Rapid Alert: CRACKDOWN AGAINST FALSIFIED PRODUCTS

Rapid Alert

DRAP Alert NoNo  I/S/01-25-01
Action Date2nd 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 various products have been identified as spurious (falsified). Details of test reports are as under:

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)
Remarks
Injection Penbiotic
(Procaine Penicillin 1500000IU, Benzyl Penicillin 500000IU, Streptomycin Sulphate 5g)

Reg# 0221448
V044B23Purported to be manufactured by
Nawan Laboratories, Karachi
Substandard & Spurious
Orthoplast Plaster of Paris bandage 10cm x 2.7cm

Reg# MDME-0000149
03E24Purported to be manufactured by
Cotton Craft (Pvt.) Ltd., Lahore
Spurious
Suspension Carfen 90ml
(Ibuprofen 100mg/5ml)

Reg# 066500
CN-035Purported to be manufactured by
Well care Pharmaceuticals Sargodha
Spurious & Misbranded
Novidat tablet 500,g
(Ciprofloxacin 500mg)

Reg# 011837
FIM063Purported to be manufactured by Sami Pharmaceuticals KarachiSpurious

Risk Statement:The impact of the use of falsified / Substandard 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 the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market.
Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link.

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 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 these products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.