| Summary: | The enactment of Undang-undang No. 36 Tahun 2009 (UUK) is the legal basis for drug
consumers. The existence of the UUK can be expected that people taking the qualified drugs.
Additionally, there is Undang-undang No. 8 Tahun 1999 which regulates the rights of
consumers. The role of the Indonesian government through the BPOM is expected to make
efforts on controlling the distribution and the usage of drugs that can ensure that people
administrating the qualified drugs. This study aimed to determine the implementation of the
legal protection of consumer by BPOM through the production and distribution process of
drugs as well as supervision and efforts to prevent the marketing of counterfeit drugs in
Daerah Istimewa Yogyakarta.
This study was juridical normative and empirical literature with a combination of literature
and field research. The data was taken from the facts, related documents and legislation. Data
collection was done by field researching, interviewing and literature studying based on
obtained research data directly at BBPOM Yogyakarta and Lembaga Konsumen Yogyakarta.
The legal protection of counterfeit drugs has been accommodated by the UUPK. Besides
UUPK, Undang-undang Kesehatan also plays a role in protecting consumers of counterfeit
drugs. This legal protection process was conducted by the BPOM which is started with the
licensing process on drugs at the registration to post marketing process through the
surveillance phase of drug registration, consumer information, and the stage of examination
and investigation. Periodic determination of active substances through cooperation with
related laboratory needed to ensure that consumers get qualified drugs. In addition,
supervision is also necessary, especially unprescribed drugs in ilegal distribution fasilities as
a source of the circulation of counterfeit drugs and is followed up with appropriate legal
action.
Keywords : Legal Protection, Counterfeit Drugs, The Role of BPOM, DIY
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