Dr. Ratnesh Jain Delivers a Searingly Honest Audit of India’s Novel Drug Development Crisis
The ICT Mumbai scientist and founder of the Mumbai Biocluster uses the PharmaCore inaugural forum to argue — with data and moral urgency — that India must make the leap from biosimilar manufacturer to first-in-class biologics innovator, or watch its patients pay with their lives, Rashmi Kumari of Neo Science Hub reports from Jio Centre, Mumbai
There are moments at conferences when a speaker stops presenting and starts reckoning. Dr. Ratnesh Jain, Associate Dean and Associate Professor at the Institute of Chemical Technology (ICT) Mumbai, and Founder-Director of the Mumbai Biocluster, delivered one such moment at the Expert Insights session of PharmaCore India 2026 on Wednesday, in a forty-five-minute talk that moved, almost without pause, from regulatory frameworks to the names of children who had died.
The session, titled “Early Stage Development of Novel Biologics for Oncology and Rare Diseases,” was introduced by Dr. Uma Raghuram, Vice President Biopharma at Spinco Biotech, who framed the day’s overarching theme — Powering Biopharma: Scripting India’s Growth Trajectory — as a convergence of science, policy, and enterprise at a pivotal national moment. What Dr. Jain proceeded to offer was something rarer than optimism: a clinically precise, institutionally grounded, and at times emotionally raw diagnosis of precisely why that convergence has not yet produced what India’s patients most need — new drugs.
Sixty Years of R&D, Zero New Drugs
Dr. Jain opened with a provocation. “Even after significant years of investment, R&D investment which is happening from the last 60 to 70 years,” he told the audience, “as a country, we could not deliver new drugs.” The statement lands harder for being matter-of-fact rather than theatrical. India, the world’s third-largest biologics manufacturer by volume, home to one of the most sophisticated biosimilar development ecosystems on the planet, has not originated a single novel biologic drug of global consequence. The formulation economy that made India the pharmacy of the world — built on API chemistry and ANDA filings — is, in Dr. Jain’s reading, structurally incapable of producing the value-creation that the next phase demands.
His prescription is built around three converging missions: the Government of India’s BioE3 policy framework, the expanding bioeconomy targets, and what he termed the BioPharma Shakti framework — together representing a decisive policy-level shift from scale manufacturing to innovation-led, knowledge-intensive biopharma leadership. He described this as a transition covering advanced biologics, green manufacturing, translational research, talent development, and resilient supply chains.
Mumbai Biocluster: Accelerator, Not Incubator
A significant portion of Dr. Jain’s talk was devoted to articulating what the Mumbai Biocluster — a Section 8 company launched in 2022 that recently announced a ₹300-crore fund — actually does, and more pointedly, what it refuses to do. Dr. Jain leads one of India’s largest learning and skill development platforms in biologics, and his research group works towards developing analytical methods for protein and peptide characterization, mammalian cell culture, and upstream process development. But at PharmaCore, he was emphatic about a distinction that matters enormously in the Indian biotech ecosystem: “We are an accelerator, we are not an incubator, we are not a space provider. We are a simply hand-holding system that if you want to do something, we are there with you till the end.”
The Biocluster operates as a hub-and-spoke model drawing together Mumbai’s academic institutions, financial entities, and industry partners, supported significantly by philanthropy. Its core mission addresses the precise points in the drug development pipeline where Indian innovation consistently fails: the moment when a promising new molecule cannot find a clinical trial partner; when scale-up and process support are absent; and — most damaging in Dr. Jain’s view — when the scientist’s own mindset has never been trained to think in terms of drug development for the Indian patient.
The Biocluster’s current capability portfolio spans antibody-based model biologics, mRNA therapeutics, cell and gene therapy, biosimilar development, and regulatory compliance pathways. On mRNA, Dr. Jain was particularly animated: a conventional biologics development timeline of 30 to 40 days collapses, in the mRNA paradigm, to three or four days. “That is the beauty of mRNA therapies,” he said, “and they are highly scalable.” The Biocluster’s spin-out, Nexture Biologics, is positioned to commercialise what Dr. Jain described as the first-of-its-kind mRNA lipid nanoparticle (LNP) platform in development in India — one of only four or five such clinical-stage mRNA programmes globally.
