The Future of Pharma Manufacturing: Innovative, Visible & Sustainable

Our conversation with Dr. Tathagata Dutta on how new science is rewriting the way pharma factories are designed, run, and trusted

A recap for those who couldn’t join live.

Pharma manufacturing is being pulled three ways at once: toward molecules that are far harder to make, plants that must prove everything they do, and processes that have to get greener doing it. For the fifth episode of India Automation Hub’s practitioner series, we spoke with Dr. Tathagata Dutta, President of Jodas Expoim Pvt. Ltd., to sort what is genuinely changing on the shop floor from what is still marketing.

Dutta is a scientist with over two decades in drug and gene delivery — a PhD in Pharmaceutical Sciences, postdoctoral work on RNAi therapeutics, an IIM Calcutta background, and a law degree in intellectual property. His work spans liposomes, nanoparticles, dendrimers, complex injectables, vaccines, biologics and gene therapy. Jodas Expoim, the Hyderabad specialty company he leads, runs its manufacturing and innovation centre at Genome Valley, Telangana, with products cleared in 50-plus countries.

Here are the sharpest threads from the discussion — and the audience Q&A that followed.

Indian pharma’s quiet paradigm shift

The biggest change over two decades is appetite. Manufacturers who once chased quick returns on me-too generics and the “low-hanging fruit” of semi-regulated markets now aim at high-value, highly regulated ones — the US, Europe, Canada, Australia — where time, money and patience are the cost of entry.

Innovation has taken hold with them. Small and mid-size firms, not just the majors, are doing cutting-edge work. India now approves its own new chemical entities, and a growing cohort will run clinical trials on new biological entities — the riskier game. Academia is no longer on the sidelines: national institutes and centres of excellence are turning research into products.

New modalities demand new factories

The science drives the plant. Targeted, tissue-specific delivery systems — nanotech products already on Indian shelves — hit the target with precision, at lower doses, with fewer side effects. Biologics, grown from live cells, carry immunogenicity risk that forces them into dedicated plants. Gene therapies — low volume, high value, potentially a permanent cure for genetic disorders — need their own low-volume lines.

The point is blunt: these products cannot run on a conventional line. Each often needs a dedicated, molecule-specific process, its own skid systems for vessel-to-vessel transfer, and full automation — a clean break from manual handling.

AI: where it’s real, where it’s still a pitch

On compliance, Dutta called AI “still largely marketing” — then traced the real trajectory. Quality thinking moved from Quality Control (sampling, a game of probability) to Quality Assurance (quality at every stage), then to catching batches that drift out of trend, not just out of specification. AI’s real contribution is one step earlier: flagging a batch that maydrift, and halting the process until it’s corrected — pushing batch-failure probability toward zero.

In discovery, the payoff is time. The old way — generate thousands of leads, “fail fast,” lose years — now starts with AI screening candidates against virtual patient populations, cutting hundreds of leads to a handful. A cycle that once took 20 to 30 years can compress to five to seven.

His guardrail was blunt: “Use AI as your assistant, your secretary — not your boss, mentor or advisor. Don’t make decisions based on AI.” The real bottleneck for Indian adopters isn’t data volume or quality, which he says is ample. It’s validation — train on known problems, prove the answers, then trust it on the unknown — plus a natural wariness about sharing proprietary data. His reassurance: these tools are built per company, not recycled across clients.

Digitisation, data integrity and the connected plant

If AI is the headline, digitisation is the foundation. Data integrity is the industry’s single biggest pain point — and the regulators’ too. A fully connected plant answers it structurally. From order release through dispensing to the electronic batch record, data is pulled straight from the machines in real time. No manual keying. No room for the “plus-or-minus” fudging that paper invites. A balance-linked weighing step records exactly what the scale shows.

