Pharmacovigilance for clinical trials in India: Current practice and areas for reform
2011
Pharmacovigilance for Clinical Trials in India: Current Practice and Areas for Reform
publication
Author Information
Author(s): Brahmachari Ballari Fernandes, Melanie Bhatt, Arun
Primary Institution: Clininvent Research Pvt. Ltd.
Hypothesis
This article explores potential areas of Indian pharmacovigilance requiring reform.
Conclusion
The study highlights the need for a robust pharmacovigilance system in India that aligns with international standards.
Supporting Evidence
- India's clinical research industry is relatively new, highlighting the need for improved pharmacovigilance.
- Amended Schedule Y introduced legal support for safety reporting in India.
- Current guidelines have discrepancies that need to be addressed to align with global practices.
Takeaway
This study talks about how India needs to improve its safety reporting for clinical trials to keep up with global practices.
Limitations
The article does not provide specific data or case studies to support its recommendations.
Digital Object Identifier (DOI)
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