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Efforts to improve the health of the highest in the beginning of efforts to cure the disease by consuming drugs at the production well and responsibly. Drugs are the ingredients or substances derived from plants, animals, minerals and certain chemicals that can be used to reduce pain, slow the disease process and or cure disease. When this has been rife in the community circulating counterfeit drug products so that people are very disadvantaged. So far, counterfeit drugs are widely consumed drugs, both generic and patented drugs. In fact, drug-free, such as cold medicines and headache medicine to cure Erectile Dysfunction was subjected to fake a drug syndicate. Impact can be felt by the public from consuming counterfeit medicines is threatened health and safety can lead to death. So what form of business responsibility of drug products that harm consumers and how remedies for consumers who have been harmed. This research is a normative legal research is descriptive analysis, the study looking at a picture and description of circumstances or facts about the responsibility of the business of drug products that harm consumers, then the picture is analyzed based on legislation, legal theories that had to do substantively aimed at finding and getting answers from legal issues to be discussed. Business responsibility arises because of the relationship between producers and consumers. Business actors may be subject to liability if the goods purchased by consumers are suffering losses, the product was defective and dangerous, and the danger incurred but previously unknown product liability law as part of its own. The basis for product liability lawsuit can be made on the basis of breach of warranty, negligence and strict liability. Business responsibility for drug products that harm consumers should immediately withdraw the products and do not distribute medicine or traded again to consumers and soon returns to the drug processing companies, and other responsibilities of the business of drug products that harm consumers is to replace all the losses experienced by consumers, provided that the consumer can prove that indeed there is an error on medicinal products issued by the business through no fault of the consumers themselves. relating to information to be provided for a drug product contained on the label or leaflet should be able to provide an opportunity for consumers to decide whether or not drug use. But often the information provided is leading to more economic gains alone, without any explanation as side effects from the use of the drug product, if the circumstances are very detrimental to consumers as users of the drug product is to be done by the consumer is reported in the relevant agencies, such as POM institution and Consumer Protection Agency and local authorities
Kata kunci: tanggungjawab, pelaku usaha, obat, perlindungan konsumen