Home Controlled Substance and Medical Device Division

Controlled Substance and Medical Device Division

Background

The Controlled Substances and Medical Device Division (CSMDD) 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
Tshering Choden Dy.Chief Pharmacist tsheringc@bfda.gov.bt
Zhenphen Kuenchap Program Officer zkuenchap@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 ImportExport 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.
To import Precursor Chemicals the entity must register with the Bhutan Food and Drug Authority using Application for Registration of Entity for Precursor Chemical Activities.pdf. Upon successful registration, a unique registration number will be issued to the entity which can be used to meet the requirements for obtaining import authorization for Precursor Chemicals.
The registered entity with BFDA shall submit a duly completed import application form Application for ImportExport for Precursor Chemicals.pdf. The import authorization will be issued within two working days, provided all requirements outlined in the form are duly submitted.
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.
Section 89 of the Narcotic Drugs Psychotropic Substances and Substance Abuse Act (Amendment) 2018 mandates BFDA to authorize professionals and institutions to conduct drug of abuse testing. This authorization must comply with the provision of the Act, considering the sensitive nature and potential legal implication of such testing. Drug of abuse testing plays a crucial role in detecting illicit or controlled substances in individuals and facilitating timely intervention. Authorized facilities must use validated testing methods, maintain chain-of-custody procedures and ensure confidentiality. Therefore, personnel and institutions performing these tests must undergo training to ensure correct sample collection, analysis, interpretation, and result reporting.

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 drug with medicinal value)
  4. List of Schedule IV Substances.pdf (Psychotropic Substances with medicinal value)
  5. List of Schedule V Substances.pdf (Precursor Chemicals)
Close Search Window
↑