Current Affairs · New Drugs and Clinical Trials Rules
Consider the following statements regarding the New Drugs and Clinical Trials (NDCT) Rules: Statement I: Under the NDCT Rules, the requirement of obtaining a test licence from the Central Drugs Standard Control Organisation (CDSCO) has been completely abolished for all categories of drugs used in research and clinical trials. Statement II: Bioavailability and Bioequivalence (BA/BE) studies for low-risk categories of drugs can be initiated on the basis of prior intimation to CDSCO without obtaining prior permission. Which of the statements given above is/are correct?
Verified Solution4 OptionsUpdated: October 2026👁️1 View
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- 1None
- 2Both I and II
- 3II only✓
- 4I only
Correct answer
II only
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