Where India Stands and Where It Must Go
Dr. Jain situated India’s challenge with the precision of a market analyst. The global biologics and biopharma market stands at approximately $400 billion today and is projected to reach $800 billion by 2030. Monoclonal antibodies account for roughly 55 per cent of this market. Crucially, of twelve major antibodies launched last year, 70 per cent came not from established giants such as Pfizer, Roche, Genentech, or Johnson & Johnson, but from new companies — entities funded by governments and venture capital, many of whose names are unfamiliar to the broader industry. “India has to create that story,” Dr. Jain said with visible urgency.
The areas he identified as highest-priority for Indian investment are two: antibody-drug conjugates (ADCs) and bispecific antibodies. On ADCs, he was unsparing: “China is the only country at this moment that has large ADC capacity. It actually aligns with India more — historically we are pretty good with chemistry, and ADC requires both biology and chemistry together.” With 50 active global clinical trials for antibody-drug conjugates currently underway, the window for Indian capability-building is open — but not indefinitely. India has, he noted, not a single ADC GMP facility.
The survival data point he used to crystallise the stakes of this gap will stay with anyone who heard it: “If you are in the US and some patient got cancer, the chances of survival are 9 out of 10. If you are born in India and got cancer, the chances of survival are 5 out of 10.” The reason, he argued, is not poverty or hospital infrastructure alone. It is the absence of later-line therapies — the combination of antibody treatment, bispecific treatment, and ADC treatment — that transforms cancer from a death sentence into a managed condition in high-income settings.
The Rare Disease Crisis
The most striking passages of Dr. Jain’s talk concerned rare diseases — which he explicitly called a crisis, noting that 90 per cent of rare disease patients are under 14 or 15 years of age, and that for the majority, there is no survival pathway in India. He named patients: Mohammed Ahmed, a Gaucher disease patient who died last year while the annual cost of therapy stood at ₹4.8 lakh and government support was capped at ₹50 lakh across three years. Nidhi Sarol, who also died, and whose father founded an awareness organisation. Kaya, an SMA patient surviving on crowdfunded treatment costing crores.
“These are real children, real patients which we all have a responsibility to develop new molecules for,” he said. Average diagnosis delay for rare diseases in India is five to seven years — a consequence of the country’s historically poor health data-reporting culture, the absence of disease-specific biobanks, and a national rare disease centre framework that, in practice, requires families to travel great distances merely to obtain a certificate confirming their child’s diagnosis.
The Biocluster’s rare disease pipeline reflects this sense of moral urgency: it is developing glucocerebrosidase biosimilar for Gaucher disease (no Indian biosimilar currently exists for this molecule), a PCSK9 inhibitor biosimilar (evolocumab, for familial hypercholesterolaemia in children, currently priced at ₹8.5 lakh per year — which Dr. Jain projected could be brought under ₹1 lakh through domestic development), and gene-editing therapies for beta-thalassemia and Duchenne Muscular Dystrophy (DMD).
The Structural Gaps
In a section that he framed as a national audit — “what we have and what we don’t have” — Dr. Jain laid out India’s biopharma contradictions with unusual directness. India is third globally in biologics manufacturing. It has over 60 per cent approval rates for biosimilars it chooses to develop. It has more than 120 biotech companies. But fewer than ten of these companies are meaningfully engaged in drug development. India files ANDAs, not INDs. “Less than 3 per cent of global IND filings come from India,” he said. “Value comes when you develop a new molecule. A ₹100 million deal and a $3 billion deal — the difference, I think everybody understands very well.”
The talent shortfall he described is particularly alarming. Trained CMC (Chemistry, Manufacturing and Controls) biologists in India number fewer than 50. The country needs 20,000. Regulatory clarity, while improving — Dr. Jain predicted a “major overhaul” of India’s biologics regulatory system within 18 months, with faster approval pathways for the majority of biologics — remains a bottleneck. Reference standard access is compromised by what he termed global supply-chain blockages by multinational pharmaceutical companies, who restrict availability of comparator drugs needed for Indian biosimilar and novel drug development.
