PSUR Submission in India: Periodic Safety Update Reports for CDSCO, Prepared and Filed on Time

PSUR Full Form and What a PSUR Is

The PSUR full form is Periodic Safety Update Report. A PSUR is a structured report that the holder of a new drug's marketing permission submits to the regulator at fixed intervals after approval. It brings together all the safety information gathered in the reporting period, from India and abroad: adverse drug reactions, serious and unexpected events, findings from studies and literature, regulatory actions in other countries and changes to the product's safety information. It ends with an overall evaluation of whether the drug's benefits still outweigh its risks.

In India, a periodic safety update report India regulators require is submitted to CDSCO under the New Drugs and Clinical Trials Rules, 2019. For companies in India, PSUR submission is a central obligation: reports go to the State Drug Licensing Authority through ONDLS or your state drug licensing portal, and the same rules apply in every state.

PSUR in pharmacovigilance

PSUR in pharmacovigilance is the periodic, big-picture review that sits on top of day-to-day case reporting. Individual adverse event reports tell the regulator about single cases as they happen; the PSUR looks across all cases, exposure data and new evidence for the period and asks whether the safety profile has changed. It is how a new drug's real-world safety is checked in its first years on the Indian market, when it is used by far more patients than in clinical trials.

Periodic safety update report India: key points at a glance

These PSUR India requirements apply in the same way whether the company is based in India or elsewhere in India. What differs between companies is the strength of the system behind the report: the pharmacovigilance services India firms put in place to collect cases, review signals and write each report on time. The PvPI PSUR link, the launch-date rule and the 30-day window are where most companies slip, so they deserve the closest attention.

PSUR India Requirements: Who Must Submit

The PSUR India requirements apply to the applicant who holds marketing permission for a new drug, whether it is made in India or imported. CDSCO's online PSUR system on SUGAM covers:

• New drugs, including new chemical entities approved for marketing in India
• Subsequent new drugs, where the same new drug is approved for another applicant while it is still treated as new
• New fixed-dose combinations
• Biological products approved as new drugs, such as vaccines and recombinant products
• Veterinary new drugs

The obligation sits with the holder of the permission: the Indian manufacturer, or for imported new drugs, the importer or authorised agent. Distributors and marketing partners must pass on any adverse event they learn about, but the PSUR itself is filed by the permission holder.

Who does what in a PSUR

Writing these roles into SOPs and partner agreements before launch prevents the most common PSUR problem: data that exists somewhere in the business but never reaches the report.

For smaller companies, one person may hold several of these roles, and that is acceptable as long as each responsibility is written down and someone is clearly accountable for the filing date. What CDSCO looks for is not the size of the team but evidence that safety information is collected, assessed and reported consistently. A short organogram and a one-page responsibility matrix, kept with your pharmacovigilance SOPs, is often enough to show that during an inspection or audit, and it makes onboarding new staff or partners much easier when the product range grows.

PSUR CDSCO: what the regulator does with it

PSUR CDSCO reviewers check the report for new safety signals, changes in the frequency or seriousness of known reactions, and actions taken abroad. If a PSUR shows a new risk, CDSCO can ask for label changes, additional studies, restricted use or, in serious cases, suspension of the permission. A late, incomplete or inconsistent PSUR invites queries and can put the permission itself at risk, which is why companies treat PSUR submission as a compliance priority.

PSURs for Imported New Drugs

When a new drug is imported, the Indian permission holder, usually the importer or the overseas manufacturer's authorised agent, is responsible for the PSUR, even though most of the safety data sits with the manufacturer abroad. This creates three practical challenges. First, the global safety team works to its own reporting calendar, often based on the international birth date, while the Indian PSUR must follow the Indian launch date. Second, the global report may not separate Indian data, which CDSCO expects to see. Third, Indian cases received by the importer, its distributors and PvPI must be shared with the manufacturer so they appear in the global database as well as the Indian report.

The solution is a written safety data exchange agreement between the manufacturer and the Indian permission holder. It should set who collects which cases, the timelines for passing them on, who prepares the Indian PSUR, what global outputs the manufacturer supplies for each Indian data lock point, and who files with CDSCO. Regovex drafts the regulatory parts of this agreement and prepares the Indian PSUR from the manufacturer's data plus the Indian cases. See our Drug Import Registration page for the import approvals that come before the PSUR period.

PSUR New Drugs NDCT Rules: The Legal Basis

The PSUR new drugs NDCT rules framework sits in the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, which deals with post-marketing assessment of new drugs. It replaced the earlier requirements in Schedule Y of the Drugs and Cosmetics Rules. The Fifth Schedule requires the holder of a new drug's permission to collect and evaluate safety data after launch, report serious unexpected adverse reactions promptly, and submit Periodic Safety Update Reports at set intervals in a prescribed structure. The Central Licensing Authority can extend the PSUR period if the safety data calls for it.

