Encube’s Mehul Shah charts strategic blueprint for the next pharma decade

When Mehul Shah took the stage at Envision 2025, it was clear he had no interest in the typical keynote. Instead, he proposes a guided workshop. Not just a story about Encube, but a story about India, growth, systems, and mindset. “I have made lots of mistakes,” he says, “but fortunately, the number of right decisions has been more.”

Shah builds his talk in three arcs. First, a macroeconomic lens to frame opportunity. Then, a company-level view of building for scale. Finally, a personal reflection on what it takes to institutionalise success.

Shah doesn’t just drop this fact as a flex. He uses it to build a case for relentless thinking, unlearning, and reimagining what comes next.

“When I graduated in pharmacy in 1986, India’s total pharma output was about USD 1-billion,” Shah states. “By 2005, it had grown to USD 5-billion. Today, it is inching toward USD 60-billion.” This isn’t just linear growth. It’s compounding at scale. According to Shah, the Indian government’s Vision 2047 estimates peg pharma’s future valuation at a staggering USD 450-billion. For context, that’s over 10 times today’s market size. “We are sitting on a tectonic opportunity,” he says.

This expansion is not a one-off event but the outcome of years of ecosystem shifts: from regulatory maturity and export orientation to an explosion in pharmaceutical education. “Back in the day, Mumbai had only three pharmacy colleges. Today, there are more than 30,” Shah points out, noting that similar academic infrastructure is mushrooming across India.

Shah credits this upward trajectory to a combination of factors: strong infrastructure spending, wealth creation and its equitable spread, and the digital backbone that has powered everything from payments to manufacturing. But he warns against resting on macro tailwinds alone. “Everyone talks about India being a USD 4.3-trillion economy now, up from USD 850-billion in 2005. That’s a fivefold growth in 20 years. But the next jump, from USD 4-trillion to USD 20-trillion, will not happen by accident,” he cautions. “It will take clarity, courage, and conviction.”

Encube’s evolution from CDMO to brand owner
Within pharma, the real opportunity lies not just in size, but in specialisation. Shah gives the example of Encube’s pivot. Once purely a contract development and manufacturing organisation, it now owns global brands and runs one of the world’s largest topical dosage plants, with a capacity of 500 million units in Goa alone. The company’s R&D centre in Palghar, outside Mumbai, is now the largest topical research facility globally. “We chose to focus. We could’ve done ten things, but instead we did one thing ten times better,” Shah explains.

He underlines that success in this new pharma era will demand more than market share. It will require data integrity, documentation discipline, and surgical precision. “You can’t fix your processes with cement once the FDA audit begins,” he quips, alluding to the high stakes of regulatory compliance.

What also stood out in his talk was the connection between macro-level growth and micro-level execution. “If you don’t know where you are and where the world is going, how will you stay relevant?” he asks. For Shah, the founder's mindset starts with admitting that the bottleneck is often oneself. “Unless you believe ‘I am the bottleneck’, transformation will never happen.”

He also offers a peek into Encube’s internal transformation, from implementing a paperless MES (manufacturing execution system) integrated with IoT, to investing in leadership pipelines. “We are building a digital-first, people-centric organisation. One of my team members started as my executive assistant when our turnover was INR 14-crore. Today, he is number two in the company and is soon to be CEO.”

Shah’s thesis is not just that India’s pharma industry is growing. It’s that it’s evolving. From generics to speciality, from manufacturing scale to personalised medicine, the country is at the cusp of redefining its pharma identity. And the time to act is now. “If someone says there’s no opportunity in India, they’re not paying attention,” he concludes. “There’s only opportunity in India.”

Personalised medicine powers the next wave of pharma innovation
Shah draws a bold line from India’s pharmaceutical past to its precision-driven future. For Shah, the next frontier is not just about increasing capacity but tailoring treatment to the individual. “You must’ve heard the term personalised medicine,” he says. “But do you understand what it means for manufacturing?”

