Mars Remedies requests NAFDAC to remove it from the blacklist

Gujarat-based Mars Remedies, which was recently blacklisted by the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), has written a letter to the agency, providing an explanation and requesting the authority to remove it from the blacklist.

In the letter, the company has mentioned that it received a request from its importer Pinnacle Health Pharmaceuticals (through Trident Lifeline,  the Indian exporter) to manufacture Ciprofloxacin 500 mg product in Alu PVC pack in yellow and white coloured tablets. The company says in the letter, “We acknowledge a serious oversight on both parties (manufacturer and importer) for producing tablets in two colours. It was nearly an oversight that we missed to obtain the intended variation approval from our importer, but it was never a deliberate attempt to subvert the National Agency for Food and Drug Administration and controlled approved process. After completing the manufacturing, we decided to go ahead and gave samples for analysis as per the norms of the National Agency for Food and Drug Administration and Control. We have even held the shipment in our premises to ensure our commitment to adhere to Good Manufacturing Practice. We have strictly followed the National Agency for Food and Drug Administration and Control regulation and fulfilled our part of the commitment by ethically giving samples for testing to an approved agency for food and drug administration and control and also did not ship the material until we received proper certificate/communication for the change in final packaging. Submission of samples for analysis clearly signifies that we had nothing to hide and we did not compromise on standards as prescribed by the agency’s approved facility to assess the quality.”

As per the records of National Agency for Food and Drug Administration and Control, Ciprofloxacin 500 mg is registered under the firm name of Pinnacle Health Pharmaceuticals, Nigeria with product registration number C4-0498. And, it is registered under Alu-Alu strip blister packaging.

M Y Karbhari, MD, Mars Remedies said, “On July 16, 2020, we received the manufacturing order from Trident Lifeline, (which is exporting to the firm in Nigeria; Pinnacle Health Pharmaceuticals) to manufacture Ciprofloxacin tablet 500 mg. As per the order communication, we need to pack each 18,10,000 tablets in titanium dioxide and tartrazine. As per the contract, all the raw material for manufacturing and packaging of Ciprofloxacin 500mg tablet was supplied by Trident Lifeline and to initiate the manufacturing process, we took the regulatory approval from our State FDA (Gandhinagar) and then initiated the production. On September 24, Silis Labs carried out the inspection and submitted the analysis report, which highlighted the colour difference as against the product registration. And based on the report the agency falsified the medicines produced at our end.”

The lab analysis report of Silis Labs states that a single Product Blister Strip of Ciprofloxacin Tablets BP 500 mg was found but in two entirely different colours of tablets (White & Yellow). However, the tablets are to be white, oblong biconvex scores on one side and plain on the other and this is captured on the lab report. The package does not reflect tartrazine – and changes are noted on the package design. The product was not registered with different colours as they claim.

Commenting on the lab analysis report, Karbhari said, “We were not kept informed about the findings of the analyst report, however, we came to know when we got the letter from the agency informing about the blacklisting of our firm. However, we would like to urge to the authority that our facility does not display any potential to ship any substandard and falsified medicine into Nigeria as we have not shipped the consignment, waiting for proper authorisation from the National Agency for Food and Drug Administration and Control.”

He added, “We are an upcoming company with relatively small turnover expecting to grow on the basis of our strict adherence to quality and compliance with regulatory boards’ guidelines. And we have been exporting to Nigeria, Kenya, Cambodia, Ghana, Liberia, Afghanistan, and Venezuela since the last four to five years, therefore we have requested to the agency to remove our firm from the blacklist as it will affect our ethical reputation in those countries as well.”

The company has 364 registered brands with licences from the Food and Drug Council Administration (FDCA), Gandhinagar, Gujarat.