#HealthMinistry #NDCTRules #ClinicalTrials #PharmaIndia #EaseOfDoingBusiness #DrugDevelopment #ClinicalResearch #BA_BEStudies #ModiGovernment #PharmaGrowth
New Delhi – In a significant step towards regulatory reform and ease of doing business, the Union Health Ministry has announced amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at simplifying procedures for test licence applications and bioavailability/bioequivalence (BA/BE) study approvals.
The proposed amendments, published in the Gazette of India on August 28, 2025, are now open for public comments before their final adoption. The move comes under the direction of Prime Minister Narendra Modi, who has emphasized reducing compliance burdens and promoting India as a global hub for pharmaceutical research and development.
Shift from Licence to Intimation System
One of the most impactful changes in the proposed amendments is the conversion of the existing licence system for test licences into an intimation/notification system.
At present, companies must wait for official approval from the Central Licensing Authority (CLA) before conducting tests on drugs. Under the new system, applicants will only need to intimate the CLA, allowing them to proceed without delays—except in cases involving high-risk category drugs, where licensing will still be required.
Additionally, the statutory processing time for test licence applications will be halved from 90 days to 45 days, significantly speeding up the initiation of testing activities and clinical evaluations.
BA/BE Studies to Become Faster and Simpler
The amendments also propose major reforms for bioavailability and bioequivalence (BA/BE) studies, which are essential for evaluating the safety and effectiveness of generic drugs.
Currently, BA/BE studies require a formal licence from regulators. Under the revised rules, certain categories of BA/BE studies will no longer require licensing. Instead, companies will only need to submit an intimation or notification to the CLA before initiating such studies.
This move is expected to cut down bureaucratic delays, enabling quicker drug development and smoother pathways for generic drug approvals—an important factor in maintaining India’s role as a leading global supplier of affordable medicines.
Efficiency Gains for CDSCO
By reducing the number of applications requiring active licensing intervention, the amendments are expected to reduce regulatory filings by nearly 50%.
This will allow the Central Drugs Standard Control Organization (CDSCO) to redeploy its human resources more efficiently, focusing regulatory oversight on high-risk drugs and critical approvals rather than routine, low-risk applications.
The streamlined process is expected to not only enhance the efficiency of regulatory reviews but also improve transparency and predictability for stakeholders across the pharmaceutical and clinical research sectors.
Boost for Ease of Doing Business
The amendments are part of the government’s broader agenda of regulatory reform across sectors to promote Ease of Doing Business (EoDB).
For the pharmaceutical industry, which is one of India’s strongest global sectors, these changes could prove transformative. By reducing compliance timelines, paperwork, and approval bottlenecks, the amendments will accelerate drug development pipelines, making it easier for Indian companies to innovate, test, and bring new products to market.
Officials noted that the changes are also aligned with global best practices, helping India position itself as a preferred destination for clinical trials and research investments.
Impact on India’s Pharma Growth Story
India is already known as the “pharmacy of the world”, with its pharmaceutical industry playing a pivotal role in supplying affordable medicines worldwide. With the global demand for generics, vaccines, and innovative therapies rising, regulatory reforms like these are critical to:
-
Attract foreign investment in clinical research.
-
Enhance competitiveness of Indian pharma companies.
-
Accelerate timelines for drug approvals and exports.
-
Strengthen India’s R&D ecosystem by removing unnecessary delays.
Experts suggest that quicker initiation of BA/BE studies will also reduce the time-to-market for new drugs, benefitting patients through faster access to affordable therapies.
Government’s Reform-Oriented Approach
This initiative underscores the Modi government’s continued commitment to fostering a supportive ecosystem for industries through simplification of procedures and reduction of regulatory bottlenecks.
In recent years, India has launched several reforms to align its pharma regulations with international standards, improve transparency, and support innovation. The latest amendments to the NDCT Rules are expected to further enhance India’s credibility as a trusted and efficient global pharmaceutical hub.
Conclusion
The Union Health Ministry’s proposal to amend the New Drugs and Clinical Trials Rules, 2019 marks a bold and progressive step towards streamlining drug testing and clinical research regulations in India. By shifting from a licence-based system to an intimation-based process for test licences and BA/BE studies, and by halving approval timelines, the government is creating a more efficient, predictable, and industry-friendly environment.
For India’s pharma sector—which is already poised to grow into a $130 billion industry by 2030—such reforms could unlock new levels of innovation, investment, and global leadership.
Hashtags:
#HealthMinistry #NDCTRules #ClinicalTrials #PharmaIndia #EaseOfDoingBusiness #DrugDevelopment #ClinicalResearch #BA_BEStudies #ModiGovernment #PharmaGrowth
