Stakeholders build capacity for local production of WHO pre-qualified medicines

Concerned that none of the over 120 pharmaceutical manufacturers in the country is pre-qualified by the World Health Organisation (WHO) to produce medicines for global procurement and use, stakeholders have renewed their efforts to address the gaps.

The Bloom Health, yesterday, in Lagos, started a three-day capacity building of Nigerian Pharmaceutical Manufacturers towards producing medicines that are not only of high quality but meet the WHO’s prequalification (PQ) standards.

Chief Executive Officer (CEO), Bloom Public Health, Prof. Chimezie Anyakora, said the attainment of WHO PQ by the pharmaceutical manufacturers in Nigeria will establish their capability to produce medicines that consistently meet stringent standards of quality in line with WHO specifications and global standards.

Anyakora said this will provide opportunities for increased sales and market access by conferring eligibility for international, donor-sponsored tenders for medicines; improved capacity to manufacture products for entry into stringently regulated markets; increased potential to compete successfully for contract manufacture for local markets; and faster registration. These will facilitate international procurement and distribution of locally produced medicines in Nigeria.

Anyakora, who is a pharmaceutical chemist, said, yearly, billions of dollars’ worth of products are donated to Africa without local participation in the tender because they are not WHO pre-qualified.

Anyakora said the three-day World Bank-funded capacity-building training is a strategic intervention by Bloom Public Health to build capacity for sustainable local pharmaceutical manufacturing in Nigeria.

He said the training will address the challenges of weak compliance by local manufacturers with Good Manufacturing Practices (GMP) and support Nigerian pharmaceutical companies to improve their quality management systems using internationally accepted regulatory standards.

Director-General, National Malaria Elimination Programme (NMEP), Dr. Godwin Ntadom, in his remarks, said over the years, malaria commodities have consistently been procured from outside the country due to international regulations and practices that control quality, efficacy and safety profiles of these commodities, particularly, the need to meet WHO’s pre-qualification standards.

Ntadom, unfortunately, said most drugs manufacturing companies in the country are yet to meet this standard, which have affected their chances of being considered as suppliers of these essential commodities by international development partners and funding organisations like the Global Fund, US President’s Malaria Initiative and World Bank/Islamic Development Bank.

He said of greater concern is the fact that part of the funding mechanism to support malaria elimination is country driven with particular reference to the credit facility from the World Bank and Islamic Development Bank, especially in the face of spending a large chunk of these facilities on commodities obtained from outside the country.

Ntadom, who is also a parasitologist and malariologist, said it is therefore expedient to set up a structure where the credit facility will not only support the elimination of malaria but also serve as an incentive to increase local manufacturers of malaria commodities through a purposeful measure geared towards upgrading their manufacturing and product status to WHO PQ and Good Manufacturing Practice (GMP) and by default increase their competitive edge as local and international suppliers of these commodities.

He said it is against this backdrop that NMEP/Federal Ministry of Health (FMOH) in collaboration with the World Bank resolved to commit $1 million (USD) through the IMPACT Project to invest in the upgrade of these manufacturing companies through a structured system.

Ntadom said this activity is being driven by the National Institute for Pharmaceutical Research and Development (NIPRD) with the following objectives: general education of the Nigerian manufacturers on the process of WHO PQ; support a few selected manufacturers through the process of improving their GMP; help at least five manufacturers achieve WHO PQ during the life of the project; and stimulate a renewed quality manufacturing consciousness in Nigeria.

The NMEP DG said the project is expected to be carried out in phases and phase one will last for 12 months.

He said at the end of the project, it is expected that the first antimalarial commodity manufacturer in the West African region to have a WHO PQ product would have been produced; and at least five indigenous companies would have been supported to attain WHO PQ status and GMP.

He also added that there is optimism that there would be improved donor procurement of locally manufactured medical products; advance pharmaceutical manufacturing would be entrenched in Nigeria thereby projecting the country as a model on the continent; immense economic growth would be stimulated by increasing the pharmaceutical sector’s contribution to GDP; and in-country capacity to manufacture health product would be strengthened to contribute to epidemic preparedness, and build a resilient system without over-reliance on imported products.

Ntadom said to kickstart the process of implementing this project, NIPRD, in collaboration with NMEP and the World Bank launched this activity at Eko Hotel and Suites, Victoria Island, Lagos with key stakeholders from both public and private sectors in attendance.

The malariologist is optimistic that if the project is successfully implemented, it will be Nigeria’s biggest pharmaceutical intervention and will achieve the first ever WHO PQ of pharmaceutical as well as more net manufacturing companies in Nigeria. “It promises to have a tremendous impact on the Nigerian health system by increasing availability of quality-assured medicines and building national capacity for sustainable manufacturing and monitoring of quality medicines and insecticide treated nets, as well as position both the pharmaceutical and insecticide treated net industry in Nigeria as a global competitor. Above all other donor-funded projects (including Global Fund, United States Agency for International Development/USAID etc.) will be able to leverage this programme for local procurement of WHO pre-qualified products in the country. The health and economic impact of this intervention cannot be overemphasised,” he said.

The keynote speaker and DG of Nigerian Natural Medicine Development Agency (NNMDA), Prof. Martins Emeje, said there is no disease in Nigeria that does not have an indigenous treatment. Emeje, who is a pharmacist, said he supports anything that has to do with indigenous manufacturing and that is not going to support capital flight out of Nigeria.

A Director at the Federal Ministry of Industry, Dr. Francis Onuorah, said it is an opportunity for made in Nigeria products to be made in other places in the world. “We need the seriousness of everybody to get Nigeria where we want it to be. We have to develop our own strategy, the industrial revolution strategy,” Onuorah said.

Director Food and Drugs at the National Agency for Food and Drug Administration and Control (NAFDAC), Olubunmi Aribeana, said three pharmaceutical companies have been selected for WHO PQ. “We have a critical issue of bioequivalence. All products must be subjected to bioequivalence,” she said.