BPOM Ensures Safe Access to Innovative Diabetes Medication
The Food and Drug Monitoring Agency (BPOM) has stated that access to safe innovative medicines is strengthening treatment for diabetes patients, and it is committed to ensuring the safety of these drugs to protect the public.
BPOM Head Taruna Ikrar said in Jakarta on Friday that Ministry of Health data shows the number of diabetes sufferers in Indonesia is very high, reaching 31 million people or 11 percent of the population, due to genetic factors and high glucose consumption patterns. Therefore, the presence of well-supervised innovative medicines is crucial.
“In addition to tightening physical controls, BPOM’s public protection is also realised through accelerating access to innovative medicines that are urgently needed by the public, one of which is a drug with the active substance tirzepatide for type 2 diabetes patients and weight management,” he said.
He stated that the agency successfully completed the drug registration process in just 98 days, without compromising the principles of scientific evaluation.
As a form of commitment to protecting the public, the agency also conducted a direct working visit to the National Distribution Centre (NDC) of PT Anugerah Pharmindo Lestari (APL) to ensure that medicines consumed by the public maintain their quality, safety, and efficacy from upstream to the hands of patients.
However, BPOM reminded that post-marketing protection remains a top priority. Therefore, the Head of BPOM requested all business actors, including distributors, to strengthen the pharmacovigilance system to prevent the risk of adverse side effects in the community.
“We have just issued a regulation. Vigilance is very important because one thing that has not developed well is pharmacovigilance. Whether it is adverse reactions or other undesirable events, please report it. Because that is the function of post-marketing,” he said.
Collaborative synergy between BPOM and business actors who comply with the principles of Good Distribution Practice (CDOB) is the key to a robust national health ecosystem.
As a regulator recognised globally through its WHO-Listed Authority (WLA) status, BPOM continues to modernise supervision through digital innovation, such as real-time 2D barcode tracking.
“This progressive step serves as the main fortress to completely block the movement of illegal or counterfeit drugs that could threaten the safety of the Indonesian people,” he said.