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Latest News & Updates
Digital Shift: CDSCO Mandates Online Submissions for r-DNA Post-Approval Changes
Digital Shift: CDSCO Mandates Online Submissions for r-DNA Post-Approval Changes

CDSCO now requires online submission of Post Approval Changes for r-DNA products through the SUGAM portal, ending offline applications.

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CDSCO Streamlines Drug Testing for Fast-Track Approvals
CDSCO Streamlines Drug Testing for Fast-Track Approvals

The circular dated 23-Feb-26 provides updated guidelines and instructions for [specific audience] to ensure compliance and operational alignment. Key highlights include purpose, key instructions, timelines, and support contacts.

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India Proposes Streamlined Registration for Ethics Committees (2026 Amendment)
India Proposes Streamlined Registration for Ethics Committees (2026 Amendment)

India has proposed a 2026 amendment to simplify and streamline the registration process for ethics committees, aiming to improve efficiency and compliance in clinical research oversight.

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Draft Notification on Post-Approval Changes under NDCT Rules, 2019: What Stakeholders Need to Know
Draft Notification on Post-Approval Changes under NDCT Rules, 2019: What Stakeholders Need to Know

The Ministry of Health and Family Welfare has issued a draft notification proposing amendments to the New Drugs and Clinical Trials Rules, 2019, to regulate post-approval changes. The draft introduces a risk-based classification of quality changes and out

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New CDSCO Guidance for IVD Imports in India 2026
New CDSCO Guidance for IVD Imports in India 2026

The Central Drugs Standard Control Organization (CDSCO) has recently released a new draft guidance document (2026) specifically for the import of In-Vitro Diagnostic (IVD) medical devices.

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