INSTITUTE OF HERBAL MEDICINE AND PROCESSING KASESE UGANDA

SAFETY AND  HERBAL MEDICINE

1.1 General objective

This document aims to facilitate the registration and regulation of herbal medicines by

establishing the foundation for a harmonized regulatory standard to meet the common demands

of the Region and establish the institute of herbal medicine in Uganda . The members have established AFRICAN ARK OPEN SOCIETY INSTITUE for exploration of herbal medicine design.

1.2 Specific objectives

To propose a classification for herbal medicines;

To propose regulatory requirements for the registration of each category of herbal

medicines;

To set up minimum requirements for registration and regulation of herbal medicines.

Guidelines for the Regulation of Herbal Medicines

2 in the East Africa and Uganda  Regions in particular.

2.Classification of herbal medicines

For practical purposes, herbal medicines can be classified into four categories, based on

their origin, evolution and the forms of current usage. While these are not always mutually

exclusive, these categories have sufficient distinguishing features for a constructive examination

of the ways in which safety, efficacy and quality can be determined and improved in Uganda .

 Indigenous herbal medicines

This category of herbal medicines is historically used in a local community or region and is

very well known through long usage by the local population in terms of its composition,

treatment and dosage. Detailed information on this category which also includes folk

medicines, may or may not be available. It can be used freely by the local community or in

the local region.

However, if the medicines in this category enter the market or go beyond the local

community or region in the country, they have to meet the requirements of safety and efficacy

laid down in the national regulations for herbal medicines.

 Herbal medicines in systems

Medicines in this category have been used for a long time and are documented with their

special theories and concepts, and accepted by the countries. For example simpriosio nyaruruke fall into this category of  traditional medicine

 Modified herbal medicines

These are herbal medicines as described above in categories except that they have

been modified in some way–either shape, or form including dose, dosage form, mode of

administration, herbal medicinal ingredients, methods of preparation and medical indications.

They have to meet the national regulatory requirements of safety and efficacy of herbal

medicines.

mported products with a herbal medicine base

This category covers all imported herbal medicines including raw materials and products.

Imported herbal medicines must be registered and marketed in the countries of origin. The

safety and efficacy data have to be submitted to the national authority of the importing

country and need to meet the requirements of safety and efficacy of regulation of herbal

medicines in the recipient country.

The Acid-Base balance is crucial to a person's health, because disease states flourish in an acidic environment. If your body is alkaline, disease and illness cannot exist. The primary determinant of whether your body is acidic or alkaline is what you ingest. When a food or beverage is ingested, digested, and absorbed, each component of that food reach the kidneys as either an acid-forming compound or a base-forming one. If the overall diet provides more acidic components, than alkaline components, it will result
Every cell of the body is designed to function best within a specific pH range (pH is a measure of the acidity or alkalinity of the body). The optimal pH varies depending on the type of body cell in question; however, it is important that the net pH of the body remains tightly regulated. One common problem with most industrialized societies is that our diets produce what's called a "low grade chronic metabolic acidosis." In other words, the average person is chronically in a state of high acidity. While this imbalance would not be enough for most doctors to pick up on it, your body will let you know that things are not functioning optimally. The body must operate at a stable pH no matter what, so the dietary acid load that most people have has to be neutralized by a homeostatic base-producing mechanism. This will keep your pH in the correct balance, but at a price. Here are three of the many potential consequences of your body's attempt in ones life.

1. Hypercalciuria (high concentrations of calcium in the urine). Since calcium is a strong base and bone contains the body's largest calcium store, metabolic acidosis causes a release in calcium from bone. As a result, bone is lost in order to neutralize the acidic environment of the body.

2. Negative nitrogen balance (high concentrations of nitrogen in urine). We can act much like calcium to neutralize the body's acidosis. Metabolic acidosis causes muscle breakdown to liberate glutamine from the muscle, where it is primarily stored. The amino acids from this muscle breakdown are then excreted, causing a net loss of muscle from the body. This decreases strength and lowers the metabolism.Increased susceptibility to illness and a reduction in metabolism due to lost muscle weight, which in turn can lead to an increase in bodyfat levels and eventual weight gain.

