The National Agency for Food and Drug Administration and Control, NAFDAC, had announced on 25th October 2020 that she has blacklisted Mars Remedies PVT Limited India for manufacturing falsified Ciprofloxacin Tablets BP 500mg with NAFDAC Registration Number C4 – 0498 for Pinnacle Health Pharmaceutical Ltd at 16/18, Nuru Oniwo Street, Surulere, Lagos. NAFDAC found the practice unprofessional and declared that all products manufactured by the Mars Remedies PVT Limited, at the address 635, GIDC Estate Waghodia, Vadodara, Gujarat, India, are banned from Nigeria with immediate effect.
NAFDAC stated that Mars Remedies PVT Limited disregarded global standards by changing the formulation for the production of the drug at will without getting in touch with the Agency as required by global regulations and the extant laws of the Agency.
The Agency, in a letter dated 9th October 2020 addressed to the Managing Director of Mars Remedies PVT Limited, captioned: Notice of Blacklisting as a Manufacturer of Substandard and Falsified Medicines, NAFDAC’s Director General, Professor Mojisola Christianah Adeyeye, stated the agency’s position regarding zero tolerance for substandard and falsified medicines proliferation in Nigeria, in fulfilment of the Agency’s regulatory obligation to safeguard the health of the country.
Mars Remedies PVT Limited violated the extant laws and regulations of NAFDAC by illegally manufacturing different formulations of Ciprofloxacin tablets instead of the approved formulation for export to Nigeria.
On their website, NAFDAC reported that “according to Professor 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.”
Source: NAFDAC Website