Rapid Alert: CRACKDOWN AGAINST FALSIFIED PRODUCT

Rapid Alert

DRAP Alert NoNo  I/S/01-25-05
Action Date10th January, 2025
Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
3. General Public
Problem StatementDirectorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been identified as spurious (falsified):

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)
Remarks
Ketamine Injection
(Ketamine 500mg)
20158Purported to be manufactured by Pan Pharma, France.Spurious

Risk Statement:The impact of the use of falsified products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems.
Action InitiatedThe field force under administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

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 at this link.
Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.