3. Increased blood cortisol levels. This leads to an increase in abdominal fat and is correlated with heart disease.

What's Wrong With The Average ugndans meals

Our ancestors evolved eating a diet that was very alkaline/basic, rather than acidic. However, modern people are eating a diet that is high in acid, and therefore very different from what we evolved to eat. As a result, our modern diet is responsible for this net acidic problem. The shift from net base producing foods to net acid producing foods comes mostly as a result of replacing a diet that used to be almost all plant-based with the occasional meats,mainly beef,goats as redmeat, to a diet that is much higher proportionally in grains and processed foods. Furthermore, the produce we do eat is less rich in nutrients, mainly due to the overuse of the soil which becomes depleted of nutrients over time. Also, the animal protein we consume typically is not free-range, meaning the animals are not eating a nutrient-dense diet as nature intended. They are instead raised to fatten up quickly eating a diet that is largelygrain-based.

Animal flesh typically is highly acidic, except fish which is less acidic but still on the acidic side. Dairy products and eggs are highly basic which is helpful for your protein sources. Fruits and vegetables are the absolute best thing you can eat to improve your acid-base balance, and you really cannot get too much. Grain products tend to be a little on the acidic side although not as high as meats. Beans are preferable to grains in terms of carbohydrate sources. Fats are basic, and water, natural fruit and vegetable juices, and teas are basic. Coffee and soda are acidic to our bodies and I advise these not givern to children.

Polluted foods,poorly fied with a lot of cooking oil are acic to our bodies.

What You Can Do to Improve Your Diet and Your Health in Uganda

Try to eat at least two servings of fruits and vegetables with every meal, and at least one with every snack. Supplementation with glutamine can also be helpful (available in a powdered form). Avoid capsules because they cost much more per gram. 5-15 grams per day of glutamine is an effective dose.

3.2 SAFETY CATEGORY

A drug is defined as being safe if it causes no known or potential harm to users. There are

three categories of safety that need to be considered, as these would dictate the nature of

the safety requirements that would have to be ensured.

• Category 1: safety established by use over long time
• Category 2: safe under specific conditions of use (such herbal medicines should
• preferably be covered by well-established documentation)
• Category 3: herbal medicines of uncertain safety (the safety data required for this
• class of drugs will be identical to that of any new substance)
• Data will be required on the following:
• Acute toxicity
• Long-term toxicity
• Data may also be necessary on the following:
• Organ-targeted toxicity
• Immunotoxicity
• Embryo/fetal and prenatal toxicity
• Mutagenicity/genotoxicity
• Carcinogenicity

3.2 GENERAL CONSIDERATIONS FOR ASSESSMENT OF SAFETY OF HERBAL MEDICINES

Any assessment of herbal medicines must be based on unambiguous identification and

characterization of the constituents. A literature search must be performed. This should

include the general literature such as handbooks specific to the individual form of therapy,

modern handbooks on phytotherapy, phytochemistry and pharmacognosy, articles published

in scientific journals, official monographs, national monographs

and other authoritative data related to herbal medicines and, if available, database searches

Guidelines for the Regulation of Herbal Medicine in Uganda .Drug . The searches should not only focus on the specific herbal medicinal preparation, but should include different parts of the plant, related plant species and

information originating from chemotaxonomy. Toxicological information on single ingredients

should be assessed for its relevance to the herbal medicines.

3.2.1 SPECIFIC REQUIREMENTS FOR ASSESSMENT OF SAFETY OF FOUR CATEGORIES OF HERBAL MEDICINES

Before any category of herbal medicine listed above is introduced into the market, the relevant

safety category needs to be reviewed and the required safety data obtained, based on thatparticular safety category.

Category 1: Indigenous herbal medicines

These can be used freely by the local community or region, and no safety data would be

required. However, if the medicines in this category are introduced into the market or moved

beyond the local community or region, their safety has to be reviewed by the established

national drug control agency.

If the medicines belong to safety category 1, safety data are not needed. If the medicines

belong to safety category 2, they have to meet the usual requirements for safety of herbal

medicines. Medicines belonging to safety category 3, i.e. ‘herbal medicines of uncertain

safety’, will be identical to that of any new substance.

