WHO PREQUALIFICATION IN NIGERIA PHARMA INDUSTRY PERSPECTIVE CHIEF OLUBUNMI OLAOPA OCTOBER 30, 2013

OUTLINE NIGERIAN PHARMA SECTOR PRINCIPLE OF WHO PREQUALIFICATION PRODUCTS OF INTEREST FOR WHO PQP PROCESS OF WHO PREQUALIFICATION PROGRESS SO FAR BY NIGERIA BENEFITS OF THE WHO PQP SO FAR CHALLENGES TO WHO PQP CRITICAL SUCCESS FACTORS

NIGERIAN PHARMA SECTOR LOCAL MANUFACTURE OF MEDICINES ENCOURAGED WITH OVER 120 MANUFACTURERS REGULATION OF PRODUCTS IS BY THE NATIONAL AGENCY FOR FOOD & DRUG ADMINISTRATION & CONTROL(NAFDAC) PMG-MAN PROMOTES GMP AND UPHOLDS QUALITY ASSURANCE STANDARDS IN NIGERIA THROUGH SELF REGULATION MECHANISMS

PRINCIPLE OF WHO PREQUALIFICATION WHO PREQUALIFICATION refers to the standardized quality assessment procedures put in place to evaluate the acceptability of pharmaceutical products. The purpose is to evaluate whether certain products meet requirements recommended by The WHO and are manufactured in compliance with current codes of GMP

PRINCIPLE OF WHO PREQUALIFICATION Applies unified standards of acceptable quality, safety and efficacy. Comprehensively evaluates the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites. 5

WHO-PREQUALIFICATION Prequalification Programme A United Nations Programme managed by WHO http://www.who.int/prequal/ or http://healthtech.who.int/pq/ In close cooperation with national regulatory agencies and partner organizations, the Prequalification Programme aims to make quality priority medicines available for the benefit of those in need. This is achieved through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines 6

PRODUCTS OF INTEREST PRODUCTS ARTEMISIN COMBINATION THERAPIES INDICATIONS MALARIA ANTI-RETROVIRAL MEDICINES FLUCONAZOLE Cycloserine, Ethambutol Pyrazinamide Oxytocics ZINC SULPHATE HIV/AIDS OPPORTUNISTIC INFECTIONS Tuberculosis REPRODUCTIVE HEALTH MNCH COMMODITIES

WHO PREQUALIFICATION INAFRICA - There is no local pharmaceutical manufacturer in Nigeria or in the entire West Africa pre-qualified by the WHO but there are some in Africa such as: Aspen Pharmacare Ltd Port Elizabeth - Republic of SOUTH AFRICA(2007) Maphar SA Casablanca - MOROCCO (2008) Quality Chemical Industries Ltd (QCIL) - Kampala - UGANDA (2010)

Steps STEin prequalification PREQUALIFICATION PROCESS Expression of Interest. Product dossier. SMF Assessment Inspections Additional information and data Corrective actions Compliance Compliance Prequalification Monitorin 9

MOTIVATION FOR WHO PREQUAL. BY NIGERIA Conforming to International Requirements such as the UN systems Possibilities of participation in international tenders Facilitated registration for export and Donor transactions Prestige and national pride

PRE-QUALIFICATION PROCESS & ACTIVITIES Expression of Interest Upgrade of GMP Facilities Capacity Building & GMP training Pre-Inspection Visits by WHO Implementation Of CAPA Selection of Products for Prequalification

Packaging Hall

Tableting Suites

Air Handling Unit

GMP Compliant Warehouse

INSTRUMENTS LABORATORY

NEXT STEPS Continuous GMP upgrade Continuous Capacity Building Implementation Of CAPA Final WHO audit Publication of WHO Public Inspection Report Development of Dossiers Bio-equivalence & Bio-availability Studies WHO Prequalifivation

FINAL OUTCOME= ENLISTMENT OF MEDICINES If the product is found to meet the specified requirements, and the manufacturing site complies with GMP, both the product linked to this manufacturing site and company are added to a list hosted by WHO on a public web site. 19

PROGRESS SO FAR BY NIGERIA STATUS EXPRESSION OF INTEREST UPGRADED FACILITIES ALREADY INSPECTED BY WHO NEW FACTORIES ALREADY INSPECTED BY WHO NEW FA TORIES PENDING COMPLETION COMPANIES ELEVEN COMPANIES EVANS MEDICAL PLC NEIMETH PHARM PLC SWISSPARMA LIMITED CHI PHARMA LTD JUHEL NIGERIA LTD MAY & BAKER NIG. PLC AFRABCHEM LTD DAILY NEED IND LTD EMZOR PHARM IND LTD IND FIDSON HEALTHCARE PLC PHAMA TEX INDUSTRIES LIMITED

Benefits of the WHO PQ Process to Nigeria Better Appreciation Of The Tenets Of Good Manufacturing Practice (GMP) Quality Improvement & Upgrade Of Manufacturing Facilities Investment in New Factories Investment in Capacity building Improved collaborations between Industry & Regulators

Benefits of the WHO PQ Process to Nigeria Access to WHO, UNICEF & The UN System, Regular Training in aspects of GMP & Quality assurance Local Industry developing new products for Mothers Children & Newborns such as Zinc Sulphate & Chlorhexidine gel Better Prospects For Patronage from Government Agencies

CURRENT CHALLENGES TO PQ Sourcing Quality Active Pharma Ingredients Human Resource & Expertise Quality Of Submissions/Dossiers Resources For Bio Equivalence Studies Services Of Contract Research Organizations (CROs) Guaranty Of Patronage

FINANCIAL COST OF PRE- QUALIFICATION Nigerian Pharmaceutical Manufacturers processing WHO Prequalification have invested more than N70 Billion or $450m so far Financial & Technical Support have been received from WAHO & WHO/UNITAID Special Funding package expected from ECOWAS Bank for International Development & African Development Bank

UGANDAN EXPERIENCE World Health Organization (WHO) certified the facility as a contract manufacturing plant for CIPLA Limited, India and then began approving manufactured medicines. QCIL is also accredited by the International Committee of the Red Cross Drugs for Neglected Diseases Initiative (DNDi), Pharmacy and Poisons Board of Kenya, Tanzania Food & Drug Authority (TFDA), and the National Drug Authority of Uganda(NDA).

AREAS FOR SUPPORT Expertise & Resources for GMP Expertise & Resources for DOSSIER DEVELOPMENT Resources for BIO-EQUIVALENCE Contract Research Organizations required in West Africa Funding Patronage

CRITICAL SUCCESS FACTORS FOR PREQUALIFICATION PROCESS Political Will of Regulator & Government Determination of Industry & Advocacy Expertise and Human Resources Technical Assistance & International Support Choice Of Products For Prequalification Availability of Finance Guarantee of Patronage

THE WAY FORWARD FOR ECOWAS Sustained Advocacy Engagements With WHO & Partners Continuous Support From WAHO Long Term Funding Required WAHO Certification As A Stepping Stone Bio-availability-bio-equivalence Centre Required In ECOWAS

CONCLUSION The WHO Prequalification Process has POSITIVELY IMPACTED the Nigerian Pharmaceutical Industry through improved standards and eligibility for international tenders. We expect as many as FIVE NIGERIAN MANUFACTURERS to have products prequalified by the World Health Organization in 2014.

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