- What are Health Supplements?
Health supplements are products intended to supplement the diet. They are not medicines and, therefore, are not intended to treat, diagnose, mitigate, prevent, or cure diseases. Health Supplements are also known by different names such as dietary supplement, nutrition supplement, nutraceuticals, complementary medicines etc.
- How are Health Supplement Products regulated in Bhutan?
Currently, the Drug regulatory Authority (DRA) controls the Health Supplements. Once an application for listing Health Supplement is received, the Drug Regulatory Authority (DRA) follows a risk based approach by classifying all Health Supplement Products into following three categories based on ingredient and label claim/ingredient.
i. Nutrition/General Claim Products
ii. Functional Products
iii. Disease Risk Reduction Product
- What is a Nutrient/ Claim product and how is it controlled?
Health Supplement with claims for nutritional support and general maintenance are classified as Nutrient/General Claim Product. This category of health supplements can be sold either from general shops or licensed pharmacies. Applicants are required to apply for listing health supplement using the Health Supplement submission form. Subsequently, Import Authorization (IA) should be obtained from the DRA to import, sale and distribute Health Supplements.
- What is a functional claim product and how is it controlled?
Health Supplements with claims which relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health in the context of the total diet on normal function or biological activities of the body or maintains or enhances structure or function of the body, excluding disease related claims are classified as Functional Claim Product. Examples of such claims include: maintains healthy joints, promotes healthy skin etc.
This category of Health Supplements should be sold only from the licensed Pharmacy. Thus, the applicant should have Technical Authorization for Sale & Distribution (TA) obtained from the DRA prior to obtaining a listing certificate. Applicants are required to apply for listing health supplement using Health Supplement submission form. Subsequently, IA should be obtained from the DRA to import, sale and distribute Health Supplements.
- What is Disease Risk Reduction Claim product and how is it controlled?
Health Supplements with claims of significantly altering or reducing a risk factor of a disease or health related condition are classified as disease risk reduction products. Examples include, reducing the risk of osteoporosis.
This category of Health Supplements should be sold only from the licensed Pharmacy. Thus, the applicant should have Technical Authorization for Sale & Distribution (TA) obtained from the DRA prior to obtaining a listing certificate. Applicants are required to apply for listing health supplement using Health Supplement submission form. Subsequently, IA should be obtained from the DRA to import, sale and distribute Health Supplements.
- What if a Health Supplement product claims benefit/cure in disease like diabetes, blood pressure, weight loss, sexual function, cancer etc.?
Health Supplements are not allowed to claim benefit, cure/treatment of any of the above disease conditions. More information on the list of prohibited disease/condition can be obtained by clicking on this link. Products with prohibited claims will not be listed/granted import authorization.
- Are there any other reasons due to which a Health Supplement may not be allowed in the country?
Yes. If the product contains prohibited ingredients, the Health Supplement will not be allowed in the interest of public safety. Some examples of prohibited ingredients include stem and bark extracts of the popular fruit pomegranate.
- Where should I contact for further information?
You can email to the following address or call the Registration Division during office hours at the following:
E-Mail: registration@dra.gov.bt
+975-2-337075