He was equally critical of India’s genomic data utilisation gap: India’s population genomic database is 70 to 80 per cent developed and deposited in national repositories accessible through DBT — yet most researchers are unaware of this resource. Cancer therapies calibrated for Western genomic profiles are being administered to Indian patients who are genetically distinct. “Our drugs are not fit for the purpose,” he said. “It’s a random trial we are doing.”
The Toolkit for Those Who Will Act
Dr. Jain closed with a pragmatic toolkit for early-stage biologics developers — the kind of practical guidance that separates his talks from purely aspirational biopharma discourse. Computational tools such as AlphaFold 2 and NVIDIA’s protein development platforms are freely available and can generate hundreds of candidate antibody propositions without a laboratory. IP filing must precede experimentation, not follow it: Novo Nordisk’s failure to extend a key patent in Canada and Brazil for semaglutide — costing it a billion-dollar market — was offered as a cautionary example. USFDA Orphan Drug Designation, which reduces regulatory costs by 50 per cent, can be applied for by individual innovators and academics, not only companies.
For SMEs — a concern raised forcefully in the Q&A by Mr. Vaidya, a senior IDMA committee member — Dr. Jain had a direct proposal: give him one MSME willing to develop one biosimilar, and the Biocluster will hand-hold it from development to commercialisation. He cited Beta Drugs, Mohali as an early example of this model in action. “Unless we create an example,” he said, “everybody is afraid. But developing and taking a biosimilar to commercial market is no longer a very high-powered game. It’s possible.”
His vision for 2030: at least five clinical-stage candidates launched, a functional domestic rare disease market, and India repositioned as a global first-in-class biologics originator — the role that China is rapidly consolidating for itself. “We should not miss this bus,” he said. It was the third time he used that phrase in forty-five minutes. The repetition, one sensed, was not rhetorical habit but genuine alarm.
Closing Observations
Dr. Uma Raghuram, wrapping up the session before Messe Muenchen Project Director Babandeep Singh felicitated Dr. Jain, offered a contextualising note that resonated with much of what the speaker had argued: personalised medicine is already being pursued at the expo floor level, with autogrammer technologies for genetic cancer profiling and on-frame drug development among the exhibiting priorities. The diagnostics and the therapeutics, she implied, need to converge — and platforms like analytica Lab India and PharmaCore India are precisely the spaces where those conversations begin. The Mumbai Biocluster’s stated mission is to connect biopharma developers, model innovators, and regulators to co-create solutions that make therapies safer, faster, and more affordable. At PharmaCore India 2026, Dr. Jain made the cost of not doing so viscerally clear. The children he named — Mohammed, Nidhi, Kaya — are not statistics in a policy brief. They are the indictment and the mandate, in equal measure.
SPEAKER PROFILE
Dr. Ratnesh Jain Associate Dean & Associate Professor, Dept. of Biological Sciences & Biotechnology, Institute of Chemical Technology (ICT), Mumbai | Founder & Director, Mumbai Biocluster | Chairman, SME Committee, IDMA Research focus: Nanomedicine, protein characterisation, mRNA therapeutics, biosimilar development, translational biologics Leads India’s largest biologics skill development platform; consulting contributions span FDA-cleared peptoid, non-clonal antibody and vaccine programmes Mumbai Biocluster ₹300-crore fund launched 2026 | Spin-out: Nexture Biologics
KEY DATA POINTS FROM THE SESSION
Global biopharma market: $400 billion (2026) → $800 billion (2030 projection) | Monoclonal antibodies: ~55% of market share | India IND filings: <3% of global total | Active global ADC clinical trials: 50+ | Trained CMC biologists in India: <50 (need: 20,000) | Cancer survival probability — US: 9/10; India: 5/10 | Rituximab cost reduction by Indian biosimilar entry: 70% | mRNA drug development timeline: 3–4 days vs. 30–40 days for conventional biologics | Rare disease diagnosis delay in India: avg. 5–7 years
