In Act No. 17 of 2023, the state clearly guarantees each citizen's right to have a good, healthy, and prosperous life from the inside. Therefore, to avoid harming countries, a transformation of health would be required to achieve a rise in public health. Additionally, Act No. 17 of 2023 concerning Health explains that good public health development creates self-reliance, encourages national health industries at regional and global levels, and promotes improved safety, quality, and affordable service to communities in improving quality of life.

Apart from that, the government's efforts to advance the level of public health care include providing facilities to buy medicine, namely pharmacies (Sholehah et al., 2020). Each pharmacy is run by pharmacy graduates who already have a license and have undertaken professional education. In addition, the medicines being traded are medicines that have obtained a distribution permit. Several hard drugs are sold if the buyer has received a prescription from a doctor. Medicine is defined as a substance used to reduce the pain experienced by humans, animals, and plants. Medicine is one of the efforts to improve health status. If there is no medicine, humans will continue to experience pain, resulting in humans not living their lives productively.

According to the Republic of Indonesia Minister of Health Regulation Number 949/Menkes/Per/III/2020 concerning Drug Registration, drugs are classified into several groups. First, over-the-counter drugs are drugs that can be consumed without a doctor's prescription. This drug is usually used to treat mild symptoms of the disease. The drug has a sign, namely a green circle with a black border, meaning that it is the safest drug that can be purchased freely. Examples of them are vitamins or multivitamins (Nachrawi & Dewi, 2021). Second is limited drugs, namely drugs that can be purchased in certain quantities at pharmacies without a doctor's prescription. The markings on the drug are limited to a blue circle with a black border. Examples of these drugs are hangover medicine (Antimo) and anti-flu (noza). Limited medicines can be consumed without a doctor's prescription if the illness is mild, but if the illness is serious, it is recommended to see a doctor (Riyanti & Emelia, 2021).

The third is hard drugs, which are drugs with great medicinal properties. To get hard medicine, buyers have to get a doctor's prescription (Irawansyah et al., 2022). The sign of Ferry Irawan Febriansyah et.al hard drugs is a red circle with a black border with the letter K written inside. Drugs included in hard drugs are antibiotics (penicillin, tetracycline, and others). Aside from that, they include drugs containing hormones (tranquilizers, diabetes meds, and others). Hard drugs cannot be consumed carelessly, as they can cause harm, poison the body, and even worsen disease and result in death (Nachrawi & Dewi, 2021). The fourth is psychotropic or narcotic, and this drug causes addiction (Dwi, 2023). Therefore, the use of this drug is strictly monitored by the government and can only be dispensed by pharmacies with a doctor's prescription. Pharmacies are required to report usage and sales to the government (Nachrawi & Dewi, 2021).

Furthermore, drug distribution is required to obtain a distribution permit. Marketing authorization means obtaining approval by registering a drug so that it can be distributed throughout Indonesia. Therefore, if a drug is distributed without a distribution permit, the perpetrator will receive sanctions or punishment by the provisions set by the government, namely criminal law (Samosir, 2020). Additionally, if a drug has received a distribution permit but is bought and sold without complying with procedures, the dealer will also be subject to criminal penalties. Some of these behaviors harm other people by distributing drugs without efficacy and quality, which will result in nerve damage and even death.

The legal substance of the criminal act of distributing pharmaceutical preparations that do not meet the efficacy standards or efficacy and quality standards is present in several laws, namely (Marianti et al., 2020):

a. Act No. 1 of 2023 concerning the Criminal Code

b. Act No. 8 of 1981 concerning the 2009 Criminal Procedure Code

c. Act No. 17 of 2023 concerning Health

d. Government regulation No. 30 of 2017 concerning the Supervision of Drugs and Food in the Indonesian Territory

