India Tightens Oversight Of CROs With Mandatory Registration

 
• By Vibha Sharma
  
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Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.

A CRO May Be Inspected With Or Without Prior Consent Under New Rules

The Indian government has made legislative changes to introduce mandatory registration requirements for clinical research organizations, also referred to as contract research organizations in some jurisdictions, to better oversee their conduct and operations.

Key Takeaways

  • The Indian government has amended its 2019 clinical trials rules to introduce mandatory registration requirements for clinical research organizations (CROs).

The new rules, effective from 1 April 2025, specify strict conditions for the initial registration of CROs with the central...

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India Tightens Oversight Of CROs With Mandatory Registration

 
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Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.

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