In almost all countries, the responsibility for regulating drugs belongs to government. However, depending on national circumstances, the government may delegate certain regulatory activities to the private sector, such as consumer groups, expert or interested groups, professional associations or industry associations.
Within government, the division of drug regulation responsibilities will vary from country to country, depending on national conditions. Some examples are given in Box 2.
Box 2. Assignment of Drug Regulation Responsibilities in Three Countries Zimbabwe
The Medicines Control Authority of Zimbabwe is an independent body with the capacity to sue and be sued. The Authority is accountable to the Minister of Health and Child Welfare but managed by an executive committee that has legal powers and which is independent in its decision-making. Drug regulatory decision-making is centralized and is the responsibility of the Authority. The Authority has the power to collect and use fees, or to raise other money and assets. It can also employ its own staff.
In Tunisia, the authority responsible for drug regulatory affairs (Direction de la Pharmacie et du Medicament (DPM)) is organized as a department of the Ministry of Health, under the supervision of the Director-General of Health. Other semi-autonomous units supervised by the Director-General of Health, and that are involved in drug regulatory affairs, include the Laboratoire National de Controle de Médicament, the Institute Pasteur, the Direction de l’Inspection Pharmaceutique, the Laboratoire Nationale de Controle and the National Pharmacovigilance Centre. DPM supervises the administrative work and coordinates the activities of all the units involved in drug regulation.
In India, responsibility for drug regulation is divided between the federal government and the country’s 31 states. Each state has its own drug control organization (responsible for quality control of drugs) and a licensing system covering the manufacture, sale and distribution of drugs. Each state employs drug inspectors as the first line of enforcement and the state authorities issue WHO-type certificates. Federal authorities are responsible for developing standards for drugs, quality control of imported drugs, coordination of state activities, provision of expert advice to ensure consistency in enforcement, and control of manufacture of vaccines, sera and blood products. Four port offices under the federal authority regulate imports.
The examples in Box 2 show that no standard formula exists for organizing drug regulation. Rather, when planning drug regulation, countries should consider all options open to them, and choose the most appropriate structure. Such a structure should provide: independence in decision-making, financial and administrative autonomy (including in appointment of staff) and, accountability to the highest government body responsible for health and the general public. In countries where the government is also the owner of pharmaceutical industries and import-export companies, drug regulation responsibilities must be separated from management of those companies, if conflict of interest is to be avoided.
If several agencies or divisions or departments are involved in drug regulation, care should also be taken to ensure appropriate distribution of responsibilities, duties, functions and powers between the different bodies. This should be done in accordance with the drug legislation or written terms of reference. There should also be written terms of reference that describe the linkages between the various bodies. Also, as far as possible, related activities should be grouped together since they will require a high degree of coordination and will need to be carried out by personnel of similar training and experience. Tasks should be divided so that no supervisor carries an excessively heavy load. Functions that need to be centralized should be carried out at central level and a mandatory reporting system between the different levels should be operated. A planning, monitoring, evaluation and reporting system should be built into the regulatory hierarchy so that implementation of drug regulation can be assessed, shortcomings and the reasons for them identified, and timely decisions to correct them taken.
Agencies, such as consumer unions, professional associations and industry associations, that are involved in drug regulation but who do not form part of government drug regulation, should also be required to operate in accordance with written terms of reference or an established code of practice, in line with national drug legislation. Their role, responsibilities, and powers with respect to drug regulation must be clearly defined.