Date of Publication: 02-Feb-2026
INTELLIGENCE OVERVIEW
Agency: Central Drugs Standard Control Organization – India/ Ministry of Health & Family Welfare – India
The Ministry of Health and Family Welfare (MoHFW), India, has issued a draft notification (G.S.R. 97(E)) proposing amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, introducing a risk-based classification of post-approval quality changes.
Industry Impact
The proposed framework will significantly affect pharmaceutical manufacturers and MAHs by:
- Introducing Level I (major), Level II (moderate), and Level III (minor) quality change categories
- Requiring prior regulatory approval for major and moderate changes
- Allowing implementation with annual reporting for minor changes
- Aligning India’s post-approval change management with global best practices
Overall, this proposal signals a shift toward predictable, lifecycle-focused regulation, enabling faster innovation while maintaining product quality and patient safety.
Keywords: Quality Changes, Lifecycle Management, Manufacturing Changes
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NTI=