JAKARTA - The Ministry of Industry (Kemenperin) is collaborating with the Food and Drug Supervisory Agency (BPOM), the Ministry of Health, and the entire pharmaceutical industry to ensure the quality of all medicinal products, from raw materials to finished products to comply with applicable regulations.
This was done following up on President Joko Widodo's (Jokowi) directives regarding the supervision of drug production, particularly related to the incidents of Ethilen Flikol (EG) and Dietilen Glikol (DEG) contamination which exceeded the threshold for Merena drug.
"So that products that are distributed, quality and quality are guaranteed and safe for consumption by the public," said Minister of Industry (Menperin) Agus Gumiwang Kartasasmita in a statement in Jakarta, quoted from Antara, Wednesday, October 26.
The Ministry of Industry continues to urge the pharmaceutical industry to use raw materials in accordance with regulations and monitor and evaluate regularly, both together with BPOM and independent testing.
To ensure the safety of medicinal products, the Ministry of Industry asks companies to conduct laboratory tests on critical parameters such as the sprinkling requirements for medicinal raw materials used, in accordance with Indonesian Farmakope or other applicable quality standards.
"We also ensure that the company implements quality management systems in the pharmaceutical industry to ensure that the products produced meet the terms of quality, safety and efficiency in accordance with applicable regulations," explained the Minister of Industry.
It aims to explore all risk factors that cause kidney failure, both from drug sources and other potential causes.
Until now, he continued, the Ministry of Industry has coordinated directly by visiting several pharmaceutical industry production facilities to ensure that production facilities owned by industrial companies have met the requirements for Good Manufacturing Practices (CPOB) and registered products, and have an Circular 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 sirop,” said Acting Director General of Chemical, Pharmaceutical and Textile Industries (IKFT) of the Ministry of Industry, Ignatius Warsito.
The Ministry of Industry ensures that the industry stops the production, distribution and recall process of all products based on 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 added.
The Ministry of Industry also ensures that the industry has a special team that handles reports/subscription of its products and conducts pharmacovrowians to monitor the side effects of the drugs produced.
The English, Chinese, Japanese, Arabic, and French versions are automatically generated by the AI. So there may still be inaccuracies in translating, please always see Indonesian as our main language. (system supported by DigitalSiber.id)
