Prof. Mojisola Christianah Adeyeye, the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), has disclosed that the agency has blacklisted Mars Remedies PVT Limited, India.
According to the press release issued, the agency blacklisted Mars Remedies PVT Limited for manufacturing falsified Ciprofloxacin Tablets BP 500mg (NAFDAC REG. NO C4-0498) for Pinnacle Health Pharmaceutical Ltd, 16/18. Nuru Oniwo Street, Surulere, Lagos.
In view of the unprofessional practice, Prof. Adeyeye explained that all products manufactured by the Indian company will not be allowed into Nigeria with immediate effect.
According to Prof. Adeyeye, the variation in the formulation of the Ciprofloxacin 500mg tablets, which may impact 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.
What you should know
This decision is a follow up to the notice sent to the Indian company, in a letter dated October 9, 2020 and addressed to the Managing Director of Mars Remedies PVT Limited, with the title; “Notice of blacklisting as a manufacturer of substandard and falsified medicines.”
The DG of NAFDAC, in the letter, reiterated the agency’s position of zero tolerance for substandard and falsified medicines preponderance in Nigeria, in fulfillment of the regulatory obligation to safeguard the health of the nation.
She explained that the company illegally manufactured different formulations of Ciprofloxacin tablets, instead of the approved formulation for export to Nigeria, and this is in violation of NAFDAC’s extant laws and regulations.
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There must be a consequence for pinnacle action so as to serve as detriment for other company that wish to do the same either an heavy fine or court action.