Pharmacovigilance (PV) Legislation in the USA and India:
Pharmacovigilance in the USA:
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Regulatory Body: The Food and Drug Administration (FDA) regulates pharmacovigilance through its Center for Drug Evaluation and Research (CDER), with an emphasis on post-market drug safety. The FDA also manages adverse event reports through the FDA Adverse Event Reporting System (FAERS).
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Legal Framework: Pharmacovigilance in the USA is governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act), updated by the Food and Drug Administration Amendments Act of 2007 (FDAAA). This law enhanced the FDA’s authority to enforce pharmacovigilance requirements, particularly for post-market safety.
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Key Elements:
- Risk Evaluation and Mitigation Strategies (REMS): For high-risk drugs, manufacturers must implement REMS to ensure the benefit-risk balance remains favorable.
- Adverse Event Reporting: Manufacturers must report adverse events to FAERS, and both healthcare professionals and patients can report voluntarily.
- Sentinel Initiative: This system uses electronic health data to actively monitor drug safety in the real world.
- Periodic Adverse Drug Experience Reports (PADERs): These must be submitted regularly to assess ongoing drug safety.
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Transparency: FAERS provides public access to safety data, but compared to other regions (like the EU), it can offer more limited transparency concerning detailed risk assessments.
Pharmacovigilance in India:
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Regulatory Body: The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, governs pharmacovigilance. India’s PV program is supported by the Indian Pharmacopoeia Commission (IPC) and coordinated through the Pharmacovigilance Programme of India (PvPI).
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Legal Framework: Pharmacovigilance is governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945, with amendments and specific guidelines issued by the CDSCO. In recent years, India has made significant strides to align its PV system with international standards.
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Key Elements:
- Adverse Event Reporting: Reports of adverse drug reactions (ADRs) are collected through VigiFlow, a global PV software used by PvPI. Healthcare professionals and patients can report ADRs through a centralized system.
- Risk Management: Although Risk Evaluation and Mitigation Strategies (REMS) are not as formalized as in the USA, India is working on improving post-market surveillance.
- Periodic Safety Update Reports (PSURs): PSURs are mandatory and must be submitted periodically to CDSCO for continued drug safety evaluation.
- Signal Detection and Management: PvPI has a well-established signal detection process to identify new drug safety concerns.
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Transparency: PvPI provides public access to some safety data but is less centralized and accessible than FAERS. India is gradually working on improving its transparency measures, especially in the area of public reporting.
Comparative Analysis:
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Regulatory Structure: Both the USA (through the FDA) and India (through CDSCO and PvPI) have well-defined regulatory frameworks, but the USA's system is more established with extensive post-market surveillance mechanisms like REMS and the Sentinel Initiative.
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Risk Management: The USA has a more structured and proactive approach to managing drug risks, particularly with REMS for high-risk drugs. India is evolving in this area and is focusing more on PSURs and voluntary reporting through VigiFlow.
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Reporting Systems: Both countries allow healthcare professionals and patients to report adverse events, but the USA has the added advantage of the Sentinel Initiative, which actively monitors drug safety using electronic health records. India relies on a more traditional ADR reporting system but is enhancing its capabilities through PvPI.
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Transparency: Both countries provide access to safety data, but the USA's FAERS and Sentinel systems offer broader public access compared to India's PvPI, though India is making strides toward greater transparency.
Conclusion: Both the USA and India have robust pharmacovigilance frameworks, with the USA having a more mature system due to advanced risk management strategies and data monitoring tools like REMS and Sentinel. India is rapidly advancing its PV practices, particularly since the launch of PvPI, and is aligning its regulatory practices with global standards.
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