Authorities directed to remove seven batches of drugs immediately

ISLAMABAD: In a bid to purge drug market of spurious/falsified drug products the Drug Regulatory Authority of Pakistan (DRAP) has started a crackdown against spurious/falsified pharmaceuticals and directed the authorities to immediately remove seven batches of drugs from distributors, pharmacies and hospitals.

In an alert issued by the DRAP said the Directorate of Drugs Control (DDC) Punjab has detected the following falsified drug products based on their analysis from Drug Testing Laboratories (DTLs).

(i) Ativan 2mg Tablets Composition Lorazepam batch number 17C7019 Purported to be manufactured by M/s Pfizer Pakistan, Karachi owing to spurious quality. (ii) Marfix 400mg Tablet active ingredients Cefixime batch number MK-0002 manufactured by M/s Mirak Pharmaceutical, Lahore owing to spurious quality. (iii) Payodine 10g/100ml Solution active ingredients Povidone-Iodine batch number 002709 manufactured by M/s AMannan Lab, Karachi owing to spurious quality.(iv) Froxime 400mg Capsule active ingredients Cefixime batch number FRX-400/C-6 manufactured by M/s Froxx Pharmaceuticals, Karachi owing Spurious and misbranded quality. (v) Noa-Xime 400mg Capsule active ingredients Cefiximebatch number nx-00525-02 manufactured by M/s NoaHemis Pharmaceuticals, Karachi owing to spurious and misbranded quality. (vi) Biovim Injection active ingredients Benzyl Penicillin batch number 500000 IU, Procaine Penicillin 1500000 IU produced by C. B-86 M/s. Uniline Pharma, Karachi owing to spurious quality. (vii) Novazone Plus Drench active ingredients Oxyclonazde 3% w/v, Levamisole HCl1.5% w/v, Cobalt Sulphate 0.075%/v, Selenium Selenite 0.035% batch number 061 manufactured by M/s Uniline Pharma, Karachi owing to spurious quality.

Spurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. The safety and quality of the falsified products referenced in this alert are unknown.

The Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. 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 to halt the distribution/supply of this product. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of these products.

Meanwhile, the DRAP has issued an immediate recall alert for recall of 11 substandard and adulterated batches of some pharmaceutical products from the market.

In the recall alert the DRAP has directed national regulatory field force including, (i) pharmacists and chemists at distribution, pharmacies and medical stores. (ii) Healthcare professionals, physicians, pharmacists, and nurses at hospitals and clinics and (iii) general public.

The Directorate of Drugs Control (DDC) in Punjab and the Quality Control Board in Balochistan have identified the following substandard batches of pharmaceutical products based on analysing their samples from Drug Testing Laboratories, revealing out-of-specification results.

The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock should be quarantined and returned to the supplier/company.

(i) Zyocain gel 15g composition of Lidocaine HCL 2%, batch number 244275 produced by M/s. Pharmawise Laboratories, Lahore owing to substandard quality.

(ii) Metrorise injection composition of Metronidazole 500mg/100ml, batch number LV2303 manufactured by M/s. Pak risen Pharmaceuticals, Hattar substandard quality.(iii) Safemed Injection composition Metronidazole 500mg/100ml batch number S-825 produced by M/s. Ahad International Pharmaceutical Ltd. DI Khan substandard quality.(iv) Lyosafe Infusion active ingredients Levofloxacin batch number L-784 produced by M/s. Ahad International Pharmaceutical Ltd. DI Khan substandard quality.(v) Enzol-WFI injection active ingredients Sterile water for injection batch number 1240003 manufactured by M/s. Enzon Pharma, Lahore substandard quality. (vi) Oxytofas Injection active ingredients Oxytocin batch number OTI-1419 M/s. Intervac (Pvt) Ltd Sheikhupura Substandard quality and Misbranded. (vii) Painsa 75mg Injection active ingredients Diclofenac Sodium batch number PA420 produced by M/s. Wimits Pharmaceuticals, Lahore Substandard quality. (viii) Midoven Injection active ingredients Furosemide batch number H-21924 produced by M/s. Venus Pharma, Lahore adulteration. (ix) Mencobal Injection active ingredients Mecobalamin batch number 083084 produced by M/s. Treat Pharmaceutical Industry, Lahore adulteration.

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