Track-and-trace and serialisation — 2D barcodes and QR codes carrying a product’s full provenance — is a frontier where Indian exporters already lead the domestic market, and a real weapon against the counterfeit and adulterated products flooding local shelves (including loosely regulated nutraceuticals and cosmeceuticals). The CapEx is real; so is the return — fewer failures and recalls, and business reclaimed from counterfeiters.

From lab to line — and why retrofitting is a trap

The gap between invention and innovation is commercial viability, and it’s where most programs stall. Patents get granted; few become products. Dutta’s fix: embed process-development and packaging scientists from day one, designing for machinability, scale, environment and batch size before the chemistry is frozen. Bolt manufacturability on late and it costs money and time — sometimes the whole product, dropped because the facility couldn’t support it. Packaging drew particular attention: it’s the product’s first line of contact, it imparts stability, and cold-chain demands now run from 2–8°C down to the deep-frozen storage of mRNA and cell-and-gene therapies.

He made a striking point on sterile lines: the shift to robotics on injectables is driven less by human error than by human biology — cutting the bio-burden operators introduce and lifting the product’s safety profile.

Sustainability, measured in litres and solvents

Dutta was concrete. Energy is moving from coal and furnace oil toward gas and electricity. Water is the bigger prize: one facility can burn through half a million to a million litres a day, making reduction, treatment and recycling non-negotiable. Green and circular chemistry is cutting toxic organic-solvent use — with early cases of solvent-free API synthesis. Ultrasonic sealing replaces gas-fired sealing at near-zero heat and emissions. Biodegradable polymers are entering packaging.

The honest scorecard on India

Dutta didn’t dodge the uncomfortable numbers. India exports a huge share of the world’s generics but captures a low single-digit share of global pharma revenue — and talent and outcomes still flow outward. His sharpest illustration: one blockbuster oncology molecule earned its maker more than US$40 billion last financial year — more than India’s entire pharma export earnings outside the US, at roughly US$31 billion.

The counterweight is momentum. Indian firms have won new antibiotic approvals after a two-decade drought in the category. Several new chemical entities sit in the regulatory pipeline. Startups are working on new biological entities, and premier institutes are collaborating with industry, with government behind them. Beyond scale, his boldest ask was structural — judicial and IP reform: time-bound resolution of commercial disputes, stronger confidentiality enforcement, and a faster patent system, so investors and innovators can trust that what they build in India stays protected.

From the audience

Sharp, practical questions came from across manufacturing, quality, automation and integration:

• AI-driven decisions in the plant: not yet welcome to regulators. AI suggests; a human vets it and owns the call. AI, he said, is still “a newborn infant.”
• QA under electronic batch records: review still takes time today — and should, at this “hand-holding” stage. Over the next few years, review-by-exception should narrow it to the flagged items, much as an AI report still leaves the final call to the doctor.
• Catching quality issues earlier: be more predictive with data, so problems surface in-process, not at release.
• Ageing, validated equipment: retrofitting is possible, but he leans toward waiting and investing in newer kit.
• Justifying digital spend: build the case from historical failures, recalls and complaints that could have been avoided. Let the numbers speak.
• Connected-plant projects that stall after go-live: usually inadequate risk assessment or funding shortfalls.
• Digital twins vs. the real floor: simulations rarely match perfectly, but they’re near enough — and there’s no going back.
• Skills for smart manufacturing: master the advanced tools, but never lose the fundamentals of physical pharmacy.
• India’s cost advantage as investment rises: greater scale should preserve it, keeping India competitive rather than eroding it.

His closing charge to the room: the age of working in silos is over. No one is an expert in everything. The way forward is collaboration — across disciplines, companies and continents.

Our thanks to Dr. Tathagata Dutta  for a wide-ranging, generous conversation, and to everyone who joined live — the questions were as sharp as the answers.

India Automation Hub is a platform for industrial innovation in India and actively engages the Industrial automation and the manufacturing community in India.

The full recording will soon be on our website and social channels. Follow us for the next episode, announced soon.

Have a question for our guest? Reach out and we’ll follow up.