Shah recounts a visit to a US-based facility that specialises in personalised cosmetic formulations. What he saw there redefined his understanding of pharmaceutical production. “It was like watching the future run in real time,” he explains. The system could analyse a selfie uploaded by a consumer, detect their skin type using AI, and determine the ideal formulation for that individual. This data then flows seamlessly into a manufacturing line capable of producing 120 customised bottles per minute, each one coded, labelled, and filled for a specific user.

This convergence of AI, manufacturing, and patient data is more than a tech marvel. It marks a structural shift in how drugs will be formulated, distributed, and monitored. “Imagine a batch where you are producing 20,000 units, and each one is for a different patient,” Shah explains. “That’s 10,000 individual data points tracked in real time, every component adjusted based on the profile. This isn’t a pipe dream. It’s already operational.”

For India’s pharma ecosystem, the implications are massive. The country that once scaled the global supply of generics is now being called to rethink its approach to volume and value. “Personalised medicine flips the equation. It is not about economies of scale. It’s about economies of precision,” he notes.

Shah points out that this will demand entirely new thinking in terms of equipment, execution, and mindset. “What kind of batch processing do you need when every bottle is different? How do you train teams to handle variations in real time? Can your software and systems hold up under the weight of such complexity?”

At Encube, this future is already being anticipated. Its innovation centre is being designed with flexible lines and data-centric systems that will enable real-time traceability and recipe adjustments. “We’re moving towards a world where every patient might get a different version of the same medicine. And that means we need to be ready, not just with machines, but with a mindset of adaptability,” Shah states.

This shift also invites regulators to rethink norms. Shah underlines the tension between flexibility and compliance, especially in tightly governed markets like the US and Europe. “How do you validate something where no two units are identical? How do you document accuracy when precision looks different for each SKU?”

He warns that old rules won’t serve new formats. “If you try to handle personalised medicine with the SOPs of yesterday, you’re going to crash into a wall. We need smart protocols, agile validation, and above all, end-to-end visibility.”

As India eyes a USD 450-billion pharma future, personalised medicine will be one of the most critical growth engines. But to get there, Shah says, manufacturers will need to think like data companies, not just drug companies. “It’s not just science anymore. It’s science, software, and the speed of trust,” he says. “And the players who crack this trifecta will define the next decade.”

Smart factories and the digital leap in packaging
Shah makes a compelling case for viewing packaging not as a final step, but as a data touchpoint. “Every label, every carton, every seal — that’s not just packaging. That’s information,” he says. In a market where packaging typically makes up 4% of the product cost, its impact on compliance and brand integrity is disproportionately high.

Encube’s strategy hinges on deploying IoT-enabled systems and a robust manufacturing execution system (MES) to eliminate paperwork, boost precision, and unlock traceability. “In our facilities, every machine is now a node in a network,” Shah explains. “Each action, from weighing raw materials to applying a label, is captured, time-stamped, and stored.”

The goal is simple but transformative: a fully paperless factory. Shah and his team have partnered with a specialist MES provider to integrate over 30 systems across the plant floor. “Batch records are no longer handwritten or manually compiled. They are generated automatically, validated digitally, and connected upstream to raw material sourcing and downstream to final dispatch,” he says.

This shift is particularly significant for packaging, where variation is high, compliance is strict, and speed is essential. “Every label, every carton, every seal — it’s all data now,” Shah explains. “And that data fuels decision-making, quality control, and faster release cycles.”

One critical benefit of this architecture is how it builds resilience. “We can pinpoint faults within seconds and trace their source without shutting down the entire line,” Shah says. “That kind of granularity gives us agility in a regulatory environment that demands nothing short of perfection.”

Encube has also been upgrading legacy equipment with IoT sensors and smart interfaces, allowing older lines to plug into the same ecosystem. “You don’t need to rebuild everything. You need to rewire how you think about visibility and control,” he adds.

Beyond machinery, the digital transformation touches people and processes. Operators interact with intuitive dashboards rather than binders full of SOPs. Supervisors review live production metrics on mobile devices. Quality assurance teams can run audit trails with a few clicks. “It’s not just automation. It’s empowerment,” Shah notes.

Still, Shah is clear that digitalisation is not a fix-all. It’s a cultural shift. “You can buy sensors and software, but if your people are not trained, aligned, and incentivised to think digitally, it won’t stick,” he cautions. “It’s about habits, not just hardware.”

