India CDSCO News: Clinical and Bioequivalence Procedures for Regulatory Efficiency
- Sharan Murugan
- 1 hour ago
- 2 min read
Last week, two pivotal updates were introduced: the Union Health Ministry proposed major amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, and CDSCO issued a new circular on leveraging IBSC (Institutional Biosafety Committee) approval for test material permissions. Both initiatives aim to streamline processes and enhance regulatory agility.
Released by the Press Information Bureau on 3 September 2025, these amendments reflect the Prime Minister’s push for ease of doing business within the pharma and clinical research sectors. The key changes include:
Test Licences Simplified: Applicants will now notify rather than await a licence—except for limited high-risk drugs. This bypasses long wait times and eases administrative burden.
Reduced Processing Time: The statutory review period for test licence applications now drops from 90 to 45 days.
BA/BE Study Licensing Relaxed: Certain bioequivalence study categories no longer require licensing—initiated instead via intimation to the Central Licensing Authority.These reforms are expected to slash licensing application volumes by around 50%, enabling faster initiation of crucial BA/BE studies and improving drug development timelines. The updated process also allows CDSCO to better manage its human resources and apply oversight more effectively—all contributing toward regulatory modernization
On the same day, CDSCO issued a circular permitting the use of IBSC approval in lieu of formal licensing, specifically for the manufacture of test items for examination and analysis when following the form CT-10.This circular, issued on 3 September 2025, enables institutions to rely on Institutional Biosafety Committee (IBSC) clearances from recombinant DNA meetings, facilitating faster and smoother conduct of lab-based testing without the need for extra regulatory steps.
Regulatory Impact in Practice
Domain | Previous Process | New Procedure | Primary Benefit |
Test Licence | Formal licence + 90-day review | Notification-based + 45-day processing | Faster approvals, reduced paperwork |
BA/BE Study Approval | Licence required for many study types | Intimation accepted for key categories | Quicker clinical study initiation |
Test Material Permission | Formal licences for IBSC-related materials | IBSC approval via circular replaces licence | Simplified internal testing workflows |
Why This Matters to Pharma Stakeholders
Drug Developers & CROs can now accelerate study timelines, skip redundant approvals, and start critical testing faster.
Academic & Institutional Labs benefit from streamlined procedures, especially for internal product testing and analysis.
Regulators gain capacity for better oversight while reducing manual processing stages—a win for efficiency and compliance.
Public Health stands to gain from quicker access to data, faster drug development, and potentially more competitive and timely market entries.
With the proposed amendment to the NDCT Rules and the CDSCO circular enabling IBSC-based permissions, India is taking significant strides toward regulatory modernization. Together, these reforms underscore a commitment to reduce red tape, align with global best practices, and strengthen India's position in clinical and pharmaceutical innovation.