesis. Those it imports. Industry estimates put the share of enzymes used in India that are imported at 70 to 80 per cent, primarily from Europe and China.
The cause is not a lack of ambition but the peculiar difficulty of the manufacturing itself. Fermentation — growing the microbial strains that produce these enzymes — is operationally unforgiving. A minor contamination can destroy an entire batch and inflict heavy losses, so many firms rationally prefer to buy proven enzymes from established international suppliers rather than shoulder the risk of making their own. The global market is itself highly concentrated: roughly three-quarters of world enzyme production sits with just three players — Denmark’s Novozymes (now Novonesis), the United States’ DuPont and Switzerland’s Roche. India’s own market echoes that concentration, with the top three firms holding about two-thirds of the domestic industrial-enzyme business.
The deeper dependency
The enzyme gap does not stand alone. It sits on top of a far larger and more dangerous dependency that gives this cover story its real stakes — India’s reliance on China for the basic chemical building blocks of its medicines.
Here the numbers are stark. India imports roughly 70 per cent of its total active pharmaceutical ingredient and key-starting-material requirement from China; in FY2024-25 China accounted for about 74 per cent of India’s API import bill. For a list of some 45 critical bulk-drug molecules the dependence approaches 100 per cent, and for antibiotics such as penicillin and the cephalosporins — built on a fermentation intermediate called 6-APA that China overwhelmingly controls — a Chinese export restriction could halt global production within weeks. In March 2026 the Department of Pharmaceuticals placed before Parliament a list of APIs for which China supplied 70 per cent or more of imports across two consecutive years.
The government’s answer has been the Production Linked Incentive scheme for bulk drugs — a ₹6,940-crore programme, launched in 2020, targeting 41 critical products, complemented by three mega Bulk Drug Parks. It has produced results: by December 2025, some 56,800 tonnes a year of domestic capacity across 28 of those products, with sales that displaced imports worth over ₹2,000 crore. But the deeper trap is upstream. Even where an API is now made in India, its key starting materials are frequently still bought from China — so a new plant often shifts the point of dependence one link up the chain rather than removing it. And Chinese suppliers have met the PLI push with deliberate price cuts of 30 per cent and more on targeted molecules, precisely to keep Indian capacity from becoming viable.
This is why enzymes matter beyond their own market. Biocatalysis is not merely a greener way to make a drug — it is a different chemical route to the same molecule, one that can bypass some of the very fermentation intermediates and harsh chemical steps where Chinese dominance is tightest. An engineered enzyme that collapses six chemical steps into one does not just cut cost and waste; it can, in principle, shorten a supply chain’s exposure to a single foreign source. Mastering pharmaceutical biocatalysis is therefore not a side-quest in India’s self-reliance drive. It is one of the few genuinely structural levers available.
The shift to designer enzymes
The industry is not standing still, and the direction of travel is unmistakable: from standard, off-the-shelf enzymes toward customised and engineered ones designed for a specific drug and a specific reaction. As drug molecules grow more complex, generic enzymes simply cannot deliver the selectivity, stability and specificity required, and the tools to build bespoke ones — protein engineering, directed evolution, synthetic biology, and increasingly AI-driven enzyme design — have matured to the point of routine industrial use.
Executives in the Indian sector describe the same transition. Prashant Nagre, managing director of Fermenta Biotech — which approved a ₹110-crore expansion of its Gujarat facility in late 2025 — frames the question sharply: it is no longer whether enzymes will become central to the industry, but how quickly India can position itself at the front of enzyme innovation. He points to APIs, and specifically to penicillin G acylase for semi-synthetic antibiotics, as the segment of greatest strategic weight for India’s pharmaceutical exports, and to the expanding world of biologics — peptides, recombinant proteins, next-generation therapeutics — as the fastest-growing frontier, where enzyme quality is critical and premium-priced.
