1. The selection of drugs will be done by the National Essential Drug List of Tanzania Selection Committee (NEDLITSC), which shall be composed of experts in all the medical and pharmaceutical fields necessary, to enable informed decisions to be taken.

As need arises, additional members may be co-opted and consultations may be undertaken with interested parties including professional bodies. Selection shall reflect broad policy objectives and the process of selection by the committee shall be carried out independently.

The NEDLIT contains all the drugs, selected for use in the public sector. It will continue to be produced and distributed to all health facilities, including training schools and to all medical, dental, pharmaceutical staff and health administrative personnel. The main list will indicate the level of use of each item, based on the following classification:

A = drugs for use at Dispensary level
B = drugs for use at Health Centre level
C = drugs for use at District Hospital level
D = drugs for use at Regional and Referral hospital level.

Drug items not included in the NEDLIT may be requested for specific patients under exceptional circumstances by the responsible physician. For that purpose a special form has to be completed and approved by the head of the relevant department. It shall then be sent for consideration by the Hospital Therapeutic Committee.

The NEDLITSC will also be responsible for revising and approving the revisions of the Standard Treatment Guidelines (STG) at least every three years

Suggestions for amendments to the NEDLIT and the STG shall be made in writing to the NEDLITSC - using standardised REVISION FORMS -through the Pharmaceutical and Supplies Unit (PSU) in the Ministry of Health. The PSU acts as the secretariat to the committee.

Full justification for each proposed amendment shall be provided.

2. Where several drugs are available for a given indication or two or more drugs are therapeutically equivalent, the product with the most favourable benefit/ risk ratio will be selected.

Preference will be given to:

- drugs which have been thoroughly investigated
- drugs which improve compliance due to their favourable pharmacokinetic properties
- drugs for which reliable local manufacturing facilities exist.

Fixed ratio combinations will only be selected if one or more of the following criteria are met:

- the clinical condition requires the use of more than one drug

- the therapeutic effect of the combination is greater that the sum of the effects of each drug alone (synergism)

- the cost of the combination is less than the total cost of the individual products

- compliance is improved

New drugs will only be registered if they offer specific advantages over existing drugs. If information on existing drugs shows they no longer have a favourable benefit/risk ratio, they will be removed and replaced with safer alternatives.

3. All drugs used in the public and private sector have to be registered for use in Tanzania by the Pharmacy, Medicines and Poisons Board.

This Board will establish and maintain a suitably equipped and manned computerised Drug Registration Unit, whose function will be to keep all the data and information, relevant to the registration of medicinal (drug) products. Unless a medicinal/pharmaceutical product has been duly registered by the Board, it will not be permitted to be imported, exported, manufactured, wholesaled, retailed, prescribed and dispensed in the country.

Drugs imported in non-commercial quantities for specific use by individuals need not to be registered, but will be granted special permission by the Board.

4. For the public sector procurement of drugs will be carried out by Central Medical Stores (CMS), based on a tender system.

Preference in procurement will be given to local and regional manufacturers. Procurement will also be directed towards manufacturers in preference to wholesalers, brokers and trading houses.

However notwithstanding these preferences, in order to make the best possible use of available funds, procurement will continue to be aimed at securing the lowest possible and available price for a product of desired quality.

The MOH will encourage the improvement of procurement and management efficiency by providing the CMS full autonomy in running their own day-to-day business.

For both the public and private sectors procurement of drugs will be limited to items, registered for use in the country, unless otherwise approved by the Pharmacy, Medicines and Poisons Board. Donations will only consist of registered drugs, included in the NEDLIT, unless otherwise approved by the MOH and the Board.

Manufacturers of branded drugs will be requested (local manufacturers required) to label their product packages and containers with the generic name of the drug at least one third the size of and displayed adjacent to the trade name.

5. Managerial elements in the quality assurance system include:

- The Pharmacy Board will strengthen the drug inspectorate unit, which is authorised to ensure that quality assurance policies are implemented in all aspects at all levels of the drug supply system.

- Drugs will be procured only from reputable suppliers, applying the WHO Certification Scheme and only drugs, confirming to internationally recognised quality control standards, will be registered and permitted to be procured and distributed in the country.

6. Technical elements in the quality assurance system include:

- The MOH will establish and maintain an adequately equipped and manned National Drug Quality Control Laboratory (NDQCL) under the Pharmacy Board, to carry out the testing of pharmaceutical products moving in the local markets.

- In order to make maximum use of the limited resources, other local or Regional Quality Control Laboratories will be utilised whenever need arises.

7. Legal elements in the quality assurance system include:

- To achieve the required quality standards for the local pharmaceutical manufacturing companies, the MOH through the Pharmacy Board will establish guidelines on Good Manufacturing Practises (GMP).

- The Pharmacy Board will institute regular and thorough inspection procedures for manufacturing and quality control facilities, to ensure full implementation of the GMP requirements.

8. The National Drug Policy mentions Hospital Pharmaceuticals and Supplies Committees. The Masterplan for the Pharmaceutical Sector mentions similar committees under a variety of names (eg. pharmaceutical committees, therapeutic committees). Because of their overall role in achieving rational use of drugs, the name to be preferred will be therapeutic committees.

A comprehensive document, dealing with functions, role and set-up of Hospital Therapeutic Committees can be found elsewhere in this manual. Therapeutic committees at other levels will have similar structures and responsibilities within their own operational frameworks.

The coordination centre for all therapeutic committees will be a National Therapeutic Committee, appointed by and operating under the Chief Medical Officer (CMO), MOH.

9. The Pharmaceutical legislation and regulation will reflect the National Drug Policy. The policy will ensure rapid and full implementation of the provisions of the Pharmacy, Medicines and Poisons Act and full compliance with the Act as well as vice versa.

The Government will strengthen and support the activities of the Pharmacy Board and its related committees, whose functions it is to ensure compliance with all areas of the law, related to drug handling and use.

Through its Board the MOH will monitor the functioning of the pharmaceutical legislation and its relation to other legislation, affecting implementation of the National Drug Policy.