India's drug regulatory authority has achieved a breakthrough in streamlining approval processes for advanced therapies, with digital transformation initiatives cutting cell and gene therapy review times by more than 80%. The Central Drugs Standard Control Organisation (CDSCO) reported that global clinical trial applications for cell and gene therapies now take just 40 days from submission to Subject Expert Committee deliberations, down from 226 days in 2022.
Dramatic Timeline Reductions Through Digital Innovation
Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), announced these improvements during a follow-up meeting on "Transforming the regulatory ecosystem of the medical products in India," chaired by Principal Scientific Adviser Ajay Kumar Sood. The digital dashboard rollout has been the primary driver behind these efficiency gains.
The impact extends beyond initial approvals to post-market modifications. CT-04 applications for post-approval changes in cell and gene therapies have seen processing times reduced from 218 days in 2022 to 98 days in 2024, representing a 55% improvement in regulatory efficiency.
Comprehensive Regulatory Framework Overhaul
The digitization initiative encompasses multiple regulatory improvements beyond timeline reductions. CDSCO has released a comprehensive guidance framework for Subject Expert Committees (SECs), providing clear guidelines on the application review process. This standardization aims to create more predictable and transparent regulatory pathways for pharmaceutical companies.
The organization has also established a harmonized national database that unifies analysis processes for pharmaceutical product certification according to World Health Organisation (WHO) standards. This alignment with international standards positions India's regulatory framework to meet global benchmarks while maintaining domestic oversight.
State-Level Performance Benchmarking
On August 12, 2025, CDSCO launched the State Drug Regulatory Index, an evaluation system designed to benchmark state-level drug regulator performance through objective evaluation mechanisms. Principal Scientific Adviser Sood emphasized that "such competitive benchmarking would bring all states into the system and significantly raise the overall standard of drug regulation in the country."
Enhanced Access to Biologics
As part of the broader regulatory modernization, CDSCO has prepared biosimilar guidance aligned with global standards. This development is expected to facilitate enhanced access to biologics—medicines derived from living organisms or their components, including cells, proteins, or nucleic acids—throughout India.
The regulatory improvements reflect recommendations from the PM-STIAC (Prime Minister's Science, Technology and Innovation Advisory Council) to create a transparent and accountable system while promoting innovation in reliable medical products for both domestic and international markets.
