India Eases Drug Trial Rules to Cut Delays and Accelerate Pharma R&D

The change is expected to save at least 90 days in the drug development life cycle — a major boost for research timelines and innovation.

India has moved to significantly simplify drug development and clinical research approvals, with the Union Ministry of Health and Family Welfare notifying key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 aimed at reducing regulatory burden and improving Ease of Doing Business.

The reforms, introduced in line with the direction of Prime Minister Narendra Modi, are designed to shorten approval timelines, streamline compliance and fast-track pharmaceutical innovation, while maintaining safeguards for public health.

Test licences replaced with faster intimation process

Under the amended rules, pharmaceutical companies will no longer need a test licence from the Central Drugs Standard Control Organization (CDSCO) to manufacture small, non-commercial quantities of drugs for research, testing or analysis.

Instead, companies can proceed after submitting a prior online intimation to CDSCO. The exemption does not apply to a limited category of high-risk drugs, including cytotoxic drugs, narcotics and psychotropic substances, where licensing requirements will continue.

The change is expected to save at least 90 days in the drug development life cycle — a major boost for research timelines and innovation.

For categories where test licences remain mandatory, the statutory processing time has been cut from 90 days to 45 days. With CDSCO handling 30,000–35,000 test licence applications annually, officials say the reform will substantially ease regulatory pressure across the sector.

Faster clinical studies for generics

In another major reform, the Government has removed the requirement for prior approval for certain low-risk Bioavailability and Bioequivalence (BA/BE) studies.

These studies can now begin after a simple online intimation to CDSCO, enabling quicker start-up — particularly for the generic pharmaceutical industry, which relies heavily on BA/BE trials.

CDSCO processes around 4,000–4,500 BA/BE study applications each year, and the revised system is expected to sharply reduce procedural delays.

Digital-first implementation

To ensure smooth rollout, new online modules will be launched on the National Single Window System (NSWS) and the SUGAM portal, allowing companies to submit intimations transparently and without administrative friction.

Officials say the reforms will also help CDSCO optimise its existing manpower, improving regulatory efficiency without compromising oversight.

Strengthening India’s global R&D position

The Ministry said the amendments strike a balance between regulatory trust and safety, enabling faster testing, examination and initiation of studies across the drug development continuum.

“These reforms reinforce India’s commitment to trust-based regulation, aligned with the Jan Vishwas Siddhant and global best practices,” the Ministry said.

By reducing timelines and compliance costs, the Government aims to promote R&D-led growth, support innovation in the pharmaceutical sector, and strengthen India’s position as a preferred global hub for drug research and development.