From capacity to capability: Five proofs for India’s pharma future

India’s ability to supply affordable medicines at scale is strategic infrastructure for patients, health systems and global supply chains—not a past chapter to leave behind. The 75th Indian Pharmaceutical Congress has chosen a fitting Platinum Jubilee theme: “Transforming India from Pharmacy of the World to Pharma Powerhouse @2047”. The harder test is not simply whether India can make more. It is whether scientific knowledge remains intact as a medicine moves from development to a plant, from one site to another, and from an approved process into years of reliable supply.

Capacity is what a plant can make. Capability is what an organisation can reproduce when the molecule, team, supplier, site or market changes.

Capacity is not capability

The Economic Survey 2025-26 describes India as the world’s third-largest pharmaceutical industry by volume, while ranking it eleventh in pharmaceutical exports by value. Those measures have different denominators and should not be turned into a simplistic productivity ratio. They do, however, reveal the strategic brief: protect the scale that widened access while building more of the knowledge, evidence and specialised execution that can compound from one programme to the next.

“Value” must also be handled carefully. It is not a polite synonym for higher prices, stronger patents or abandoning generics. A reliable generic that prevents a shortage can create enormous patient and health-system value. A costly product supported by weak evidence or fragile supply can destroy it. The stronger definition combines patient benefit, reliable access, embedded know-how, regulatory confidence and an economic return capable of funding the next cycle of development.

The decisive test is the handoff

Industry naturally celebrates discovery, approval and commercial capacity. Patients, however, receive the result of a chain of handoffs: from a patient or delivery problem to a formulation; from formulation to analytical and clinical evidence; from development to manufacturing; from one supplier or site to another; and from market experience back into the product lifecycle.

The first proof is therefore not the category label attached to a programme. It is whether formulation choices begin with a clear target product profile: the intended patient benefit, dose and delivery requirements, stability, usability, manufacturability and supply constraints. Scientific novelty matters, but it must remain workable under the conditions in which a medicine will actually be made, stored and used.

The next handoff is technical transfer. A receiving team needs more than a recipe. It needs the scientific rationale, critical quality attributes, material and process knowledge, analytical methods, control strategy, development history, relevant process changes, deviations and investigations. Some of the most valuable knowledge is tacit: why one excipient grade was selected, which parameter first signalled drift, where an assay proved fragile, and what was tried and abandoned.

WHO’s 2022 technology-transfer guidance describes a demanding but practical test of success: documented evidence that the receiving unit can routinely reproduce the transferred product, process or procedure against predefined specifications. ICH Q10 reinforces the same lifecycle logic by connecting pharmaceutical development, technology transfer and commercial manufacturing within one quality system. The real proof is reproducibility across shifts, sites, suppliers and teams—not continuing dependence on tacit knowledge held by a small number of people.

Evidence and quality must travel together

Evidence should not be assembled at the end as a dossier detached from the decisions that shaped the product. It should travel with the medicine: formulation performance, stability, comparability, bioequivalence or clinical evidence where appropriate, process data, deviations, complaints and post-market learning. Each layer should make the next decision more informed and the remaining uncertainty more visible.

The most useful evidence of capability is therefore receiving-side performance. Can a prepared team reproduce the product or process routinely against predefined criteria? How much avoidable rework was required? Which analytical methods failed to transfer, and did the lessons change development or the control strategy? Those questions turn “knowledge retained” into observable results. They also prevent a successful batch at the sending site from being mistaken for a transferable operating capability.

Revised Schedule M is an important foundation because it encompasses pharmaceutical quality systems, quality-risk management, qualification and validation. A requirement being in force is not proof of universal compliance, however, and compliance alone is not differentiation. The higher-order question is whether the quality system preserves scientific intent as variability and organisational distance increase: whether changes remain controlled, signals are investigated, learning reaches development and the process continues to perform after transfer.

Capital must follow proof

The easy prescription is to spend more on R&D. The harder question is what each rupee buys. Capital can create reusable capability or prolong attachment to a programme whose assumptions have weakened.

Investment should therefore be released against pre-agreed evidence gates. Is the unmet need clear? Does the formulation offer a credible advantage? What evidence would change a regulatory, clinical or purchasing decision? Can the process and analytical methods transfer? Is the receiving site ready? At each gate, leadership should be prepared to continue, redesign, partner, license or stop.

Pharmaceutical development requires long horizons, failed hypotheses and persistence. Long-duration capital must tolerate scientific time while remaining responsive to stage-appropriate evidence. Boards should favour platforms, analytical capability, experienced people and transfer readiness that remain useful beyond one asset. Announced schemes, laboratories, patents and project starts are enabling inputs; validated products, accepted evidence, reproducible transfer and dependable supply are outcomes.

By 2047, a meaningful powerhouse scorecard should ask how often receiving units meet predefined transfer criteria, whether analytical methods perform at the new site, how quickly dependence on the sending team can end and whether methods and learning are reused in the next programme. A difficult medicine made once is an achievement. A system that can reproduce it, transfer it and learn from it is a pharmaceutical powerhouse.