Nigerian regulator blacklists Vadodara firm over substandard drugs

Matter relates to eight batches of drug made by Mars Remedies from for a Nigerian pharma company; all its products are now barred from entry into African nation

Nigerian regulator National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Vadodara-based Mars Remedies Pvt Ltd over substandard drugs manufactured by the company. 

NAFDAC has written to Mars Remedies based on a recent incident of pharmaceutical products inspection violation by the company with respect to manufacturing of eight batches of falsified ciprofloxacin 500mg film coated tablets for export to Nigeria. Mars Remedies is engaged in contract manufacturing for Nigerian pharmaceutical companies.

The outcome of inspection by NAFDAC has showed marked deviation of the eight batches of the drug manufactured by Mars Remedies from the Ciprofloxacin 500mg film coated tablets registered by NAFDAC for Pinnacle Health Pharmaceutical Ltd, a Nigerian pharma company. 

"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 x10's 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 regulator has written to the company.

NAFDAC has declared the company as a high-risk foreign manufacturer of finished pharmaceutical products with its Waghodia unit in Vadodara being blacklisted even as all products manufactured by the company will not be allowed into Nigeria with immediate effect.

The matter of blacklisting Mars Remedies has also come to the notice of the state Food and Drug Control Administration (FDCA) in Gujarat. In fact, few months ago, Mars Remedies had also been issued a show cause notice along with immediate stop production notice by the state FDCA. 

"The blacklisting issue has come to our notice. We too had inspected few months ago and had found discrepancies following which we had issued a stop manufacturing notice for gross violation of regulatory norms. Later, the company had responded assuring necessary remedial measures and had met compliances in subsequent inspections," said H G Koshia, commissioner, FDCA Gujarat.

Established in 1993, NAFDAC has been regulating and controlling the manufacturing, import, export, distribution, advertisement, sale and use of drugs, food, cosmetics, medical devices, chemicals, detergent and packaged water in Nigeria.

According to NAFDAC, the regulator has taken a position of zero tolerance for substandard and falsified medicines preponderance in Nigeria as part of fulfilment of its regulatory obligation.

"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 regulator has further stated.