PSUR & DSUR Writing for Pharma in India: Practical Guide

Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) are the primary mechanism through which pharmaceutical companies communicate the evolving safety profile of their products to regulatory authorities worldwide — including CDSCO in India. These documents are not marketing materials. But they are directly relevant to a pharma company's marketing strategy because they define what can legitimately be claimed about a product's safety profile.

PSUR Under ICH E2C(R2)

The PSUR framework is governed by the ICH E2C(R2) guideline (Periodic Benefit-Risk Evaluation Report), which was adopted in India under CDSCO's pharmacovigilance programme. PSURs are required:

• For products with active marketing authorisations in India
• At intervals determined by the product's approval date and data lock point
• In the standard ICH E2C(R2) format (also called PBRER — Periodic Benefit-Risk Evaluation Report)

PSUR structure under ICH E2C(R2):

1. Introduction (product overview, development history, indication)
2. Worldwide Marketing Approval Status
3. Actions Taken in the Reporting Interval (regulatory actions, label changes, risk communications)
4. Changes to Reference Safety Information (updates to SmPC/PIL)
5. Estimated Exposure and Use Patterns
6. Data in Summary Tabulations (ICSRs — Individual Case Safety Reports)
7. Summaries of Significant Findings from Clinical Trials
8. Findings from Non-Interventional Studies
9. Information from Other Clinical Trials and Sources
10. Non-Clinical Data
11. Literature
12. Other Periodic Reports
13. Lack of Efficacy in Controlled Clinical Trials
14. Late-Breaking Information
15. Overview and Evaluation of Signals
16. Benefit Evaluation
17. Risk Evaluation
18. Benefit-Risk Evaluation
19. Conclusions

Signal Detection: The Core of PSUR Value

A "signal" in pharmacovigilance is information suggesting a new, potentially causal relationship between a drug and an adverse event. Signal detection — identifying signals from the accumulating ICSR data — is the most demanding intellectual component of PSUR preparation.

ICG's Pharos Vigil platform automates signal detection analysis from structured ICSR data. Pharos Vigil applies disproportionality analysis (reporting odds ratio, proportional reporting ratio) to the spontaneous reporting database to identify candidate signals. These signals are then assessed by ICG's medical affairs team for clinical plausibility and causal evaluation.

Signals identified during PSUR preparation must be:

• Documented in Section 15 (Signal Evaluation)
• Assessed for benefit-risk impact in Sections 16-18
• Actioned appropriately (protocol amendment, label update, risk communication, or no action with justification)

Failure to detect and report signals is the most serious PSUR deficiency — and the one most likely to result in regulatory action.

DSUR for Clinical Development Safety

The Development Safety Update Report (DSUR) is the equivalent of the PSUR for drugs in clinical development — not yet approved for marketing. The ICH E2F guideline governs DSUR format.

DSURs are submitted annually to all participating regulatory authorities during active clinical development. For Indian clinical trials registered with CDSCO/ICMR, the DSUR requirement is active.

DSUR vs PSUR: Key differences:

• PSUR covers approved marketed products; DSUR covers investigational products
• PSUR's primary audience is the post-market regulator; DSUR's is the IND/CTA reviewer
• DSUR's benefit-risk section is forward-looking (should development continue?); PSUR's is post-market (does the approved indication remain justified?)

ICG's Pharos Scribe produces DSURs for Indian CROs and sponsor companies running clinical trials in India. Pharos Scout monitors the literature for safety information relevant to the investigational product during the DSUR period.

Practical PSUR Writing: The ICG Process

ICG's PSUR production workflow:

Month 1 of reporting interval:

• Confirm PSUR data lock point (DLP) and submission deadline
• Initiate literature search via Pharos Scout (running throughout interval)
• Confirm ICSR database completeness with pharmacovigilance team
• Review previous PSUR's outstanding actions — confirm all actioned

Approaching DLP (2 months before):

• Run Pharos Vigil signal detection analysis
• Prepare exposure data (from sales/distribution data)
• Compile ICSR summary tabulations
• Draft benefit and risk evaluation sections (most time-intensive)

Post-DLP (final 4-6 weeks):

• Complete all 19 sections
• Medical affairs review (clinical accuracy)
• Regulatory affairs review (format compliance, cross-reference accuracy)
• Submit to CDSCO and other applicable national competent authorities

ICG works with pharma companies as an outsourced pharmacovigilance writing partner. The Pharos suite — Scout + Vigil + Scribe — provides an integrated infrastructure for PSUR/DSUR production at any scale.

Read next on ICG

• Pharos Vigil — pharmacovigilance
• Pharos Scribe — regulatory writing
• Pharma marketing agency India

Common PSUR & DSUR Rejection Triggers (And How to Avoid Them)

Across the pharmacovigilance work our medical-writing pod supports, four failure patterns account for the majority of CDSCO queries and MAH clarification requests. Every one of them is preventable at the outline stage.

1. Signal-management sections written as case listings. Reviewers want the evaluation logic, not a dump of MedDRA-coded events. State the disproportionality method, the observed-vs-expected ratio, and the causality assessment framework in plain language before the tables.
2. Benefit-risk conclusions that don't match the data. If Section 18 says "benefit-risk remains favourable," every subsection above it must show why. Auditors will trace the sentence back to the safety data — inconsistency is the fastest way to lose credibility.
3. Missing India-specific exposure estimates. For products marketed in India, CDSCO expects patient exposure broken down by region where practically feasible. Global-only denominators trigger clarification loops that add 30-45 days.
4. Late line-listings and CIOMS attachments. Annexes are not optional. A PSUR submitted without the reconciled line-listing gets returned before the review team even opens Section 16.

Where ICG Fits

Our medical-writing pod runs a two-reviewer QC loop (writer + senior pharmacovigilance reviewer) before any PSUR or DSUR draft leaves the building. We also help pharma marketing teams operationalise the output of these reports — turning safety-communication updates into HCP-facing content that Google indexes and doctors actually read. If that's the gap, our Client Elevation Programme covers medical content operations end-to-end. For discovery and search visibility on your safety-communication and disease-awareness pages, pair it with YODA for AI-native YouTube education and Meta Catalyst IQ for compliant Meta Ads. To scope a pilot, WhatsApp Rohit or read our pharma content marketing playbook next.