Amendments to New Drugs and Clinical Trials Rules, 2019

From 90 Days to 45: The Double-Edged Promise of NDCT Amendments

On January 31, 2026, the Ministry of Health and Family Welfare notified sweeping amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, promising to halve approval timelines for clinical research from 90 days to 45. For an industry that contributes 20% of global generic drug exports by volume, this regulatory recalibration is being hailed as transformative. Yet, the fine print raises as many questions as it seeks to resolve.

What Changed — and Why It Matters

The amendments hinge on three key measures. First, the requirement for a test licence for the small-scale, non-commercial manufacture of drugs for research has been replaced with a prior online intimation mechanism. This significantly reduces bureaucratic hurdles, except for high-risk drugs like cytotoxics, narcotics, and psychotropic substances, which still require active licensing—a critical safeguard. Second, the obligation to secure prior approval for specified low-risk Bioavailability/Bioequivalence (BA/BE) studies has been waived; researchers merely need to notify the Central Drugs Standard Control Organisation (CDSCO) before commencing such studies. Finally, digital platforms like the National Single Window System (NSWS) and the SUGAM portal will now handle the workflow, ostensibly guaranteeing transparency and ease of compliance.

The reforms are as much about messaging as mechanics. India’s pharmaceutical sector has long complained that its potential to lead in global R&D-driven clinical trials is stymied by cumbersome timelines. As of 2023, India’s share in global clinical trials stood at 8%, a number far below its capacity as the “pharmacy of the world.” The government now seeks to bridge the intent-action gap by aligning domestic regulatory practices with international norms.

The CDSCO’s Balancing Act

The Central Drugs Standard Control Organisation is expected to be a clear beneficiary of these changes. By eliminating redundant licensing processes, the CDSCO can devote more resources to higher-stakes approvals and inspections. But therein lies the catch. A lighter compliance burden for low-risk activities must not morph into an altogether lax regulatory regime.

Consider this: While the reduced timeline may foster competitiveness and encourage research, it also compresses the window for due diligence. Training and upskilling the CDSCO’s staff will now be non-negotiable. The regulator must effectively evaluate submissions, interpret complex trial results, and anticipate novel forms of noncompliance emerging from loopholes in the online systems. Simply cutting timelines without parallel capacity building risks overloading an already stretched institutional apparatus.

Safety, Speed, and Lack of Clear Checks

The official rationale—that these changes merely target “low-risk” endeavours—obscures some uncomfortable questions about regulatory oversight. Recent experience offers a cautionary tale: During the COVID-19 pandemic, fast-tracked clearances for vaccines faced significant public skepticism. Any erosion in trust from perceived leniency in new reforms could hurt India’s well-earned credentials in pharmacovigilance. Moreover, the amendments fail to adequately address the ethical concerns that have plagued clinical trials in the developing world—particularly informed consent, trial-related harm coverage, and the representation of vulnerable groups like rural and low-income populations.

The amended rules also seem disproportionately focused on facilitating industry rather than enhancing public health outcomes. While expedited BA/BE studies aid drug manufacturing timelines, they do little to improve the pipeline for high-risk drug innovation that addresses rare diseases or India’s dual burden of communicable and non-communicable diseases. This is a policy bias that aligns neatly with global market priorities, but not necessarily with national healthcare imperatives.

Looking Outward: Lessons from Brazil

India may fancy itself a global leader in pharmaceuticals, yet its regulatory infrastructure still lags behind that of much smaller competitors. Take Brazil: Faced with similar industry demands, the country’s Agência Nacional de Vigilância Sanitária (ANVISA) streamlined its drug approval process in 2016. But unlike India, it coupled regulatory liberalisation with parallel measures to expand funding for clinical research infrastructure. Moreover, ANVISA retains a robust framework for monitoring trial outcomes, with sanctions for noncompliance that are robustly enforced. India’s framework, by contrast, remains silent on scaling up post-approval monitoring or penal measures, leaving such gaps to the discretion of state-level officers.

The Political Economy of Speed

While the amendments are marketed as “ease of doing business,” their timing raises pertinent questions about the political economy behind them. India’s rising global drug market shares coincide with electoral cycles where healthcare nationalism—export triumphs in vaccines and generics—serves as a critical achievement banner. Yet, these reforms bypass a larger systemic inefficiency: variable state-level enforcement. Between 2017 and 2022, states like Kerala and Maharashtra conducted nearly five times more inspections than states like Bihar and Uttar Pradesh, according to Parliamentary panel reports. Taking the regulatory burden off the CDSCO achieves very little if state regulators remain undertrained and under-resourced.

Unanswered Questions

Where does this leave participants in India’s clinical trials system? The reforms offer few answers on legal recourse for patient harm under these expedited reforms. Neither do they spell out the mechanisms of coordination between CDSCO and complementary agencies like ICMR, which oversees ethical compliance. Simply disaggregating “low-risk” from “high-risk” trial categories is not enough; the absence of granular safeguards—informed by real-world trial outcomes—places all stakeholders in a more precarious terrain.

The Ground Ahead

As ambitious as these changes may seem, their success depends on implementation, transparency, and sustained capacity building. Paper amendments alone will not inspire trust or elevate India’s R&D output. Without comprehensive reforms to strengthen institutional accountability and equitable enforcement across states, the amendments risk becoming another layer of regulatory theatre, catering to global investors without safeguarding public health.

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