The objective of the drug selection process is to have a national list of drugs rationally chosen to satisfy the health care needs of the majority of the population. Such a list shall be revised regularly and shall form the basis of drug selection by primary, secondary and tertiary public health-care institutions. In this regard, the Federal Government shall take the following steps:
i A revised Essential Drugs List shall be published by the Federal Ministry of Health and made available to health professionals, state and local governments, primary, secondary and tertiary health institutions.
ii Drugs included on the list shall:
• be listed using generic or International Non-Proprietary Names (INN)
• be based on the health needs of the majority of the population
• have substantial safety and risk/benefit ratio with sufficient accumulated scientific data
• be registered by the national drug regulatory authority
iii As much as possible, formulations containing more than one active ingredient shall be avoided, unless one or more of the following criteria are met:
• the clinical condition justifies the use of more than one drug in a fixed combination, or
• two or more pharmacologically active ingredients are synergistically active in a product, or
• patient compliance is enhanced by the combination.
iv When two or more drugs are therapeutically equivalent or several drugs are available for the same indication, preference shall be given to products with the:
• most scientific research and clinical data
• most favourable pharmacokinetic properties
• best cost advantage
• best patient compliance
• most stable pharmaceutical dosage form for which appropriate storage facilities exist.
v The Essential Drugs List Review Committee shall update the list every four years.
vi Suggestions for amendment shall be made in writing on a prescribed form to the Federal Ministry of Health, justifying each suggested amendment. New drugs shall only be added to the list if sufficient scientific and clinical data are available to show that they offer distinct advantages over existing ones. Drugs on the list for which information becomes available that they no longer have a favourable risk/benefit ratio shall be withdrawn and replaced with safer alternatives.
vii The Essential Drugs List shall be used for:
• the procurement of drugs and their use in the public sector;
• prescribing drugs in the public sector;
• drug information to health care providers;
• the production of Standard Treatment Guidelines and a National Formulary;
• reimbursements on drugs in the National Health Insurance Scheme.