In many Indian pharma companies, PSURs have often been treated as a formality. They are usually filed away for compliance, assembled close to the deadline by someone in safety monitoring. The quality varies each time, and they rarely get much attention.
This approach changed in April 2026. CDSCO introduced a rule that redefines how Periodic Safety Update Reports should be planned, scheduled, and written. For manufacturers and importers, it is now important to consider professional Regulatory and Scientific Writing support. Organized scientific writing services will soon become essential for compliance rather than just a helpful option.
What CDSCO Actually Changed
The advisory, issued on 21 April 2026 under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, makes two things explicit.
First, PSUR submission deadlines now start on the date of the new drug’s actual marketing, not on the approval date. CDSCO noticed that companies received approval but launched much later, and still counted the PSUR time from the approval date. This meant important safety data after launch never reached the regulator in a useful way. That gap is now closed.
Second, all dosage forms, versions, and uses of a new drug should usually be included in one combined PSUR. In that single report, safety data for different forms, uses, and patient groups must be shown separately. No more duplicate reports. No more broken-up data.
The standing schedule continues to apply: six-monthly PSURs for the first two years of marketing, then annual submissions for the next two.
Why This Is Harder Than It Sounds
While the change may look simple at first, it actually transforms the PSUR from a routine report into a detailed scientific document.
A combined PSUR that includes multiple dosage forms and uses needs careful analytical writing. Adverse event data must be separated by form and patient group, then brought together into a clear benefit-risk summary. With deadlines now tied to the marketing date, the first PSUR is due when launch activities are at their peak and internal teams are already stretched. Since the regulator has highlighted past mistakes, these reports will now face closer review.
This is where professional medical writing services can help. A poorly organized PSUR now risks regulatory issues, while a well-written report demonstrates strong safety monitoring.
What Good Regulatory and Scientific Writing Looks Like in a PSUR
A good PSUR is more than just a collection of data. It explains the product’s safety profile.
It begins with a clear statement of marketing status and an estimate of how many patients have used the product. It presents adverse event data separated by dosage forms and patient groups, as required by the new rule. It addresses safety signals openly and connects Indian post-marketing data with global safety information for products sold internationally. Finally, it provides a benefit-risk assessment that is easy for reviewers to understand.
Creation of such reports on a six-monthly basis for a number of new drugs is a job that needs special expertise. This includes not only pharmacovigilance and biostatistics but also regulatory strategy. Due to this, more and more companies nowadays opt for employing an outsourced medical writer rather than giving an extra burden to their internal staff.
The Outsourcing Question, Answered by the Directive Itself
The April advisory is part of an ongoing trend. CDSCO has been steadily strengthening post-marketing monitoring, including required online PSUR submission through the SUGAM portal, shorter deadlines for queries, and now schedules based on the marketing date. The direction is clear: documentation standards in India are moving closer to global expectations.
The formation of such a team would not be feasible for smaller and medium-sized enterprises. This may be achieved by working alongside partners who will manage the documentation process from data evaluation, medical writing, quality management, up to submission preparation. For NCR pharma companies, opting for a scientific writing CRO in Delhi will be advantageous since proximity to the CDSCO HQ will make the job easier..
The Way Forward
The regulator’s message is clear: safety reporting is no longer just a routine task. It is now a scientific responsibility that begins as soon as your product reaches patients.
Manufacturers who treat the new PSUR rules as a writing and documentation challenge and allocate the right resources will manage them well. Those who see it as just paperwork may face compliance issues. Often, the outcome depends on who prepares the report.
Frontro Pharma’s Regulatory and Scientific Writing team helps manufacturers and importers with complete PSUR preparation, following the latest CDSCO requirements. Contact us before your next submission window opens.
FAQ's
What did CDSCO change about PSUR submissions in 2026?
CDSCO directed that PSUR timelines be calculated from the actual marketing date rather than the approval date. It also recommended consolidating all dosage forms and indications into a single PSUR.
How often must PSURs be submitted in India?
PSURs must be submitted every six months for the first two years after marketing and annually for the following two years.
Why do companies outsource PSURs to medical writing services?
Medical writing providers offer expertise in safety analysis, benefit-risk evaluation, regulatory compliance, and quality-controlled documentation.
What should a company look for in a regulatory medical writing CRO?
Look for CDSCO experience, SUGAM portal expertise, pharmacovigilance-trained writers, strong quality processes, and global safety data integration capabilities.
Does location matter when choosing a writing partner in India
Yes. A Delhi NCR-based partner may provide easier coordination and regulatory communication due to proximity to CDSCO headquarters.