PSUR Frequency India and PSUR Due Date CDSCO

The PSUR frequency India applies to new drugs is:

Each PSUR must be submitted within 30 days of the last day of its reporting period. That is the PSUR due date CDSCO checks: a report covering January to June is due by the end of July, and a report covering July to December is due by the end of January.

The clock starts at launch, not approval

In an advisory issued on 21 April 2026, CDSCO clarified that PSUR timelines start from the date the new drug is actually marketed in India, not from the date of approval. Some companies had been counting from the approval date, which left gaps when launch was delayed and lost safety information from the real period of use. The same advisory states that one PSUR should ordinarily cover all dosage forms, formulations and indications of a new drug, with the data for each presented separately inside the report, so that duplicate PSURs are not filed. Record your launch date carefully, because every due date is calculated from it.

Worked example

A new drug is first marketed in India on 1 January 2027. Its PSURs fall due as follows:

Regovex builds a calendar like this for every product at launch and sends reminders well before each data lock point.

PSUR for veterinary products India

The same schedule applies to new veterinary drugs. CDSCO has directed applicants holding permission for veterinary new drugs to submit PSURs every six months for the first two years and annually for the following two years, and veterinary PSURs are filed through the same SUGAM system. For PSUR for veterinary products India, the safety data comes from animal use: adverse reactions in the target species, lack of efficacy, problems for people handling the product and any residue concerns in food-producing animals. Veterinary companies should set up adverse event collection from veterinarians, distributors and farmers from the day of launch.

Extended PSUR periods and the end of the PSUR cycle

The four-year cycle is the default, not a guarantee. The rules allow the Central Licensing Authority to extend the period during which PSURs are required, for example when a new safety concern emerges or when the drug is used in a new population. If CDSCO asks for PSURs to continue, the schedule it sets replaces the default. When the cycle ends, pharmacovigilance does not: individual serious adverse reactions must still be reported, signals must still be evaluated, and CDSCO can ask for a safety report at any time. Keep your safety system running at the same standard after the last PSUR is filed.

Biologicals and vaccines

Biological products and vaccines approved as new drugs follow the same PSUR schedule, but their reports need extra attention. Safety can differ between batches, so lot numbers should be captured for every case and lot-related trends reviewed. Vaccines are used in healthy people, often children, so even rare events draw close scrutiny, and adverse events following immunisation reported through the national immunisation surveillance system should be considered alongside company data. Immunogenicity, such as the development of antibodies against the product, and any changes in the manufacturing process during the period should also be discussed in the PSUR.

PSUR Format: What CDSCO Expects

The PSUR format used in India follows the structure set out in the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, which is based on the international periodic report model. A complete report typically contains:

1. Title page with the drug, the permission holder, the reporting period and the data lock point
2. Introduction describing the product, its approved indications and the period covered
3. Worldwide marketing authorisation status, listing countries where the drug is approved, launched, withdrawn or refused
4. Actions taken for safety reasons in India and abroad during the period
5. Changes to the reference safety information, such as new warnings or contraindications
6. Estimated patient exposure, in India and worldwide, with the method of estimation
7. Presentation of individual case histories, with line listings and summary tables of adverse drug reactions, including Indian cases
8. Studies: new safety findings from clinical, non-clinical and published studies
9. Other information, such as lack of efficacy reports or late-breaking information after the data lock point
10. Overall safety evaluation, discussing any changes in the nature, frequency or severity of reactions and any new signals
11. Conclusion on whether the benefit-risk balance remains favourable and what action, if any, is proposed
12. Appendices, including the current prescribing information and supporting tables

Indian data must be presented separately where the Fifth Schedule or CDSCO asks for it, and, following CDSCO's 2026 advisory, data for different dosage forms, indications or populations should be shown separately within one report.

PSUR template: build it once, reuse it every period

A good PSUR template saves time on every report. Build a master template with fixed sections, standard tables for exposure and case listings, and placeholders for the period-specific data, the data lock point and the evaluation. Keep a running log of signals, actions and reference safety information changes between reports, so each new PSUR starts from an up-to-date base instead of a blank page. Regovex prepares a template for each product and keeps it aligned with any CDSCO format updates.

