India’s next leap in healthcare reform

This article is authored by Anil Matai, director general, OPPI.

India's transformation into a global leader in pharmaceuticals and healthcare innovation is underpinned by a relentless drive to simplify regulations, harmonise standards, and prioritize patient access. In 2025, the government’s focus on ease of doing business has been matched by parallel policies safeguarding quick, affordable access to medicines and treatments. In the dynamic world of health care, “ease of doing business” isn’t a corporate agenda — it’s a public health imperative. Simplified rules and predictable pathways don’t just attract investment; they strengthen the ecosystem that ensures timely, affordable, and safe access to medicines for millions.

Health care

India’s pharmaceutical sector long known as the pharmacy of the world is now undergoing a major regulatory evolution aimed at aligning ease of doing business with patient welfare. In recent years, the government has introduced reforms that bridge efficiency and accountability across the entire drug development cycle.

India is working towards becoming a PICS member and this alignment with international inspection standards will allow India’s manufacturing quality to be recognised globally, reducing duplication of audits and accelerating export approvals. For patients, this translates into faster access to globally trusted medicines and an enhanced supply of high-quality drugs. Meanwhile, CDSCO has been steadily digitising approval and licensing processes through the SUGAM portal. This digital shift enables real-time tracking of applications, simplifies submissions, and reduces bureaucratic delays — making regulatory decision-making more transparent and predictable.

India’s reform journey echoes global efforts to enhance patient access through regulatory agility. For instance, the US FDA recently launched a pilot program to fast-track the review of generic drugs manufactured domestically — a move designed to reduce dependency on imports and ensure a more reliable, lower-cost drug supply. Similarly, the European Medicines Agency has streamlined conditional marketing authorisations, allowing earlier patient access to therapies for rare and life-threatening conditions while maintaining strict post-approval monitoring.

Over the next three to five years, India’s health care landscape could be fundamentally reshaped by the successful implementation of these reforms. The goal is not just faster approvals but smarter, evidence-based, and patient-focused pathways that bring innovative, life-saving therapies to market more swiftly.

In diseases with high unmet needs — such as rare diseases, cancers, neurological disorders, and liver conditions — accelerated or conditional approval mechanisms could become increasingly common. These frameworks will allow access to critical treatments earlier, especially for conditions where time-to-treatment can determine patient survival or quality of life.

For example, in oncology, adaptive regulatory pathways could enable Indian patients to access breakthrough immunotherapies and targeted drugs shortly after their global launch, supported by robust post-marketing surveillance. Similarly, in the field of cardiovascular and metabolic disorders, where disease burden remains high, regulatory incentives for innovative therapies could improve outcomes and reduce long-term health care costs.

Ultimately, these reforms could help India evolve beyond its longstanding identity as the pharmacy of the world for generics. The country could emerge as a global destination for pharmaceutical innovation, clinical research, and advanced drug development underpinned by globally accepted data integrity, high manufacturing standards, and regulatory maturity. In this envisioned future, India wouldn’t just supply medicines to the world; it would set new benchmarks for how innovation and access can coexist to serve humanity better.

The next few years will be critical in cementing these gains. Success will depend not just on announcing reforms, but on ensuring their consistent implementation. This means training regulators, expanding digital infrastructure, engaging patient groups in policymaking, and continuously benchmarking India’s systems against global best practices.

The interplay between regulatory agility and patient welfare must remain at the heart of policy decisions. Each reform should be judged not by how much it simplifies corporate paperwork, but by how effectively it shortens the distance between discovery and delivery — from innovation to impact.

In the evolving Indian health care ecosystem, ease of doing business is no longer just an economic reform — it’s a health care reform. Streamlined regulations, harmonised standards, and transparent pathways form the backbone of an ecosystem where innovation thrives and patients receive timely, affordable care.

This article is authored by Anil Matai, director general, OPPI.