Based on the explanation of Act No. 17 of 2023 Article 142, section 1, "Pharmaceutical preparations in the form of drugs and drug ingredients must meet the standards and requirements of the Indonesian pharmacopeia and/or other recognized standards." According to the explanation of Act No. 17 of 2023 concerning Health, Article 143, section (2), "Any person who produces and/or distributes Pharmaceutical Preparations, Medical Devices, and Household Health Supplies (PKRT) products that have obtained a business license, which is proven not to meet the requirements for safety, efficacy/benefit, and quality shall be subject to administrative sanctions in accordance with the provisions of laws and regulations in the field of business licensing". Moreover, according to the Regulation of the Minister of Health of the Republic of Indonesia Number 10101menkes/Per/Xi/2008, Article 18 section 4, the granting of a distribution permit for medicines requires the head of the agency to approve or reject the distribution permit based on recommendations provided by the National Committee for Drug Evaluation, the Committee for Evaluation of Efficacy and Safety, and the Committee for Evaluation of Quality, Technology, Labeling and Rationale for Medicines, which reports marketing permits to the Minister once a year. The distribution permit is valid for five years and can be extended as long as the applicable provisions are met (Kesehatan, 2008).

The Indonesian Food and Drug Authority is an institution that monitors or supervises the circulation of medicines and food in Indonesia (Hartanto & Wilda Meutia Syafiina, 2021). The supervision carried out by the Indonesian Food and Drug Authority on food and medicine should be very effective and efficient because this agency can detect, monitor, and prevent a product by protecting the health of consumers both abroad and domestically (Yusuf Dm et al., 2023). However, today's drug distribution cannot be controlled. Many drugs that do not have distribution permits are distributed freely, with the risk of endangering users (Gondokusuma & Amir, 2021). Medicines in circulation must have a distribution permit, and business actors or pharmacies are required to obtain a distribution permit and business permit. If there is a drug that does not have a distribution permit but is consumed or misused without a doctor's prescription at an unclear dosage, it will result in the risk of disability and even death. Apart from medicines that must have a distribution permit, every pharmacy or drug distribution business must also obtain a permit according to the laws and regulations in Indonesia (Marianti et al., 2020).

The enactment of Act No. 17 of 2023 concerning Health is a consideration in the imposition of criminal sanctions for the distribution of drugs without a distribution permit by the judge. Sanctions have been regulated in Article 435 of the Health Law, which states that "Any person who produces or distributes pharmaceutical preparations and/or medical devices that do not meet the standards and/or requirements for safety, efficacy/benefit, and quality as referred to in Article 138 sections (2) and (3) shall be punished with imprisonment for a maximum of 12 (twelve) years or a maximum fine of IDR 5,000,000,000.00 (five billion rupiah) (Pemerintah, 2023). In addition to the regulations above, every community has the right to be protected, which is regulated in Act Number 8 of 1999 (Nugroho, 2020). Article 8, section 1 point a of Act Number 8 of 1999 concerning Consumer Protection states that business actors are prohibited from producing or distributing drugs that do not meet the applicable standards in statutory regulations. Inappropriate medicines include counterfeit medicines. With the above regulations, consumers have the right to obtain protection from the distribution of drugs that do not comply with the provisions.

The above legal materials are taken into consideration by judges when imposing sanctions on drug dealers without distribution permits or drug dealers who do not comply with the efficacy and quality standards. With these legal materials, people will be deterred and not do these dangerous things. If the distribution of medicines is carried out based on their efficacy and quality, health in Indonesia will improve and have a good impact on national development.

Ratio decidendi for distributors of pharmaceutical preparations who do not meet the standards of efficacy, usefulness, and quality, as revealed in the Ponorogo District Court Decision Case Study Number 115/Pid.Sus/2023/PN Png illustrates the complexity of the legal aspects involved in responding to violations in the pharmaceutical sector.

Pharmaceutical law is a legal framework that regulates all aspects related to the production, distribution, and sale of pharmaceutical preparations. This legal basis has the main aim of protecting the public from the risks of using pharmaceutical products that do not meet established health standards. Thus, pharmaceutical regulations form a crucial basis for maintaining the integrity and safety of health products consumed by the public (Novita et al., 2023). Pharmaceutical regulations also play an important role in ensuring that innovation in the pharmaceutical industry can occur safely. By setting clear standards and monitoring industry compliance, pharmaceutical law helps create an environment that supports the development of innovative and effective new drugs.