PSUR Preparation: Step by Step

PSUR preparation for each period follows the same cycle:

1. Fix the data lock point at the end of the reporting period, counted from the launch date.
2. Collect safety data: spontaneous reports, reports from distributors and doctors, PvPI reports, literature, studies and global safety database outputs from the manufacturer.
3. Estimate exposure from sales or distribution data for India and worldwide.
4. Prepare line listings and summary tables of adverse reactions, separating serious and non-serious, expected and unexpected.
5. Review the literature for new safety information on the drug and its class.
6. Evaluate signals and the benefit-risk balance, with input from a medical reviewer.
7. Write and review the report in the PSUR format, with quality checks for consistency.
8. Submit on SUGAM within 30 days of the data lock point and keep the acknowledgement.

Where PSUR data comes from

A complete PSUR draws on more sources than most companies expect:

Set up the collection routes before launch. A PSUR written from incomplete sources may be on time, but it will not stand up to CDSCO's review.

PSUR vs PBRER: What Is the Difference?

The question of PSUR vs PBRER comes up for every multinational product. Internationally, the ICH E2C(R2) guideline replaced the older PSUR with the Periodic Benefit-Risk Evaluation Report (PBRER), which puts more weight on benefit-risk analysis and on signals across the product's whole life. Many regulators, including the European system, still use the name PSUR for a report written in the PBRER format.

Companies that already prepare a global PBRER can usually adapt it for India, but should not simply file it unchanged. The Indian PSUR must cover the Indian reporting period counted from the Indian launch date, present Indian data as required and follow the Fifth Schedule structure. Regovex converts global reports into India-ready PSURs and fills the Indian sections from local data.

Signal Detection and the Overall Safety Evaluation

The overall safety evaluation is the part of the PSUR that CDSCO reads most closely, and it is where weak reports fail. It should not simply restate the case counts. It should answer specific questions: Has the frequency of any known reaction increased? Have any new reactions appeared, especially serious or unexpected ones? Are there reactions in particular groups, such as children, the elderly, pregnant women or patients with kidney or liver disease? Have there been medication errors, misuse or lack of efficacy? Have regulators abroad acted on any of these?

For each potential signal, the report should say how it was identified, what evidence supports or argues against it, and what the company has done or proposes to do, such as further analysis, a label update, a communication to doctors or a study. The conclusion should then state clearly whether the benefit-risk balance remains favourable and whether any change to the prescribing information is proposed. A clear, evidence-based evaluation reduces queries and shows CDSCO that the company is actively managing the drug's safety, not just filing paperwork.

PSUR Submission SUGAM: How Filing Works

PSUR submission SUGAM has been mandatory since CDSCO stopped processing offline PSURs on 11 March 2024. Reports for new drugs, subsequent new drugs, fixed-dose combinations, biologicals and veterinary products are all filed online on SUGAM at cdscoonline.gov.in, following the checklist in the portal.

The filing involves selecting the PSUR application type for the approved product, entering the reporting period and data lock point, uploading the PSUR and its annexures as searchable PDFs, adding a covering letter, and submitting. The acknowledgement and any query from CDSCO appear on the same dashboard. Keep the acknowledgement for every PSUR, because CDSCO, auditors and partners may ask for proof that each report was filed on time.

What happens after you file a PSUR

After submission, CDSCO reviews the PSUR and may accept it without comment, raise a query, ask for additional data or analysis, or request changes to the prescribing information. Answer queries completely and within the time given, through the same SUGAM application. If CDSCO asks for a label change, plan the update across packs, package inserts and promotional material, and record it in the next PSUR under changes to the reference safety information. Keep a register of every PSUR, its acknowledgement, any queries and the responses; it makes the next report easier and is the first thing an auditor will ask for.

PvPI PSUR: How the Pharmacovigilance Programme of India Fits In

The Pharmacovigilance Programme of India (PvPI) collects adverse drug reaction reports across the country. Its National Coordination Centre is at the Indian Pharmacopoeia Commission in Ghaziabad, and a network of ADR monitoring centres, mostly in medical colleges and hospitals, receives reports from doctors, pharmacists and patients. PvPI shares its data and signals with CDSCO, which acts on them.

The PvPI PSUR link works in both directions. Cases reported to PvPI for your drug form part of the Indian safety picture that your PSUR should reflect, and CDSCO may compare your PSUR with what PvPI has received. Companies should therefore monitor PvPI communications and safety alerts for their products and classes, include relevant Indian cases in their line listings, and make sure their own case reports reach CDSCO as the rules require. For medical devices, a parallel Materiovigilance Programme of India handles device adverse events.

Expedited reporting between PSURs

A PSUR does not replace prompt reporting of individual serious cases. Under the Fifth Schedule, serious unexpected adverse reactions to a new drug must be reported to CDSCO within 15 days of the company receiving the information, without waiting for the next PSUR. The PSUR then summarises these cases along with everything else in the period. A good pharmacovigilance system therefore runs two tracks at once: case processing and expedited reporting every day, and periodic aggregate review for each PSUR.

