प्रतिकूल प्रतिक्रिया रिपोर्टिंग में चूक के लिए जुर्माना
Definition
Mandatory pharmacovigilance under PvPI requires reporting all suspected ADRs for herbal/Ayurvedic medicines to CDSCO. Non-compliance results in fines under Drugs & Cosmetics Act.
Key Findings
- Financial Impact: ₹5-50 lakhs per violation (statutory fines); 20-40 hours/month manual reporting per clinic
- Frequency: Per unreported serious ADR; ongoing for high-volume dispensaries
- Root Cause: Manual documentation delays, lack of standardized PvPI forms, under-reporting of herbal ADRs
Why This Matters
The Pitch: Alternative Medicine players in India waste ₹5-50 lakhs annually on ADR reporting fines and compliance audits. Automation of adverse reaction documentation eliminates this risk.
Affected Stakeholders
Ayurvedic practitioners, Herbal product manufacturers, Clinic owners
Deep Analysis (Premium)
Financial Impact
Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.
Current Workarounds
Financial data and detailed analysis available with full access. Unlock to see exact figures, evidence sources, and actionable insights.
Get Solutions for This Problem
Full report with actionable solutions
- Solutions for this specific pain
- Solutions for all 15 industry pains
- Where to find first clients
- Pricing & launch costs
Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
प्रतिकूल प्रतिक्रियाओं से उपभोक्ता मुआवजा
एडआर दस्तावेजीकरण पर अनावश्यक श्रम लागत
रेफरल कतार हानि
GST अनुपालन दंड
रेफरल भुगतान विलंब
रेफरल कमीशन चोरी
Request Deep Analysis
🇮🇳 Be first to access this market's intelligence