BPOM uncovers new chemical adulteration in herbal products as pyrimidenafil poses health risks to consumers
The Indonesian Food and Drug Authority (BPOM) has issued a critical warning following the discovery of a synthetic chemical substance, pyrimidenafil, identified in various herbal medicinal products marketed for male vitality. This development marks a significant shift in the landscape of illegal drug adulteration, as pyrimidenafil has never previously been detected in the Indonesian pharmaceutical or traditional medicine market. The discovery has prompted immediate regulatory action, including the revocation of distribution licenses for implicated products and an intensified surveillance campaign across the nation.
The Emergence of Pyrimidenafil
Pyrimidenafil is a chemical compound that functions as a phosphodiesterase-5 (PDE5) inhibitor. This class of compounds is medically recognized for its ability to dilate blood vessels and increase blood flow, which is why they are commonly utilized in clinical treatments for erectile dysfunction. However, unlike regulated pharmaceuticals such as sildenafil or tadalafil—which undergo rigorous safety testing and require professional medical supervision—pyrimidenafil is being illegally added to herbal supplements, or "jamu," to mimic the efficacy of prescription drugs.
The BPOM laboratory identified this substance in three specific products: EXIE, YUBOKKI, and DURAMAX. All three items were reportedly produced by PT Bintang Kupu-Kupu, a manufacturing entity based in Tangerang. The presence of this compound suggests a sophisticated attempt by illicit manufacturers to bypass standard laboratory detection protocols by utilizing chemical analogues that differ slightly in structure from commonly monitored substances.
A Calculated Shift in Modus Operandi
BPOM Chief Taruna Ikrar described the finding as a strategic pivot by irresponsible manufacturers. For years, regulatory bodies have successfully monitored for common adulterants like sildenafil, tadalafil, and sibutramine. By introducing pyrimidenafil, illicit actors appear to be attempting to circumvent these established screening methods.
"The use of compounds that deviate from the standard list of prohibited chemical substances is a clear attempt to deceive regulatory oversight," Ikrar stated. "This is not merely a manufacturing shortcut; it is a calculated effort to elude the detection capabilities of our laboratory testing systems."
This discovery underscores an ongoing "cat-and-mouse" game between regulators and underground producers. As BPOM enhances its testing capabilities, illicit manufacturers are increasingly resorting to "designer" chemical variants that may not be present in current diagnostic databases. Consequently, BPOM has initiated a comprehensive upgrade of its analytical methodologies, expanding the scope of its testing to include novel, derivative, and analogue compounds that may appear in the market under the guise of natural herbal remedies.
Timeline and Regulatory Response
The discovery follows a period of heightened surveillance conducted throughout July 2026. During this timeframe, BPOM launched a nationwide operation targeting herbal products that claimed to provide instantaneous health benefits—a common red flag for the presence of chemical additives.
The chronology of the incident unfolded as follows:
- Early July 2026: BPOM intensified its market surveillance in response to reports of adverse health effects linked to unregulated herbal products.
- Mid-July 2026: Laboratory analysis of samples collected from the market identified an unknown chemical structure in the EXIE, YUBOKKI, and DURAMAX brands.
- August 2026: Further forensic analysis confirmed the substance as pyrimidenafil, a compound that mimics the pharmacological effects of PDE5 inhibitors.
- September 12, 2026: BPOM officially announced the discovery, confirming the revocation of the distribution licenses for the implicated products and the commencement of legal proceedings against the manufacturer.
In addition to the pyrimidenafil-positive products, the July surveillance operation resulted in the seizure of 35 other herbal products that were sold without proper distribution permits. These products were found to contain a cocktail of other prohibited substances, including sibutramine (often used in weight-loss supplements), dexamethasone (a corticosteroid), and paracetamol.
Health Implications and Risks
The inclusion of PDE5 inhibitors in unregulated supplements poses severe health risks, particularly for consumers who may be unaware of the active ingredients they are ingesting. Because these products are marketed as "all-natural," users may take them without consulting a physician, failing to account for underlying cardiovascular conditions.
PDE5 inhibitors can cause dangerous drops in blood pressure, especially when combined with nitrates often prescribed for heart conditions. Furthermore, the lack of quality control in illicit manufacturing means that consumers have no way of knowing the dosage of the chemical adulterant. A single capsule could contain a sub-therapeutic amount or a toxic overdose, both of which present significant dangers to consumer safety.
The presence of other adulterants like sibutramine—which has been withdrawn from many global markets due to links with increased risk of stroke and heart attack—further complicates the public health landscape. The trend of mixing multiple synthetic drugs into a single herbal product indicates a disregard for basic pharmacology and consumer safety.
Strengthening Market Surveillance
BPOM’s response to this crisis is twofold: immediate enforcement and long-term systemic improvement. By revoking the licenses of the involved manufacturers, the agency is signaling a zero-tolerance policy toward the adulteration of traditional medicines. However, the sheer scale of the 35 other products found to be non-compliant indicates that the practice of "spiking" herbal remedies remains a pervasive issue in the Indonesian market.
Moving forward, the agency plans to invest heavily in the capacity of its regional laboratories. The goal is to move toward a more predictive model of surveillance, where the agency uses machine learning and advanced chemical profiling to identify potential adulterants before they become widespread.
Guidance for Consumers
BPOM has issued a series of advisories for the public to navigate the risks of the herbal market:
- Skepticism Toward "Instant" Claims: Consumers should treat products promising immediate results for stamina, weight loss, or pain relief with extreme caution. These claims are frequently associated with the addition of prohibited synthetic chemicals.
- Verify Official Permits: All legitimate herbal products in Indonesia must carry a BPOM registration number. Consumers are encouraged to verify these numbers via the official BPOM mobile application or website.
- Source Reliability: Purchases should only be made through licensed pharmacies or authorized distributors. The rise of e-commerce has made it easier for unlicensed products to reach consumers, making it imperative to check the reputation of online sellers.
- Label Transparency: Consumers should carefully review ingredient lists. While illicit manufacturers often omit the harmful chemical from the label, the absence of detailed contact information or manufacturer addresses is a major warning sign.
Broader Implications for the Jamu Industry
The "Jamu" industry is a cornerstone of Indonesian culture and a significant contributor to the national economy. However, incidents of adulteration threaten to erode public trust in traditional medicine as a whole. The industry is currently at a crossroads; while the vast majority of producers adhere to safety standards, the persistence of rogue manufacturers threatens the reputation of the entire sector.
The discovery of pyrimidenafil serves as a stark reminder of the complexities inherent in regulating traditional medicine in the modern era. As the line between herbal products and synthetic pharmaceuticals becomes increasingly blurred by illegal actors, the pressure on regulatory bodies to adapt at the speed of innovation is unprecedented. For BPOM, the challenge now lies in balancing the support for the traditional medicine industry with the absolute necessity of ensuring that no product marketed to the public poses an hidden, synthetic threat to their well-being.
As the legal proceedings against PT Bintang Kupu-Kupu progress, the industry will likely see stricter monitoring of chemical imports and increased scrutiny of manufacturing processes. Whether these measures will be sufficient to curb the rise of "designer" herbal adulterants remains to be seen, but the agency’s recent actions signal a definitive shift toward more aggressive, technology-driven enforcement.