Category 2: Herbal medicines in systems

The medicines in this category have been used for a long time and have been officially

documented. Review of the safety category is necessary. If the medicines are in safety categories

1 or 2, safety data would not be needed. If the medicines belong to safety category 3, they

have to meet the requirements for safety of ‘herbal medicines of uncertain safety’.

Category 3: Modified herbal medicines

The medicines in this category can be modified in any way including dose, dosage form,

mode of administration, herbal medicinal ingredients, methods of preparation, or medical

indications based on categories 1 and 2. The medicines have to meet the requirements of

safety of herbal medicines or requirements for the safety of ‘herbal medicines of uncertain

safety’, depending on the modification.

Guidelines for the Regulation of Herbal Medicines in Uganda

Category 4. Imported/exported products with a herbal medicine base

Exported products shall require safety data, which have to meet the requirements for safety

of herbal medicines or requirements for safety of ‘herbal medicines of uncertain safety’,

depending on the safety requirement of the importing/recipient countries.

3.3 Literature review of herbal medicines

Member  of the project in uganda should share information from reliable sources.

In assessing these bibliographic data, particular attention should be paid to the following

aspects:

ü      The characteristics and type of preparation described in the literature: Does the

literature refer to the same herbal preparation? Can the data be extrapolated?

ü      The extent of time and use of the herbal medicines: Can the use have generated

sufficient experience on safety? Is it plausible that the risks would have been recognized

empirically?

The need for additional data or new tests should be considered in the light of the

information requirements for new substances. Many of the tests required for new substances

may be replaced by documented experience. However, it should be carefully considered if all

the questions on toxicology raised for new substances could be answered sufficiently and in

a plausible way by the available general knowledge. A specific focus should be given to

effects that cannot be detected or are very difficult to detect empirically, e.g. genotoxicity.

The assessment should determine if there is sufficient information to guarantee safe use

in vulnerable populations, such as pregnant or lactating women, and in children. For the

assessment of safety in pregnancy, information on misuse, e.g. as an agent to induce abortion,

should be assessed.

Guidelines for the Regulation of Herbal Medicines in Uganda

4. MINIMUM REQUIREMENTS FOR ASSESSMENT

OF THE EFFICACY OF HERBAL MEDICINES

4.1 CLAIMS CATEGORIES

Disease

ü      Acute disease: Diseases that have a rapid onset and a relatively short duration.

ü      Chronic disease: Diseases that have a slow onset and last for long periods of time.

Diseases of acute onset could also progress to a chronic state.

In most cases, severe diseases refer to a life-threatening illness or those diseases

in which delayed treatment will lead to deterioration of the disease state or loss of

capability to cure them. For example, severe cardiovascular, gastrointestinal, endocrine,

haematological diseases, and immune disorders and diseases fall into this group.

ü      Health condition: Problems related to health conditions are those which, with time,

could recover spontaneously, even without any medical intervention, e.g. loss of

appetite, hay fever, menopause, etc. The efficacy for this category could be supported

by data in existing well-established documents such as national pharmacopoeia and

monographs as well as other authoritative documents such as UGANDA  monographs.

Pre-clinical and clinical data of efficacy may not be necessary.

Type of disease Pre-clinical data of efficacy Clinical data of efficacy Other data or information required Acute Needed Control trial neededChronic May be needed Clinical data may or

may not be neededHealthcondition

May not be needed May not be needed Supported by wellestablished documents

such as national pharmacopoeia and monographsTable 1. Summary of the efficacy data requirements for the

three types of disease and conditions

Guidelines for the Regulation of Herbal Medicines IN UGANDA

4.3 Minimum requirements for assessment of the efficacy of

herbal medicines

ü      The assessment of efficacy for herbal medicines in categories 1 and 2 are not required

if they are used locally;

ü      For medicines in category 3, pre-clinical data and clinical data may or may not be

required depending on the modification(s), which are given in Table 2;

ü      For medicines in category 4, efficacy data are required.

