Rapid Alert – Spurious Drug Products (NOVIDAT 500 mg Tablets and TONOFLEX-P Tablets)

On 3rd June DRAP issued Rapid Alert regarding Spurious Drug Products 

DRAP Alert No.: I/S/06-26-33
Action Date: 03 June 2026

Spurious Drug Products:  means a drug-
(i) which purports to be a drug but does not contain the active ingredient of that drug; or
(ii) which purports to be the product of a manufacturer, place or country of whom or of which it is not truly a product; or
(iii) which is imported or exported or sold or offered or exposed for sale under a particular name while actually it is another drug; or
(iv) the label of which bears the name of an individual or company purporting to be its manufacturer or producer which individual or company is fictitious or
does not exist;

Target Audience

• Regulatory Field Force of DRAP and Provincial Drug Control Departments

• Healthcare Professionals

• Pharmacies and Medical Stores

Problem Statement

The Drug Regulatory Authority of Pakistan (DRAP) received test and analysis reports from the Provincial Drug Testing Laboratory (Punjab) concerning two drug products collected from the market. The laboratory classified these products as spurious under Section 3(zb)(i) of the Drugs Act, 1976. Subsequent investigations by SAMI Pharmaceuticals (Pvt.) Ltd. confirmed that the products were not manufactured by the company and were therefore falsified/spurious.

Therapeutic Goods Information

1. NOVIDAT 500 mg Tablets

• Generic Name: Ciprofloxacin HCl equivalent to Ciprofloxacin 500 mg

• Registration No.: 011837

• Batch No.: 139N086

• Purported Manufacturer: SAMI Pharmaceuticals (Pvt.) Ltd., Karachi

• Laboratory Findings: Assay testing detected 0.00 mg of ciprofloxacin per tablet, whereas the labeled strength was 500 mg per tablet.

• Status: Spurious/Falsified Product

2. TONOFLEX-P Tablets

• Generic Composition: Tramadol HCl 37.5 mg + Paracetamol 325 mg

• Registration No.: 067163

• Batch No.: 248N105

• Purported Manufacturer: SAMI Pharmaceuticals (Pvt.) Ltd., Karachi

• Laboratory Findings: Assay testing detected 0.00 mg per tablet for both tramadol and paracetamol, despite labeled strengths of 37.5 mg and 325 mg, respectively.

• Status: Spurious/Falsified Product

Risk Statement

The distribution and use of spurious medicines lacking the declared active pharmaceutical ingredients present a significant threat to public health. Such products may lead to therapeutic failure, worsening of disease conditions, and other adverse health outcomes. Healthcare professionals, distributors, pharmacies, and other stakeholders are advised to remain vigilant and promptly report any information concerning the distribution or availability of these batches.