CDSCO (India)
NOTICE
larification on the submission of applications for grant of Permission to Import and Market New Drugs not approved anywhere in the world, wherein phase III Global Clinical Trials (GCT) are ongoing or completed with participation of Indian subjects under the New Drugs and Clinical Trials Rules, 2019
Published: 8/10/2026Detected: 8/11/2026
Summary preview
Clarifies the regulatory submission pathway under India’s New Drugs and Clinical Trials Rules, 2019 for granting Permission to Import and Market new drugs that are not approved anywhere globally when Phase III Global…
Get the full analysis, free
Create a free account to see the complete summary, key takeaways, and why this matters for your products, and to get alerts like this by email.
Create free accountOfficial Source Document Source Verified
Access the original document directly from INDIA CDSCO.
More from CDSCO (India)
- Indiscriminate use of painkillers (NSAIDs), antibiotics and associated risk of Chronic Kidney Disease9/22/2026
- LIST OF REGISTRED BA-BE STUDY CENTRE & BIO-ANALYTICAL LABORATORY under NDCT Rules 20199/18/2026
- Public Health alert against the use of unauthorised Cosmetics Products9/14/2026
- 2026.09.08 G.S.R. 791(E)_Draft notification for amendment in the Drugs Rules 1945 regarding mandatory installation of CCTV surveillance system at sales premises9/8/2026
- Drug Regulatory and Law Enforcement Agencies Intensify Coordinated Action Against Illegal Manufacture and Distribution of Misbranded Drugs9/5/2026