To institutionalise this mindset, Encube has set up an experience centre to showcase digital tools, run simulations, and onboard cross-functional teams. “We treat tech the same way we treat formulations — we prototype, we pilot, and we scale,” Shah explains.

For packaging businesses watching India’s pharma boom and wondering how to stay competitive, Shah has a clear message. “Don’t wait for a mandate. Don’t wait for a breakdown. If you’re serious about growth, you need to digitise upstream, midstream, and downstream. All three. Together.”

Precision by design
In topical drug manufacturing, regulatory scrutiny is relentless and rightly so. For Shah, this is where operational discipline meets existential necessity. “When a regulator walks into your facility, the inspection doesn’t begin with documents. It begins with the mindset of your team,” he says.

Topical dosage forms, though applied externally, demand the same precision as any systemic drug. Shah highlights that one complaint on product integrity, a leaking ophthalmic container, for instance, can cascade into full-scale audits, product recalls, or market exits. “In regulated markets, there are no second chances. Precision is not a virtue. It’s a prerequisite,” he asserts.

At Encube, the commitment to quality is built into every layer of manufacturing, not bolted on after the fact. From raw material traceability to packaging validation, each step is codified, audited, and reinforced. “You can’t rely on patchwork corrections. Your systems must be airtight from the start,” Shah explains.

He points to the challenges of documentation as one of the trickiest areas to navigate. “A standard operating procedure is not just a manual on the shelf. It is a legal promise,” he says. “Every word, every comma, must be lived and demonstrated in practice.” Operators are trained to treat SOPs not as instructions, but as contracts — binding, non-negotiable, and always audit-ready.

The stakes rise even higher when operating across multiple regulatory regimes. With Encube’s footprint covering the US, Europe, and other tightly governed regions, the level of compliance must be harmonised yet flexible. “Each region has its nuances. The art is in achieving global uniformity without local blind spots,” Shah explains.

One strategic shift has been to embed quality professionals into every function — not siloed in inspection rooms but embedded in product development, production, and even procurement. “One-third of our workforce is in quality. That’s not an overhead. That’s our licence to operate,” he says.

Training plays a foundational role. Shah insists that no technology, however advanced, can replace the human judgment needed in high-stakes environments. “Precision is not just about machines. It’s about people who notice what machines miss,” he notes. That’s why Encube invests heavily in continuous training, simulation audits, and cross-site knowledge transfer.

The company’s integration of real-time quality control with its digital MES has further sharpened its edge. By capturing every deviation, exception, and intervention at the point of origin, teams can prevent recurrence before a regulator even arrives. “Prevention is the new compliance,” Shah says.

He’s also candid about the reality of reputational risk. In an era of instant information and global supply chains, one error in one market can trigger alarms worldwide. “You could do a thousand things right, but one missed detail in a secondary packaging label can undo all of it,” Shah warns. “That’s the level of discipline topical manufacturers need to uphold.”

And if you want to earn trust in this environment, Shah says, transparency is non-negotiable. “We don’t wait for a regulator to find issues. We document, disclose, and rectify faster than the audit cycle. It’s not about passing inspections. It’s about being inspection-ready all the time.”

R&D and the global playbook
For Shah, innovation isn’t a department. It’s a mindset. And in pharma, it begins long before the first molecule is tested. “The success of a formulation often depends on how well the problem was defined at the outset,” Shah says. “You don’t start with a lab. You start with a question.”

Encube’s R&D model reflects this philosophy. The company’s newest facility in Palghar, on the outskirts of Mumbai, is designed to be more than a laboratory. It is an ecosystem for iteration, a space where formulation scientists, packaging technologists, and regulatory teams co-develop, refine, and stress-test ideas. “We don’t just chase approvals. We engineer relevance,” Shah explains.

This R&D centre is now the largest dedicated facility for topical drug research globally, but Shah is careful not to conflate size with innovation. “The value is not in square footage. It’s in how quickly and smartly we move from hypothesis to commercialisation,” he says. Stage-gate processes guide every project, from pre-kickoff to post-launch review, enabling faster, data-driven go/no-go decisions.

