2. Product Categories

Ingredients Regulation Overview for Ingredient Manufacturers
Indonesia

This section provides the regulatory definition of the ingredients' categories in scope.

2.1 Pharmaceutical Product

Drug means a finished product including a Biological Product, which is a substance or combination of substances used to affect or investigate the physiological system or state of pathology in order to establish diagnosis, prevention, treatment, recovery, and improvement of health, and contraception for humans.

New Drug means a Drug with a New Chemical Entity, new dosage form, new strength, or new combination that has never been approved in Indonesia.

Generic Drug means a drug with a name according to International Nonproprietary Names Modified determined by the World Health Organization or the name specified in the national health program.

Branded Generic Drug is a Drug with trade names containing Active Pharmaceutical Ingredients with the same Composition, strength, dosage form, route of administration, indications, and posology with originator drugs that have been approved in Indonesia.

2.2 Health Supplement

A food supplement is “a product that is meant to complement the nutritional need, maintain, increase and improve health function, containing one or more ingredients in the form of vitamin, mineral, amino acid or other ingredient (originating from plant or non-plant) that have nutritional value and/or physiological effect, not intended as food.”

Food supplements must also meet the following criteria:

• Use materials that meet quality standards and safety requirements as well as other prescribed standards and requirements.
• Have benefits that are assessed from the composition and/or supported by the evidential data.
• Produced by applying the Proper Production Methods.
• Labeling that must mention complete, objective, correct, and non-misleading information.
• Be in the form of a pill, tablet, capsule, powder, granule, semi-solid, or liquid preparation that is not purposed for food.

2.3 Veterinary Drugs

Veterinary medicines according to their intended use are used for: 

1. Determining the diagnosis, preventing, curing, and eradicating animal diseases
2. Reducing and eliminating symptoms of animal diseases
3. Helping soothe, numbing, euthanizing, and stimulating animals
4. Eliminating abnormalities or beautifying the bodies of the animals
5. Improving the quality and production of animal products
6. Improving animal reproduction

There are four types of veterinary medicines:

1. Biological preparations: manufactured through a biological process in animals or animal tissues to cause immunity, diagnose diseases, or cure diseases with an immunological process.
2. Pharmaceutical preparations: produced through non-biological processes containing ingredients such as vitamins, hormones, enzymes, and antibiotics.
3. Premix preparations: preparations containing veterinary medicine materials processed into a Feed Additive or Feed Supplement, which is mixed into animal feed or drinking water.
4. Natural medicines: containing natural ingredients such as plant or animal materials which are used as veterinary medicines. 

These are further classified into Hard Medicines, Limited Over-the-Counter medicines, and Over-the-Counter medicines based on their level of hazard to the animal and/or human consuming the animal. 

2.4 References

1. Regulation of the Chairperson of the Indonesian Food and Drug Authority of the Republic of Indonesia Number 24 of 2017 on Criteria and Procedures for Drug Regulation

https://peraturan.go.id/files2/peraturan-bpom-no-24-tahun-2017_terjemah.pdf

2. Regulation of the Drug and Food Control Agency Number 32 of 2022 on Criteria and Procedure for Health Supplement Registration 

3. Government Regulation of the Republic of Indonesia No. 78 of 1992 Concerning Veterinary Medicines

https://ditjenpkh.pertanian.go.id/uploads/download/4476da77f653c2bf6501602421291809.pdf

4. Regulation of the Minister of Agriculture of the Republic of Indonesia No. 14/Permentan/PK.350/5/2017 Concerning Classification of Veterinary Medicines

https://ditjenpkh.pertanian.go.id/uploads/download/345ff324b6018890882fe9a65dfc0ee3.pdf