We must ensure that the quality of medicines distributed is safe for the public
Jakarta (ANTARA) - The Industry Ministry cooperates with the Food and Drug Supervisory Agency (BPOM), Health Ministry, and pharmaceutical industry to ensure the quality of medicinal products, from raw materials to finished products, to comply with applicable regulations.

This collaboration was forged in keeping with the direction of President Joko Widodo (Jokowi) regarding the supervision of drug production, particularly related to Ethylene Glycol (EG) and Diethylene Glycol (DEG) contamination that exceeded the threshold for syrup drugs.

"We must ensure that the quality of medicines distributed is safe for the public," Industry Minister Agus Gumiwang Kartasasmita stated in Jakarta, Wednesday.

Kartasasmita remarked that the ministry continued to remind the pharmaceutical industry to use raw materials in accordance with regulations and to monitor and evaluate regularly with the BPOM and independent testing.

To ensure the safety of medicinal products, the ministry urges companies to conduct laboratory tests on critical parameters, such as the requirements for contamination of raw materials used for drugs in accordance with the Indonesian Pharmacopoeia or other applicable quality standards.

"We also ensure that the company implements a quality management system in the pharmaceutical industry to ensure that the products produced meet the quality, safety, and efficacy requirements in accordance with applicable regulations," Kartasasmita added.

The efforts aim to explore all risk factors that may cause kidney failure, both from sources of drugs and other potential causes, he noted.

He noted that the Industry Ministry had coordinated directly by visiting several production facilities of the pharmaceutical industry to ensure that production facilities owned by industrial companies have met the requirements for Good Manufacturing Practices (GMP) with registered products equipped with the Marketing Permit Number (NIE).

"The visits aim to ensure that the industry does not use EG and DEG as additional raw materials in medicinal syrups," the ministry's Acting Director General of the Chemical, Pharmaceutical, and Textile Industry, Ignatius Warsito, remarked.

The ministry also ensures that the industry had stopped the process of production, distribution, and recall of all products based on test results suspected of containing EG/DEG contamination above the threshold.

"The industry has quarantined all medicinal syrup products as well as PEG, PG, sorbitol, and glycerin/glycerol raw materials that are in warehouses at production facilities," he added.

Moreover, the Industry Ministry ensures that the industry has a special team to handle customer reports and complaints about their products and conducts pharmacovigilance to monitor side effects of the drugs produced.

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Translator: Sella Panduarsa G, Resinta S
Editor: Sri Haryati
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