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How Orhii’s innovative leadership at NAFDAC is transforming the agency

JOSEPH UNDU

THE innovative and sterling leadership of Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Dr. Paul Orhii is unquestionable as the Benue-born world acclaimed Medical Doctor, Biomedical Scientist and Attorney continues to receive local and international awards in recognition of his efforts in curtailing the menace of counterfeit drugs in Nigeria using cutting-edge technology.
Apart from his laudable initiatives like the Truscan; a technology which NAFDAC is the first medicines regulatory agency in the world to use,  Orhii and his formidable team’s excellent leadership prompted the recent inclusion of NAFDAC Scientists in the WHO Ebola  Trial Vaccine review in Geneva and the inclusion of the agency Assessors in  the WHO Prequalifications Dossier Review Panel.
Other notable feats recorded by the agency recently include, the current secondment of NAFDAC Inspector to WHO’s Inspection team as the first ever West African FDA and the first ever Chair of the WHO member state mechanism on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit medical products.
Mr. ‘Digital’ as he is fondly called by his admirers  was recently at the prestigious Protea Hotel Lagos, honoured with the U.S. Pharmacopeial Convention (USP) Leadership Award for his innovative and outstanding leadership at NAFDAC.
It was a double celebration for the elated Scientist and his Laboratory staff as one of their Laboratories, the Central Drug Control Laboratory Yaba, became the first government medicine laboratory to get ISO/IEC 17025:2005 Laboratory Accreditation in Nigeria .
Shortly after collecting the accreditation certificate on behalf of the agency, Dr.Orhii was presented with his own award by the Vice President, Global Health Impart Programs, USP Dr. Patrick Lukulay who showered praises on Orhii  describing his achievements as a “big feats for the entire Africa.”
The award which is one of the numerous local and international awards received Dr.Orhii  was given to him by USP, a scientific non-profit organisation that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide.
Presenting the award  in the presence of Captains of industries, the media and some select staff of NAFDAC, Dr.Lukulay in a remark said, just about three years ago the United States Agency for International Development (USAID) and United State Pharmaceuticals (USP) came together in partner with NAFDAC to strengthen the quality assurance and the Quality Control Systems in Nigeria.
“Today we are here to mark very important milestone on this journey that stated about three years ago. I want to put into perspective the relevance and significance of this milestone. The relevance of this accreditation speaks of the fact that the laboratory at Yaba is now generating result on quality control issues that are credible result; that are defensible results and that can be depended in an accurate standard international project.
“This is a big feat not just to Nigeria, but this is a big feat for the entire Africa. The Geo-Political relevance of Nigeria cannot be over emphasized.  The secure supply chain in Nigeria and across Africa cannot be ignored. This is why USP is so grateful for their assistance that United State Agency for International Development has continued to allow our scientists to come to Nigeria to be of help to NAFDAC to strengthen their quality control and quality assurance systems.
“We have set up drug quality monitoring systems all over the World including Nigeria where anti-malaria drugs are collected and tested to ensure that Nigeria public are not exposed to substandard medicines. Something close to my heart is local manufacturing through USAID support which we are also strengthening the local pharmaceutical companies in Nigeria.
“Therefore we are tieless in supporting local manufacturing in this great Nation to ensure that they rise to the top and be able to demonstrate that Nigerian medicines are as good as medicines   outside Nigeria. Other development partners are also supporting NAFDAC and other institution and we acknowledge their contribution and World Health Organisation and those of them that are partnering with USP and other agencies.
In a special remark after receiving the award, Orhii who could not hide his joy said the agency has added another feather to her cap with the accreditation of the Central Drug Control Laboratory Yaba.
He said, “It gives me great pleasure to welcome you all to this historic and important event as we gather to celebrate the ISO/IEC 17025:2005 Laboratory Accreditation of NAFDAC Central Drug Control Laboratory Yaba, the first government medicine laboratory to attain ISO/IEC 17025:2005 Laboratory Accreditation in Nigeria.
“I strongly believe in an objective, scientific and factual system with strong conviction in minimal human interference in the regulatory testing systems and I have continued to encourage, support and drive the accreditation program of NAFDAC Laboratories.
