NAFDAC blacklists firm for producing falsified drug

The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Mars Remedies PVT Limited of India for the manufacture of falsified Ciprofloxacin Tablets BP 500mg.

The product has NAFDAC registration number C4-0498.

The alleged falsified drug was manufactured for Pinnacle Health Pharmaceutical Limited of 16/18, Nuru Oniwo Street, Surulere, Lagos.

In a statement by its Director-General, Prof. Mojisola Adeyeye, the agency noted that in view of the unprofessional practice, all products manufactured by Mars Remedies PVT Limited of 635, GIDC Estate Waghodia, Vadodara, Gujurat, India, will not 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,” NAFDAC restated its zero tolerance for substandard and falsified medicines in Nigeria in fulfillment of its regulatory obligation of safeguarding the health of the nation.

“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.

“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,” it said.

“This constitutes a violation of the NAFDAC Act. We note 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,” the statement said.