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NAFDAC, NHIA collaborate to strengthen local pharmaceutical manufacturers

The National Agency for Food and Drug Administration and Control (NAFDAC) has collaborated with the National Health Insurance Authority (NHIA) to strengthen local pharmaceutical manufacturers in order to guarantee medicines security and ensure sustainable access to affordable and acceptable quality medicines for Nigerians

According to both agencies the collaboration will bring about branding of 33 products for the health insurance ecosystem in the first phase of implementation.

The Director General of NAFDAC, Prof. Mojisola Christianah Adeyeye disclosed that NAFDAC has collaborated and continues to collaborate with NHIA to ensure sustainable access to affordable and acceptable quality medicines for Nigerians.

Adeyeye said, the Executive Order 3 (EO3) on support for local content in public procurement by the Federal government requires that all MDAs shall grant preference to local manufacturers of goods and service providers in their procurement of goods and services.

“It was based on this collaboration with NAFDAC and in line with Executive Order 3 (EO3), that NHIA worked with Local Pharmaceutical Manufacturers whose manufacturing facilities have been approved by NAFDAC as meeting Good Manufacturing Practice (GMP) requirements for the procurement of needed medicines.

“These manufacturing companies have also had their products registered by NAFDAC. This means that all the attributes of quality, safety, and efficacy pertaining to these products have been duly assured by NAFDAC.”

“The Federal Government has just launched the operational guidelines for the 2022 National Health Insurance Authority Act as part of efforts to ensure all Nigerians have access to affordable healthcare services.”

“The operational guidelines are crucial to clarifying the roles, responsibilities, and obligations of various stakeholders in the health sector because access to affordable quality health care for all Nigerians is key on the path to achieving Universal Health Coverage.”

Adeyeye, therefore, maintained that NAFDAC carries out this mandate by ensuring appropriate documentation of product attributes (Dossier Assessment), conducting inspections of manufacturing facilities to ensure they comply with good manufacturing practice (GMP) requirements, laboratory evaluation of products to ensure compliance with quality attributes, granting marketing authorization, conducting post-marketing surveillance to monitor products on the market for continued compliance with quality and safety requirements among others.

“NAFDAC has in the past five years developed a GMP Roadmap which continuously assures that pharmaceutical manufacturers in Nigeria remain compliant with global best practices. The requirements. This initiative has enabled the Agency to establish a baseline for monitoring compliance”.

“The National Health Insurance Authority (NHIA) signed a Memorandum of Understanding (MoU) with Pharmaceutical Companies and Drugs Management Organisations (DMOs) for the production of 33 different drugs to address the perennial problem of out-of-stock syndrome in the nation’s health facilities.

“Under the initiative, 12 Pharmaceutical companies will be branding 33 products for the health insurance ecosystem in the first phase. Already, NHIA has chosen seven states (Delta, Enugu, Gombe, Jigawa, Niger, Osun, and Sokoto states) and the Federal Capital Territory (FCT) for the pilot phase of this initiative.

“The initiative is also geared towards strengthening Local Pharmaceutical manufacturers, which will ultimately guarantee medicines security.

“This drive to guarantee medicines security has been a deliberate and intentional effort by NAFDAC in the past five years and continues to be on the front burner to ensure that pharmaceutical manufacturing facilities are fit for purpose. This will help to reduce the proliferation of substandard and falsified medical products.”

“The categories of drugs involved will start from simple to complex, which will be used to address prevailing health conditions in Nigeria, such as malaria, upper respiratory tract infections, childhood illnesses, and drugs being used by pregnant women.”

“As mentioned earlier, every drug to be manufactured will be certified and approved by the National Agency for Food and Drug Administration and Control (NAFDAC)- in terms of quality, safety and efficacy.”

“The medicines will be tested in the WHO-Prequalified NAFDAC Laboratory. Also, as part of its Post post-marketing surveillance activities, NAFDAC will continue monitoring to ensure that these branded medicines are used exclusively in the nation’s healthcare facilities. They are not to be found on the shelves for sale.

“The branding of NHIA medicines and other health products was introduced as a way to help eradicate out-of-stock syndrome, as well as ensure the quality of its medicines.”

“The 33 drugs would be branded with NHIA inscription under the National Health Insurance Authority. NAFDAC, through the Directorate of Registration and Regulatory Affairs, will also ensure that appropriate and adequate labeling of the medicines is met in line with the Agency’s labeling requirements and in accordance with NHIA guidelines.”

“NAFDAC will continue to collaborate with NHIA to ensure that the terms spelled out in Executive Order 3(EO3) will be implemented to enable the attainment of Universal Health Coverage as specified in the National Drug Policy.”

Earlier, the Director General of NHIA, Prof. Mohammed Nasir Sambo, also explained that the initiative is to eradicate out-of-stock syndrome as well as ensure the quality of NHIA medicines.

Sambo further explained that the National Health Insurance Authority Medicines Supply Initiative (NMSI), was geared towards the strengthening of local pharmaceutical manufacturers, which will ultimately guarantee medicine security.

“The 12 pharmaceutical companies are expected to brand 33 products for the health insurance ecosystem in the first phase. The product’s activity and production are expected within the next 30 days.”

He, therefore, optimism that the initiative would help to reduce the cost of medicines especially that of intravenous fluids which will reduce by as much as 50% of current market price.

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