Traditional Medicines & OTC Products
Traditional medicines & OTC products in South Africa – a legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
In terms of the Medicines Act medication is classified into 4 categories from Category A- Category D depending on the
In terms of the Act, “Complimentary medicines” means any substance or mixture of substances that –
- Originate from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substances as determined by the Authority;
- Is used or purporting to be suitable for use or manufactured or sold for use –
- In maintaining, complementing or assisting the physical or mental state; or
- To diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or they symptoms or signs thereof or abnormal physical or mental state of a human being or animal; and
- Is used –
- As a health supplement
- In accordance with those disciplines as determined by the Council
- Is declared by the Minister, on recommendation by the Council, by notice in the Gazette to be a complementary
Combination Products means “a single product that contains:
- A mixture of substances of different discipline-specific origins or philosophies;
- A mixture of at least one substance of discipline-specific origin;
- A mixture of at least one substance of discipline-specific origin and one more of its isolated constituents.
It is important to note that the SAHPRA Guideline on Complementary Medicines – Discipline-specific Safety and Efficacy, specifically identify six major disciplines within the Complementary Medicines sphere namely: Homeopathy, Western Herbal Medicine, Traditional Chinese Medicine, Ayurveda, Unani Medicine (Unani-Tibb) and Aromatherapy.
All manufacturers of complementary medicines shall comply with all relevant aspects of Good Manufacturing Practice as outlined in the latest version of the SAHPRA “Guide to Good Manufacturing Practice for medicines in South Africa” and Good laboratory practice as well as the WHP Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants if applicable. Any alternative standards must be specified, referenced and justified.
The Regulatory Authority classify medicines into different categories and complementary medicine is categorised as a Class D medicine, which is medicine intended for use in humans and animals which are without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine.
Under this classification there are two sub-categories which include discipline-specific medicines (which disciplines will be determined by the Regulatory Authority) and health supplements.
With regards to Traditional Medicine, it is considered to form part of Complementary Medicine for the purposes of regulation by the SAHPRA and in order for the relevant registration to be completed as set out in the Medicines Act. However, a Traditional Health Practitioners Act was published in the Government Gazette bringing forth the vision of having the practice of Traditional Health practitioners regulated by a Regulatory body functioning with similar onus and responsibilities as SAHPRA and the Health Professions Council of South Africa (last mentioned being responsible for the regulation of the practice of medical practitioners, physiotherapists, radiographers and other health care practitioners who fall within the ambit of the Act).
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Under the General Regulations relating to medicines, complementary medicines may only be advertised through a statement identifying the discipline of the medicine where relevant and an indication that the medicine must be used in accordance with the applicable complementary discipline and principles where relevant. It must also be stated whether the medicine has not received registration with the Authority and if so, the following disclaimer must be present when advertising is done:
“this unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”.
Direct advertisement to the public thus in this regard must adhere to the above requirement and must be clear, direct and factual – no misleading or vague statements about the product can be made.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
According to the SAHPRA guideline on Complementary Medicines – Discipline-specific Safety and Efficacy, any advertisement or marketing claims for complementary medicine must adhere to specific requirements. An important aspect of this is that the claims made must not cause any member of the public to become anxious or stressed or have the effect that unnecessary concern about their health is created through the advertisement or marketing claims made for the relevant product.
In general, and unless specifically pre-approved as a disease risk reduction claim, indications that refer (explicitly or implied) to the treatment, or cure of specific disease are not suitable for use for health supplements. The following disclaimer must appear on the immediate (as appropriate) and outer container label: “Health supplements are intended only to complement health or supplement the diet”.
Reference to the relative Nutritional Reference Value as a percentage may also be included on the label where relevant.
Any use of artificial sweeteners must be clearly stated as in the Guideline: Complementary medicines: Registration Application ZA-CTD – Quality.
The General Regulations under the Medicines Act further state that Schedule 0 and Schedule 1 medicines may be advertised to the public directly.
From Schedule 2 through to Schedule advertising of the medication may only be done to Medical practitioners, Dentists, Veterinarians, Pharmacists and other persons authorised to prescribe medicines, Persons in receipt of certain publications containing the advertising.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The SAHPRA determine the categories of medicines – the primary method in doing so is based on a Schedule system which is determined from Schedule 0 to Schedule 7.
