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 Ltd, in Nigeria.
NAFDAC Director General, Professor Mojisola Adeyeye, who made this disclosure in a statement said: “In view of the unprofessional practice, the agency states that all products manufactured by the Mars Remedies PVT LTD, 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”, the DG reiterated the agency’s position of zero tolerance for substandard and falsified medicines preponderance in Nigeria in fulfillment of the regulatory obligation of safeguarding the health of the nation.
The statement added, “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 Prof 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, adding that “this constitutes a violation of the NAFDAC Act”.
She further 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, which was why the company has been blacklisted accordingly.
She also warned all manufacturers and importers of medicines to adhere strictly to the conditions for which their products were registered by NAFDAC or face similar sanctions.