Guidelines for the Regulation of Herbal Medicines

in  Uganda:

5.QUALITY ASSURANCE OF HERBAL MEDICINAL

PRODUCTS

Quality assurance of herbal medicinal products is the shared responsibility of manufacturers

and regulatory bodies. National drug regulatory authorities have to establish guidelines on

all elements of quality assurance, evaluate dossiers and data submitted by the producers, and

check post-marketing compliance of products with the specifications set out by the producers

as well as compliance with Good Manufacturing Practices (GMP).

The manufacturers have to adhere to Good Agricultural and Collection Practices (GACP),

GMP and Good Laboratory Practice (GLP) standards, establish appropriate specifications for

their products, intermediates and starting materials and compile a well-structured,

comprehensive documentation on pharmaceutical development and testing. The producers

should make continued efforts to improve standards and adapt them to the present state of

knowledge. A cooperative approach between different manufacturers, e.g. by establishing

drug master-files for specifications and quality control, should be encouraged.

5.1 COORDINATING QUALITY CONTROL

A coordinating HERBALISTS  should be established to facilitate the availability of goodquality

herbal medicines to the market by giving training and advice to small producers and

farmers. To encourage implementation of Herbal processing, incentives should be given to producers of

botanical raw materials. These include giving technical and logistic support in the selection

of appropriate sites for agricultural production, providing seeds and seedlings, selecting

fertilizers and pesticides, providing or giving advice on machinery for harvesting and primary

processing. The government should honour efforts by issuing certificates to producers and

farmers who adhere to the production of herbal medicine, based on the country situation. Implementation of such

requirements is only possible if the production and marketing of herbal medicines is subject

to an adequate registration scheme by a drug regulatory authority.

5.2 QUALITY ASSURANCE

Elements of quality assurance are:

ü      adherence to guidelines

setting specifications; and

ü      quality control measures.

Guidelines for the Regulation of Herbal Medicines

10 in our country

5.3 QUALITY CONTROL FOR HERBAL MEDICINAL PRODUCTS

All herbal-based medicinal products should meet the requirements for safety, efficacy and

quality, as per the Categories of Herbal Medicines (see the section on Minimum requirements

for assessment of safety of herbal medicines).

All imported herbal medicinal products need to meet the requirements for safety, efficacy

and quality control regulations in the importing countries. To control the quality of imported

herbal medicinal products, the following requirements should be taken into consideration.

5.3.1 LICENSING AUTHORITY

Licensing for importers, wholesalers, manufacturers and assemblers of herbal medicinal

products should be issued by the national drug regulatory authority. Dealers of imported

herbal medicinal products need to apply for one or more of the licences depending on the

type of business involved, such as licence of importers, wholesalers, manufacturers and

assemblers.

5.4 GUIDELINES RELATED TO GOOD AGRICULTURAL AND COLLECTION

PRACTICES UGANDA  AND GOOD MANUFACTURING PRACTICES(GMP)

The coordinating agency should adhere to the principles set out in KARC Guidelines on

Good Agricultural and Collection Practices for Medicinal Plants (for GACP) and manufacturers

and assemblers should follow KARC Good Manufacturing Practices (for GMP). Manufacturers

of herbal medicines should obtain a licence and register their products. The quality control

system for production should be in place. The implementation of a credible concept of

quality assurance, e.g. identifying and eliminating potential sources of contamination, should

be a primary goal of the manufacturers rather than the implementation of all individual

technical aspects.).

5.5PRODUCT INFORMATION FOR REGISTRATION

This should include all necessary information on the proper use of the product. The detailed

information of the herbal medicinal products should include the following requirements for

registration:

• Quantitative list of ingredients; if this is difficult, it could be replaced by including the

               plant names and plant parts used (i.e. Latin name);

• Full product formula for imported herbal-based medicinal products (in the language

        of the importing and exporting countries);

• A set containing labels, pamphlet, carton and specimen sales pack;

        Particulars of manufacturer(s) and assembler(s);

• Manufacturer’s licence or certificate from the drug regulatory authority. Pre-export

        notification and Certificate of Free Sale of the herbal-based medicinal product should

        be obtained from the concerned authority;

• Brand name of product;
• Dosage form;
• Indications;
• Dosage;
• Mode of administration;
• Duration of use;
• Adverse effects, if any;
• Contraindications, warnings, precautions and major drug interactions, if possible;
• Date of manufacture;
• Expiry date of product;
• Lot/Batch number;
• Storage condition.

