DRAP Issues Rapid Alert on Spurious Brexin Tablets and Danzen DS Batches

💊Rapid Alert – Spurious/Falsified Brexin Tablets 20 mg

DRAP Alert No.: I/S/06-26-31
Action Date: 02 June 2026

Target Audience

Regulatory Field Force of DRAP and Provincial Drug Control Departments
Healthcare Professionals
Pharmacies and Medical Stores

Problem Statement

The Drug Testing Laboratory (DTL), Government of Punjab, has reported that, in accordance with Section 3(z-b)(i) and (ii) of the Drugs Act, 1976, and based on laboratory findings as well as confirmation from the Marketing Authorization Holder (MAH), the following drug product has been declared spurious/falsified:

Product Name	Batch No.	Purported Manufacturer	Remarks
Brexin Tablets 20 mg (Piroxicam-β-Cyclodextrin), Reg. No. 010637	1207863	Purportedly manufactured under license of Chiesi Farmaceutici S.p.A., Parma, Italy	Declared spurious by DTL. Piroxicam was not detected and assay results showed 0.0% of the labeled active ingredient. The Marketing Authorization Holder confirmed that the product is not a genuine Chiesi product and has disowned the batch.

M/s Chiesi Pharmaceuticals (Pvt.) Ltd., Pakistan, the authorized marketer of Brexin in Pakistan, has formally informed regulatory authorities that the seized sample was neither manufactured under license from Chiesi Farmaceutici S.p.A., Italy, nor distributed through its authorized supply chain. The company has further identified several differences between the counterfeit product and authentic Brexin tablets and has categorically rejected the product as counterfeit/spurious.

📌Key Differences Between Genuine and Spurious Brexin

Genuine Brexin (Chiesi)	Spurious/Counterfeit Brexin
Unit carton sealed with transparent tape on both closure sides	Unit carton not sealed with Chiesi-specified tape
Chiesi-specific font size and style	Different font size and style
Variable data printed using inkjet technology	Variable data pre-printed
Tablets are pale yellow in color	Tablets are dark yellow or show pigmentation spots
Aluminum foil conforms to Chiesi specifications	Shiny aluminum foil inconsistent with Chiesi specifications
Blister color is off-white	Blister color is white
Variable data printing on blister follows Chiesi standards	Stamping of variable data differs from genuine product
Leaflet printed on white imported paper	Leaflet printed on pale yellow local paper

⚠️Risk Statement

Laboratory testing conducted by the Drug Testing Laboratory, Punjab, confirmed that the declared active pharmaceutical ingredient, Piroxicam, was absent from the analyzed sample. Assay testing demonstrated 0.0% Piroxicam content against the labeled claim of 20 mg per tablet, indicating complete absence of the active ingredient.

Use of this counterfeit/spurious product may lead to:

Complete therapeutic failure in patients requiring anti-inflammatory and analgesic treatment.
Delayed or inadequate medical management due to reliance on an ineffective product.
Potential exposure to unknown or undeclared substances with unverified quality, safety, and efficacy.
Increased risk of adverse health outcomes, particularly among patients suffering from painful inflammatory conditions.

💊Rapid Alert – Spurious/Falsified Danzen® DS Tablets

DRAP Alert No.: I/S/06-26-31
Action Date: 02 June 2026

Target Audience

Regulatory Field Force of DRAP and Provincial Drug Control Departments
Healthcare Professionals
Pharmacies and Medical Stores

Problem Statement

The Drug Testing Laboratory (DTL), Government of Punjab, has reported that, under Section 3(z-b)(i) and (ii) of the Drugs Act, 1976, and based on laboratory findings as well as confirmation received from the manufacturer, the following drug product has been declared spurious/falsified:

Product Name	Batch No.	Purported Manufacturer	Remarks
Danzen® DS Tablets (Serratiopeptidase 10 mg), Reg. No. 028173	4476	Purportedly manufactured under license of Helix Pharma (Pvt.) Ltd., Karachi	Declared spurious by DTL. Serratiopeptidase was not detected and assay testing showed 0.0 mg/tablet against the labeled claim of 10 mg/tablet. The manufacturer confirmed that the sample was not manufactured by Helix Pharma and has disowned the batch.

Helix Pharma (Pvt.) Ltd. has formally informed the regulatory authorities that the submitted sample was not manufactured by the company. Following a comparative investigation against its authentic reference sample, several discrepancies were identified between the genuine and suspected counterfeit products.

📌Key Differences Between Genuine and Spurious Danzen® DS Tablets

Genuine Danzen® DS (Reference Sample)	Spurious/Counterfeit Danzen® DS
Tablet color is dark pink with a smooth coating	Tablet color and appearance differ from the genuine product
Blister strip color is blue	Blister strip color is dark blue
Font size and style of embossed batch number and expiry date conform to company specifications	Font size and style of embossed batch number and expiry date differ from the reference sample

⚠️Risk Statement

Laboratory analysis conducted by the Drug Testing Laboratory, Punjab, revealed that the declared active pharmaceutical ingredient, Serratiopeptidase, could not be identified in the tested sample. Assay testing demonstrated complete absence of the active ingredient, with results showing 0.0 mg/tablet against the labeled claim of 10 mg/tablet.

Use of this counterfeit/spurious product may result in:

Complete therapeutic failure.
Failure to achieve the intended anti-inflammatory effect.
Delay in appropriate treatment and recovery.
Exposure to unknown or undeclared ingredients of uncertain quality, safety, and efficacy.
Potential adverse health consequences associated with the use of falsified medicines.

🚨Actions Taken

The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned batches of the medications.

Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.

Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms@dra.gov.pk.

👩‍⚕️Guidance for Healthcare Professionals

Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.

How to download VigiMobile App for ADRs reporting

Guidance for Consumers

Consumers must avoid this product. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.

Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.

References

Drug Regulatory Authority of Pakistan. (2026, June 2). Rapid alert – Spurious/falsified Brexin tablets 20 mg. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/31-rapid-alert-spurious-falsified-brexin-tablets-20-mg/

Drug Regulatory Authority of Pakistan. (2026, June 2). Rapid alert – Spurious/falsified Danzen DS tablets. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/32-rapid-alert-spurious-falsified-danzen-ds-tablets/