NAFDAC blacklists indian company over falsified medicines
The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Mars Remedies PVT Limited, India, over making of falsified medicine for its Nigeria pharmaceutical counterpart.
This was contained in a statement issued by NAFDAC Director-General, Prof. Mojisola Adeyeye on Tuesday in Abuja.
Prof. Adeyeye said that in view of the unprofessional practice, all products manufactured by Mars Remedies PVT, 635, GIDC Estate Waghodia Vadodara, Gujurat, India, will not be allowed into Nigeria with immediate effect.
She said that a letter has been forwarded to the Managing Director of Mars Remedies PVT Limited titled “Notice of blacklisting as a manufacturer of substandard and falsified medicines” to that effect.
The statement reads: “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.”
Prof. Adeyeye said that the agency, therefore, also delisted Ciprofloxacin tablets BP 500mg with (NAFDAC Reg. No. C4-0498) which was manufactured for Pinnacle Health Pharmaceutical, Surulere, Lagos.
“This constitutes a violation of the NAFDAC Act.
“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.”
She warned all manufacturers and importers of medicines to adhere strictly to NAFDAC terms and conditions or face similar sanctions.