BPOM: Pharmacy Industry Also Responsible for Drug Safety Assurance

TEMPO.CO, Jakarta - The Food and Drug Supervisory Agency (BPOM) head Penny Lukito said the drug quality and safety system is not only the sole responsibility of her agency but also the pharmaceutical industry.

“Industry has the obligation to control quality from incoming materials to production. If they don't do it, then they must be held accountable,” said Penny in a press conference held virtually on Thursday, October 27, 2022.

The BPOM, Penny explained, has a role in setting standards and conducting supervision. She also claimed that her agency has built a strong system and in fact, drug control is stricter than food and cosmetic products supervision.

Thus, regarding the alleged drug contamination which is suspected to cause acute kidney injury in children, she asserted that the responsibility also rests with the drug producers. Moreover, the agency found that there are manufacturers whose medicinal products contain very high levels of contaminants.

The BPOM is also preparing administrative sanctions, such as permit revocation or even taking the case to the police if there is an intention.

Penny further emphasized that BPOM had carried out its duties and would tighten supervision of the pharmaceutical industry, especially related to quality control of raw materials for drugs.

“We will tighten the industry's obligation to observe quality control. The industry may scream, but we will do it because trust is not only proven but there must be inspections,” she said.

RIRI RAHAYU

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