Government moves to trim red tape around drug research

In a bid to improve ease of doing business in drug research, India’s Union Health Ministry has proposed changes to the New Drugs and Clinical Trials (NDCT) Rules, 2019, following Prime Minister Narendra Modi’s directive to simplify regulations and support the pharmaceutical sector. The amendments, published in the Gazette of India on 28 August 2025, are now open for public feedback.

Currently, companies that wish to conduct laboratory tests on new drug formulations must secure a formal licence from the Central Licensing Authority, a process that can take up to 90 days. The proposed rules aim to make this process more flexible. For most drugs, companies would only need to notify the regulator before starting tests, rather than wait for approval, the government said in a statement. Only high-risk drugs—those with potentially serious side effects or stricter safety requirements—would still need a full licence. The notification system is expected to reduce the waiting period to 45 days, the statement added.

The amendments also cover Bioavailability and Bioequivalence (BA/BE) studies, which assess how a drug is absorbed and behaves in the body compared with its original or reference version. These studies ensure that generic medicines perform as safely and effectively as the original branded drugs. The government said that under the proposed changes, many BA/BE studies would no longer require a licence to begin, and companies could proceed after notifying the regulator.

India has emerged as a significant hub for BA/BE studies, with its data accepted by global regulators including the US FDA, the European Medicines Agency (EMA), Health Canada, and the Australian Therapeutic Goods Administration, according to Credevo, 2025. This recognition underscores the quality and reliability of Indian clinical research, attracting international pharmaceutical companies.

The proposed reforms are expected to reduce licence applications by around 50 per cent, enabling research to begin more quickly and cutting delays in drug launches, the government said. The Central Drugs Standard Control Organization (CDSCO), India’s main drug regulator, would also be able to deploy staff more efficiently, focusing on oversight and safety monitoring instead of paperwork, the statement added.

As per government data, India’s pharmaceutical market was valued at USD 50 billion in FY23-24, with domestic consumption at USD 23.5 billion and exports at USD 26.5 billion. India ranks third globally in market volume and 14th by value. The Indian clinical trials market is valued at USD 1.42 billion in 2024 and is projected to grow at a CAGR of 8% from 2025 to 2030, according to Grand View Research, 2024. India conducted approximately 3,674 clinical trials in 2023, representing around 8% of the global clinical trial market, as per Clival, 2023.

The move is part of the government’s broader effort to enhance ease of doing business in drug research. By simplifying procedures, reducing timelines, and aligning India’s regulations with international standards, these changes aim to make the country a more attractive destination for clinical research and strengthen its role in global drug development, the government said.