India Fast-Tracks New Drug & Clinical Trial Approvals with 2026 NDCT Amendments

India has rolled-out new amends to New Drug and Clinical Trials Rules, 2019, to cut drug development timelines, replace licenses with prior intimation, ease BA/BE approvals, digitize compliance, and improve regulatory predictability for pharmaceutical manufacturers, CROs, and investors globally.

India’s Union Ministry of Health and Family Welfare has notified amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019.  The 2026 regulatory changes aim to reduce regulatory friction and accelerate research and development (R&D) timelines across the pharmaceutical value chain, consistent with India’s ease-of-doing-business agenda. The changes also reflect a shift toward trust-based, risk-proportionate oversight for low-risk research and non-commercial manufacturing.

At a high level, the amendments introduce prior-intimation mechanisms in place of selected licenses, shorten statutory processing timelines, waive prior approvals for specified low-risk bioavailability/bioequivalence (BA/BE), and expand digital regulatory infrastructure. Together, these changes seek to shorten drug development cycles while maintaining safeguards for public health.

India’s pharmaceutical and clinical research ecosystem play a central role in global drug development, particularly in generic medicines, vaccines, and contract research. As regulatory requirements expand alongside innovation, approval timelines and procedural complexity have become a key concern for domestic manufacturers, research institutions, and foreign investors alike.

Overview of the NDCT Rules, 2019

The NDCT Rules, 2019 established a centralized regulatory framework governing new drug approvals, clinical trials, and BA/BE studies in India. These rules consolidated multiple earlier regulations to create a single approval pathway covering the entire lifecycle of drug development, from early-stage research to market authorization.

Under the NDCT framework, the Central Drugs Standard Control Organization (CDSCO), along with central and state licensing authorities, oversees approvals, inspections, and licensing for both domestic and foreign entities engaged in clinical research or drug manufacturing in India.

Prior to the 2026 amendments, the NDCT Rules imposed several procedural requirements that directly affected development timelines. Companies engaged in non-commercial manufacture of drugs for examination, research, or analysis needed to obtain a test license from CDSCO. Sponsors also had to secure prior regulatory permission before initiating BA/BE studies, which support generic drug approvals, including studies considered low risk. The rules prescribed statutory timelines for application review, often extending to several months, depending on the activity and risk category.

Despite strengthening regulatory oversight, the framework drew industry concerns over approval delays and procedural duplication.

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Latest amendments to new drug and clinical trials in India

Test license requirement replaced with prior intimation

Under the earlier regime, pharmaceutical companies had to obtain a test license to manufacture small quantities of drugs for examination, research, or analysis, even when the activity involved no commercial sale.

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The amendments replace this licensing requirement with an online prior-intimation mechanism for non-commercial manufacture. Companies may now proceed with manufacturing activities after notifying CDSCO through the prescribed digital system. The reform applies broadly but retains stricter oversight for high-risk categories, including cytotoxic drugs, narcotic drugs, and psychotropic substances, where test licenses continue to apply.

This change reduces regulatory lead time at the pre-clinical and early research stage while preserving controls over substances that carry higher safety or misuse risks.

Reduced statutory processing timelines

For categories where test licenses remain mandatory, the amendments shorten the statutory processing period from 90 days to 45 days. CDSCO processes approximately 30,000 to 35,000 test license applications annually. The shorter statutory timeline represents a material reform. It should improve regulatory throughput and increase certainty for development planning and investment scheduling.

Waiver of prior permission for low-risk BA/BE studies

BA/BE studies form the backbone of generic drug approvals, yet the earlier framework required prior regulatory permission that often delayed study initiation, even for low-risk designs.

The amendments waive prior permission for specified low-risk BA/BE studies. Sponsors may now initiate these studies after submitting an online intimation to CDSCO. India conducts approximately 4,000 to 4,500 BA/BE studies annually. The latest reform carries broad implications for the domestic generic pharmaceutical industry.

The waiver enables faster study initiation while preserving oversight through reporting obligations and risk-based audits.

Digitalization of regulatory processes

To support implementation, the central government has announced dedicated online modules through the National Single Window System (NSWS) and the SUGAM portal. These platforms allow companies to submit intimations, applications, and supporting documents electronically, reducing manual intervention and improving traceability.

Digital integration also standardizes compliance workflows and strengthens audit trails, supporting both regulatory efficiency and transparency.

Earlier NDCT precedents on emergency regulatory flexibility

The latest amendments build on earlier instances of regulatory flexibility under the NDCT framework. During the COVID-19 pandemic, India introduced temporary relaxations to address urgent public health needs.

In February 2022, authorities deferred the requirement for prior central permission to manufacture and stockpile new drugs undergoing Phase III clinical trials for COVID-19 treatment and management. The notification allowed manufacturers to proceed with production while maintaining conditions around post-trial approval and controlled distribution.

These measures demonstrated the regulator’s willingness to adopt risk-based and situational flexibility without abandoning oversight. The current amendments extend that philosophy beyond emergency contexts into routine regulatory governance.

Significance of the amendments for pharma firms in India

The amendments signal a shift toward trust-based, risk-proportionate regulation in India’s pharmaceutical sector. By easing requirements for low-risk activities while retaining controls for higher-risk substances and studies, the framework aligns more closely with global regulatory practices.

The central government estimates suggest that replacing test licenses with prior intimation alone may reduce drug development timelines by at least 90 days. Combined with shorter processing timelines and BA/BE waivers, the cumulative time savings may materially strengthen India’s position as a research and manufacturing destination.

The reforms also improve regulatory capacity. By reducing routine licensing workloads, CDSCO can redirect resources toward complex evaluations, inspections, and pharmacovigilance activities that directly affect patient safety.

Impact on businesses and industry stakeholders

Pharmaceutical manufacturers

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For pharmaceutical manufacturers, the amendments shorten R&D cycles and support earlier market entry. Reduced licensing requirements lower compliance costs for non-commercial manufacturing and improve predictability across development stages. Companies may plan capital deployment and scale-up activities with greater confidence in regulatory timelines.

Generic drug companies

Generic manufacturers stand to benefit significantly from faster BA/BE study initiation. Earlier study commencement accelerates product filings in both domestic and export markets, strengthening competitiveness in time-sensitive tender and patent-expiry scenarios.

CROs and research institutions

Contract research organizations (CROs) and academic research institutions benefit from reduced approval bottlenecks and more efficient project onboarding. Digital filings and intimation-based mechanisms also improve coordination with sponsors and regulators, reducing administrative delays.

Foreign investors and multinationals

For foreign investors and multinational pharmaceutical companies, the amendments signal India’s commitment to ease of doing business and regulatory modernization. Alignment with international norms and risk-based oversight improves regulatory predictability for multinationals evaluating India as a regional base for clinical research and pharmaceutical R&D.

Compliance considerations for businesses in drug development

The 2026 amendments shift compliance from pre-approval gating to stronger internal controls and post-market readiness. Companies should strengthen quality assurance and monitoring systems to manage the higher burden under a trust-based approach. Businesses must first implement a precise risk assessment matrix to distinguish between low-risk products eligible for the new “online intimation” mechanism and high-risk categories, such as cytotoxic, that still require licensure. 

Standard Operating Procedures (SOPs) should be updated to leverage the NSWS and SUGAM portal, ensuring teams are proficient in digital filings that replace the 90-day waiting period with immediate project initiation.

With regulatory barriers lowered, companies must reinforce pharmacovigilance and data integrity protocols to withstand retrospective audits. Ultimately, maintaining robust post-market monitoring is essential to balancing accelerated R&D timelines with the safety standards that remain non-negotiable

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