The Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Gujarat-based pharma firm, Mars Remedies for manufacturing of substandard and falsified Ciprofloxacin 500 mg tablets.
NAFDAC was established with the mandate to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of drugs, foods, cosmetics, medical devices, chemicals, detergent and packaged water.
The agency reportedly said that based on the inspection of the eight batches of pinnacle Ciprofloxacin 500 mg tablet BP (NAFDAC Reg No.C4-0498 batch number T-374 to T-381) for export to Nigeria, it has received yellow coloured tablets and white coloured tablets x 10s packed in Alu Alu PVC blister pack. Whereas, as per the Agency’s record, it has registered white coloured pinnacle Ciprofloxacin 500 mg film tablet BP x 10s packed in Alu Alu strip blister primary packages.
The agency reportedly said that the difference may cause a lot of negative effect on the product quality and shelf-life even as the variation was not communicated to the agency before the changes were made thereby constituting a violation of the NAFDAC Act.
“In fulfilment of this regulatory obligation of safeguarding the health of the nation, the agency had taken a position of zero tolerance for substandard and falsified medicines preponderance in Nigeria. Undeniably, this international violation which typifies bad manufacturing practice indicates that your facility lacks transparency and quality commitment with the propensity for clandestine manufacturing of possible substandard and falsified medicines,” the agency reportedly said.
The agency admonishes the public to be vigilant and report cases to the Agency.
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