6. PHARMACOVIGILANCE OF HERBAL MEDICINAL

PRODUCTS

Of the 11 Member Countries in the East Frica and Central Africa , there are only four with national

systems for monitoring the safety of traditional medicinal products. There is an urgent need,

therefore, to set up national systems for monitoring the safety of medicinal products in the

Region. The national system for monitoring safety of medicinal products should include

herbal medicinal products in the scope of its activities.

The national government needs to strengthen capacity building in setting up and running

such systems through training programmes etc. While developing a national programme to

monitor the safety of medicinal products, care should be taken to ensure that this will include:

• Establishing a national pharmacovigilance centre for monitoring the safety of medicinal
• products including herbal medicinal products;
• Training staff who will be included in the reporting system;
• Setting up necessary equipment;
• Developing the reporting forms;
• Setting up a multidisciplinary advisory committee to review and analyse the collected

data.

6.1 ADVERSE DRUG REACTION

Pharmacovigilance units or national pharmacovigilance centres are necessary to collect and

assess information on adverse drug reaction (ADR) relating to medicinal products including

herbal medicines. Where such units/centres exist, they should include herbal medicines in

the current scope of their activities.

Each ADR report should be evaluated and assessed on the causality with the suspected

herbal medicines. Health professionals should be encouraged to ask their patients about the

use of herbal products and herbal medicines, including ‘medicinal foods/health food/dietary

supplement’ and any other medicines, and to include information on concomitant use in

their ADR.

Each herbal medicine should be clearly identified by its constituents, brand name (if

applicable) and dosage. If such information is missing in the ADR, the pharmacovigilance

unit/centre should immediately try to gather complete information, e.g. by asking the reporting

health professional. To avoid the missing vital information, national drug regulation on herbal

Guidelines for the Regulation of Herbal Medicines

14 in the Uganda and DRC

medicines and herbal medicines should include all the necessary information on registered

herbal medicinal products and an ADR reporting form.

In analysing ADR reports the following aspects should be considered:

(1) A literature search on the herbal product, its constituents and any co-medication

should be performed;

 (2 The dosage used should be compared with the traditional dosage described

in the literature:

• Did the patient use a higher dose than recommended? Would it be intoxication
• rather than an ADR?
• Is the dosage so low compared to the traditional dose that a link is not plausible?
• However, be aware of allergic reactions!



(3 How common is the symptom with other diseases?

• What is the prevalence of diseases with the same symptoms, e.g. hepatitis?
• Can other causes be eliminated, such as viral markers or ethanol misuse in hepatitis?

(5) Search databases for similar case reports for association with the same or

similar herbal medicines or combination products. In the case of suspicious

files, go to original reports, because the database file may not be complete

and additional information may be found in the original report;

(6) If no association was found in literature, or if an association is not plausible

because of the low dose, there could be a problem related to the product’s

quality. Check for possible adulteration, substitution or contamination, e.g.

by mycotoxins, heavy metals, etc.

Guidelines for the Regulation of Herbal Medicines.

The assessment should be done in cooperation with an expert panel comprising experts

in pharmacognosy, toxicology and other health professionals including providers of herbal

medicines.

6.2 HOW TO SET UP OR EXPAND THE REPORTING SYSTEM ON

ADVERSE EVENTS RELATING TO HERBAL MEDICINAL PRODUCTS

To begin with, the report will be voluntary. If possible, the report should be mandatory later.

The following actions should be taken into account when setting up a reporting system, or

including providers of herbal medicinal products in a pre-existing reporting system:

• Provide education and awareness for the public/consumers and professionals including

       doctors, pharmacists, herbal medicine practitioners, etc.;

• Establish a proper regulatory system for herbal medicines;
• Activate medicine information centres in health authorities for the establishment of

        special sections and systems for ADR of herbal medicines and any other possible

• medicine-related problem;
• Use existing tools (for conventional drugs) to collect and analyse data supported by

        a computerized system;

• Emphasize the scientific use of herbal medicines;
• Solve existing problems in the reporting systems by using advanced database

               programmes;

• Ask for KARC assistance in establishing an ADR reporting system;
• Encourage manufacturers, the public/consumers and professionals including doctors,

pharmacists, practitioners of herbal medicine, etc. who produce, prescribe or use

herbal medicines, to report ADR to relevant authorities.

