1. 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.

2. How are Health Supplement Products regulated in Bhutan?
Currently, 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

3. 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. The applicant is requested to submit evidence to substantiate claims for nutrient content. Once the evidence is assessed by DRA, the applicant is be issued Regulatory Approval. The applicant can then apply for import authorization by using the Regulatory Approval. The sale of this category of product is not restricted to a licensed Pharmacy.

4.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 claim include: maintains healthy joints, promotes healthy skin etc.

If the Health Supplement is classified under Functional Claim Product, the applicant is asked to process for obtaining Technical Authorization for Sale & Distribution (TA). Once the TA is issued, the applicant is requested to submit evidence of functional claim. Once the evidence is assessed by DRA, the applicant is be issued Regulatory Approval. The applicant can then apply for import authorization by using the Regulatory Approval. The sale of this category of product is not restricted to a licensed Pharmacy.

5. What is are 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, reduced the risk of osteoporosis. If the Health Supplement is classified under this category, the applicant is asked to process for obtaining Technical Authorization for Sale & Distribution (TA). Once the TA is issued, the applicant is requested to submit evidence of disease risk reduction claim. Once the evidence is assessed by DRA, the applicant is be issued Regulatory Approval. The applicant can then apply for import authorization by using the Regulatory Approval. The sale of this category of product is restricted only through a licensed Pharmacy.

6. 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 list of prohibited disease/condition can be obtained by clicking on this link. Products with prohibited claims will not be listed/granted import authorization.

7. 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 example of prohibited ingredient include stem and bark extracts of the popular fruit pomegranate.

8. Where should I contact for further information?

You can e-mail to the following address or call the Registration Division during office hours at the following:

E-Mail: registration@dra.gov.bt
+975-2-337075