Controlled Substances Division
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Controlled Substances Division

Background

The Controlled Substances Division (CSD) is responsible to oversee the regulation, control and monitoring of narcotic drugs, psychotropic substances, precursor chemicals and inhalants inline with the Narcotic Drugs, Psychotropic Substances and Substance Abuse Act (NDPSSA) of Bhutan. Its core function is to ensure that these substances are used safely and legally for medical and scientific purposes while preventing their misuse, abuse, and illicit trafficking, while also ensuring the implementation of effective treatment, rehabilitation, and harm reduction services.

In addition, the Division also oversees the implementation of the Tobacco Control Act of Bhutan 2010, which regulates the sale, distribution, and use of tobacco and tobacco products in the country. The division strives to reduce both supply and demand of the controlled substances and tobacco and tobacco products through effective implementation of policies, inter-agency collaboration, capacity development, and awareness programs, ultimately promoting a safe society.

Who is Who

Name Designation Email ID
Kelzang Wangdi Chief Program Officer kelzangwangdi@bfda.gov.bt
Tshering Choden Dy.Chief Pharmacist tsheringc@bfda.gov.bt
Thuji Zangpo Pharmacist thujiz@bfda.gov.bt
Sonam Wangchuk Assistant Program Officer swangchuk@bfda.gov.bt
Karma Procurement Assistant karma@bfda.gov.bt
Ogyen Choying Rangdol Sr. Inspector ocrangdol@bfda.gov.bt
Tshewang Choden Inspector tshewangc@bfda.gov.bt
Sangay Tenzin Inspector stenzin@bfda.gov.bt

Mandates

  1. Regulate and ensure effective enforcement, prevention, and measures of Controlled Substances and tobacco and tobacco products by the implementing agencies.
  2. Establishes licensing requirements for the manufacture, sale, distribution, and import/export of Narcotic Drugs, Psychotropic substances and Precursor Chemicals.
  3. Establishment of systems for reporting on the production, distribution, and use of controlled substances in accordance with the International Drug Control obligations.
  4. Develop policy, regulatory guidelines, standards, national strategies and other documents on Controlled Substances, Drug Treatment and Rehabilitation Centers, and Tobacco and Tobacco Products.
  5. Accreditation of Drug Treatment and Rehabilitation Centers/services.
  6. Regulate and monitor the Drug Treatment and Rehabilitation service providers as per the National Standards.
  7. Develop and enhance competency of law enforcement agencies and stakeholders.
  8. Authorize, institutionalize and regulate the drug testing programs in the country.
  9. Facilitate the referral of the known/unknown substances to the National Confirmatory Testing Laboratory.
  10. Ensuring compliance for substance testing laboratories with relevant regulations, standards, and accreditation.

Services

To import narcotic drugs and psychotropic substances (NDPS), the applicant must be registered with the Medical Product Division and must submit the product’s Authorization for Sale and Distribution in order to obtain import authorization for the controlled NDPS. Similarly, exporters must provide a valid authorization granted by the narcotic control authority of their respective country for the export purpose. The applicant is also required to submit specific documents as outlined in the application form Application for Import/Export for NDPS.pdf and once all the required documents are received, the import authorization will be processed online through the I2ES (International Import & Export System) platform, and the authorization will be issued accordingly.

1. Fill out the Application for Registration of Entity for Precursor Chemical Activities. 

2. Attach a copy of your valid Trade License to the completed application form. 

3. Submit the completed application form along with a copy of your valid Trade License to the Bhutan Food and Drug Authority (BFDA) by            email at (thujiz@bfda.gov.bt).

4. Upon successful review and approval of the application, BFDA will register the entity.

5. A Registration Certificate, containing the entity’s unique Registration Number, will be sent to the registered email address.

6. Use the Registration Number provided in the Registration Certificate when applying for Import Authorization for Precursor Chemicals.

 

1. Complete the Application for Import/Export of Precursor Chemicals. All fields in the application form must be completed. Applications          with incomplete or unfilled fields will be considered invalid and must be corrected and resubmitted.

2. Attach the following documents:

  • A copy of the valid Trade License.
  • A copy of the Registration Certificate issued by BFDA. Ensure that the registration has been renewed and is valid.
  • A Proforma Invoice issued by the supplier (for imports) or the buyer (for exports).
  • If the import or export is being undertaken on behalf of an organization or agency (e.g., FAO, UN, or other agencies), attach the relevant            Purchase Order or Official Order Letter.

3. Submit the completed application form together with all the required supporting documents to the Bhutan Food and Drug Authority                  (BFDA) by email at (thujiz@bfda.gov.bt).

4. BFDA will review the application and supporting documents to verify that all requirements have been met.

5. If the application is complete and all required documents have been submitted, the Import/Export Authorization will be issued within two        (2) working days.

Note: 

  • The two-working-day processing period applies only to complete applications. Incomplete application forms or missing supporting                          documents may delay processing and require resubmission.
  • The Import/Export Authorization is valid for six (6) months from the date of issuance.
  • The Import Authorization is valid for a single consignment only.
  • All items listed in the approved application must be imported in one single consignment only. Partial or multiple shipments against the same       authorization are not permitted.

 

To renew their registration annually, registered entities must submit a valid copy of their trade license along with a formal renewal request letter to renew their registration . This ensures ongoing compliance with the regulatory standards and the continued eligibility to import precursor chemicals.
  1. Section 89 of the Narcotic Drugs, Psychotropic Substances and Substance Abuse Act (Amendment) 2018 mandates the Bhutan Food and      Drug Authority (BFDA) to authorize personnel and institutions to conduct Drug of Abuse Testing (DOAT). Such authorization is required            due to the legal and sensitive nature of the testing, which must be carried out using validated methods, proper chain-of-custody                        procedures, and strict confidentiality by trained personnel.
  2. The DOAT training and authorization is applicable only to personnel nominated by the Human Resource Division of any agency or                      institution.
  3. The concerned agency or institution must first contact the Controlled Substances and Medical Device Division, BFDA, via official email            (thujiz@bfda.gov.bt) to request training.
  4. The email must include full details of the nominated personnel, including name, Employee ID number, agency name,                                             address, email address, and contact number.
  5. Upon receipt of the request, BFDA will review the submitted details and respond with the confirmed schedule for training.
  6. The nominated personnel must attend and successfully complete the prescribed training conducted by BFDA.
  7. After successful completion of the training, BFDA will issue a formal Authorization Letter for Drug of Abuse Testing (DOAT) specific to          the trained personnel.
  8. Only personnel who have completed the training and received the official authorization letter are permitted to conduct Drug of Abuse              Testing. Unauthorized individuals are strictly prohibited from performing such tests.

List of Schedules

  1. List of Schedule I Substances.pdf (Narcotic Drugs with no medicinal value)
  2. List of Schedule II Substances.pdf (Psychotropic Substances with no medicinal value)
  3. List of Schedule III Substances.pdf (Narcotic Drugs with medicinal value)
  4. List of Schedule IV Substances.pdf (Psychotropic Substances with medicinal value)
  5. List of Schedule V Substances.pdf (Precursor Chemicals)
  6. List of Schedule VI Substances.pdf (Solvents and Inhalants)
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