Guidelines for the Regulation of Herbal Medicines

16 in UGANDA

7.CONTROL OF ADVERTISEMENTS OF HERBAL

MEDICINAL PRODUCTS

The national authorities responsible for the regulation of herbal medicinal products and

practices should approve every advertisement before it reaches the public.

The regulatory authority should issue advertisement permits after satisfactory evaluation

of the contents of each advertisement to ensure that the public gets the correct information

about the product, devoid of ambiguous or fraudulent claims. The print and electronic media

should be notified to ensure that every advertiser of herbal medicinal products obtains the

permit from the national authority before such an advertisement is published.

It is necessary that information on the advertisement of herbal medicinal products is

shared among countries and overall cooperation with different, relevant national authorities

is encouraged.

FIELD WORK TO QUIDE HERBALISTS APROACH TO UGANDA HERBAL POLICY

UGANDA HERBAL POLICY

It is being formulated by Nationaal Drug AUTHORITY.

National Drug Authority mission is to ensure that only good quality, safe and efficacious

human and veterinary medicines are available and are correctly handled in Uganda; and

to contribute towards their accessibility, cost effectiveness and appropriate use. It is

against this background that these guidelines have been drawn to address the many

issues of quality of herbal medicines that have arisen in the recent past.

These guidelines will mostly dwell on the manufacture, registration and sale of herbal

medicines. The practice of herbal Medicine will be handled under the auspices of the

various (professional) organizations that unite herbalists in the country. It is hoped that

subsequent to putting in place guidelines for the regulation of herbal medicines the

existing herbal associations in the country will unite under one umbrella body as is the

case with other professionals. The National; Drug Authority will cooperate with MoH in

formulating a policy on Traditional Medicine.

1.1. BACKGROUND

A technical advisory select committee on herbal medicines wrote a report in September

1997, formulating policy regulations on local herbal medicines in Uganda. This has been

translated into five (5) local languages, and is currently being used. This report has been

used as a basis for sensitizing most of the districts in Uganda by the secretariat staff for

the period 2005 -2008. Although relevant at that time it has been found lacking in many

areas and hence the need to develop a comprehensive guideline.

National Drug Authority Secretariat, with funding from WHO, carried out more

sensitization workshops in the country, focusing on regulatory requirements for local

herbal medicinal products for the period 2005-2007. During these sensitization

workshops, a lot of consultations were made with different stakeholders and the data

collected has been used in developing these guidelines.

1.2. PROBLEMS/CHALLENGES;

1. Owing to very low literacy levels in Uganda, many herbalists cannot read or write

making it hard for them to compile and submit application documents to NDA.

2. There is a widespread misconception amongst herbalists that documentation

requested for by NDA is intended to steal their indigenous knowledge and thus, there

has been hesitation to submit applications.

3. Lack of funds to meet minimum requirements for NDA’s approval.

4. Uncontrolled advertising all over the country.

5. Unethical practices not limited to but including sacrifices of human beings,

adulteration of products with western medicines, peddling of products with no

therapeutic benefits, making unsubstantiated medicinal claims.

6. Haphazard Manufacture and sale of herbal products

7. Lack of a single forum for local herbalists but rather many different associations with

varying objectives. This has made it difficult for NDA to come to a unifying conclusion

in many of the controversial areas.

8. Lack of a recognized body, to certify herbalists who would work in herbal

manufacturing facilities and herbal outlets.

9. Building consensus among herbalists for the need to be regulated.

10. Limited capacity in both personnel and equipment to fully assess and analyze

information submitted by applicants.

11. Advocacy by legislators has been limited due to lack of information among stake

holders.

