CDSCO Digitisation Cuts Post-Approval Change Timelines in CGTs from 218 to 98 Days: DCGI

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.