CDMOs — the CDMOs that produce drugs for global clients — add a further pull. Serving regulated Western markets, they need biocatalytic processes that meet international standards for sustainability, quality and traceability, and that demand is dragging the whole ecosystem toward higher-specification, validated, engineered enzymes rather than commodity ones. Drug discovery is a smaller but high-value user, where enzymes speed the selective synthesis of novel compounds. The common thread is that every growth segment — biologics, CDMOs, discovery, complex APIs — is pulling demand up the value chain, toward exactly the enzymes India does not yet make.
The customisation trend cuts in India’s favour in one important respect. A bespoke enzyme is a piece of intellectual property; proprietary strains and novel enzymatic routes are defensible assets, not commodities to be undercut on price. That reframes the opportunity. India will struggle to out-cheap China on commodity fermentation, where scale, subsidised utilities and effluent-treatment capacity give Chinese producers a structural edge. But a market moving toward engineered, IP-protected enzymes rewards exactly the deep-science capability India can build — if it chooses to.
What it would take
The building blocks of a policy answer are beginning to appear. In August 2024 the government approved the BioE3 Policy — Biotechnology for Economy, Environment and Employment — aimed at high-performance biomanufacturing, with bio-based chemicals and enzymes among its six priority sectors. The 2026-27 Union Budget went further, launching Biopharma SHAKTI with a ₹10,000-crore outlay over five years to build a domestic ecosystem for biologics and biosimilars, and setting the ambition of capturing 5 per cent of the global biopharmaceutical market. India’s bioeconomy, worth about $165 billion in 2024, is targeted to reach $300 billion by 2030.
But money and mission statements are the easy part, and the industry’s own leaders say so. The harder requirements are capability and people. Leadership in enzyme innovation, Nagre argues, will rest on protein engineering, synthetic biology, computational enzyme design, metabolic engineering and advanced fermentation — disciplines that demand sustained R&D investment, not one-time subsidy. Yatinkumar Wani of Biolaxi Corporation stresses strain development and microbial engineering as the technical bottleneck, and both point to the same structural fixes: far closer collaboration between academia, research institutes and manufacturers; pilot-scale infrastructure and technology-transfer pathways to carry discoveries from lab to plant; and a multidisciplinary talent pool spanning biology, chemistry, data science and process engineering.
There is a candid warning threaded through the industry’s optimism, and it applies to the whole self-reliance project. The ₹10,000-crore SHAKTI outlay, spread over five years, is a serious statement of intent — but in the capital-intensive world of biomanufacturing, against a China that commands close to a third of the global innovative pipeline after a decade of state and private investment, it is, as one industry veteran put it, a modest starter kit. Subsidies can restart factories. They cannot, by themselves, rebuild a lost industrial ecosystem or manufacture two decades of missing process know-how.
The strategic reading
For an Indian science-and-technology readership, the enzyme gap is worth watching precisely because it is a microcosm. It contains, in miniature, the central contradiction of Indian pharma: a sector that is genuinely world-class at the visible end — finished formulations, vaccines, generics — resting on an invisible base of imported inputs, from Chinese starting materials to European enzymes. Self-reliance announced at the level of the finished tablet is not the same as self-reliance secured at the level of the enzyme and the intermediate.
The optimistic case is real. India has the chemical-engineering depth, the fermentation heritage, a hundred-plus enzyme companies, a rising bioeconomy and, now, policy attention and money pointed in the right direction. The customisation era plays to intellectual strengths rather than to the commodity-scale game India cannot win. And the country has shown, with indigenous CAR-T therapies priced at a fraction of Western equivalents, that it can master sophisticated biology and make it affordable when it commits.
The realistic case is equally clear. Closing a 70-to-80 per cent import gap in high-performance biocatalysts, while simultaneously unwinding a 70-per-cent API dependence whose roots run one link further upstream than any single factory can reach, is the work of a decade of patient capability-building, not a budget cycle. Enzymes are the silent workhorses of the pharmaceutical industry. Whether India learns to breed its own, rather than rent them, is a quiet but genuine measure of how much the phrase “Atmanirbhar Bharat” finally means in the one manufacturing sector where the country is already a global power.
- Rama Koundinya Potharaju
