Advanced excipients could emerge as India’s next big pharma advantage

When the Central Drugs Standard Control Organization (CDSCO) revised Good Manufacturing Practice norms under Schedule M in December 2023, it set in motion one of the most consequential quality upgrades for Indian pharma in recent decades. By aligning Schedule M more closely with WHO GMP expectations, regulators signalled that the era of minimal compliance is over. Hundreds of small and mid-sized manufacturers that were long accustomed to traditional batch processes and straightforward generics now need to modernise their facilities and quality systems if they wish to remain globally relevant.

At the same time, a quieter but equally significant shift is underway. The Drugs Rules have been amended to require manufacturers to disclose the qualitative list of excipients on labels under Rule 96, with effect from 31 March 2026. For the first time, excipients are moving from the background to the foreground of regulatory scrutiny. Ingredients once treated as passive “fillers” are now central to how India will be judged on transparency, safety and quality.

In that sense, excipients are no longer peripheral. They are becoming one of the levers that can shape India’s future competitiveness in complex formulations.

Why excipients matter more than ever

India’s excipient industry has significant headroom to grow, both in scale and sophistication. For years, formulators have struggled with poorly soluble active pharmaceutical ingredients, sensitive biologics and the demands of modified-release dosage forms. These challenges cannot be solved by APIs alone. They require excipients that do more than just bulk up a tablet or stabilise a solution.

Across research centres and development labs, scientists are now examining intelligent polymers, lipid-based systems and amorphous stabilisers that can improve solubility, protect fragile molecules and control drug release in very specific parts of the body. Conferences hosted by IPEC India, CPHI and academic institutions such as IISc Bengaluru are increasingly devoted to topics like solubility enhancement, stability improvement and patient adherence, underscoring how excipient science is moving closer to the centre of formulation design.

Co-processed excipients are a good example of this shift. By combining the properties of two or more materials into a single engineered system, they can improve compressibility, flow and disintegration while simplifying the manufacturing process. For many Indian generic manufacturers, co-processed excipients offer a relatively low barrier entry into more sophisticated formulation capabilities that would otherwise require much larger investments.

Regulation as a catalyst, not a constraint

The revised Schedule M guidelines, together with the broader quality framework under ICH Q8, Q9, Q10 and Q12, are reshaping how Indian manufacturers think about quality by design. These expectations come at an important moment. India is increasing its focus on complex injectables, biosimilars and controlled-release dosage forms, while also seeking to reduce dependence on critical excipients sourced from outside the country. Schemes such as Pharma Vision 2030 and the Production-Linked Incentive programme are encouraging investment into higher-value products and supporting the build-out of more advanced manufacturing infrastructure.

The new excipient labelling mandate under Rule 96 adds another layer of discipline. Requiring the qualitative disclosure of excipients on the innermost container for relevant products is more than a labelling change. It improves traceability, strengthens pharmacovigilance and makes it easier for regulators, prescribers and patients to understand what goes into a medicine. Over time, this can help build trust in Indian brands in both domestic and export markets.

These policies also open space for new types of players. Start-ups, academic spin-outs and incubation centres can begin to focus on “pharma-ready” excipients tailored for local APIs, climate conditions and therapeutic needs. If India can develop and validate its own portfolio of high-quality functional excipients, it will not only reduce import dependence but also create an export opportunity in a segment that has traditionally been dominated by a few global suppliers.

The next frontier: digital and data-driven excipient design

A parallel transformation is unfolding in how excipients are designed, screened and selected. Advances in artificial intelligence and molecular modelling are allowing researchers to simulate drug–excipient interactions before they ever reach the lab bench. By using predictive algorithms and in silico screening, development teams can narrow down candidates, anticipate compatibility issues and forecast stability outcomes in a fraction of the time that traditional trial-and-error methods would take.

These tools will be especially important for continuous manufacturing, where reproducibility and tight process control are essential. Data-driven approaches can help ensure that excipient performance remains consistent across batches and sites, reducing variability and unplanned costs.

For complex molecules such as peptides, proteins and other biologics, AI-assisted molecular design can also help identify polymer and lipid systems that protect against degradation or aggregation. Coupled with advanced analytics, rheology mapping and modern characterisation techniques, this can support the development of a new generation of engineered excipients that are designed around specific therapeutic and manufacturing needs rather than adapted from legacy materials.

The road ahead

India stands at a crossroads where excipient innovation can meaningfully reshape its position in the global pharmaceutical value chain. Moving from commodity-grade materials to engineered, functional excipients is not just a scientific upgrade; it is a strategic one. It underpins manufacturing modernisation, strengthens regulatory credibility and opens new export avenues.

Over the next decade, as continuous manufacturing becomes more common and biologics gain a larger share of pipelines, excipients will only grow in importance. To realise this opportunity, large companies, smaller manufacturers and early-stage innovators will need to work in the same direction: towards advanced materials, data-informed formulation design and alignment with international quality expectations.

If India can combine regulatory reform, scientific capability and purposeful investment, advanced excipients may well become one of its most important advantages in the next phase of pharmaceutical growth.