Violations of efficacy standards can take many forms, ranging from significant discrepancies between efficacy claims and research results to a lack of sufficient scientific evidence to support the declared therapeutic effect. In some cases, these violations can have a serious impact on public health, especially if the product is used to treat a serious medical condition. Additionally, the evaluation of violations of efficacy standards involves an examination of recommended dosages and product safety. Efficacy standards also include dosage parameters that ensure that the use of pharmaceutical preparations does not produce undesirable or even harmful side effects. Violation of the recommended dosage may result in the risk of overdose or lack of therapeutic effect, both of which may endanger the patient's health.

The importance of evaluating violations of efficacy standards is also related to understanding drug interactions. This standard includes an assessment of whether a pharmaceutical preparation can be used safely in conjunction with other medicines that the patient may be taking. Violation of this aspect can trigger adverse reactions or affect the effectiveness of other drugs used by the patient (Afianto & Qona’ah, 2020). Furthermore, analysis of violations of efficacy standards requires an in-depth understanding of the clinical research process and methodology used to prove a product's therapeutic effects. A discrepancy between efficacy claims and research design or insufficient research results can raise doubts about the accuracy of the information provided to the public. Maintaining efficacy standards is vital, not only for manufacturers' compliance with regulations but also for consumer protection. By guaranteeing that pharmaceutical preparations meet established efficacy standards, it can be ensured that people consume the product with confidence in the therapeutic benefits that the manufacturer claims.

Assessment of violations of efficacy standards is an essential step in maintaining the integrity and safety of pharmaceutical products. By involving aspects such as the consistency of efficacy claims, recommended dosages, product safety, drug interactions, and the quality of clinical research, this analysis helps safeguard public health. It ensures that the use of pharmaceutical preparations provides the expected therapeutic benefits. Analysis of violations of the benefits and quality of pharmaceutical products requires a thorough understanding of Ferry Irawan Febriansyah et.al several critical aspects, including the sustainability of the product and the quality of the raw materials used. Evaluation of this aspect aims not only to ensure that pharmaceutical products meet established quality standards but also to identify potential negative impacts that they can cause.

The sustainability of pharmaceutical products is also an important aspect to consider in the analysis of benefits and quality violations. This involves assessing the product's durability and stability throughout its expected lifetime. Violations of sustainability may include a decline in product quality over time, changes in formulation without adequate notification to consumers, or even the inability of the product to maintain its therapeutic effects. In the case of these violations, the risks facing society include uncertainty about the effectiveness of treatment and the potential for unexpected side effects. Furthermore, violations of the usefulness and quality aspects of pharmaceutical products may be related to counterfeiting or illegal duplication. These practices may include the use of unauthorized raw materials, production in facilities that do not meet standards, or distribution of counterfeit products. The impact of counterfeiting is not only detrimental to consumers by providing products that do not match their efficacy claims but can also endanger public health as a whole. (Hot et al., 2023)

The importance of preventing violations of the benefits and quality of pharmaceutical products is not only regulatory but also humanitarian by ensuring that pharmaceutical products provide the expected therapeutic benefits and meet established quality standards, unnecessary health risks can be avoided, and consumer confidence in the pharmaceutical industry is maintained.(Nurrohmah & Hufron, 2023)

In the era of globalization, international cooperation in monitoring and preventing these violations is becoming increasingly critical. Collaboration between countries can strengthen the global monitoring system and ensure that pharmaceutical products circulating on the international market meet universally recognized standards of efficacy and quality. Analysis of violations of the benefits and quality of pharmaceutical products requires a holistic approach that includes evaluation of product sustainability, quality of raw materials, production processes, and efforts to prevent counterfeiting. By paying attention to all these aspects, it can be guaranteed that pharmaceutical products on the market truly provide the desired therapeutic benefits, meet strict quality standards, and protect public health as a whole.

Specifically, Ponorogo District Court (PN) decisions have a crucial role in the legal system, and understanding the ratio decidendi when analyzing this case is essential. The ratio decidendi, or the basis of the court's considerations in making a decision, forms the legal basis, which can then become a guide for similar cases in the future. In detailing the ratio decidendi of the Ponorogo District Court decision, it is important to pay attention to the reasons explained by the court when making the decision. Factors such as the evidence presented, legal interpretation, and ethical considerations often form an integral part of the ratio decidendi.

