The National Agency for Food and Drug Administration and Control of Nigeria (NAFDAC) has blacklisted an Indian firm, Mars Remedies PVT Limited for manufacturing falsified Ciprofloxacin tablets BP 500mg (NAFDAC REG. NO C4-0498) for Pinnacle Health Pharmaceutical Limited located at No 16/18 Nuru Oniwo Street, Surulere, Lagos State.
In a letter addressed to the Managing Director of Mars Remedies PVT Limited and titled: ‘Notice of Blacklisting As A Manufacturer of Substandard and Falsified Medicines’, the Nigerian agency noted that all products manufactured by the Mars Remedies PVT Limited, 635, GIDC Estate Waghodia, Vadodara, Gujarat, India, will henceforth not be allowed into Nigeria with immediate effect.
Speaking on the back of NAFDAC’s decision to ban the Indian firm, Prof. Mojisola Christianah Adeyeye, Director-General of NAFDAC, reiterated the agency’s position of zero tolerance for substandard and falsified medicines dominance in Nigeria in fulfilment of the regulatory obligation of safeguarding the health of the country.
Adeyeye revealed that 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.
The statement read;
“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, Surulere, Lagos.
“In view of the unprofessional practice, all products manufactured by 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 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 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.”
