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CSMDD FAQs

Precursor Chemicals

Precursor Chemicals are substances that have legitimate industrial or commercial use but are susceptible to diversion or misuse for illicit purposes. These chemicals fall under the classification of Schedule V Substances in the Narcotic Drugs, Psychotropic Substances and Substances Abuse Act of Bhutan.
Precursor chemicals are regulated by the Controlled Substances & Medical Device Division, a division under Bhutan Food and Drug Authority operating within the Ministry of Health.
Yes, a licensed supplier or manufacturer has to register with the Controlled Substances & Medical Device Division under Bhutan Food and Drug Authority. Upon registration, confirmation of registration in respect of Schedule V Substances will be issued by the Authority.
If all necessary documents are provided during the registration process, the firm/company can complete the registration within two business days.
At present, there is no fee structure associated with registering Precursor Chemicals.
If all necessary documents are provided during the registration process, the firm/company can complete the registration within two business days.
At present, there is no fee structure associated with registering Precursor Chemicals.

Narcotic Drugs and Psychotropic Substances (NDPS)

The Controlled Substances and Medical Devices Division(CSMDD) under BFDA regulates the import and export of NDPS in the country.
To import and export NDPS, the product should be registered with the Medical Product Division, BFDA. Upon the receipt of the complete document CSMDD will issue the import/export permit.
At present, there are no import authorization fees for NDPS.
Individual travelers who are required to carry CDs should acquire a permit form CSMDD and MDP of BFDA with valid documents. However, the quantity of import/export of CDs depends on the country of destination

Drug of Abuse Test Kits

Registered firms with the Medical Product Division under Bhutan Food and Drug Authority can supply the drug of abuse test kits as per their requirements set in the guidelines for Registration of Medical Devices, 2022. Guideline for Registration of Medical Devices
The drug-of-abuse test kits can be purchased from the identified supplier by BFDA. You can contact us during the office hours @ 02-337076
The price will vary depending on the yearly quotation rate.
The individual should reach out to the Human Resource department of their current employer for drug of abuse testing related to employment or long-term training. For overseas travel purposes as per the requirement of the institutions, the individual can visit JDWNRH for the same service.

Drug Treatment/Rehabilitation Regulation

The Controlled Substances & Medical Device Division under Bhutan Food and Drug Authority regulates all the drug treatment & rehabilitation centers in the country.
The interested firms or individuals should register with CSMDD, and BFDA. The CSMDD, and BFDA will carry out technical assessment upon fulfillment of national standards and shall issue the authorization and register accordingly.

Tobacco Regulation

Yes, Tobacco and Tobacco products are regulated within the country. The implementing agencies are responsible for enforcement of the tobacco and tobacco products as specified in the Tobacco Control Rules and regulations. Link
No, import authorization is not required for tobacco and tobacco products. However, suppliers must register with the MOICE (Ministry of Industry, Commerce, and Employment) for sales and distribution.
No, only individuals or entities that have obtained the trade license from the Ministry of Industry, Commerce and Employment are allowed to supply the tobacco and tobacco products.
As per the Tobacco Act, no person is allowed to smoke in public places. The individual will be imposed penalties as per the tobacco regulation by the Law Enforcement Agencies. Link and penalty list

The non-smoking areas are:

  1. Inside Private Vehicle
  2. Dratshang, Shaydras and Lhakhangs
  3. Commercials Centers
  4. Recreational Centers
  5. Public Gatherings
  6. Institutions
  7. Public Transportation
  8. Public Spaces (Where there is a gathering of people more than Two peron)
Shopkeepers are:
  1. I Not allowed to sale to minors (below 18 years of age)
  2. Dratshang, Shaydras and Lhakhangs
  3. Not allowed to display the tobacco and tobacco products
  4. Not allowed to sale in sticks/pieces
  5. Ensure no person smoke in their premises
  6. Display ‘No Smoking signs’ in their premises

You can email or contact us during the office hours at the following;

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