First, the court will usually evaluate the evidence presented by both parties at trial. Analysis of the validity and relevance of this evidence is a crucial part of the ratio decidendi. The court will consider whether the evidence is sufficient to support the claims or defenses put forward by the parties to the dispute. Mistakes in assessing evidence can be the basis for overturning a decision or appealing it. Furthermore, legal interpretation becomes a key element in the ratio decidendi (Sumawan & Saravistha, 2023). The court will evaluate the legal arguments submitted by the parties to the dispute and align them with applicable law. Careful interpretation of legal regulations and norms is the basis for forming court decisions. The ratio decidendi will detail how existing law is applied to the facts presented in a particular case.

Ethical considerations can also be an element that influences the ratio decidendi. Courts often have to consider the moral and ethical values involved in the case. This may include consideration of the justice, truth, and social impact of decisions taken. The court will explain how these ethical considerations played a role in shaping the decision and how the decision can reflect the value of justice. Jurisprudence or legal policies that develop from previous decisions are also an important part of the ratio decidendi. The Ponorogo District Court's decision can create a legal precedent that will serve as a guide or reference for similar cases in the future. The court will detail how this ruling aligns with or may provide guidance for the decision in the broader legal context.

Therefore, the ratio decidendi will reflect the court's efforts to achieve balanced justice and ensure legal certainty. In preparing the ratio decidendi, the court may also consider other aspects, such as public interests, principles of procedural law, and norms developing in Ferry Irawan Febriansyah et.al society. A careful and detailed ratio decidendi will provide a solid foundation for future courts in handling similar cases. Thus, an in-depth understanding of the ratio decidendi in the Ponorogo District Court decision is important not only for the parties to the dispute but also for legal practitioners, academics, and policymakers to understand the evolution of jurisprudence and provide direction for future legal developments. This decision not only reflects law enforcement at the local level but can also shape the direction of legal policy more broadly in society.

Consumer protection in the context of pharmaceutical law receives special emphasis, recognizing consumers' rights to obtain safe and quality pharmaceutical products. Analysis in this framework includes an in-depth understanding of how the law protects consumers in the pharmaceutical industry, as well as the policies and practices that support consumer rights. Consumer rights in pharmaceutical law further include access to clear and accurate information about products, the right to receive pharmaceutical products that meet health standards, and the right to be protected from the risks of using products that do not match their claimed efficacy. As such, analysis of consumer protection must take into account the effectiveness of regulation in ensuring that these rights are respected and applied consistently.

In addition, research on legal sanctions imposed to perpetrators of violations is essential for determining the extent to which the pharmaceutical legal system can provide a deterrence effect (Asshiddiqie, 2021). The type of sanction, whether criminal or administrative, reflects the seriousness of the violation and signals the potential consequences for the perpetrator. An in-depth analysis of these sanctions allows an assessment of the extent to which they can deter future violations and provide justice for affected consumers. In terms of consumer protection, information transparency is key. Effective regulation must ensure that consumers have access to accurate and comprehensive information about the pharmaceutical products they consume. Clear labels, easy-to-understand directions for use, and information about potential risks or side effects are integral to consumers' right to make informed and wise decisions regarding their health (Janah, 2020).

Improving the pharmaceutical regulatory system is also a pivotal aspect of this analysis. Evaluation of the ineffectiveness of existing regulations allows the identification of areas where improvements are required. This could include increased oversight of the production, distribution, and marketing processes of pharmaceutical products, as well as increased transparency in responding to detected violations (Gowasa et al., 2023). Recommendations for improving the pharmaceutical regulatory system could include strengthening cooperation between health regulatory agencies and the pharmaceutical industry, introducing more sophisticated technology for product tracking and verification, and improving consumer education about their rights and how to report violations (Sihotang et al., 2024). Additionally, it is important to consider the role of consumer education in the context of protection (Daeng et al., 2023). Increasing consumer awareness about their rights, potential risks in using pharmaceutical products, and how to report non-compliance can improve the safety and security of pharmaceutical products on the market.

