{"id":2129,"date":"2013-04-14T10:34:04","date_gmt":"2013-04-14T10:34:04","guid":{"rendered":"http:\/\/disnaija.com\/nigerian-newspapers\/new-deal-for-drug-manufacturers-as-american-govt-intervenes\/"},"modified":"2013-04-14T10:34:04","modified_gmt":"2013-04-14T10:34:04","slug":"new-deal-for-drug-manufacturers-as-american-govt-intervenes","status":"publish","type":"post","link":"https:\/\/disnaija.com\/new-deal-for-drug-manufacturers-as-american-govt-intervenes\/","title":{"rendered":"New Deal For Drug Manufacturers, As American Govt Intervenes"},"content":{"rendered":"
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NIGERIA will benefit from a United States government intervention to boost drug production in the country.<\/p>\n

The deal, coming under the auspices of the United States Pharmacopeia (USP), an organisation that seeks to improve global health through public standards and related programmes, will ensure quality and safety and increase the capacity of manufacturers.<\/p>\n

The National Agency for Food and Drug Administration (NAFDAC) is partnering USP to support local drug producers in Nigeria.<\/p>\n

NAFDAC and USP officials met in Abuja at the weekend to develop a work plan to actualise the new initiative.<\/p>\n

Vice President of the Global Health Impact Programme and Director of USAID\u2019s Promoting the Quality of Medicines Programme (PQM), Mr. Patrick Lukulay, spoke at the stakeholders\u2019 meeting on quality monitoring of medicines in Nigeria.<\/p>\n

He said that by a technical assistance programme signed with Nigeria some months ago, the country would benefit from support for local drug producers.<\/p>\n

The assistance, which he said would focus on drug manufacturers, would provide technical assistance on Good Manufacturing Practices (GMP), on-site assessment of facilities, and feed back on Corrective and Preventive Action (CAPA).<\/p>\n

Among other things, he said the programme would expedite World Health Organisation (WHO) pre-qualification process by increasing company readiness at no cost to them.<\/p>\n

WHO prequalification aims to ensure that diagnostics, medicines, vaccines and immunisation-related equipment and devices for high burden diseases meet global standards of quality, safety and efficacy, in order to optimise use of health resources and improve health outcomes.<\/p>\n

The prequalification process consists of a transparent, scientifically sound assessment, which includes dossier review, consistency testing or performance evaluation and site visits to manufacturers.<\/p>\n

The UN and other procurement agencies use this information, in conjunction with other procurement criteria, to make purchasing decisions regarding diagnostics, medicines and\/or vaccines.<\/p>\n

Lukulay said part of the USP mission in Nigeria would be to assist manufacturers improve their GMP compliance and prepare them for prequalification by WHO.<\/p>\n

Meanwhile, Nigeria and a number of African countries need not face serious capacity hurdles anymore in detecting fake and substandard drugs, as a US government facilitated Centre for Pharmaceutical Advancement and Training (CePAT) sets to open in Ghana next month.<\/p>\n

According to Lukulay, CePAT will serve Sub Sahara Africa, a region facing serious health issues and a proliferation of substandard and counterfeit medicines.<\/p>\n

\u201cCePAT will strive to build SSA\u2019s human resource capacity in pharmaceutical quality control by developing local talent to serve as technical experts in the quality control (QC) and the quality assurance (QA) of medicines. USP envisions CePAT to be the start of a transformative, global initiative that can be expanded to help at-risk communities worldwide,\u201d he added.<\/p>\n

On why CePAT for the region, he added: \u201cSSA countries and their regulatory authorities face fundamental oversight and resource deficiencies, including a shortage of qualified personnel at national laboratories, that have created an environment where substandard and counterfeit medicines have flourished and, as a consequence, so have serious diseases and drug resistance.<\/p>\n

SSA countries are heavily dependent on medicines imported from outside of the region, and there is limited regulatory oversight both prior to export and after import. In addition to imported medicines, medicines produced locally in SSA countries often fail to comply with GMP.\u201d<\/p>\n

Director General of NAFDAC, Paul Orhii, said the agency is working continuously to engage relevant stakeholders in all regulated sectors as it repositions towards building a regulatory system that is able to respond to current and emerging issues.<\/p>\n

He said: \u201cOur desire and my pledge to bring international standards to bear on our regulatory activities propelled NAFDAC to sign a Technical Assistance Programme (TAP) agreement with USP to further strengthen our regulatory capacity and effectively combat the incidence of counterfeit and substandard medicines in Nigeria.<\/p>\n

\u201c We strongly believe that this programme provides us the opportunity to benefit from the wealth of experience of the officials of USP and better position the agency to carry out its responsibilities, especially as relates to quality monitoring of medicines and other regulated products.\u201d<\/p>\n<\/p>\n<\/div>\n

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Posted in Nigerian Newspapers. <\/a>A DisNaija.Com<\/a> network.<\/p>\n

Source: Guardian Newspaper<\/p>\n

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