FAQs on Health Supplement Regulation
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.
Currently, Drug regulatory Authority (DRA) controls the Health Supplements. Once an application for listing Health Supplement is received, the DRA follows a risk based approach by classifying all Health Supplement Products into following three categories based on ingredient and label claim/ingredient and different control measures are applied.
- Nutrition/General Claim Products
- Functional Products
- Disease Risk Reduction Prod
Health Supplement with claims for nutritional support and general maintenance are classified as Nutrient/General Claim Product. The applicant is required to submit evidence to substantiate claims for nutrient content. Once the evidence is assessed by the DRA, the applicant is issued Listing Approval. The applicant can then apply for import authorization by using the Listing Approval. The sale of this category of product is not restricted to a licensed Pharmacy.
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.
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.
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.
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.
You can e-mail to the following address or call the Registration Division during office hours at the following:
Phone Number : +975-2-337075
If you are importing medicinal products for large-scale sale & distribution in the country, you will have to register. However, registration is not required in following cases:
- If you are bringing medicinal products for personal use accompanied by a valid medical prescription.
- Non-prescription medicines for personal use (the list is published on DRA website at www.dra.gov.bt) the quantity of which is less than one month dose.
To register medicinal products, first a local dealer (called Market Authorization Holder) or manufacturer should apply for Technical Authorization for Sale and Distribution from the DRA based on which Trade License will be issued by the Department of Trade, Ministry of Economic Affairs. After obtaining the Trade License and Technical Authorization for sale and distribution, a local dealer can submit documents related to medicine to the DRA for registration. If a manufacturer outside Bhutan wishes to register medicines directly, they may do so. The documents required for registration of medicines can be viewed at www.dra.gov.bt
If all the documents are complete during the time of application, a medicine can be registered within 1-3 months.
An initial application fee of BTN 150/- per product is levied. Once the assessment of the document is completed, a registration fee of BTN 1500/- per product will be charged. The fees may be however revised from time to time.
Once registered, the registration status of a medicine is valid for a period of three years. After the expiry of validity of three years, you can apply for renewal of registration. Fees and charges remains same as initial registration.
A Competent Person is one who is registered with DRA based on:
- the qualification and practical experience (as per the Bhutan Medicines Rules and Regulation 2012); and
- passed the competency exam conducted by DRA.
The Competent Person will supervise sale and distribution of medicinal products.
If you are a Pharmacist/Pharmacy Technician/Medical Doctor/Veterinary Doctor Drungtsho (Traditional Medicine Physician) or if you possess Diploma in gSso-ba Rig-pa medicine, you can apply for registration as a Competent Person. You will be asked to pay a fee of BTN 300/- as application fee and will be assigned a date for examination. If you pass the theory and practical exams, you will be issued a certificate of Competent Person.
No. You are not eligible for the Competent Person Examination for Sale & Distribution of Medicinal products. But you can still open a Pharmacy by employing a Competent Person.
You can access this web-link for more information Guideline for Registration of Medicinal Products.
To open a pharmacy, you should fulfill following requirements:
- Competent Person certified by DRA
- A suitable location separates from meat shops/living rooms etc.
- Apply to DRA for Technical Authorization for Sale & Distribution of Medicinal Products.
- DRA will visit & inspect your location.
- You will get Technical Authorization.
- Proceed to obtain Trade License.
- You are ready to stock/ sale medicines.
Import Authorization is a permit to import medicines in the country issued by the Drug Regulatory Authority. A one-time authorization is valid for a period of 6 months.
All medical supplies for public health services in Bhutan are centrally procured and distributed through the Department of Medical Supplies and Health Infrastructure (DMSHI) under the Ministry of Health. You should contact this office at +975-2-325955/56.