NAFDAC bans India company for manufacturing substandard medicines
delists Pinnacle Nigeria Ciprofloxacin
THE National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted an Indian Company, Mars Remedies PVT Limited for manufacturing falsified Ciprofloxacin Tablets BP 500mg with NAFDAC registration NO, C4-0498 for Pinnacle Health Pharmaceutical Limited.
This is contained in a statement signed by Moji Christianah Adeyeye, the Director-General of NAFDAC and made available to The ICIR on Monday.
“In view of the unprofessional practice, the Agency states that all products manufactured by the Mars Remedies PVT LTD, 635, GIDC Estate Waghodia, Vadodara, Gujarat, India, will not be allowed into Nigeria with immediate effect,” the statement read.
NAFDAC said the company was blacklisted 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.
According to the statement, the company violated the NAFDAC extant laws and regulations by illegally manufacturing different formulations of Ciprofloxacin tablets instead of the approved formulation for export to Nigeria.
NAFDAC further noted in the statement 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.
“This 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,” Adeyeye said.
The Director-General warned other manufacturers and importers of medicines to adhere strictly to the conditions for which their products were registered by NAFDAC or face similar sanctions.