Business

Govt plans easing of clinical trial rules to attract global pharma, faster approvals likely

Under this framework, companies conducting certain types of clinical trials—such as bioavailability and bioequivalence (BA/BE) studies—would no longer need to wait for formal approvals from the Central Drugs Standard Control Organization (CDSCO). Instead, they could initiate trials by merely informing the regulator, reducing both time and compliance costs.

• By Newsdesk
• New Delhi
• Sep 04, 2025

Business

In a landmark move poised to transform India’s pharmaceutical regulatory landscape, the Union Health Ministry has proposed draft amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. The reforms aim to slash bureaucratic hurdles, halve approval timelines, and strengthen India’s position as a preferred global hub for clinical research.

At the core of the amendments is a major shift from a cumbersome licensing system to a simplified notification-based model. Under this framework, companies conducting certain types of clinical trials—such as bioavailability and bioequivalence (BA/BE) studies—would no longer need to wait for formal approvals from the Central Drugs Standard Control Organization (CDSCO). Instead, they could initiate trials by merely informing the regulator, reducing both time and compliance costs.

The proposed changes also seek to cut the mandatory processing period for test licence applications from 90 days to 45. This acceleration is expected to ease drug development timelines, offering a boost to both domestic innovators and multinational pharmaceutical firms. The government anticipates that the number of license applications could drop by nearly 50 percent, thereby speeding up the initiation of trials and research activities across the country.

The draft amendment was published in the Gazette of India on August 28, inviting public feedback as part of the government’s broader “Ease of Doing Business” agenda. Officials emphasize that these reforms will bring India’s regulatory framework more in line with global practices, making the country a more attractive destination for clinical trials and pharmaceutical investment.

India currently lags behind major global competitors in the clinical trials space. In 2022, the country accounted for just 8 percent of global trials, compared to 29 percent in China and 25 percent in the United States. Industry leaders have repeatedly underscored that faster approvals and patient recruitment processes are vital if India is to capture a greater share of the international clinical research market.

The proposed overhaul is therefore being seen as a critical step toward modernizing regulations, enhancing efficiency, and positioning India as a competitive player in global drug development. If implemented effectively, these changes could translate into quicker access to innovative treatments for patients, greater foreign investment, and a stronger national R&D ecosystem.