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Nigerian Drug Regulator Blacklists Gujarat Pharma Company For Providing 'Substandard, Falsified' Antibiotics
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India, 20 Oct 2020 9:45 AM GMT | Updated 20 Oct 2020 10:01 AM GMT
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In a letter to the Gujarat firm and Drugs Controller General of India, the Nigerian drug regulator said they are blacklisting the firm as they have found eight batches of falsified Pinnacle Ciprofloxacin 500mg film-coated Tablets.
Nigeria's drug regulator National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Gujarat-based pharma firm Mars Remedies for manufacturing 'substandard and falsified' antibiotic tablets.
The agency has barred all products manufactured by the pharmaceutical company from entering Nigeria.
In a letter to Mars Remedies on October 9, the NAFDAC said the company manufactured falsified Ciprofloxacin 500mg tablets, used to treat bacterial infections. The letter was also marked to Dr V.G. Somani, Drugs Controller General of India (DCGI), reported The Print.
"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," read the letter accessed by the media.
"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," the letter was written by Moji Christianah Adeyeye, director general, NAFDAC further read.
India is one of the world's largest exporters of antibiotic tablets and Nigeria is its fifth-largest importer.
NAFDAC is the agency to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of drugs, foods, cosmetics, medical devices, chemicals, detergent and packaged water.
The action by the agency has come after conducting an inspection of eight batches of Pinnacle Ciprofloxacin film-coated 500mg Tablets BP manufactured by Mars Remedies. The company has also been charged for changing the colour of the tablet from white to yellow. The variation in colour constitutes a violation of the NAFDAC Act.
Adeyeye said that this intentional violation qualifies as bad manufacturing practice and indicates that the facility lacks transparency and quality commitment.
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