New Delhi: 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.
In a letter written to Mars Remedies on 9 October, the NAFDAC said the company manufactured “falsified” Ciprofloxacin 500mg tablets. The letter was also marked to Dr V.G. Somani, Drugs Controller General of India (DCGI).
“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 ThePrint.
ThePrint reached Mars Remedies via e-mail but is yet to get a response. Somani too hadn’t responded to call and text messages by ThePrint until the time of publishing this report.
Ciprofloxacin is an antibiotic which is used to treat bacterial infections. India is one of the world’s largest exporters of antibiotic tablets. According to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), an arm that functions under the Ministry of Commerce and Industry, Nigeria is the fifth largest export destination for India’s pharmaceuticals by value.
Also read: Why India saw only 4 pharma products launched in April, its lowest count ever
‘Zero tolerance for substandard medicines’
The letter, written by Moji Christianah Adeyeye, director general, NAFDAC, 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,” Adeyeye said.
By blacklisting, the agency has barred all products manufactured by the Gujarat-based pharmaceutical company from entering into Nigeria.
Company charged for changing the colour of tablets
According to the letter, the move by the NAFDAC is the outcome of inspection of the eight batches of “Pinnacle Ciprofloxacin film coated 500mg Tablets BP” manufactured by Mars Remedies.
The tablet, according to the Nigerian agency, showed marked deviation from the tablets “registered by the NAFDAC”.
“We have on record that the agency registered white coloured Pinnacle Ciprofloxacin 500mg film coated Tablets BP x10’s, packed in Alu-Alu strip blister primary, package while the falsified product as manufactured by your company came as yellow coloured tablets 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 agency said.
The letter further conveyed to the company that it is a “high-risk” foreign manufacturer of finished pharmaceutical products based on its “unprofessional practice, lack of transparency and poor commitment to product quality.”
Your facility, it said, has displayed evidence that amounts to “high potential for covert manufacturing and shipment of substandard and falsified medicines into Nigeria and therefore, has been blacklisted accordingly.”
According to the industry experts, not complying with conditions of the regulator and deviating from the permitted colours can be rightly construed as not being the one as permitted and hence falsified.
Also read: Watchdog on pharma ethics violations says it has no such power in RTI reply, takes U-turn later