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India CDSCO Notice: Draft Notification on Post-Approval Changes (PAC) in Drugs
India’s Central Drugs Standard Control Organization (CDSCO) has released a draft notification dated 09 March 2026 proposing amendments to the Drugs Rules, 1945 to establish a structured framework for managing post-approval manufacturing changes. This draft notification introduces clear regulatory requirements for notifying authorities when manufacturers make changes to manufacturing processes, excipients, packaging, shelf life, specifications, testing procedures, or docume

Sharan Murugan
2 days ago2 min read
