# Regulator mandates full review of globally unapproved drugs 2026-08-12T22:04:16+00:00 | Governance | Indian Opinion Desk Corroboration: 1 independent outlet India's drug regulator has clarified that new drugs not yet approved anywhere in the world must undergo the full domestic regulatory process, even if Indian patients participated in global clinical trials. The Central Drugs Standard Control Organisation (CDSCO) issued a circular on August 10 after noticing a rise in applications to import and market such drugs, which were either under review abroad or had completed phase III global trials with Indian subjects. The CDSCO's internal technical committee decided that these investigational new drug applications must go through the IND division under the New Drugs and Clinical Trials Rules, 2019. An official said companies cannot use Indian participation in global trials as a shortcut. The move ensures thorough safety and efficacy evaluation before any such drug reaches Indian shores. ## Coverage - economictimes.indiatimes.com Tags: CDSCO, clinical trials, drug regulation, India, new drugs, pharma Canonical: https://indianopinion.org/regulator-mandates-full-review-of-globally-unapproved-drugs/ License: Summary and commentary (c) Indian Opinion, reusable with attribution. Facts belong to the linked sources. Cite: https://indianopinion.org/regulator-mandates-full-review-of-globally-unapproved-drugs/#story-in-brief Review state: restored archive article, accurate at time of publication, not offered to search indexes.