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The State of Medicine Quality in the Mekong Sub-Region

 | 
Sauwakon Ratanawijitrasin
, 
Souly Phanouvong

Annex I. Legal Definitions of Medicines from the Quality Perspective-by country

Texte intégral

Category/country

WHO

Cambodia

Lao PDR

Name of law in year of enactment

The 1996 Law on the Management of Pharmaceuticals

Law on Drugs and Medical Products promulgated in 2000

Substandard

Substandard medicines are products of which the composition and ingredients do not meet the correct scientific specifications and that are consequently ineffective and often dangerous to the patient. Substandard products may occur as a result of negligence, human error, insufficient human and financial resources or counterfeiting.

A substandard drug is defined as a registered product of which the specifications are out of defined pharmacopoeias or accepted standards.

A substandard drug is termed in this law as a “non-standard” drug, and is defined as any modern or traditional medicine, the composition of which is inconsistent with the drug’s registered formula.

1This Annex provides brief descriptions of legal definitions related to medicine quality, with special focus on substandard and counterfeit medicines, in the five countries—Cambodia, China, Lao PDR, Thailand and Vietnam.

Thailand

Vietnam

Yunnan of China

Drug Act of 1967 (BE 2510)

Pharmaceutical Law was adopted in 2005

The Drug Administration Law of the People’s Republic of China, revised in 2001

A sub-standard drug as a drug:
(1) which was not produced in accordance with standard such that the product contains the active ingredient in quantity or strength is lower than the minimum or higher than the maximum amount registered, but to a degree less than that stated in Article 73
(2) which is produced such that the purity and other characteristics which are deemed important to its quality deviate from the criteria specified in the registered formula or the formula modified according to the Minister’s order.

A substandard drug as a drug that has failed to meet the quality standards registered with the competent authorities.

Any drug with content not up to the national drug standards is a substandard drug. In addition, the law specifies that any drug shall be treated as a substandard drug in any of the following cases:
(1) the date of expiry is not indicated or is altered;
(2) the batch number is not indicated or is altered;
(3) it is beyond the date of expiry;
(4) no approval is obtained for the immediate packaging material or container;
(5) colourants, preservatives, spices, flavourings or other excipients are added without authorization; or
(6) other cases where the drug standard are not conformed (Order of the President of the People’s Republic of China 2001)

2 ANNEX I - Legal Definitions of Medicines from the Quality Perspective-by country

Category/country

WHO

Cambodia

Lao PDR

Counterfeit

A counterfeit medicine is one that is “deliberately and fraudulently mislabelled with respect to identity and/or sources.” Counterfeiting can apply to both branded and generic products. These products may contain correct ingredients or wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. (WHO 2003)

as a drug:
(1) which is deliberately produced with incorrect quantity of or wrong active ingredients, or
(2) without active ingredients or an unregistered product in which the amounts of active ingredients are deliberately outside the defined pharmacopoeias or accepted standard, or
(3) which is deliberately and fraudulently mislabelled with respect to the identity source or with fake packaging
(4) which is repacked or produced by unauthorized person(s).

as any modern or traditional medicine that is a fake or is an imitation of a drug that is produced, distributed and legally registered

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Thailand

Vietnam

Yunnan of China

The definition of counterfeit or fake drug is clearly specified in the law (Article 73) as any drug or substance:
(1) which is wholly or partly an imitation of a genuine drug; or
(2) which shows the name of another drug, or an expiry date which is false; or
(3) which shows a name or mark of a producer, or the location of the producer which is false;
(4) which falsely shows that they are in accordance with a pharmaceutical preparation that has been registered; or
(5) which was not produced in accordance with standards such that the product contains the active ingredient in a quantity or strength is lower than the minimum or higher than the maximum amount registered by more than 20%.

A counterfeit drug is a product deliberately and fraudulently made in drug forms, including the followings:
(1) containing no pharmaceutical substances;
(2) containing pharmaceutical substances different from those stated on the label;
(3) counterfeiting product names, industrial designs of drugs that have been already registered by other manufacturers for industrial property protection.

A counterfeit medicine is considered as a drug in any of the following cases:
(1) the ingredients in the drug are different from those specified by the national drug standards; or
(2) a non-drug substance is simulated as a drug or one drug is simulated as another.
(3) its use is prohibited by the regulations of the drug regulatory department under the State Council;
(4) it is produced or imported without approval, or marketed without being tested, as required by this Law;
(5) it is deteriorated;
(6) it is contaminated;
(7) it is produced by using drug substances without an approval number as required by this Law; or (8) the indications or functions indicated are beyond the specified scope.

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