Post-Market Surveillance in Pakistan and NPC Adverse Event Reporting

1. Key takeaways

Post-market surveillance of medical devices in Pakistan is anchored at the National Pharmacovigilance Centre (NPC), which sits within DRAP in Islamabad and was established in 2017. For any company that holds a device enlistment or registration certificate in Pakistan, this is the institution that receives safety information after the product has entered the market. Reports can be submitted through the Adverse Event Reporting Form in its official format, or through the MedSafety mobile application and the Med Vigilance E Reporting online channel, so a registration holder has both paper-based and electronic routes available from day one. A registration holder that has not mapped these channels in advance will discover them under time pressure, which is the worst moment to learn how a safety system works. It is worth stating plainly that medical devices are explicitly covered by the pharmacovigilance plan. In practice this point is frequently misunderstood: many manufacturers assume the system is “drugs only”, because the governing instrument is titled the Pharmacovigilance Rules and because the receiving centre grew out of the medicines framework. That assumption is wrong, and acting on it leaves a device registration holder without a functioning adverse event channel precisely when one is needed. The practical conclusion is straightforward: build the device reporting workflow around the NPC entry points before the first shipment, not after the first incident.

2. Legal basis

The obligations summarised above are not free-floating; each of them can be traced to a specific instrument or to an official DRAP record. The table below maps each item to its legal source and, where applicable, to the section number or reference number that supports it. Two documents carry most of the weight: the Drug Regulatory Agency Act of 2012, which creates the institutional mandate, and the Pharmacovigilance Rules of 2022, which convert that mandate into duties for named actors including national and provincial centres, hospitals and registration holders. Pakistan’s membership of the WHO Programme for International Drug Monitoring supplies the international dimension.

3. Expert insights

Insight one: the vigilance obligations sit at the level of rules, not guidance. The Pharmacovigilance Rules, 2022 are a formal rule instrument made under the DRAP Act, and the data collection, assessment and reporting duties of registration holders are statutory requirements. This is not the same thing as voluntary industry guidance, which a company may adopt or ignore at its own discretion. Where guidance describes good practice and leaves room for interpretation, a rule prescribes conduct and attaches consequences to non-compliance. Companies that treat the 2022 Rules as a reference document rather than a binding obligation tend to under-resource their vigilance function, and the gap usually becomes visible only when an adverse event actually arrives.

Insight two: s.4(1)(g) is the structural pivot under the whole system. The Drug Regulatory Agency Act, 2012 writes pharmacy services, including vigilance, directly into the functional clauses that define what DRAP does. This explains why the NPC is housed inside DRAP rather than established as a separate, independent institution. For operational planning the consequence matters more than the theory: correspondence, submissions and follow-up questions on post-market safety all run through the same authority that handles registration, so the registration team and the vigilance team are dealing with a single regulator whose internal units are coordinated. The structure is deliberate rather than accidental, and understanding it helps a company address the right office the first time. A company that structures its Pakistan-facing documentation around that reality avoids duplicated or contradictory filings.

Insight three: full membership shapes the reporting format. Pakistan has been a full member of the WHO Programme for International Drug Monitoring since 2018, having previously held associate member status since 1994. This means the country’s reporting format and terminology are aligned with internationally accepted practice, which has a direct, practical benefit for companies that register devices in several markets at once: adverse event data prepared for one PIDM-participating authority can, with limited adaptation, be reused for another. Vigilance data is therefore not a market-by-market reinvention exercise; a well-structured global case file maps efficiently onto the Pakistan channels.

4. Practical recommendations

The vigilance system that GRZAN builds for clients in Pakistan contains four components: a designated local pharmacovigilance lead in Pakistan, established adverse event collection channels across hospitals, distributors and end users, reporting forms prepared in the official format, and an internal assessment and escalation procedure. Each component answers a specific failure mode. The local lead ensures there is a named person who can respond to DRAP within working days rather than weeks. The collection channels ensure that events occurring at hospitals, at distributors or at the point of use actually reach the registration holder instead of terminating at an intermediary. The official-format forms prevent avoidable back-and-forth with the receiving centre. The assessment and escalation procedure ensures that once an event is collected, someone decides whether it is reportable, how quickly, and who signs. Each of the four components also feeds the others: channels without a lead produce collected events with no owner, and forms without a procedure produce submissions with no internal review. When all four pieces are in place, post-market surveillance does not descend into improvisation the first time an incident appears; the company already knows who collects, who assesses, who submits and who decides.

5. Verification checklist

• □ The NPC has been confirmed as the entry point for adverse event reporting
• □ A local pharmacovigilance lead has been designated
• □ Channel-side adverse event collection mechanisms have been established
• □ Reporting forms in the official format are in place
• □ An internal assessment and escalation procedure has been defined

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Pakistan. Our team prepares dossiers to DRAP expectations, manages eCTD-format submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com