The local inspection reports and manufacturing audit feedbacks about the companies have prompted National Agency for Food and Drug Administration and Control of Nigeria (NAFDAC) to ban eleven drug companies from India, mostly from Maharashtra and Gujarat from supplying medicines to Nigeria.
According to sources in the independent agency for quality clearance for Nigerian exports in India, the ban is not on the basis of the substandard consignments seized by the Nigerian Authority as it was reported in the media earlier.
The sources said that along with these Indian companies, the Agency has banned their local importers as well on the charge that they were indulged in faking the brands after importing Indian products.
"The NAFDAC ban could be on the basis of reports from their audit sources about the non-standard and non-specific manufacturing practices followed by the companies," said Ramakant Gudal, chief consultant in the independent quality inspection agency for Nigerian exports in India. He added, "The action could be even based on our inspection report. Though we have the list of the black listed Indian exporters, we are not allowed to disclose the same."
Gudal confirmed that the NAFDAC's action was certainly not on the basis of substandard import consignments from India. Declining to go into the details of the actual causes for the blacklisting, Gudal said that the reason could be some thing beyond the defects in the imported products," he said.
The Nigerian Regulatory Agency had recently brought out a list of banned drug suppliers, which includes exporters from various countries including India. However, the Agency had not revealed the reasons for the ban on the drug suppliers to the country while announcing the list.
Hence, there was confusion among the Indian exporting community whether the companies have actually indulged in supplying fake products. However, the sources from the independent agency appointed by the Government of Nigeria in India to issue Clear Report of Inspection and Analysis (CRI) to the formulation exports after physically inspecting samples from each consignments, said that there the matter of ban is directly connected with the shipments.
Indian Embassy, following the requests from the Pharmaceutical Export Promotion Council, has initiated talks with NAFDAC on this issue. As reported by Pharmabiz earlier, the Pharmexcil had in a meeting convened soon after the NAFDAC announcement, decided to give a report and the matter could be referred to the ministry of commerce as well as the Indian Embassy in Nigeria.
Pharmexcil has stated that it had given an assurance to all International Regulatory Agencies including NAFDAC that the country's hard earned reputation as a quality supplier will not be allowed to be tarnished. The Council had also written to NAFDAC to give all the parties concerned an opportunity to prove their bonafides and that they are not involved in any way with supply of fake and counterfeit drugs to Nigeria.