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DRAP22 Oct 2026DRAP Alert I/S/10-26-44 dated 22 October 2026; Drugs Act 1976, section 3(z-b)

DRAP identifies falsified Brexin batch W68C lacking the declared active ingredient

Active product alertRapid safety alert

DRAP reports that Brexin Tablet batch W68C is spurious: laboratory analysis did not identify the declared piroxicam beta-cyclodextrin ingredient, and the purported manufacturer disowned the sample.

REGULATORY INTELLIGENCE / RESEARCH NOTE

Official primary source: DRAP Alert I/S/10-26-44 dated 22 October 2026; Drugs Act 1976, section 3(z-b) · Reviewed 26 October 2026. Legal effect, provisional status and dates are identified below; the full official document and any later amendments govern.

The regulator directs surveillance and confiscation of falsified stock; procurement teams and pharmacies should verify batch W68C and avoid dispensing it.

01 / REGULATORY ANALYSIS

Precisely what DRAP found

DRAP Rapid Alert No. I/S/10-26-44 dated 22 October 2026 concerns Brexin Tablet, batch W68C. The Sindh Drug Testing Laboratory in Karachi classified the referred sample as spurious/falsified under section 3(z-b)(i) and (ii) of the Drugs Act, 1976.

The tested sample did not contain the declared active ingredient, piroxicam beta-cyclodextrin. The product purported to bear GSK Pakistan/Chiesi licensing details, but the manufacturer disowned the sample. That alleged branding should not be interpreted as evidence that the named legitimate manufacturer produced the falsified batch.

DRAP's finding concerns the identified sample and batch, not an adverse finding about all genuine Brexin products.

02 / REGULATORY ANALYSIS

Regulatory action and risks

DRAP and provincial drug-control field teams have been directed to increase supply-chain surveillance and confiscate falsified products. Absence of the intended active ingredient risks ineffective treatment, while falsified medicines can pose additional safety concerns.

Healthcare providers, pharmacies and wholesalers should verify the batch code, segregate suspect stock and follow the authorities' reporting and recall procedures rather than dispensing it while provenance is uncertain.

The alert should be communicated to purchasing, receiving, stores, clinical and pharmacovigilance staff.

03 / REGULATORY ANALYSIS

What affected businesses and consumers should do

Pharmacists and distributors should audit purchasing and inventory records for batch W68C, preserve evidence of suspected falsified supply and contact regulatory inspectors as appropriate.

Consumers should not use suspect Brexin batch W68C and should consult their doctor or pharmacist about alternative treatment, especially if they have experienced inadequate relief or other problems. Suspected adverse events or product-quality issues should be reported to DRAP's National Pharmacovigilance Centre.

Continue to monitor DRAP for updates and differentiate this October alert from other Brexin alerts concerning different batch numbers.

CHAMBERS / PRACTICAL VIEW

Why this development matters

Pharmacies and distributors should screen for batch W68C and activate falsified-product controls immediately.

Specific steps for affected organisations

  • Check receipt and stock records specifically for Brexin batch W68C.
  • Segregate suspect stock and follow DRAP or provincial inspector instructions.
  • Document supplier provenance, quarantine and pharmacovigilance notifications.
  • Advise affected patients to consult a clinician; do not substitute or discontinue treatment without professional guidance.

Timing and legal status

DRAP rapid alert dated 22 October 2026; immediate market surveillance and confiscation instructions.

The alert concerns falsified batch W68C and does not implicate other genuine batches or establish liability of the purported manufacturer.

PRIMARY REFERENCEDRAP Alert I/S/10-26-44 dated 22 October 2026; Drugs Act 1976, section 3(z-b)

Drug Regulatory Authority of Pakistan — Rapid Alert 44, October 22, 2026

READ THE ORIGINAL REGULATORY SOURCE ↗