33. Rapid Alert – SPURIOUS DRUG PRODUCTS (NOVIDAT 500MG Tablets and TONOFLEX-P Tablets)

Rapid Alert

SPURIOUS DRUG PRODUCTS (NOVIDAT 500MG Tablets and TONOFLEX-P Tablets)
DRAP Alert NoNo I/S/06-26-33
Action Date03 June, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementThe Drug Regulatory Authority of Pakistan (DRAP) has received test and analysis reports from the Provincial Drug Testing Laboratory, Punjab, regarding the following drug products sampled from the market. The laboratory has declared the products Spurious under Section 3(zb)(i) of the Drugs Act, 1976. Further investigation conducted by the manufacturer, SAMI Pharmaceuticals (Pvt.) Ltd., confirmed that the products were not manufactured by the company and are falsified/spurious.
Risk StatementThe presence of spurious medicines containing no detectable active pharmaceutical ingredients poses a serious risk to public health due to treatment failure, disease progression, and potential harm to patients relying on these products. Healthcare professionals and supply chain stakeholders are advised to remain vigilant and immediately report any information regarding the availability or distribution of the above-mentioned batches.
Action InitiatedThe Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to  National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.