The National Agency for Food and Drug Administration and Control, NAFDAC, says it has blacklisted Mars Remedies PVT Limited, India, for manufacturing falsified medicine for a pharmaceutical company in Nigeria.
This is contained in a statement signed by the agency’s Director General, Prof. Mojisola Adeyeye on Tuesday in Abuja.
The NAFDAC Director-General said that the agency also delisted Ciprofloxacin tablets BP 500mg with (NAFDAC Reg. No. C4-0498) which was manufactured for Pinnacle Health Pharmaceutical, Surulere, Lagos.
According to Mrs Adeyeye, 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 addressed to the Managing Director of Mars Remedies PVT Limited titled “Notice of blacklisting as a manufacturer of substandard and falsified medicines” reiterated the agency’s position for zero tolerance for substandard.
Mrs Adeyeye said that the stand was in fulfilment of the regulatory obligation of the agency to safeguard the health of the nation.
“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.
“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 stressed.
Mrs Adeyeye, therefore, 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.