CDSCO Digitisation Cuts Post-Approval Change Timelines in CGTs from 218 to 98 Days: DCGI
New Delhi: The Drug Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), Dr Rajeev Raghuvanshi, has recently clarified that the approval process for major Post Approval Changes in Cell and Gene Therapies (CGTs) has been expedited, with durations reducing from 218 days in 2022 to 98 days in 2024.
This milestone was highlighted during the fourth follow-up meeting of the 24th PM-STIAC on 'Transforming the regulatory ecosystem of the medical products in India', chaired by Principal Scientific Adviser (PSA) to the Government of India, Prof. Ajay Kumar Sood, on August 19, 2025.
The PM-STIAC had earlier recommended improving the regulation of medical processes to create a transparent and accountable system while promoting innovation in reliable medical products for India and the world.
During the meeting, Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), updated the progress in priority areas and informed about key initiatives being undertaken. This included the successful launch of the State Drug Regulatory Index on August 12, 2025, which benchmarks states based on the performance of their drug regulators through an objective evaluation mechanism. Prof. Sood remarked that such competitive benchmarking would bring all states into the system and significantly raise the overall standard of drug regulation in the country.
Dr. Raghuvanshi also informed about the release of a comprehensive guidance framework for Subject Expert Committees (SECs), providing clear guidelines on the application review process. He highlighted that the rollout of digital dashboards for tracking and prioritisation has substantially reduced application processing timelines. For example, in the case of CT-04 applications for Global Clinical Trials for CGTs, the time taken from application submissions to SEC deliberations has dropped from 226 days in 2022 to just 40 days in 2024.
Along with these measures, CDSCO has also operationalised several digital systems, including analytics for Not of Standard Quality (NSQ) data, a Dual-Use No Objection Certificate (NOC) platform, and a digital system for the WHO Certificate of Pharmaceutical Product. These initiatives are creating a harmonised national database and enhancing transparency in the regulatory framework. Additionally, in alignment with global norms, CDSCO has prepared biosimilar guidance to facilitate enhanced access to biologics in India.
Prof. Sood emphasised the importance of defining long-term, quantifiable milestones for India’s regulatory system in line with international gold standards, including periodic internal audits and measurable targets. He noted that the ongoing transformation will enhance patient safety, strengthen domestic capabilities, and provide Indian manufacturers with a competitive edge in global markets. Acknowledging the progress made so far, he reiterated that these reforms will boost trust in India’s regulatory framework, improve predictability and credibility, and enable quicker access to safe, affordable medical products through innovation.
The review meeting 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; and Mr. Apoorv Chouhan, Project Manager, One Health PMU, Office of PSA. They were joined by Shri Nikhil Gajraj, Joint Secretary, Department of Health and Family Welfare.
