The Union Health Ministry has proposed amendments to streamline regulations for new drug testing and clinical trials in India, with the stated aim of promoting ease of doing business and strengthening the country’s position as a global hub for pharmaceutical research. The initiative focuses on simplifying licensing requirements and reducing procedural delays in the pharmaceutical and clinical research sectors.
According to the Ministry, the proposed changes target the New Drugs and Clinical Trials (NDCT) Rules, 2019. The draft notification, published in the Gazette of India on August 28, has been opened for public comments. Officials said the move reflects the government’s ongoing push for regulatory reforms in the pharmaceutical sector, part of wider efforts to align Indian processes with global standards.
The amendments propose converting the current system of obtaining test licences into a notification or intimation-based mechanism. Under this model, applicants for most categories would no longer need to wait for formal licence approvals before commencing work. Instead, they would simply be required to notify the Central Licensing Authority, except in the case of high-risk drugs which would still undergo the licensing process.
In addition, the statutory processing time for test licence applications will be reduced from 90 days to 45 days, effectively halving the waiting period for applicants. The Health Ministry said these steps are intended to reduce bureaucratic hurdles and allow research activities to proceed faster, thereby cutting delays in the drug development and approval pipeline.
The amendments also propose doing away with the existing licence requirement for certain categories of Bioavailability/Bioequivalence (BA/BE) studies. These studies, which measure how drugs behave in the body and whether generics are equivalent to branded versions, are a key part of pharmaceutical research. Under the new framework, they could be initiated simply by notifying the Central Licensing Authority, rather than waiting for approvals.
Officials highlighted that the changes would bring several tangible benefits for the pharmaceutical industry. It is estimated that the number of licence applications submitted could be reduced by nearly 50 per cent. This would not only ease compliance burdens for companies but also allow quicker initiation of BA/BE studies and testing, reducing delays that often slow down the introduction of new drugs to the market.
The Ministry also noted that the changes would help optimise the resources of the Central Drugs Standard Control Organization (CDSCO). With fewer applications requiring detailed scrutiny, the regulatory body could redeploy its human resources more efficiently, focusing on higher-risk cases and strengthening overall oversight.
The proposed reforms are being framed against the backdrop of India’s rising profile in the global pharmaceutical sector. Already known as the “pharmacy of the world” for its role in producing affordable generic drugs, India is also positioning itself as a centre for pharmaceutical research and clinical trials. Streamlined regulations are expected to make India more attractive for global pharmaceutical companies seeking to conduct research and development in cost-effective and technically capable environments.
Industry observers note that regulatory bottlenecks have often been a sticking point for the sector, deterring investment and slowing research progress. By reducing timelines and simplifying procedures, the amendments aim to address these challenges while ensuring that safety and quality standards remain intact.
While the notification is currently open for feedback, the Health Ministry emphasised that the reforms are part of its broader commitment to creating an enabling environment for pharmaceutical innovation. If implemented, the changes could shorten the journey from research to approval, enhance India’s competitiveness, and encourage greater participation by domestic and international players in clinical research.
The Ministry’s announcement signals an important step toward striking a balance between regulatory rigour and ease of business, with the ultimate goal of improving access to safe, effective, and timely medicines for patients in India and beyond.