A holistic analysis of consumer protection under pharmaceutical law must also involve dialogue between the government, health regulatory agencies, the pharmaceutical industry, and consumer groups. Involving all these parties in the process of improving and developing regulations can create a system that is more responsive, effective, and proactive in protecting consumer rights. To maintain the integrity of the pharmaceutical industry and protect the public, a comprehensive analysis of consumer protection, legal sanctions, and improving the regulatory system is a crucial step. This can create a solid legal foundation, support consumer confidence, and encourage the pharmaceutical industry to adhere to the highest standards in producing and distributing health products.

The Ponorogo District Court issued a decision in the case of a distributor of pharmaceutical preparations that did not meet the standards of efficacy or usefulness and quality with Decision Number 115/Pid.Sus/2023/PN Png. The defendant, in the name of BA, was proven to have sold medicines that did not meet the efficacy and quality standards to one of his neighbors. With the available evidence and witnesses, the judge stated that BA had committed a criminal offense under Article 196 of Act No. 36 of 2009concerning Health (Indonesia, 2023). The judge's decision on the sentence is based on the existing evidence, the legal interpretation used, and the ethical considerations of the accuser. By considering the three things above, the judge will decide on the charges or sanctions to be received by the defendant. The Ponorogo District Court judge's considerations will become a reference for similar cases or even for researchers or students as material for consideration or research material.

From the evidence in Decision Number 115/Pid.Sus/2023/PN Png, it has been proven that the defendant committed an unlawful act by carrying out drug sales transactions without looking at the efficacy and quality. The defendant bought the drug on the TikTok application. The defendant never received education in the pharmaceutical field. The medicines sold did not have expiration labels, the name of the medicine, and the composition of the ingredients. The drugs sold were those containing the active ingredient of trihexyphenidyl or tramadol. This kind of drug is useful for relieving moderate to severe pain, for example, in pain after surgery. If an individual takes the trihexyphenidyl drug inappropriately, it will cause him to feel more excited. Meanwhile, if he consumes too much tramadol, he will feel tired and sleepy easily, affecting his overall body condition. The above matters were taken into consideration by the judge when deciding the charges by looking at the evidence.

After considering these three things, the defendant was proven to have intentionally distributed pharmaceuticals that did not comply with efficacy and quality. This was used as material for the judge to give a decision because the defendant was proven to have violated government regulations. The judge's next consideration was the defendant's ethical considerations. During the trial, the panel of judges will consider the attitude and behavior of the defendant. The panel of judges considered that the defendant admitted that he was guilty of his behavior; the defendant asked for leniency in his sentence, which he obtained with a guarantee that the defendant promised not to repeat the act and that the defendant had never committed a crime.

As seen from the analysis above, the panel of judges considered the charges in two circumstances. The aggravating circumstance is that the defendant did not support the government's program to eradicate the young generation's use and distribution of hard drugs, which are destroying the nation's future. Meanwhile, mitigating circumstances are that the defendant admitted guilt, regretted his actions, and promised not to repeat his actions, and the defendant had never been convicted (Indonesia, 2023). By considering the mitigating and aggravating factors, the judge gave a verdict that the defendant BA deliberately distributed pharmaceutical preparations that did not meet the standards, safety requirements, efficacy, usefulness, and quality as stated in the single indictment. The judge sentenced the defendant to imprisonment for 1 (one) year and a fine of IDR 5,000,000.00 (five million rupiah) with the provision that if the fine were not paid, it would be replaced by imprisonment for one month (Indonesia, 2023).

Hopefully, the above court decision will have a deterrent effect on perpetrators, and the public will be more careful. With cases of pharmaceutical distribution that do not match the efficacy and quality, it is expected that the government will review products, quality, raw materials, production processes, and efforts to prevent counterfeiting. In addition, with the existence of online transactions, people prefer to buy online without looking at the efficacy and quality of the drug. Therefore, the government should pay more attention to pharmaceutical distribution in Indonesia.

Fundamentally, cases where pharmaceutical distribution does not match the efficacy and quality violate consumer rights, resulting in more serious illnesses, organ damage, and even death. The government, thus, should pay more attention to consumer rights, which must be fulfilled. People should be more careful when purchasing medicines, and the Indonesian Food and Drug Authority should educate the public about pharmaceuticals, especially for people in rural areas or underprivileged people.