BPOM Reveals Indications of Drug Crimes in Indonesia's Pharmaceutical Industry

TEMPO.CO, Jakarta - The Food and Drug Supervisory Agency (BPOM) said it had identified indications of drug crime in the Indonesian pharmaceutical industry. This is related to the case of using ethylene glycol (EG) and diethylene glycol (DEG) as a solvent that exceeds the safe threshold, which had caused acute kidney injuries in hundreds of children.

"There are aspects of crime and negligence. Together we [must] close the gap to ensure that supervision can be strengthened. Let's transform our nation's pharmaceutical industry," BPOM chief Penny K Lukito said in a press conference on Thursday, November 17.

According to Penny, there are gaps or gaps in the drug safety and quality system from upstream to downstream. This is seen in the rules of importing EG and DEG, which are not included in the limited ban through BPOM's import certificate (SKI). This means that BPOM does not have the authority to supervise the imports of substances used to make drug solvents.

Penny said he has met with several related ministries and institutions to immediately categorize some medicinal raw materials as limited/restricted products through a certificate of imports. Penny promised that changes would be made soon so that BPOM could monitor the import flow of raw materials for medicines.

Penny said that the provisions for EG and DEG contamination limits in medicinal products have not been included in the Indonesian and international Pharmacopoeia standards. So there is no legal umbrella for BPOM to carry out supervision. But this will change soon.

He said that BPOM had provided input to the Ministry of Health so that rules concerning the safe limits for using EG and DEG would be made immediately. In fact, BPOM will provide input to the WHO cases of acute kidney failures in children that do not occur in other countries.

The BPOM also identified differences in the maturity of the various pharmaceutical industries due to the very diverse industry players. Penny said there need to be clearer rules, especially regarding the security of raw material supply, since there have been shortages of medicinal raw materials due to the price difference between pharmaceutical and chemical grade products.

"That is a loophole that is used as a modus operandi," he said. Therefore, BPOM stated that it would continue to encourage independence in the procurement of medicinal raw materials in Indonesia.

Aspects of Drug Control in Indonesia Still Weak

The aspect of drug control in Indonesia, according to Penny, is also not strong enough. He said that the current system for monitoring the side effects of drugs has not been effective—be it in healthcare facilities, by health workers, or in the pharmaceutical industry. Drug crime cases that have occurred so far have not provided a deterrent effect for the criminals.

He hoped that the task of supervising drugs and food would not only be given to BPOM but also to two other pillars; business actors and consumers. Penny requested that business actors comply with applicable regulations and carry out quality control independently during production and distribution.

Consumers are also asked to help monitor and report to BPOM if they find violations or losses due to the drugs consumed.

"This incident is also a reminder for us to evaluate medicines more closely, especially those that have a high risk," he said.

Riani Sanusi Putri

Click here to get the latest news updates from Tempo on Google News