- NAFDAC emphasized that the variation may affect product quality and shelf-life.
- Besides, the variation in drugs it also indicated a violation of the NAFDAC Act.
THDNewsDesk: The Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) has ostracised Gujarat-based pharma firm ‘Mars Remedies’ for producing bad quality and fraudulent Ciprofloxacin 500 mg tablets.
The NAFDAC is an institution to monitor and check the production, importation, exportation, distribution, advertisement, sale, and use of drugs, foods, cosmetics, medical devices, chemicals, detergent, and packaged water.
NAFDAC reported to the company that from the inspection of the eight batches it obtained, had yellow colored tablets and white-colored tablets x 10s packed in Alu Alu PVC blister pack. Though, according to the Agency’s record, it had lodged white-colored pinnacle Ciprofloxacin 500 mg film tablet BP x 10s packed in Alu Alu strip blister original packages. The drug, pinnacle Ciprofloxacin 500 mg tablet BP ( NAFDAC Reg No.C4-0498 batch number T-374 to T-381) was for export to Nigeria. NAFDAC emphasized that the variation may affect product quality and shelf-life. Besides, this unspecified variation to the Agency, also it develops a violation of the NAFDAC Act.
The letter stated, “In fulfillment 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.”
Dr. Hemant Koshia, Commissioner, Gujarat FDCA stated, “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 realized 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 to the norms.”