NAFDAC

… Urges Agency to address disposal of expired drugs, drug guidelines, others

By Chioma Obinna

 The Pharmaceutical Society of Nigeria, PSN, has urged the new Acting Director-General of the National Agency for Food and Drug Administration and Control, NAFDAC, to redress challenges associated with the disposal of expired drugs as well as strengthen the National Drug Distribution Guidelines, NDDG, in the interest of Nigerians among others.

Other areas, the Society also charged the Agency under the leadership of Dr Monica Eimunjeze to tackle include; developing a sustainable framework for the handling service and orphan drugs, tackle proper classification of the registered drugs in line with new realities, activating the Federal and State Task Forces in partnership with PCN to cleanse the drug distribution channels as well as debunk the unfortunate notion that NAFDAC has become a fund generating agency.

Speaking during a courtesy visit to the Acting DG NAFDAC, the President, Pharm. Cyril Usifoh said in the past few months, there has been a silent but raging war on the disposal of expired drugs and unwholesome food substances because of directives that those in possession of such should pay fees to NAFDAC for disposal of such.

Usifoh said the development may be dangerous for the country as it may lead to the recycling of expired drugs for use in the health system if not well managed now.

“The stakeholder who has expired consignment loses money and it is unthinkable to expect such a person to submit to a system where he loses more due to payment of tariffs to the government. It is in this light we call on the management of NAFDAC to have a rethink on this subject matter moving forward.”

On the framework for the handling of services and orphan drugs, Usifoh recalled that in 2014, the acceptable fee regimen as well as other administrative procedures to handle orphan and service drugs, have been completely disrupted and PSN strongly solicit a redress of these measures in the public interest.

“As far back as the Dora Akunyili days at NAFDAC, there were firm resolves to delineate drugs into cadres including over-the-counter, pharmacist-initiated medicines, and prescription-only medicines. These classifications have become more expedient in view of recent advances in other climes where pharmacists are approved to carry out limited prescriptions of medicines. Even here in Nigeria, the Federal Ministry of Health at the prompting of some foreign donor agencies now canvass the sales of antibiotics like Amoxil in patent medicine shops to treat pneumonia. Technically we are saying PPMVL holders can sell antibiotics without prescriptions, but we hamstring registered pharmacies and other facilities. It is therefore appropriate to deal with this situation once and for all to ensure professionalism in our endeavours.

“The unwieldy nature of our drug distribution channel appears to be escalating by the day. The Fake Drug Act was first enacted as decree 21 of 1988. Almost 35 years after it is a messier state of affairs in our drug distribution channels. The Pharmaceutical Society of Nigeria was part of proceedings at NASS a few weeks ago when attempts were made to amend the existing Fake Drug Act. We are convinced that the militating bane has always been a deliberate resolve of the PCN and NAFDAC not to work together to break this logjam. In this dispensation, I believe we have a unique opportunity because both the Acting DG NAFDAC and the Registrar/CEO of PCN share our burdens directly. The Pharmaceutical Society of Nigeria vouches to facilitate a table to cement new ideas and fresh strategies to get us out of the bottomless pit in this regard with a firm commitment from you on this auspicious occasion of our visit.

 “In furtherance to the above, it is pertinent that I submit that the NDDG is still a wild goose chase for similar reasons I advanced earlier. We must allow the CWC concept to work as canvassed in our policy statements. One of our Past Presidents, Pharm. Olumide Akintayo put on record the historical discourse of a meeting he presided over held in this office in 2015 with former DG NAFDAC, Dr. Paul Orhii and Pharm. Titi Owolabi representing NAFDAC; Immediate Past Registrar, Pharm. N. A. E. Mohammed and the incumbent Registrar, Pharm. I. B. Ahmed representing PCN; PMGMAN; APIN; ACPN and representatives of Open Drug Markets in Idumota, Lagos; Head bridge, Onitsha in Anambra State and Ariaria in Abia State were all in attendance. It was heart-warming that all stakeholders resolved to push the NDDG goals through on that occasion. Seven years on, the NDDG is stalled and the resultant impasse puts our profession in disrepute and tatters.

He said the only people who can salvage the situation from a regulatory perspective are NAFDAC and PCN Registrar. I have a role as PSN President which is to embark on ceaseless advocacy.

 He also urged her to dismiss rumours that NAFDAC has become an epitomised fundraising image. “It is good to be transparent and solvent which we see with NAFDAC operations, but NAFDAC needs to have a more cursory look at the fees imposed on the wide range of regulatory products and services.

“We need to promote better stakeholder engagement to make sure we secure the buy-in of all crucial segments who rely on NAFDAC in one way or the other.

He pledged that PSN will work with her office to ensure that her dispensation stands out.

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