“This is evident in the quick successive accreditation of the Pesticide Residues, Mycotoxins and Proximate Analyses Laboratories Units in the Central Food Laboratory, Oshodi and now the Drug Laboratory, thus ensuring that quality Management System (QMS) is being entrenched in the Laboratory Services’ process.”
In the year 1978, the Central Drug Control Laboratory one of the seven Laboratories in the Laboratory Services Directorate of NAFDAC started operation under the Department of Food and Drug Administration of Nigeria, Federal Ministry of Health.  This was later turned to Central Drug Quality Control and Vaccine Laboratory when NAFDAC was established in 1993.
It was renamed Central Drug Control Laboratory (CDCL), in 2009 with the Vaccine Unit established as a separate and independent Laboratory.
As a Drug Quality Control Laboratory, CDCL according to Orhii is responsible for testing all medicinal products submitted for regulatory actions and investigation. The Laboratory tests various  medicinal dosage forms for example tablets, capsules, powder, liquid, cream, oral, topical, parenteral and suppositories.
The objective of the Laboratory is to provide reliable and accurate analytical laboratory services to the Agency by ensuring compliance to ISO/IEC 17025:2005 standards.
He also stated that, the attainment of ISO/IEC 17025:2005 accreditation wouldn’t have been possible without the continued strengthening of the Laboratory capacity through continuous training both internal and external, equipment calibration as well as support for participation in proficiency testing.
Saying that, “This enormous support and collaboration resulted in the final actualization of ISO/IEC 17025:2005 Laboratory Accreditation after due  assessment of the laboratory in December, 2014 by ANSI-ASQ  National Accreditation Board (ACLASS).
“ISO Accreditation as we know is internationally recognised as a reliable indicator of technical competence and operation of a laboratory quality management system which has become almost a de facto prerequisite to international trade.
On the benefits of the Accreditation to the agency and the country as a whole, the NAFDAC Boss stressed that, it would confers national and international recognition which would   thereby promotes patronage and economic benefits to both NAFDAC and Nigeria.
Continuing, he noted that, the Accreditation of NAFDC CDCL Yaba would therefore provide assurance to Nigerian Pharmaceutical industry, development partners and other stakeholders that NAFDC is competent to test both locally manufactured and imported pharmaceutical products.
Central Drug Control Laboratory handles between 7,000 to 8,000 samples in a year which is about 70% of total medicines that the Agency analyses.
ISO accreditation of CDCL will therefore ensure that only safe and quality medicines are available and distributed in the country, and will also boost the customer confidence in the integrity of the test result.
“As you are aware, the issue of fake, counterfeit, spurious and substandard medicines has been a great challenge to the pharmaceutical industry and the general populace as millions of Nigeria and thousands of live are lost because of this scourge. However the ISO Accreditation has added another strong tool that will help in making accurate and reliable pronouncement on medicines within the country.
“The medicine market will be better controlled and regulated, thus safe guarding the public health. The Accreditation will also help the Pharmaceutical Inspection Cooperation Scheme (PICS) to build confidence in NAFDC as a regulatory partner not just in inspection programs but in producing accurate and reliable laboratory results for medicines.
“ISO Accreditation of NAFDAC CDCL will not only do the aforementioned, but also give the laboratory into serving as a good reference laboratory for the pharmaceutical industries seeking WHO product and manufacturer prequalification since the laboratory test result will be globally acceptable.”
Dr.Orhii applauded the unparalleled efforts and supports of development partners, USP/PQM and USAID whose support he said made the drive towards laboratory accreditation a reality as he also hailed the commitment of staff and management of CDCL Yaba and the Laboratory Services leadership.
“Your contributions and tireless efforts to achieving this great feat are appreciated greatly by NAFDAC Management and in fact the country as this will further drive the Transformation Agenda of President GoodluckEbele Jonathan.”
In conclusion, Orhii requested for more collaboration in creating massive and intensive public awareness on the use of the mobile Authentication Services ( MAS) and other public health strategies. He also requested for provision of more TRUSCAN, more laboratory equipment and assistance with accreditation of regional laboratories.

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