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Wednesday, February 11, 2015

NAFDAC- Nigeria Can Now Approve Drugs for Global Use

Dr. Paul Orhii, Director General of NAFDAC
By Martins Ifijeh
The National Agency for Food and Drug Administration and Control (NAFDAC) has now been authorised to test all medicinal products submitted for regulatory actions and investigations, as well as approve those that meet global standards.
This was made known by the Director General of the agency, Dr. Paul Orhii, during the official presentation of the certificate of accreditation of the Central Drug Control Laboratory (CDCL)presented by the Vice President, Global Health Impact Programmes, United States Pharmacopoeia,(USP) Dr. Patrick Lukulay, in Lagos, recently.
According to Orhii, the accreditation means CDCLis the first government medicine laboratory to attain ISO/IEC 17025:2005 accreditation in Nigeria, hence, the laboratory would therefore provide assurance to Nigerian pharmaceutical industry, development
partners and other stakeholders that NAFDAC is competent to test both locally manufactured and imported pharmaceutical products.
He explained that with this accreditation, the CDCL has now attained both national and international recognition, thereby promoting patronage and economic benefits to both NAFDAC and Nigeria at large.
“This accreditation will give assurance to pharmaceutical companies coming to our laboratory that test results are obtained using properly validated and calibrated systems by staff with the right expertise, which therefore offers confidence to customers on the reliability of analytical services provided by CDCL.”
“As you are all aware, the issue of fake, counterfeit, spurious and substandard medicines has been a great challenge to the pharmaceutical industry and the general populace as million of naira and thousands of lives are lost because of this scourge. However, the ISO accreditation has added another strong tool that will help in making secure and reliable pronouncement on medicine within the country,” he said.
The DG who was visibly excited, said the pronouncement will also help the pharmaceutical inspection cooperation scheme to build confidence in NAFDAC as a regulatory partner not just in inspection programs but in producing accurate and reliable results for medicines.
Speaking further, he said, “hence forth, our CDCL will serve as a good reference laboratory for the pharmaceutical industries seeking World Health Organization product and manufacturer pre-qualification since the laboratory test results will be globally acceptable.
“Today, NAFDAC adds another feather to her cap with accreditation of the laboratory. We strongly believe in an objective, scientific and factual system, with strong conviction in minimal human interference in the regulatory testing systems and have continued to encourage, support and drive the accreditation programme of NAFDAC laboratories.”Orhii explained that the hard work of the agency is evident in the quick successive accreditation of the Pesticide Residue, Mycotoxins and Proximal Analysis Laboratory units in the central laboratory, in Oshodi and now the drug laboratory, thus ensuring that Quality Management System (QMS) is being entrenched in the processes.
While explaining the preparations of the agency so far in actualising the feat, Orhii said, “the pursuit of this laboratory accreditation started in June, 2013 with the assessmentof the laboratoryQMS by theUSP sponsored by the United States Agency for International Development (USAID).
“The process of getting this accreditation however continued with strengthening the laboratory capacity through technical and material support, equipment calibration, as well as support for participation in proficiency testing. These enormous support and collaboration resulted in the accreditation ceremony witnessed today.
“The test scope under this accreditation is inclusive of high pressure liquid chromatography, spectrophotometry, dissolution, uniformity of dosage units, neutroceutical products, among others.”
Orhii requested assistance from USP and USAID in creating massive intensive public awareness on the use of mobile authentication service and other public health strategies, provision of more truscan and laboratory equipment as well as assistance with accreditation of regional laboratories.
The highlight of the event was the presentation of the USP leadership award by the USP in collaboration with the United States Agency for International Development (USAID) to the NAFDAC boss for his immense contribution towards eradicating fake drugs in the country
Lukulay, while presenting the award, said it was in recognition of his relentless efforts and needed leadership, which led to bringing Nigerian laboratories tointernational standards. “The ISO accreditation is internationally recognized as a reliable indicator of technical competence and operation of a laboratory quality management system,” he said.
Lukulay, said it was a great achievement for Nigeria adding that “less than 10% of laboratories in the whole of Africa have reached international standards. The accreditation will strengthen consumers confidence that results from the laboratory will be credible, defendable and can withstand international scrutiny,” he noted.
He hailed Nigerian pharmacists, stressing that they have demonstrated they could make quality products, which is equal to the onesoutside the country.

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