**Summary:**
On August 19, 2025, Principal Scientific Advisor (PSA) to the Government of India, Prof. Ajay Kumar Sood, chaired the fourth follow-up meeting regarding the transformation of India's regulatory ecosystem for medical products, a key recommendation from the Principal Minister's Science, Technology and Innovation Advisory Council (PMSTIAC). The meeting focused on progress updates from the Central Drugs Standard Control Organisation (CDSCO), presented by Drug Controller General of India (DCGI) Dr. Rajeev Raghuvanshi, regarding priority areas aimed at enhancing transparency, accountability, and innovation within the regulatory framework.
Key initiatives highlighted included the successful launch of the State Drug Regulatory Index on August 12, 2025, designed to benchmark states based on the performance of their drug regulators. The release of a comprehensive guidance framework for Subject Expert Committees (SECs) to standardize the application review process was also noted. Furthermore, the implementation of digital dashboards for tracking and prioritization has demonstrably reduced application processing timelines. As an example, the processing time for CT04 applications for Global Clinical Trials for Cell and Gene Therapy (CGTs) has decreased from 226 days in 2022 to 40 days in 2024. Similarly, the approval process for major Post Approval Changes in CGTs has been expedited, from 218 days in 2022 to 98 days in 2024.
Beyond digitization measures at CDSCO, digital systems for Not of Standard Quality (NSQ) data, Dual-Use No Objection Certificates (NOCs), and WHO Certificate of Pharmaceutical Product have been operationalized, creating a harmonized national database. CDSCO has also prepared biosimilar guidance in alignment with global norms to facilitate enhanced access of biologics.
Prof. Sood emphasized the importance of establishing long-term, quantifiable milestones aligned with international gold standards. He expects the ongoing transformation to improve patient safety, strengthen domestic capabilities, and enhance the competitiveness of Indian manufacturers in global markets. He also reiterated that these reforms will strengthen trust in India’s regulatory framework, boost predictability and global credibility, and facilitate quicker access to safe, affordable medical products through innovation within the country.
Attendees included Dr. Parvinder Maini, Scientific Secretary, Office of PSA; Dr. Sindura Ganapathi, PSA Fellow; Dr. Sangeeta Agarwal, Scientist F, Office of PSA; Mr. Apoorv Chouhan, Project Manager, One Health PMU from Office of PSA and Shri Nikhil Gajraj, Joint Secretary, Department of Health and Family Welfare.
Key Entities Referenced
Prof. Ajay Kumar Sood: Principal Scientific Advisor (PSA) to the Government of India, chaired the review meeting.
PMSTIAC: Prime Minister’s Science, Technology and Innovation Advisory Council. Recommended improving the regulation for medical processes.
Dr. Rajeev Raghuvanshi: Drug Controller General of India (DCGI).
Central Drugs Standard Control Organisation CDSCO: The national regulatory body for pharmaceuticals and medical devices in India.
State Drug regulatory Index: An index to benchmark states based on the performance of their drug regulators.
Subject Expert Committees SECs: Committees that review applications, for which a comprehensive guidance framework has been released.
Cell and Gene Therapy CGTs: A category of medical treatments involving the modification of cells or genes. CT04 applications are for global clinical trials.
Department of Health and Family Welfare: A department of the Government of India.
Office of Principal Scientific Advisor to GoI
PSA Prof. Ajay Kumar Sood chaired the 4th review
meeting on progress to improving India's regulatory
ecosystem for medical products
Posted On: 20 AUG 2025 6:26PM by PIB Delhi
The fourth follow-up meeting of 24th PM-STIAC meeting on ‘Transforming the regulatory ecosystem of the
medical products in India’ was chaired by Prof. Ajay Kumar Sood, Principal Scientific Adviser (PSA) to the
Government of India on August 19, 2025. The PM-STIAC meeting recommended improving the regulation
for medical processes to create a system that ensures transparency, and accountability while promoting
innovation in reliable medical products for India and the world.
Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), Central Drugs Standard Control
Organisation (CDSCO) updated the progress in priority areas, and informed about the initiatives being
undertaken. This included a successful launch of the State Drug regulatory Index on August 12, 2025, where
states will be benchmarked based on the performance of state drug regulators through an objective evaluation
mechanism. Prof. Sood remarked that such competitive benchmarking would draw all States into the system
and significantly raise the overall standard of drug regulation in India.
Dr. Raghuvanshi informed about the release of a comprehensive guidance framework for Subject
Expert Committees (SECs) which provides guidelines on application review process. He further
informed that the rollout of digital dashboards for tracking and prioritisation has helped reduce
processing timelines of applications. For instance, in case of CT-04 applications for Global Clinical
Trials for Cell and Gene Therapy (CGTs), the number of days from application submissions to SEC
deliberations has decreased significantly, from 226 days in 2022 to 40 days in 2024. Similarly, the
approval process for major Post Approval Changes in CGTs has been expedited, with durations of
218 days in 2022 to 98 days in 2024.Along with the digitisation measures at CDSCO, a digital system with analytics for NSQ (Not of
Standard Quality) data, Dual-Use NOC (No Objection Certificate), and digital system of WHO
(World Health Organisation) Certificate of Pharmaceutical Product have also been operationalised,
creating a harmonised national database and enhancing transparency. Further, in alignment with
the global norms, CDSCO has prepared biosimilar guidance which will facilitate enhanced access of
biologics in the country.
Prof. Sood emphasised the importance of defining long-term, quantifiable milestones for India’s regulatory
system, towards international gold standards including periodic internal audits and measurable targets. He
stated that the ongoing transformation is expected to enhance patient safety and domestic capabilities while
also giving Indian manufacturers a competitive edge in global markets. Acknowledging the progress, the PSA
reiterated that these reforms will strengthen trust in India’s regulatory framework, boost predictability and
global credibility, and facilitate quicker access to safe, affordable medical products through innovation within
the country.
The review was also attended by Dr. Parvinder Maini, Scientific Secretary, Office of PSA; Dr.
Sindura Ganapathi, PSA Fellow; Dr. Sangeeta Agarwal, Scientist ‘F’, Office of PSA; Mr. Apoorv
Chouhan, Project Manager, One Health PMU from Office of PSA. They were joined by Shri Nikhil
Gajraj, Joint Secretary, Department of Health and Family Welfare.
***
MJPS/ST
(Release ID: 2158529)