Each Schedule is applied taking into account the various conditions which is attached to the distribution and sale of the medicine depending on the nature of the schedule that is applied.
In this regard Schedule 0 medicines are available off the shelf or without prescription in a supermarket.
This includes the complementary medicines with a Schedule 0 category, as the same rules apply though they are still required by law to now apply for registration and adhere to the regulatory requirements as set out by the SAHPRA. In terms of South African Regulations Schedule 1 and Schedule 2 medicines are available without prescription, but only from a pharmacist. They are referred to as “over the counter medicines” (OTC).
In the case of health supplements and complementary medicines which contain scheduled substances, it becomes an allopathic medicine which falls into the above categories. In this instance, when considering health supplements and complementary medicines, most will be schedule 0, or has the potential to fall into a category which will be in the general market but has not yet been determined.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Schedule 0 medicines are available at supermarkets and other retail outlets and do not require the involvement of a pharmacist or other professional at all. These medicines may be sold by anyone and to anyone – which is why they are referred to as “over-the-counter” medicines. They must still be manufactured under controlled conditions in accordance with the Good Manufacturing Practice standards of the SAHPRA.
Schedule 1 medicines are made available only from pharmacies and may be sold only by a pharmacist or a pharmacist intern or pharmacist’s assistant under the supervision of a pharmacist. This Schedule medication should not be on an open shelf in a pharmacy.
Schedule 2 medication can be bought without a prescription from a medical practitioner and is considered within the South African context to be “pharmacist prescription medicines”. Only someone entitled to sell these medications (such as a pharmacist or a holder of a dispensing licence) may own Schedule 2 medicines for the purpose of sale.
6. What health, advertising, and marketing claims may be made for OTC products?
It is important that the presentation of OTC products must not be misleading or confusing as to the content of the content and proper use of the medicines. For purposes of making clear statements, the information provided must always include the correct information regarding which ingredients, components or characteristics the OTC product has. The name of the product must not be the same as the name applied to other products that are already supplied in South Africa. In addition to last mentioned, the label of the product must declare the presence of a therapeutically active ingredient and the presentation of the product must always indicate safe use of the product. The purpose and intended use of the product must always be explained to an extent which the consumer/patient/end-user will understand.
Generally, advertisements must not be misleading or disparaging (whether done directly or by implication) and claims and comparisons must be fair, balanced, objective, accurate, unambiguous and supportable – in this regard it is important that the advertisement is based on up-to-date reflections of evidence evaluated, and such evidence must be reflected clearly. Use of any terminology (medical or related) is not unacceptable; the consumer must just not be misled or confused by its inclusion.
7. Can OTC products be marketed or advertised directly to the public?
Only if the OTC product is registered as a Schedule 0 medications in terms of the Medicines Act.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Prescription-only medication will only be able to be converted to an OTC product if the composition of the medicine is changed to the extent that it becomes a Schedule 0, Schedule 1 or Schedule 2 medicine – which is available without prescription.
It must be remembered that a distinction is made between a Medicinal substance and a Medicinal product whereby last mentioned is known by both their proprietary (brand name) and by the non-proprietary (generic, scientific or “approved”) names of their active ingredients. Medicinal products are per sé not listed in the Schedules to the Medicines Act.
The Scheduling status of medicinal products depends upon the Scheduling status of their active ingredients. Thus, if the prescription-only product contains any active ingredient which falls within a Schedule 3 to Schedule 6 medicine, it will not be able to be converted to an OTC product. Such mechanism is not available under these circumstances.
9. What are the requirements for the importation of either traditional medicines or OTC products?
A licence to Import/Export medicines is required in order for any medication to enter or exit the country. This is set out in Section 22C (1) (b) of the Medicines Act and includes the requirement that an application must be made in the prescribed manner. No person is allowed to import or export any medicine unless they are the holder of a licence as contemplated in the above-mentioned Section of the Medicines Act.
The relevant licence to Import or Export medicines will be issued by the Regulator after due application and such a licence will be valid for a period of five (5) years from the date of issue.
Since traditional medicines and OTC products are also regulated under complementary medicines, they must be imported as per the requirements contained in the Medicines Act and as set out in the guidelines of the SAHPRA.