Nigeria ‘Blacklists’ Gujarat-based Pharma Company over ‘Substandard, Falsified’ Antibiotics

New Delhi: Nigeria’s drug regulator has blacklisted Gujarat-based pharmaceutical company Mars Remedies for manufacturing “substandard” antibiotic medicine while accusing the firm of lacking transparency and quality commitment, according to media reports.

Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) communicated its decision to Mars Remedies in a letter dated October 9. The letter was marked to Dr V.G. Somani, Drugs Controller General of India (DCGI) as well.

In the letter, NAFDAC’s director-general Moji Christianah Adeyeye said that eight batches of the Ciprofloxacin drug manufactured by the company violated a recent pharma product inspection. Excerpts of the letter published by The Print reads—“We wish to formally bring to your notice the recent incident of pharmaceutical products inspection violation by your company with respect to the manufacture of eight (8) batches of falsified Pinnacle Ciprofloxacin 500mg film-coated Tablets for export to Nigeria.”

Ciprofloxacin is used to treat various bacterial infections and it works by stopping the bacteria’s growth.

Nigeria faces a massive problem of imported substandard or fake drugs. Nigeria relies heavily on drug imports—70%--and India is one of the largest exporters of pharmaceutical drugs to the African nation. India has previously committed to help Nigera, its seventh-largest pharma consumer, curb the fake drugs problem.

The NAFDAC letter further says, “In fulfilment of this regulatory obligation of safeguarding the health of the nation, the agency has taken a position of zero tolerance for substandard and falsified medicines preponderance in Nigeria.”

“Undeniably, this intentional violation which typifies bad manufacturing practice indicates that your facility lacks transparency and quality commitment with the propensity for clandestine manufacturing of possible substandard and falsified medicines,” the letter added.

The letter says NAFDAC found that the inspected Pinnacle Ciprofloxacin tablets showed marked deviation from the tablets registered by the regulator. It says the agency registered white coloured Pinnacle Ciprofloxacin 500mg film-coated Tablets BP x10’s which were packed in Alu-Alu strip blister primary package. On the other hand, the said falsified drugs were both yellow and white coloured tablets packed in Alu-PVC blister pack.

“The variation which may impact on the product quality and shelf-life was not communicated to the agency before the changes were made, therefore, constitutes a violation of the NAFDAC Act,” the letter said.