He highlights a key metric: 70% of Encube’s topical drug applications have been approved in the first review cycle, a rate significantly higher than industry norms. “That’s not luck. That’s design thinking,” he notes. This performance is driven by cross-functional decision-making, rigorous portfolio validation, and market-back planning. “Before we invest in a new molecule, we map out competitors, pricing trends, and the timeline for exclusivity. We want to know the odds before we place the bet,” Shah explains.

Global expansion is another pillar of Encube’s growth engine. In just six years since launching its front-end distribution in the US, the company has climbed to the fifth position in the prescription topical space. “In 2019, we started with zero brand presence. Today, we own more than 60 approved products, including a blockbuster we acquired from Sanofi,” he says.

But Shah’s strategy has never been about chasing headlines. It’s about building deep, sustainable capability. “You can’t enter the US market just with capacity. You need regulatory intelligence, technical reliability, and a tolerance for long product cycles,” he says. Each market brings its calculus, whether it’s navigating the FDA’s dossier expectations or responding to shifting consumer preferences in Europe.

He also notes the shift in R&D investment logic. Rather than placing large bets on single molecules, Encube adopts a modular, scalable innovation model. “We break development into six or seven discrete phases, with defined milestones and exit criteria,” Shah explains. “That structure reduces risk, improves agility, and gives our teams clarity.”

Encube’s innovation strategy is now fuelling expansion in adjacent categories, from prescription products to over-the-counter (OTC) offerings and dermatological consumer brands. But even as the company scales, Shah is focused on institutionalising its innovation DNA. “We’ve made mistakes. But we’ve built a culture where good decisions outnumber bad ones,” he says.

Ultimately, Shah believes innovation must be tied to ownership. “A scientist should be able to see the product they developed on a store shelf. That’s when accountability becomes real. And that’s how breakthroughs happen — when people don’t just work on products, but believe in them.”

Balancing the equation
Shah breaks growth down into what he calls the “three investment buckets” — a simple framework with complex implications. “Every organisation has limited capital, time, and attention. Where you place those bets defines your trajectory,” he says.

The first category is sustainability, not just environmental, but operational. “This is where you invest to keep your systems healthy, your compliance tight, your infrastructure current,” Shah explains. It includes routine maintenance, energy upgrades, digitisation layers, and risk prevention. “Many companies underestimate this bucket until something breaks. We’ve learnt to front-load it,” he adds.

The second bucket is optimisation — increasing capacity within existing footprints. Shah describes this as the space between stagnation and expansion. “This is where you fine-tune throughput, reduce changeover time, and enhance yield without adding new real estate,” he says. At Encube, this has included retooling packaging lines, automating in-line checks, and consolidating material flows.

The third pillar is transformation — bold investments that alter the business model, open new markets, or redefine scale. These include acquisitions, new product launches, or technology platforms. “This is where you shift the curve, not just move along it,” Shah says. “You don’t do this every year. But when you do, you go all in.”

Shah urges leaders to regularly audit where their capital is going and whether their internal vocabulary matches their strategic intent. “Sometimes we use words like growth, but what we’re funding is maintenance,” he observes. “There’s nothing wrong with that, but we must be honest about it.”

He also warns against over-investing in the tangible at the cost of the intangible. “We spend crores on machinery but hesitate to invest in influence, communication, and learning. But in a people-centric organisation, soft skills drive hard results,” he says.

This mindset shift is reflected in how Encube manages its leadership pipeline. “We don’t just delegate tasks. We delegate thinking,” Shah explains. The company empowers managers to own projects end-to-end, while setting clear metrics and checkpoints. “We’ve moved from approval-based systems to accountability-based systems,” he adds.

Crucially, Shah believes sustainable growth is as much about discipline as it is about aspiration. “You can chase opportunity or build capacity. But long-term scale comes when you align both,” he says. Encube’s multi-year strategy includes phased investments across all three buckets, with periodic recalibrations based on market signals.

Shah closes with a quiet reminder: organisations don’t grow just because the market is booming. They grow because leaders make deliberate, balanced choices. “There’s no shortcut to maturity. You build it one trade-off at a time.”