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Our scientific team will help you identify the right tests, methods, and accreditations for your product or sample.
A complete reference to the regulatory framework governing drug safety — from CDSCO mandates and IPC PV Guidance V2.0 to ICH guidelines and EU GVP modules.
India Regulatory Framework
The foundational legislation governing the manufacture, import, and distribution of drugs in India. Schedule Y and its amendments establish the requirements for clinical trials and post-marketing safety reporting. The New Drugs and Clinical Trials (NDCT) Rules, 2019 have significantly updated pharmacovigilance obligations for all licensees.
Requirement for MAHs to maintain a PV system and appoint a PVOIC
Mandatory SAE reporting timelines — 7 days (fatal/LT), 15 days (non-fatal SAE), 90 days (non-serious AE)
PSUR submission requirements — format and periodicity defined
Risk Management Plan requirement for applicable products
Post-Marketing Surveillance (PMS) study obligations
Published by NCC-PvPI/IPC in collaboration with CDSCO, this guidance document provides practical implementation guidance for MAHs on setting up their PV system. Key updates in V2.0 include: MedDRA (replacing ICD) for all ICSR coding, electronic record-keeping requirements, updated PSUR summary format, and FAQ appendix.
CDSCO has issued a circular explicitly directing all MAHs to establish an effective pharmacovigilance system for drugs manufactured or marketed under their licence. This reinforces existing NDCT Rules obligations and signals enhanced regulatory enforcement going forward.
Global Regulatory Framework
| Guideline | Title | Key Scope |
|---|---|---|
| ICH E2A | Clinical Safety Data Management | Definitions of AEs, SAEs, SUSARs; expedited reporting timelines |
| ICH E2B(R3) | Electronic Transmission of ICSRs | E2B(R3) XML data format — mandatory for electronic ICSR submissions |
| ICH E2C(R2) | PBRER | Structure and content of periodic aggregate safety reports globally |
| ICH E2D | Post-Approval Safety Reporting | Requirements for spontaneous and solicited AE reports post-approval |
| ICH E2E | Pharmacovigilance Planning | PV planning during drug development — informs RMP structure |
| ICH E2F | DSUR | Annual safety report format for investigational products in development |
The EU Good Pharmacovigilance Practices (GVP) guidelines published by EMA provide the most comprehensive framework for PV operations globally. Key modules relevant to MAHs include:
How We Help
| Your Obligation | How Auriga Delivers |
|---|---|
| Appoint a PVOIC | We act as contracted PVOIC / advisory PVOIC and document the role in your PvMF |
| Maintain a PV system | We set up and operate the full Auriga Safety System environment for your products |
| Submit ICSRs within deadlines | We process all ICSRs and transmit electronically to regulators within statutory timelines |
| Prepare & submit PSURs | We author and submit PSURs/PBRERs in IPC V2.0 format (India) and ICH E2C(R2) format (global) |
| Detect safety signals | We run signal detection algorithms and prepare Signal Assessment Reports |
| Maintain a PvMF | We create and maintain your PvMF, keeping it inspection-ready at all times |
| Train your staff | We deliver mandatory PV training and maintain training records in DMS |
| Undergo PV audit | We conduct independent PV system audits and support CDSCO inspection preparation |
Contact our PV team for a free consultation on CDSCO compliance, ICH alignment and EU GVP readiness.
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