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Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

Indian CROs Will Need To Register Their Business From 1 April

 
• By Urtė Fultinavičiūtė

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

Domino, Impact, Continuity.
Compliance issues at one CRO can have a knock-on effect on multiple applications (Shutterstock)
Key Takeaways
  • The mandatory registration of Indian contract research organizations, starting 1 April, is expected to improve the quality and compliance of clinical research the country.
  • The new registration rules will pave the way for greater quality standards and instill confidence in Indian CROs, addressing past issues of high-profile non-compliance.
  • A compliance issue relating to one bioequivalence study or one CRO can have a far-reaching impact, as the same data can be used for multiple applications.

Contract research organizations based in India will be facing mandatory registration from 1 April in a bid to improve the country’s clinical research industry.

The registration portal was launched earlier in March, with the Central Drugs Standard Control Organization (CDSCO) providing a registration process manual. Along with all required documents, applicants will have to...

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