dc.description.abstract | Business activities carried out by business actors in producing a product
can be in the form of goods and/or services that can provide a sense of security,
comfort, safety and do not pose a danger to consumer health. Products produced
and traded by business actors must meet quality standards, provide correct,
honest and clear information about products produced and traded after going
through tests and inspections by BPOM. But in fact, one of the children's syrup
drugs produced by PT. AFPI, which is traded freely in the market, was found to
contain dangerous ingredients, namely Ethylene Glycol (EG) and Diethylene
Glycol (DEG) which threaten the health and safety of consumers. The objectives
to be achieved in this study are to know and understand consumer protection for
the use of syrup drugs containing the dangerous ingredients Ethylene Glycol (EG)
and Diethylene Glycol (DEG), To know and understand the legal responsibilities
of drug manufacturers containing the dangerous ingredients Ethylene Glycol
(EG). ) and Diethylene Glycol (DEG) which are detrimental to consumer health,
and to know and understand efforts to resolve disputes against losses experienced
by consumers due to consuming syrup containing Ethylene Glycol (EG) and
Diethylene Glycol (DEG) In this thesis, the writer uses normative juridical
method. The approach used is the Statute Approach and conceptual approach.
The author uses 2 (two) legal materials, namely primary legal materials and
secondary legal materials. Meanwhile, in the analysis of legal materials, the
author uses the deductive method, namely identifying problems in general and
then linking them to specific matters.
The results of the research that can be described are First, consumer
protection as a concrete aspect in fulfilling the rights of consumers must be
fulfilled by all parties by guaranteeing and paying attention to aspects of health,
comfort, security, and consumer safety as a form of consumer law protection
goals. This is important, because the use of the drug aquo syrup is known to
threaten the health and safety of consumers with several assessments and
considering the dangers of using chemicals such as Ethylene Glycol (EG) and
Diethylene Glycol (DEG) which exceed safe levels can result in symptoms of
poisoning and kidney disorders. even to death. Therefore, for losses from the use
of syrup containing hazardous ingredients, consumers will receive compensation,
compensation funds or reimbursement based on UUPK. Second, the responsibility
of BPOM and business actors as 2 (parties) are important in the process of
distributing syrup drugs containing the Dangerous Materials Ethylene Glycol
(EG) and Diethylene Glycol (DEG) is legal responsibility for the losses and
suffering of consumers in consuming the syrup. BPOM's responsibilities for drugs
containing various ingredients ethylene glycol and diethylene glycol (DEG)
include BPOM's responsibility in terms of drug and food control, BPOM's
responsibility in granting distribution permits and BPOM's responsibility in
providing legal advocacy. In addition to BPOM as an institution that has duties
and authorities in relation to drug and food control. Business actors in this case
as syrup drug producers have legal responsibility as stipulated in Article 8
paragraph (1) letter (a). Third, efforts to resolve consumer disputes as a result of
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consuming syrup containing ethylene glycol (EG) and diethylene glycol (DEG)
which result in acute kidney failure are revoked.
Circulation by the Government of the syrup drug producer. On the other hand,
BPOM as an institution that has the authority to resolve this problem is by
seeking to revoke the distribution permit for producers of this dangerous syrup
drug as stipulated in the Health Law article 106 paragraph 3
The conclusions that can be given are First, Consumer legal protection for
the use of syrup containing dangerous EG and diet ingredients must obtain legal
certainty because it results in a threat to consumer safety if consumed because it
contains the chemicals Ethylene Glycol (EG) and Diethylene Glycol (DEG) which
result in Symptoms of poisoning include causing disturbances of the nervous
system. Second, BPOM's responsibility in terms of drug and food control,
BPOM's responsibility in granting distribution permits and BPOM's responsibility
in providing legal advocacy. In addition to BPOM as an institution that has duties
and authorities in relation to drug and food control. Business actors in this case
as syrup drug producers have legal responsibility as stipulated in Article 8
paragraph (1) letter (a). Third, legal settlement efforts for consumer disputes as a
result of consuming syrup containing ethylene glycol (EG) and diethylene glycol
(DEG) which result in acute kidney failure can be carried out through litigation
and/or non-litigation. BPOM as a government agency that has duties and
authorities in terms of drug and food control strengthens the supervisory function
before issuing distribution permits to products that threaten the health and safety
of consumers by coordinating with the Ministry of Health, the Ministry of Industry
and the Ministry of Trade. Second, business actors as syrup producers should
uphold the principle of good faith in carrying out business activities by not using
a mixture of drug ingredients that are harmful to consumer health, according to
drug quality standards, through BPOM inspection tests. Third, consumers should
read carefully, carefully what is written on the drug label, and look at the BPOM
website to see if the drug has been registered. If the public knows about
counterfeit drugs, it is dangerous for consumers to report them to the government,
in this case BPOM, Ministry of Health, Ministry of Industry and Ministry of Trade | en_US |