The Bhutanese Leading the way.
The Drug Regulatory Authority (DRA), under the Bhutan Food and Drug Authority (BFDA), has until now detected three medicines, both traditional and modern that were found to contain lead and chemical substances beyond permissible limits for human consumption, marking its first such case.
When asked about traditional medicines, the DRA clarified that apart from the case involving Yuthok Traditional Pharmacy, no other medicines with high levels of lead or mercury have been detected to date.
BFDA said the traditional medicine identified at the pharmacy, Rinchen Jumar 500 mg, was an unregistered product that was seized during a BFDA inspection. Subsequent laboratory testing confirmed that the medicine contained extremely high levels of both lead and mercury.
The origin of the product could not be confirmed, although it was reportedly sourced from Nepal. Importantly, it was not manufactured by Menjong Sorig Pharmaceuticals Corporation Limited (MSPCL), Bhutan’s only authorized producer of traditional medicines.
To evaluate the potential risk, authorities tested both the seized unregistered samples and the locally produced, registered MSPCL products in a laboratory. The tests confirmed that while the MSPCL medicines complied with safety standards, the unregistered products contained dangerously high levels of lead and mercury, posing a significant risk to public health.
According to the DRA, lead and mercury are toxic heavy metals that can cause serious and irreversible harm. “Chronic or high-dose exposure may result in neurological damage, kidney and liver toxicity, cardiovascular effects, developmental impairment in children, and reproductive harm,” the DRA said.
For herbal medicines, international best practices set the maximum permissible limits at 10 ppm for lead and 1.0 ppm for mercury. The DRA said, “Compared to these established safety limits, the levels detected in the sample are extremely high, exceeding permissible limits by several thousand fold, and therefore represent a serious and unacceptable risk to public health, particularly with repeated or long-term use.”
BFDA added that the risk was further compounded by the fact that the medicine was unregistered, and that the proprietor did not maintain any sales records or stock ledger, making it impossible to determine how many patients were exposed or for how long. DRA added, “This uncertainty elevated the situation from a product violation to potential high public health concern, necessitating a Regulatory Notification and Public Safety Advisory to identify exposed individuals and prevent further harm.”
For chemical medicines, the DRA reported about the three cough syrup brands from India Syrup Coldrif, Respifresh TR, and Re-life were found to contain dangerously high amounts of Ethylene Glycol (EG) and Diethylene Glycol (DEG), chemicals that can be highly toxic.
According to the DRA, “Ethylene Glycol (EG) and Diethylene Glycol (DEG) are highly toxic industrial chemicals that are not safe for human consumption. Ingestion can lead to acute kidney failure, metabolic acidosis, neurological damage, and death, particularly in children.”
BFDA noted that while these syrups were not legally sold in Bhutan, people could still obtain them across the border, posing a serious risk to consumers who may be unaware of their danger. To prevent such incidents, the DRA said Public Safety Advisories (PSAs) have been placed at border checkposts to stop the entry and use of these medicines, highlighting the concern given the history of international mass poisoning cases linked to EG/DEG-contaminated cough syrups.
DRA also reported that a specific batch of Compound Herb Inhaler (Hongthai Brand-Formula 2) tested positive for microbial contamination, according to results from the Thai Food and Drug Administration, as confirmed through the South East Asian Regulatory Network (SEARN).
BFDA explained that microbial contamination in inhalation products poses a direct health risk, since the product is administered through the nose and respiratory tract. Contaminated inhalers can introduce harmful bacteria or fungi into the airways, potentially causing respiratory infections, allergic reactions, sinusitis, or worsening of asthma, especially in children, the elderly, and immunocompromised individuals.
Although the contamination was limited to a single batch, the DRA emphasized that prompt recall was essential to prevent localized but avoidable health effects, ensuring the risk was contained while maintaining confidence in unaffected batches.
When asked about measures to prevent recurrence and ensure consumer safety, the Bhutan Food and Drug Authority (BFDA) said it has taken strict regulatory and enforcement actions in line with the Medicines Act of Bhutan, 2003, and the Bhutan Medicines Rules and Regulations (BMRR), 2019.
Under the law, importing, selling, or distributing unregistered medicines or products without authorization can lead to seizure, fines, and liability for any resulting harm.
For licensed firms or individuals, the BMRR provides graduated sanctions, from reprimands and fines to suspension or cancellation of Technical Authorization and associated trade licenses for repeated or serious violations.
BFDA conducts inspections, market surveillance, and follow-up enforcement to strengthen compliance and ensure only safe, authorized medicines are available. In cases where high-risk or unsafe products are detected, the Authority issues regulatory notifications, public safety alerts, and advisories to protect the public.
BFDA urges the public to stay informed and cautious when using medicines, including traditional remedies. Medicines must meet strict safety, quality, and efficacy standards, and patients are encouraged to verify with pharmacists or registered competent persons whether a product is approved. Competent persons are legally required to dispense only registered medicines.
BFDA said that medicines should be obtained only from authorized outlets and used as directed by healthcare professionals. Moreover, public should avoid unverified sources or products with exaggerated claims.
If a medicine appears unsafe, counterfeit, substandard, expired, or unregistered, or causes unexpected side effects, report it immediately to BFDA Hotline 1555, the BFDA website, or Drug-RIMS via a QR code.
