The National Agency for Food and Drug Administration and Control (NAFDAC) weekend banned all products manufactured by Mars Remedies PVT Limited, India over falsification of Ciprofloxacin Tablets BP 500mg with NAFDAC registration number NO C4-0498 for Pinnacle Health Pharmaceutical Ltd.
In a press statement signed by the Director-General, Prof Moji Christianah Adeyeye, the agency insisted that in view of the unprofessional practice all products manufactured by the Mars Remedies PVT LTD, 635, GIDC Estate Waghodia, Vadodara, Gujarat, India, will no longer be allowed into Nigeria with immediate effect.
In a letter dated October 9, 2020, addressed to the Managing Director of Mars Remedies PVT Limited, and titled; "Notice of blacklisting as a manufacturer of substandard and falsified medicines", Adeyeye, said the agency has zero-tolerance for substandard and falsified medicines preponderance in Nigeria.
"In violation of NAFDAC extant laws and regulations, the company illegally manufactured different formulations of Ciprofloxacin tablets instead of the approved formulation for export to Nigeria."
According to Adeyeye, the variation in the formulation of the Ciprofloxacin 500mg tablets, which may impact on the product quality and shelf -life, was not approved by the Agency before the changes were made.
This constitutes a violation of the NAFDAC Act, noting with dismay that the company has displayed a flagrant disregard for compliance with global standards necessary to assure the production of quality assured products. Therefore the company has been blacklisted accordingly.
She warned all manufacturers and importers of medicines to adhere strictly to the conditions for which their products were registered by NAFDAC or face similar sanctions.