The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Mars Remedies PVT Limited, India, for the manufacture of falsified Ciprofloxacin tablets BP 500mg (NAFDAC REG. NO C4-0498) for Pinnacle Health Pharmaceutical Limited, No 16/18 Nuru Oniwo Street, Surulere, Lagos State.
In view of the unprofessional practice, the agency stated that all products manufactured by the Mars Remedies PVT Limited, 635, GIDC Estate Waghodia, Vadodara, Gujurat, India, will not be allowed into Nigeria with immediate effect.
In a letter dated October 9, 2020, and addressed to the Managing Director of Mars Remedies PVT Limited, and titled: ‘Notice of blacklisting as a manufacturer of substandard and falsified medicines’, the Director-General of NAFDAC, Prof. Mojisola Christianah Adeyeye, reiterated the agency’s position of zero tolerance for substandard and falsified medicines dominance in Nigeria in fulfillment of the regulatory obligation of safeguarding the health of the country.
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.
“The director-general wishes to warn all manufacturers and importers of medicines to adhere strictly to the conditions for which their products were registered by NAFDAC or face similar sanctions,” he stated.