Perlindungan Hukum Terhadap Masyarakat dari Konsumsi Obat Mengandung NDMA di Kota Semarang

Abstract

September 13, 2019, the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) issued a warning through the official FDA website, that contaminants were found that were thought to trigger cancer. It is known that the contamination is an impurity or nitrosamine compound or commonly called N-Nitrosodimethylamine (NDMA) which is included in chemical contamination originating from chemical elements or compounds that can endanger human health. Symptoms that appear are the skin and the whites of the eyes turning yellow, fatigue, darker urine, and abdominal pain. Based on this, there is a problem that needs to be analyzed, namely how the law protects consumers from consuming these materials, especially in the city of Semarang, are there any obstacles in the effort to protect consumers from consuming drugs containing NDMA.

The methodology used in this research is juridical normative with secondary data, which is analyzed by analytical descriptive.

The results of the analysis, it is known that the state through various provisions has protected consumers from consuming hazardous materials, including those in Article 8 "Regarding actions that are prohibited for business actors; Law Number 36 of 2009 concerning Health Articles 98, 99, 104 & 106 "Regarding the Security and Use of Pharmaceutical Preparations and Medical Devices" AND Regulation of the Minister of Health of the Republic of Indonesia 101 / MENKES / PER / XI / 2008 concerning Drug Registration. That in this protection effort, the government c.q BPOM is experiencing internal and external obstacles. Internal constraints, namely limited human resources and still low external business actors to meet the requirements for good production methods, with relatively low legal sanctions.

Keywords: Consumer Protection, NDMA Drugs, BPOM