1.3. POLICY

The NDP/A Act chapter 206 of the Uganda Laws mandates NDA to regulate manufacture,

registration and sale of herbal medicines. The regulation also includes control on

promotion/advertisements pertaining to herbal medicines. National Drug Authority

regulates only the product and information about it and not the practice.

1.4. OBJECTIVES.

These guidelines have been developed to guide applicants dealing in herbal medicinal

products conform to regulatory requirements so as to foster proper monitoring of safety

and efficacy issues involved. That is;-

•  To guide Local manufacturers on acceptable minimum requirements for the
• manufacture of herbal medicinal products;
•  To guide applicants on how to meet minimum requirements for registration of
• herbal medicinal products;
• To offer guidance on Licensing of herbal medicine sales outlets.
• To put in place a safety and monitoring mechanism;
• To guide on advertising of herbal medicinal products.
• To collaborate with other institutions to ensure that guidelines on good

Agricultural practices are followed

Applicants are advised to study these guidelines carefully and understand the sections

included herein before attempting to approach National Drug Authority in matters of

regulation.

1.5 CLASSIFICATION OF TRADITIONAL MEDICINES

1.5.1 Category 1: Home remedies

Medicines in this category are prepared by the traditional health practitioners or

family members for treatment of individual patients and each has the following

characteristics:

(i) It is prepared in an extemporaneous (prepared there and then i.e. without

previous planning but according to need) manner and according to traditional

methods.

(ii) Its safety and efficacy should be justified by long period of use (At least for more

than ten (10) years).

(iii) This category of medicines is not directly controlled by the national drug

regulatory agency. However, the traditional health practitioners should be

certified by the recognition/registration of their practice by the community

or any local Authority/Council.

(iv) It could be used freely by local people.

(v) If the medicines in this category are introduced into the market (For commercial

use), they must meet the minimum regulatory requirements for the registration

of traditional medicines.**

1.5.2 Category 2: Galenicals.

Category 2 traditional medicines are popularly used in the community with

commercial possibility and each possesses the following characteristics:

(i) It is traditionally used in a locality and is well known by the local

population, in terms of both its mode of use and treatment;

4

(ii) Its formulation is well known in a given locality and its preparation is

according to established/ traditional methods.

(iii) Its safety and efficacy should be justified by long period of use. At least

more than ten (10) years.

(iv) However, if the medicines in this category are to go into the market (For

commercial use), they have to meet the general minimum requirements

for registration of traditional medicines.**

1.5.3 Category 3 Traditional medicines

1.5.3.1 Category 3A Researched- Semi Industrial Traditional Medicines

This category of medicines is developed based on scientific research and has the

following characteristics:

         i.It is developed by research based on ethno (common cultural tradition,

       ii.indigenous) medical use.

      iii.The new formulation, dosage, dosage form and therapeutic use are based

     iv.on research data.

       v.It may be produced at semi-industrial scale

     vi.Its safety and efficacy are based on research data derived from standard

    vii.scientific and clinical investigations.

  viii.This category of medicines may be used within the research establishment.

     ix.However, if it goes into the market (For commercial use), it has to meet

the general minimum requirements for registration of traditional

medicines.

1.5.3.3 Category 3B Researched – Industrial Traditional Medicines

This category of medicines is developed based on scientific research and has the

following characteristics:

                     i. It is developed by research based on ethno (common cultural tradition,

indigenous) medical use.

                   ii.. The new formulation, dosage, dosage form and therapeutic use are based

on research data.

                  iii. It may be produced at Industrial scale

                 iv. Its safety and efficacy are based on research data derived from standard

scientific and clinical investigations.

                   v. This category of medicines may be used in the market (For commercial

use) and has to meet the general minimum requirements for registration

of traditional medicines

1.5.3 .4 CATEGORY 4:

 Imported Traditional Medicines

These are imported traditional medicines each with the following characteristics:

1. It originates from a foreign country.
2. It should meet the definition of traditional medicines.
3. It should be registered in the originating country.
4. It should also meet the requirements for regulation of traditional

medicines of National Drug Authority, Uganda. Guidelines for category

4 already exist in National Drug Authority and this category is not

included in the general minimum requirements.

MONOGRAPHY AND ECOLOGY OF HERBAL MEDICINE IN UGANDA