Pharmacovigilance Services India: What a Complete System Needs

PSURs are only as good as the system behind them. The pharmacovigilance services India companies need for a new drug usually include:

• Case intake from doctors, pharmacists, patients, distributors, call centres and social media, with a clear route into the safety team
• Case processing: checking validity, coding events, assessing seriousness, expectedness and causality, and following up for missing information
• Expedited reporting of serious unexpected cases to CDSCO within the time limit
• Literature monitoring for the drug and its class
• Signal detection and evaluation across cases and exposure data
• PSUR writing services for each reporting period, plus medical review
• Safety database and records that can be audited
• Training for sales teams, distributors and partners on how to pass on adverse events
• Standard operating procedures and a named person responsible for pharmacovigilance

Smaller companies and importers often outsource part or all of this. Regovex provides PSUR preparation and filing, due-date tracking and regulatory support, and works with your safety team or your manufacturer's global safety unit for case processing and medical review.

A 90-day pharmacovigilance plan for a new launch

Companies that follow a plan like this rarely have trouble with their first PSUR, because the data and the people are already in place when the first report falls due.

Common Mistakes in PSUR Submission

• Counting the PSUR period from the approval date instead of the actual launch date
• Filing after the 30-day window, or missing a PSUR because the calendar was not kept
• Filing separate PSURs for each strength or dosage form instead of one report with separate data
• Submitting a global PBRER unchanged, without Indian data or the Indian reporting period
• Weak exposure estimates, or line listings that do not match the summary tables
• Missing Indian cases reported to PvPI or received by distributors
• Treating the PSUR as a substitute for 15-day expedited reporting
• Stopping PSURs after four years without checking whether CDSCO has extended the period

PSUR Checklist Before Filing

• Reporting period counted from the actual launch date, and data lock point confirmed
• All data sources collected: company cases, distributors, PvPI, global database, literature and studies
• Exposure estimated with the method stated
• Line listings and summary tables consistent with each other and with the previous PSUR
• Indian data presented as required, with dosage forms and indications shown separately
• Signals and the overall safety evaluation reviewed by a medical reviewer
• Reference safety information and any changes described
• Conclusion on benefit-risk stated clearly
• Covering letter and annexures ready as searchable PDFs
• Filing date at least a few days before the 30-day deadline

Running through this list for every period is the simplest way to keep every PSUR on time and query-free.

How Regovex Handles Your PSUR Submission in India

1. Free due-date check. We confirm the launch date for each new drug and build a PSUR calendar for the full four-year period.
2. Data plan. We agree with you and your manufacturer what data each PSUR needs, who supplies it and by when.
3. PSUR template for each product, in the Fifth Schedule format, aligned with any global PBRER.
4. PSUR preparation for each period: line listings, exposure estimates, literature review and the safety evaluation, with medical review by your safety team or the manufacturer's.
5. Quality check for consistency between sections, tables and the previous PSUR.
6. PSUR submission SUGAM filing within the 30-day window, with the acknowledgement shared the same day.
7. Query replies within 24–48 hours, and updates to the calendar if CDSCO extends the PSUR period.

Why Companies Choose Regovex as Their PSUR Consultant India

• Regulatory and pharmacovigilance together. As a PSUR consultant India companies trust, we understand both the safety content and the CDSCO filing.
• Calendar discipline. Due dates are counted from the launch date, as CDSCO now requires, with reminders before every data lock point.
• Global-to-India conversion of PBRERs and international safety reports into India-ready PSURs.
• Pharmacovigilance consultant India support for setting up case intake, SOPs and partner training.
• CDSCO experience across new drug, import and manufacturing approvals, as a CDSCO registration consultant and drug regulatory consultant in India.
• Clear pricing per PSUR or per product year, in writing.

PSUR Submission Services in India and Nearby Areas

Regovex prepares and files PSURs for pharmaceutical manufacturers, importers of new drugs, biological product companies and veterinary companies in India. Work is done digitally with your regulatory and safety teams, and reports are filed on ONDLS or your state drug licensing portal. Our office is in Aligarh, and we work with clients across Delhi NCR, Uttar Pradesh and the rest of India.

We also serve companies in .

Related services:

• CDSCO Registration in India
• Drug Import Registration
• Drug Manufacturing License
• Drug Test License
• Drug License in India

What Our Clients Say

I had great experience working with Regovex Consulting on the regulatory side of my product. Since the product category was relatively new and the guidelines were not very clearly defined, it required additional research and careful interpretation of the regulations. — Parichit Dhawan, Director, Feorah Wellness & Cosmetics