An Indian firm, Mars Remedies PVT Limited has been blacklisted by the National Agency for Food and Drug Administration and Control (NAFDAC) 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 stated all products
manufactured by the Mars Remedies PVT Limited, 635, GIDC Estate Waghodia,
Vadodara, Gujurat, India, will henceforth not be allowed into Nigeria with
immediate effect.
NAFDAC's Director-General, Prof. Mojisola Christianah
Adeyeye reiterated the agency’s position of zero tolerance for substandard and
falsified medicines dominance in Nigeria in fulfillment of the regulatory
obligation of safeguarding the health of the country.
Adeyeye also disclosed 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."
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