Minister of Industry (Menperin) Agus Gumiwang said that his party encourages the pharmaceutical industry to always support public health by providing safe, efficacious, and quality medicinal products.
According to him, this step follows up on President Joko Widodo's (Jokowi) directives regarding the supervision of drug production, particularly related to the incidence of Ethilen glycol (EG) and Dietilen glykol (DEG) contamination which exceeded the threshold onemphetamine.
"In this case, we are working with the Food and Drug Supervisory Agency (BPOM), the Ministry of Health, and the entire pharmaceutical industry to jointly ensure the quality of drugs applies to all products, from raw materials to finished products, in accordance with applicable regulations," he said in a press statement on Wednesday, October 26.
The Minister of Industry explained that the pharmaceutical industry must use raw materials in accordance with regulations and carry out regular monitoring and evaluations, both together with the POM and independent testing.
"So that the products that are distributed, the quality and quality are guaranteed and safe for consumption by the community," he stressed.
To ensure the safety of medicinal products, the Ministry of Industry asked the company to conduct laboratory tests on critical parameters such as the sprinkling requirements for the medicinal raw materials used.
"We also ensure that the company implements a quality management system in the pharmaceutical industry to ensure that the products produced meet quality and safety requirements in accordance with applicable regulations," he said.
It is stated that this aims to explore all risk factors that cause kidney failure, both from drug sources and other potential causes.
Until now, the Ministry of Industry claims to have coordinated directly by visiting several production facilities to ensure that the facilities owned by industrial companies meet the requirements for Good Manufacturing Practices (CPOB), as well as being registered and having an Edar Permit Number (NIE).
"Checks on production facilities are carried out to ensure that the industry does not use EG and DEG as additional raw materials in drug sirops," he said.
The Ministry of Industry ensures that the industry stops the production, distribution and recall process of all product batches based on the test results allegedly containing EG/DEG contamination above the threshold.
"Industri has quarantined all drug sirop products as well as raw materials for PEG, PG, sorbitol, and glycerin/glicerol in warehouses at production facilities," he said.
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