Pharmacovigilance Services in India

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in India, access to Pharmacovigilance Services in India is vital for ensuring drug safety services India and regulatory compliance. From adverse drug reaction reporting to post-marketing surveillance, the right local pharmacovigilance partner in India shapes everything including signal detection, risk management planning, safety reporting, and market safeguarding.

The Pharmacovigilance Programme of India (PvPI), coordinated by the National Coordination Centre - Indian Pharmacopoeia Commission (IPC) in Ghaziabad under the leadership of the Central Drugs Standard Control Organisation (CDSCO), oversees the benefit–risk profile of medicines and ADR reporting in India. ADR data is collected from ADR Monitoring Centres (AMCs) across India, drawn from voluntary reports by healthcare professionals, other HCPs, consumers, and Marketing Authorization Holders (MAH), and reported to NCC-PvPI via IPC and CDSCO platforms. That data is subsequently analyzed to detect new safety signals or generate safety insights for existing drugs. However, a persistent challenge is under-reporting of adverse events, which PvPI aims to address through capacity building and awareness campaigns.

• + ICSR Processing and Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing via E2B(R3)-compliant systems integrated with WHO DD and MedDRA
  • Quality checks, medical reviews, and submissions per agency timelines
  • Monitoring/tracking ICSRs; customer reconciliation processes
• + Risk Management Plan
  • Drafting, reviewing, and maintaining RMPs and REMS
  • Custom procedures to classify safety risks and deliver tailored risk management services
  • Assessing risks and missing data, recommending mitigation methods
  • Implementing post-authorization measures like PASS, academic materials, observational studies, questionnaires
  • Conveying risks via labeling (SmPC, PIL)
• + Aggregate Reports
  • Periodic Benefit–Risk Evaluation Reports (PBRERs)
  • Periodic Safety Update Reports (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Detecting new safety signals or risk changes from ICSRs, literature, aggregate reports, regulatory websites
  • Using in-house tools/databases for signal tracking and analysis
  • Reviewing signal assessments including PRAC recommendations
  • Performing label update analyses
  • Recommending risk minimization strategies
  • Preparing Signal Management Tracker and Annual Signal Reports
• + PV Services & Oversight (Including PvOI Support)
  • Appointment and ongoing support of Pharmacovigilance Officer In-charge (PvOI), as mandated for Marketing Authorization Holders in India under PvPI requirements
  • PvOI ensures end-to-end compliance with local pharmacovigilance guidelines, maintains communication with CDSCO/IPC, and oversees ADR reporting
  • Reviewing PSMF, SDEA agreements, PV SOPs
  • Signing off on Aggregate reports, Signal Reports, and RMPs
  • Retainer services for QPPV (if required for global operations) and PvOI as local safety contact
  • Monthly reconciliation and compliance metric reporting
  • Monthly communication reports and medical review, with quarterly Signal Surveillance Meetings
  • Oversight of PV Quality Management Systems
• + PV Audit & Compliance
  • Auditing for compliance with PV guidelines, SDEAs, SOPs, and work instructions
  • Designing audit plans and mock audits to prepare clients for authority inspections
  • Performing gap assessments of site PV staff
  • Providing organizational training on safety audits and inspections