NAFDAC blacklists Indian company for manufacturing falsified medicines
The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted an Indian drug manufacturing Company, Mars Remedies PVT Limited, India, for the manufacture of falsified Ciprofloxacin Tablets BP 500mg with registration number: NAFDAC Reg, No. C4-0498.
It manufactured the medicine for a Nigerian Company, Pinnacle Health Pharmaceutical Ltd, Surulere, Lagos.
In view of the unprofessional practice, the Agency stated that all products manufactured by the Mars Remedies PVT LTD, 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 Director-General of NAFDAC, Prof. Mojisola Adeyeye, reiterated the Agency’s position of zero tolerance for substandard and falsified medicines preponderance in Nigeria in fulfilment of the regulatory obligation of safeguarding 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.
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.
This, according to her, 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;” she said, and 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.
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