Phase 4 & Post-Marketing Surveillance at the Celesta Healthcare clinical research centre
Clinical Trials · Phase IV & Post-Marketing

Phase 4 & Post-Marketing Surveillance

Approval is a milestone, not a finish line. We run Phase IV studies, post-marketing surveillance, and PSUR programs that keep your product compliant in India — and turn its real-world performance into usable evidence.

4 Years
New Drug Status
Under NDCT 2019
6-Monthly
PSURs in First Two
Years Post-Approval
Real-World
Evidence &
Safety Data
Pan-India
Investigator &
Site Network
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All Patient-Based Clinical Trials
Overview

What Happens After Approval

A Phase 4 clinical trial is a post-marketing study conducted after regulatory approval, monitoring a drug’s long-term safety and effectiveness in real-world use. Pre-approval trials, however large, enrol selected patients for limited durations — Phase IV is where rare adverse events, drug interactions, and performance in everyday clinical practice actually become visible.

In India this is a regulatory obligation, not an option. A newly approved product retains new drug status for four years, and the NDCT Rules, 2019 require periodic safety update reports on a fixed schedule — every six months for the first two years, then annually for the next two. Specific Phase IV or PMS studies can also be imposed as conditions of approval, including for many fixed-dose combinations.

We run the whole post-approval workload as one program: PMS study design and conduct through our pan-India site network, active safety and adverse event monitoring, PSUR compilation and submission on schedule, and real-world evidence studies that give medical and commercial teams data worth having — not just a compliance file.

Post-Marketing Surveillance (PMS)

The systematic monitoring of a drug’s safety and performance after it reaches the market — spanning adverse event collection, periodic safety reporting, and formal PMS studies in real prescribing populations.

PSUR

A Periodic Safety Update Report: the structured document summarising a product’s worldwide safety data over a reporting period, with an updated benefit-risk assessment. In India, PSURs are submitted to CDSCO every six months for the first two years after approval, then annually for two more.

Post-Approval Services

Everything Your Product Needs After Launch

Six workstreams that keep an approved product compliant, monitored, and generating evidence.

PMS Study Design & Conduct

Post-marketing surveillance studies designed, approved, and executed across real prescribing populations.

PSUR Preparation & Submission

Periodic safety update reports compiled and filed on the NDCT schedule — six-monthly, then annual.

Safety & ADR Monitoring

Adverse event collection, causality workflows, and reporting discipline that stands up to inspection.

Real-World Evidence Studies

Observational studies that document effectiveness, adherence, and outcomes in everyday practice.

Registry & Observational Programs

Patient registries and cohort designs for questions a randomized trial cannot answer economically.

Approval Commitment Management

Condition-of-approval studies and regulator correspondence tracked to closure, deadline by deadline.

Inside Our Facility

Where This Work Happens

Medical monitoring room with patient monitors and emergency equipment at the clinical research facility
Medical Monitoring & Emergency Care Unit
How It Runs

Post-Marketing Program Lifecycle

  1. 01

    Obligation Mapping

    Your approval letter and the NDCT Rules translated into a concrete calendar — PSUR dates, committed studies, reporting duties.

  2. 02

    Protocol & Approvals

    PMS or Phase IV protocol development, ethics committee clearance, and registration where applicable.

  3. 03

    Site Activation

    Sites selected across the marketed geography from our pan-India network, reflecting real prescribing practice.

  4. 04

    Surveillance & Data Collection

    Enrolment, safety monitoring, adverse event workflows, and clean ongoing data management.

  5. 05

    PSURs, Analysis & Reports

    Periodic reports submitted on schedule, and a final study report that closes the commitment — with evidence you can reuse.

Why Celesta

Why Sponsors Choose Us for Phase IV & PMS

  • PMS studies, PSURs, and safety monitoring under one accountable team
  • NDCT Rules 2019 reporting schedule tracked and met, submission after submission
  • Pan-India sites reflecting real prescribing populations
  • Adverse event workflows built for inspection, not just collection
  • Real-world evidence designed to be usable, not just filed
  • Continuity from Phase III — the same teams carry your product forward
FAQs

Phase IV & PMS — Frequently Asked Questions

1. What is a phase 4 clinical trial?
A Phase 4 clinical trial is a study conducted after a drug has received marketing approval. It monitors long-term safety and effectiveness in real-world use, detects rare adverse events that pre-approval trials were too small to catch, and can explore new populations or usage patterns. Phase IV studies range from mandated post-marketing surveillance to sponsor-driven real-world evidence programs.
2. What is post marketing surveillance?
Post-marketing surveillance is the systematic monitoring of a medicine’s safety and performance after it reaches the market. It includes collecting and assessing adverse drug reaction reports, submitting periodic safety update reports to regulators, and running formal PMS studies in real prescribing populations. Its purpose is to confirm that the benefit-risk balance seen in trials holds up at population scale.
3. What is a PSUR and when is it submitted in India?
A PSUR — Periodic Safety Update Report — summarises a product’s accumulated safety data over a reporting period with an updated benefit-risk assessment. Under India’s NDCT Rules, 2019, PSURs are submitted to CDSCO every six months for the first two years after approval and annually for the subsequent two years, each due within 30 calendar days of the end of its reporting period.
4. How long is a drug considered a new drug in India?
Four years from the date of its approval. During this period the product carries new drug obligations under the NDCT Rules, 2019 — including the PSUR reporting schedule and any Phase IV or post-marketing study commitments attached to the approval. After four years it generally moves out of new drug status unless the licensing authority specifies otherwise.
5. Are phase 4 studies mandatory in India?
PSUR submission is mandatory for every new drug. Beyond that, a specific Phase IV or PMS study is required when the DCGI attaches it as a condition of approval — common for many fixed-dose combinations and for products approved on limited local data. The approval letter defines the obligation; we translate it into a protocol, a site plan, and a submission calendar.
6. What is the difference between pharmacovigilance and post-marketing surveillance?
Pharmacovigilance is the overall science and set of activities for detecting, assessing, and preventing adverse effects of medicines — spanning a product’s entire lifecycle. Post-marketing surveillance is the post-approval portion of it: the studies, ADR monitoring, and periodic reporting that track a marketed product. In practice PMS is how pharmacovigilance obligations are delivered after launch.

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