ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) as a part of continued crackdown against falsified/spurious drugs has issued an immediate recall alert for Gabica Capsule 300 mg, which are being used to treat nerve pain that may be associated with diabetes, herpes zoster (shingles), or injury to the spinal cord.
The DRAP in a recall alert issued here on Tuesday, while addressing Regulatory Field Force, Provincial Drug Control departments, healthcare professionals, pharmacies and medical stores operators, said to immediately stop the sale, purchase and usage of the above mentioned drug.
According to DRAP, the Directorate of Drug Control Punjab (DDCP) has informed the authority that the sample of below mentioned product has been declared “Spurious”. The details of the report are as under: The GABICA CAPSULE Each capsule contains of Pregabalin 300mg batch number 399C27manufactured by M/s Getz Pharma (Pvt) Ltd, 29-30/27, Korangi Industrial Area, Karachi which has been declared “Substandard” with regards to Assay and Dissolution, “Spurious” as per Section 3(z-b) (ii) and “Adulterated” as per Section 3(a)(v) of Drugs Act, 1976.
Falsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned un-registered/falsified product. All pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these products from circulation.
DRAP 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 pharmaco vigilance centres using Adverse Event Reporting Form or online through this link. Further, information on reporting problems to DRAP is available on this link.
The consumers 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 DRAP/National Pharmaco vigilance Centre.
All therapeutic goods must be obtained from licensed pharmacies and other authorised/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, DRAP has urged.
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