May 3 2012
By Chukwuma Muanya
UNITAID is the International Drug Purchase Facility being established by Brazil, France, Chile, Norway and the United Kingdom. UNITAID is being established as an innovative funding mechanism to accelerate access to high-quality drugs and diagnostics for Human Immuno-deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS), malaria and tuberculosis in countries with a high burden of disease.
The WHO Prequalification of Medicines Programme (PQP) ensures that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy. WHO’s list of prequalified medicinal products is used by international procurement agencies and increasingly by countries to guide bulk purchasing of medicines.
Originally, in 2001, the focus was on medicines for treating HIV/AIDS, tuberculosis and malaria. In 2006, this was extended to cover medicines and products for reproductive health. In 2008, prequalification of zinc – for the management of acute diarrhoea in children – was added. Since 2001, over 240 medicines have been prequalified.
The quest for WHO prequalification status for Nigeria’s pharmaceutical firms started when the Director General of the National Agency for Food, Drug Administration and Control (NAFDAC), Dr. Paul Orhii, assumed office in 2009.
Port Harcourt-based Pan African Health Foundation (PAF), last month, became the first Nigerian pharmaceutical firm to get WHO prequalification for Auto Disposable (AD) syringes for immunisation and curative syringes with reuse prevention feature.
But bearing in mind that the bulk of WHO prequalified products are medicines, NAFDAC last year took 11 qualified medicines manufacturing companies to WHO Headquarters in Geneva, Switzerland.
The 11 pharmaceutical companies include: Evans, Swipha, Neimeth, May and Baker, Fidson HealthCare, Emzor, Juhel, CHI, Afrab Chem, Daily Needs and Drugfield.
The WHO requested for dossiers and documentation from the companies, which was followed up with auditing of the companies.
The result of the audit report on the 11 companies presented last week in Abuja to the Minister of Health, Prof. Onyebuchi Chukwu, the director general of NAFDAC and other stakeholders endorsed five Nigerian pharmaceutical firms for pre-qualification within two years. The companies are: Evans Pharmaceuticals, SWIPHA, CHI Pharmaceuticals, May and Baker, and Fidson HealthCare, have met most of WHO’s conditions for prequalification.
Leader of the WHO team and Head Technical Officer in WHO pre-qualification department in Geneva, Switzerland, Dr. Milan Smid, told journalists recently. “We are here to present the audit report which was in two tiers. It shows where the companies are. What we have presented is a summary of our findings and recommendations. The companies are at different levels of prequalification. We have seen the potential but there are processes. What I can tell you is that some of the companies are in line to get WHO pre-qualification in two years.”
NAFDAC Director General told The Guardian, “we have one company with product prequalified in Port Harcourt. We have five companies lined up. Six companies were inspected. I looks like five companies have prospects, potentials to be prequalified within the next two years, out of which two might even be prequalified within this year.”
On the products to be prequalified, Orhii said, “we have five companies that have the potentials to be prequalified now, but the products will be selected. But usually the products are anti-malaria, anti tuberculosis, HIV drugs and some drugs against diarrhea in children.”
What does it take for a company to get WHO prequalification? Orhii said, “first and foremost, for prequalification, WHO looks at the strength of the regulatory agency. The country has to have a strong regulatory agency before you can get prequalification for companies within the country. So it means that there is WHO instruction that NAFDAC should always make sure that the companies comply to Good Manufacturing Practice (GMP), that helped them to be prequalified in the first place.
“NAFDAC has a very important role to play in prequalification. NAFDAC is expected to be doing post market surveillance and pharmacovigilance. Our inspectors work hand-in-hand with WHO inspectors to make sure that our staff are being trained to inspect at the same level with WHO.”
Head of the NAFDAC/WHO prequalification team and Director Narcotics and Controlled Substance, Mr. Hashim Ubale Yusufu, told The Guardian, “it all started last year when NAFDAC went with 11 Nigeria pharmaceutical firms to the WHO headquarters in Geneva Switzerland. These companies were selected based on audit that was carried out by NAFDAC. These companies went to Geneva and they were requested by Geneva to present their Dossier expressing their willingness to participate.
“Out of these seven companies were selected by the WHO and these seven companies were audited, and five out of them were shortlisted for prequalification. One was added later on, although the audit has not been done, their submission have been accepted.”
How was the WHO audit report on the five companies? Yusufu said, “the report is very favourable. The report was able to indicate the level of the companies. Many people were thinking that our products were of lower category. But the report shows that out of the five companies, two will in no distant time achieve WHO standard.
“Why these things are going to take time is because of the review and assessment of the companies dossier, document of some of the products and companies. But as far as the GMP is concerned the corrective action is very minimal. One company will make it within two years. The other two have finished a new WHO specified factory but have not started production.”
Why WHO prequalification? The NAFDAC director explained, “one is that the world is a global village and once you are talking about empowering our people, you must also belong to the same standard so that you can find it much easier. Two, the Nigerian population is large compared to many countries. When we combine the population strength and enforced standard it will create a wider margin for our local industry. This will increase our foreign exchange earnings. Secondly, we will produce quality medicines to replace medicines that are either substandard or counterfeit that have come within our own region.
“Third reason is that donor agencies have been given a lot support because they buy only from WHO prequalified companies. Why they are doing this is to avoid the entry of counterfeit and substandard medicines. For that reason we lose huge sums of money. For example, $40 million was used to buy antimalarials from India because the companies there have been prequalified. If our companies were prequalified, then these medicines would have been bought from us and used across the malaria endemic region, which is mostly inAfrica.”
Meanwhile, President Goodluck Jonathan has assured NAFDAC on the implementation of the proposed N200 billion Pharmaceutical Sector Intervention Fund. The Guardian learnt that President Jonathan has directed the Bank of Industry and the Central Bank of Nigeria to source for the funds. The Fund is part of NAFDAC efforts to boost the capacity of Nigerian pharmaceutical industries to meet international standards.
Minister of Health assured the pharmaceutical firms seeking the WHO prequalification of Federal Government support and patronage. Chukwu said the government is ready to enforce the Procurement Act and encourage purchase of drugs from local industries.
Chukwu further stated, “government is committed. The political commitment is very high. Government is ready to partner and absorb and enforce the Procurement Act to encourage the purchase of drugs from local industries. Therefore any tender for medicines, there will be preference in the bidding for local industries, that is number one. So if there is large absorptive capacity in the country, it will encourage the manufacturers to invest more into building quality industries and producing quality drugs.
“We are looking at expanding the capacity of the local pharmaceutical industries with the intervention fund that will come from the Bank of Industry, but we are also looking at other sources of funding that will help the local pharmaceutical industries.”
Yusufu said the proposal for N200 billion Intervention Fund for the pharmaceutical sector has been done and the President has approved it. He said what NAFDAC is doing is provide the evidence for this support.
“The NAFDAC DG met with President Goodluck Jonathan and he has directed the Bank of Industry, the Central Bank and the Ministry of Finance to make sure that this thing comes out fine. But there is no better advocacy than what we have done today, to present to the federal government through the Minister of Health the evidence to be able to support the quest for WHO prequalification and expansion of the capacities of our local pharmaceutical firms.”
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