Legal Regulations Related To Medicinal Products And Capsule Shells In Indonesia
Keywords:
Regulation, Medicinal product, capsule shellAbstract
A topic of significant concern in the pharmaceutical industry, legal regulation plays a crucial role in overseeing and controlling the production, distribution, and consumption of medicinal products, including capsule shells used as packaging materials. By exploring this aspect, it is hoped to provide a deeper understanding of how the rule of law influences and shapes the sector. As such, this paper will present a comprehensive and informative analysis of the legal regulations applicable in Indonesia in relation to medicinal products and capsule shells. One of the good and responsive laws and regulations in the health sector is one that fulfills the sense of justice and expectations of the community. This research is a normative legal research where normative legal research takes data with a statutory approach, looks for the meaning and source of value of the law, only legal concepts are used and the steps taken are normative steps". The statute approach in legal research is used to observe the results of human behavior. To make regulations derived from the Health Act, various parties affected by this Act need to participate because the regulations derived from the law will be more practical. The initial phase and is expected to look at the Health Law, because, this Law is an OBL Law, which can run well if we understand not only laws related to certain fields but also related to funding, human resources, and other aspects In order to implement Food and Drug supervision, strong regulations are needed, as a non-ministerial government agency that has technical duties, not only technical regulations must be fulfilled, but administrative and strategic regulations are needed. Food and Drug Supervision is a government task that cannot be done alone, and in practice it requires cooperation with many related sectors, both government and private.Meanwhile, the capsule shell as part of a drug instrument where the capsule shell is used as a drug container is an innovation that helps in the effective administration and use of drugs. The capsule shell can protect the drug content from damage, facilitate dose measurement, and extend the shelf life of the drug. Therefore, the regulations and related instruments must be supported and run in tandem in order to create a sense of justice, comfort and order regarding legal arrangements in the health sector.
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