The National Agency for Food and Drug Administration and Control of Nigeria (NAFDAC) has placed some Indian Pharma companies on an alert list of banned suppliers for supply of counterfeit drugs to Nigeria. Names of the companies are not disclosed.

The allegations have been rejected by the companies concerned. In order to protect the interest of Indian pharma exports, Pharmaceutical Export Promotion Council (Pharmexcil) as a proactive action met the representatives of these companies and noted that all exports to Nigeria are subject to mandatory pre-shipment inspection by an independent inspection agency, which includes physical inspection of the consignments, analysis of samples drawn from ready consignments, and reports thereof by independent authorized laboratories.

Imported medicines are cleared by the Nigerian customs only after receipt of a Clean Findings Report of Inspection and Analysis by the independent inspection agency. Under these circumstances, it is not clear how allegedly fake or sub-standard medicines have been found by NAFDAC.

Since the exporters in question have not been given an opportunity to explain their case and clear their names, there is an urgent need to seek a personal hearing for affected exporters to put forth their cases before NAFDAC and establish their bona fides.

In a meeting held early this month, under D B Mody, chairman, Pharmexcil, in which all affected exporters participated, it was unanimously decided to give a full factual report to Pharmexcil so that in the interest of exports the matter could be referred to the ministry of commerce as well as Indian Embassy in Nigeria.

As a matter of service to importers in Nigeria and exporters from India, if required, a delegation of representatives of exporters concerned will be deputed to Nigeria to conduct tests, following the prescribed test protocols, in the presence of buyers with a view to satisfactorily sorting out the issue for mutual benefit of the two countries.

NAFDAC has accused the listed companies of "persistently indulging in dumping fake and counterfeit drugs into the country."

Given the strict monitoring of quality of drugs imported into Nigeria by the Independent Inspection Agency nominated by the Nigerian authorities, it is surprising as to how Nigerian importers have managed to clear such alleged fake and counterfeit drugs.

Pharmexcil has also stated that Indian drug Industry is known for its capabilities to supply quality pharmaceutical products at competitive prices. The industry has also given an assurance to all International Regulatory Agencies like NAFDAC that the country's hard earned reputation as a quality supplier will not be allowed to be tarnished. The industry is confident that justice would prevail and all affected companies need to be given an opportunity to present their case and clear their name of such false allegations.

Pharmexcil has 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. It is also approaching the Indian Embassy in Nigeria to persuade NAFDAC to keep in abeyance their recent order barring the import of drugs from the concerned manufacturers, till the matter is sorted out to mutual satisfaction.