By Henry Uche
The Pharmaceutical Society of Nigeria (PSN) has urged the National Agency for Food, Drug Administration and Control (NAFDAC) to desist from its unending excesses, which involve “intimidation, undue monitoring and control.”
In a statement signed by chairman of PSN, Lagos State, Gbolagade Iyiola, the body said, NAFDAC should have a rethink about its propensity to turn pharmacy practice to a major template of internally generated revenue through its imposition of unending taxes and tariffs on players in the value chain of the pharmaceutical sector. It added that at a time when most businesses were not running optimally, NAFDAC insists on crippling charges.
According to the statement, NAFDAC has taken up the challenge of continuing the unholy attempt to oversee the certification of pharmaceutical premises engaged in the wholesale and distribution of medicines in Nigeria.
“It is this grab-all attitude by NAFDAC that has encouraged some other regulators in the Nigerian space to imagine there is more money than common sense in the pharmaceutical sector, which was why they wanted a share of the booty in the pharmaceutical world in the recent past.
“It is also an irony that NAFDAC inspectors have been invading retail pharmacy outlets under various guises of regulatory violations, imposing fines on perceived offences.
“Some of the arbitrarily imposed fines are as heavy as N500,000.00 in some instances. NAFDAC has also insisted on continuing its agenda of forcing importers to pay as high as N4.2 million per foreign manufacturer facility for GMP clearance when the reality is that India, which is the biggest exporter of drugs to Nigeria, has banned exports of pharmaceuticals to Nigeria because of the peculiar challenge of COVID-19, which continues to ravage its local population.
“The management team of NAFDAC, led by its director-general, has frustrated all entreaties to dialogue on this particular subject-matter, which is potentially detrimental to the availability of life-saving drugs for Nigerians.”
The statement maintained that it was apparent that the remnants of the forces at NAFDAC that advanced the school of thought that NAFDAC has a statutory mandate to register and inspect pharmaceutical premises in Nigeria on the strength of section 5 of the NAFDAC act is still alive.
It reads, “Section 5 (a) of the act states inter alia: The agency shall have the following functions, that is to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, bottled water and chemicals.
“Section 5 has been amended through the creation of a new section which posits that ‘The agency shall determine the suitability or otherwise of medicines, drugs, food products, cosmetics, medical devices or chemicals for human and animal use.’
“Basically, this is where NAFDAC derives its ‘safety mandate’ in the regulation and control of specific products, which section 5 (a) identifies as food, drugs, cosmetics, medical devices, bottled water and chemicals.
“The attempts by NAFDAC to inspect wholesalers and distributors of drugs and certify for meeting Good Storage and Distribution Practice (GSDP), evaluate Standard Operating Procedures (SOP) for cleaning, environmental monitoring, monitor power and alternative power supply (e.g. generators) and determine functionality and suitability of warehouse conditions, are matters bordering directly on pharmacy practice, which remains the exclusive jurisdiction of the Pharmacists Council of Nigeria (PCN).”