India’s Central Drugs Standard Control Organisation (CDSCO) has not adopted artificial intelligence (AI) for regulatory approvals, the government informed Parliament on August 4. Chemicals and Fertilizers Minister Jagat Prakash Nadda stated that CDSCO continues to rely on scientific and technical review processes for drug approvals. The government also highlighted ongoing efforts to establish a regulatory framework for AI-enabled medical device software, according to medianama.com.
The response came during a Lok Sabha session when Sanjay Kumar Jha asked about the Department of Pharmaceuticals’ promotion of AI in drug discovery, clinical trials, and regulatory approvals. The government clarified that the Subject Expert Committee (SEC) examines clinical trial approvals and that the current process sufficiently addresses safety, efficacy, and regulatory accountability concerns. The government acknowledged the potential of AI but emphasized the importance of human oversight in critical decision-making related to medicines.
The government also noted that AI research in the pharmaceutical sector receives support through the Promotion of Research and Innovation in the Pharma-MedTech Sector (PRIP) scheme. This reflects a cautious approach toward integrating AI in regulatory processes, balancing innovation with patient safety. The move contrasts with some global regulators exploring AI tools for faster approvals but underscores India’s focus on maintaining rigorous scientific review standards.
The government’s statement on August 4 confirms that while AI is encouraged in research, CDSCO has not yet incorporated AI into its regulatory approval workflow. The PRIP scheme continues to fund AI-based research, but regulatory decisions remain grounded in expert human evaluation, as per medianama.com.