NAFDAC, U.S. group to set up mini drug firms in hospitals

AS part of efforts to making safe and quality medicines available to Nigerians at affordable prices, the National Agency for Food and Drug Administration and Control (NAFDAC) in collaboration with Global PCCA are to set up mini drug manufacturing units (MINIMAC) in medical centres, teaching hospitals, and private hospitals across the country worth over $1 billion.

Global PCCA is a United States-based investments and healthcare solutions group. MINIMAC stands for mini manufacturing of pharmaceutical, nutraceutical (refers to foods or extracts thereof claimed to have a medicinal effect on human health) and cosmeceutical (a cosmetic product claimed to have medicinal or drug-like benefits) products.

Director General NAFDAC, Dr. Paul Orhi, at the launch of the mini-manufacturing drug facility at the National Hospital Abuja said: “When Global PCCA came to Nigeria and made a presentation to NAFDAC on how it operates, we immediately saw the need to encourage the group to come and partner with us and with hospitals in Nigeria to solve the perennial problem of drug availability, accessibility and affordability, which is closely linked and perhaps is one of the main causes of counterfeit medicines in Nigeria.

“Global PCCA and its technical partners are the market leaders in compounding and manufacturing support services with the most innovative accredited training, educational opportunities, technical support, and unique compounding products available today.

“This partnership brings with it over 3,500 qualified and experienced pharmacists with over 30 years of company existence that will revolutionise the health system in Nigeria in particular and also in Africa.

“And so as we launch Global PCCA’s mini-manufacturing unit, otherwise known as MINIMAC in collaboration with National Hospital, Abuja, the first tertiary institute to embrace this revolutionary drug access mechanism, I want you to know that this is a project that has been successfully implemented in the United States, Canada, Europe, Australia and many other countries. In the United States, it is regulated by the Food and Drug Administration (FDA) and monitored by the Drug Enforcement Agency in the states.”

Chief Executive Officer and President Global PCCA, Dr. Steve Ams, said: “Global PCCA is a United States corporation that has come here to do one major thing, that is work with NAFDAC to be able to provide Nigerians active pharmaceutical ingredients, finished dosage forms that would be guaranteed so that they know what they are getting. We are going to put in a manufacturing format that both institutional and private sector corporations or hospitals can participate in.

“So what we will eventually be having across the nation are local manufacturers, mini manufacturers over the place. They owe these set ups, we do not owe them, but we will teach them how to do it and do it right, and supply them all the equipment and ingredients that they need to sustain the project.”

Ams said that the partnership was going to be a franchisee and franchiso partnership, with the teaching hospitals, the different federal medical centres and also the individual private sector hospitals being the franchisees and the franchiso, Global PCCA, providing more of the technical know-how.

Ams said that each hospital was going to have a minimac franchise set up like MacDonalds. “In the United States you see MacDonalds everywhere. So it is going to be the same thing,” he said.

The Global PCCA chief said that the corporation had zero tolerance to bad quality products and was going to bring that consciousness to Nigeria. “We work with the United States Food and Drug Administration (FDA), who regulates us. The FDA is the most intense regulatory body in the world today. We are bringing United States standard on finished product and ingredient,” Ams said.

He added: “NAFDAC regulates us, but before they regulate us, we regulate ourselves from the FDA. We have hired former FDA experts who wrote FDA regulations to sign up with us as a third eye on our products. So when we bring in a product into the market, whether it is an ingredient for manufacturing or a finished product for ingestion, we are guaranteeing the product because we have done triple layered verification.”

Orhi said that MINIMAC could assist the pharmacist or physician in customising a medication to meet a special need and provides solutions of the urgency of the now. He added that the collaboration would address the out of stock syndrome in the hospitals in the 70’s, which significantly contributed to the current challenge of fake drugs faced today.

“So if we try and address the problems of access and availability through a public private partnership such as the one we are witnessing today, I firmly believe that our people will be able to afford to pay for their medications at the hospital level. Thus we need to go to the other sources, such as markets or hawkers will be removed,” Orhi said.

The NAFDAC chief said that the agency was also working with Global PCCA on a technology called Radio Frequency Identification (RFI) that would cause a cargo to transmit data showing whether it was counterfeit or not. He said that the technique could also be used for document verification.

Orhi urged chief medical directors of teaching hospitals and commissioners of health and their directors of pharmaceutical services from all the states of the federation to consider getting this form of complementing drug supplies that is the MINIMAC to support NAFDAC efforts in stamping out fake and counterfeit medicines in Nigeria.

He said that NAFDAC was spearheading the global effort in the use of cutting-edge technologies to fight counterfeiting.

“We are the first medicine regulatory agency in the world to purchase Truscan, a handheld device that will be used at our borders and medical stores to detect counterfeit medicines at the spot. The equipment has arrived, the data base is being built and our staff are undergoing intensive training on its use,” Orhi said.

The NAFDAC chief said that they were also deploying mini labs in ports and borders for speedy evaluation of counterfeits thereby reducing congestion at the ports and borders, and would soon be using a text messaging technology to put the power of detecting counterfeits into the hands of Nigerian public in the war against counterfeiting. He said that this would help detect counterfeit medicines in pharmaceutical outlets in Nigeria.