The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Mars Remedies PVT Limited, India.
The Director-General of the agency, Prof. Mojisola Adeyeye, disclosed this on Wednesday via a press release.
According to the release, 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 company would not be allowed into Nigeria with immediate effect.
She said the variation in the formulation of the Ciprofloxacin 500mg tablets, which may impact the product quality and shelf-life, was not approved by NAFDAC before the changes were made.
This, according to her constituted a violation of the NAFDAC Act.
The release said Prof. Adeyeye noted with dismay that the company has displayed a flagrant disregard for compliance with global standards necessary to assure the production of quality assured products, adding, “therefore, the company has been blacklisted accordingly.”
It said further: “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.
“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.