RA 6675: Generics Act of 1988 Philippines

RA 6675: "Generics Act of 1988"

• Signed on September 13, 1988, to promote, require, and ensure the production, distribution, use, and acceptance of drugs and medicines identified by their generic names.

Statement of Policy

• To promote the use of generic terminology in the importation, manufacture, distribution, marketing, advertising, and promotion of drugs.
• To ensure the adequate supply of drugs with generic names at the lowest possible cost and make them available for free to indigent patients.
• To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution.
• To emphasize the scientific basis for the use of drugs, highlighting their therapeutic effectiveness.
• To promote drug safety by minimizing duplication in medications and potential adverse drug interactions.

Definition of Terms

• Essential Drug List/National Drug Formulary: A list of drugs prepared and periodically updated by the DOH based on health conditions in the Philippines.
• Core List: A list of drugs that meet the health care needs of the majority of the population, e.g., diuretics (Furosemide, HCTZ).
• Complementary List: A list of alternative drugs used when there is no response to the core essential drug or when there is a hypersensitivity reaction to the core essential drug, e.g., diuretics (Sambong, Spironolactone).
• Generic Name: Identification of drugs and medicines by their scientifically and internationally recognized name or by their official generic name as determined by BFAD.
• Chemical Name: Description of the chemical structure of the drug or medicine, serving as the complete identification of a compound.
• Brand Name: Proprietary name given by the manufacturer to distinguish its products from those of competitors.

The Use of Generic Terminology

• All government health agencies, medical, dental, and veterinary practitioners, and organizations involved in the manufacture, importation, and distribution of drugs and medicines shall use generic terminology.
• The generic name of the product shall be prominently indicated on the label.

Required Production

• Every drug manufacturing company operating in the Philippines shall produce, distribute, and make available an unbranded generic counterpart of their branded products.

Authority to Import

• The DOH is authorized to import raw materials (RMs) during periods of critical shortage and absolute necessity, to be marketed and sold exclusively under generic nomenclature.