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.
The NAFDAC is an agency 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 has communicated to the company 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 stressed that the variation may impact product quality and shelf-life. Moreover, since this variation was not communicated to the Agency before the changes were made, it constitutes 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 letter stated.
Dr Hemant Koshia, Commissioner, Gujarat FDCA informed, “Nearly six to eight months back, the Gujarat FDCA had done an independent audit and inspection at the Mars Remedies facility located in Gujarat and realised that there were manufacturing negligence and non-compliance activities in the facility. And therefore, we instructed them (Mars Remedies) to stop production activities immediately. We had also issued a show-cause notice to the company. However, approximately two months back, the company submitted the report, and based on the verification compliance, we gave permission to the firm to resume production activities and also instructed them to follow the required regulatory guidelines and adhere with the norms.”
The company (Mars Remedies) did not respond to Express Pharma’s email queries until the story was filed.