Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
ABNR / Indonesia
The low-down on the situation regarding cannabinoid drugs, medical cannabis and opioids in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
There is no definition of “Cannabinoid” under the Indonesian law. In general, under Law No. 35 of 2009 on Narcotics (“Narcotics Law”), all substances which are categorized under Class 1 Narcotics are prohibited to be used in the health sector, including as medicines.
Based on the most recent classification of narcotics as stipulated under MOH Regulation No. 20 of 2018 on the Amendment to Narcotics Classification (“MOH Regulation 20/2018”), all part and derivatives of cannabis and Tetrahydrocannabinol are categorized under Class 1 Narcotics. Pursuant to Narcotics Law, Category 1 Narcotics can only be used for the interest of science and technological development and for diagnostic reagents and laboratory reagents after obtaining approval from the MOH upon the recommendation of the Head of BPOM.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
Not applicable
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
Not applicable
4. Which are the cannabinoid drugs that have received market approval to date?
Not applicable
5. Who can prescribe Cannabinoid Drugs?
Not applicable
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
Not applicable
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
Not applicable
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
Not applicable
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
Not applicable
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
To date, we are not aware of any proposal to legalize the use of Cannabinoid Drugs.
11. When are they likely to come into force?
To date, we are not aware of any proposal to legalize the use of Cannabinoid Drugs.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
No. Medical Cannabis is prohibited in Indonesia as all parts and derivatives of cannabis are categorized as Class 1 Narcotics, which are prohibited for healthcare use.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
Not applicable
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
Not applicable
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Not applicable
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
Not applicable
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Not applicable
18. How can patients obtain Medicinal Cannabis?
Not applicable
19. Who can prescribe Medicinal Cannabis?
Not applicable
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
Not applicable
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
Not applicable
22. Where is Medicinal Cannabis available?
Not applicable
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
Not applicable
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
There have been several public discussions on whether cannabis or its derivatives should be used or utilized for medical purposes. However, the government maintains its position that the cannabis is prohibited for any use.
There was a case where a man used cannabis to treat his wife who was diagnosed for a rare disease. The Indonesian police arrested the person for violating the prohibition under Narcotics Law and the court convicted the person with imprisonment and fines.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
There is no definition of ‘Opioid Drugs’ under the Indonesian Law. Nonetheless, the Narcotics Law stipulates that substances that are categorized as Class 2 and/or Class 3 Narcotics may be used for medical purpose if they have obtained an MA from BPOM. Thus, in this chapter, reference to Opioid Drugs means drugs having substances categorized as Class 2 and or Class 3 Narcotics.
Class 2 and Class 3 Narcotics include, among others, fentanyl, oxycodone, morphine, codeine, methadone, etc.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
BPOM
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
In general, Opioid Drugs should be treated the same as any other drugs. In principle, the products must obtain an MA from BPOM before being distributed.
Further, the manufacturing and distribution of Opioid Drugs must adhere to some specific requirements as mandated by the Narcotics Law.
28. Which are the Opioid drugs that have received market approval to date?
The list of the drugs that have obtained MA in Indonesia is publicly available in BPOM’s website, https://cekbpom.pom.go.id/
The following are some examples of Opioid Drugs that have obtained MA from BPOM:
- fentanyl (Durogesic);
- morphine (MST Continus);
- codeine (Codikaf, Coditam, Codipront);
- oxycodone (Oxynorm, Oxyneo)
29. Who can prescribe Opioid Drugs?
Same as prescribed drugs, any qualified doctors can prescribe Opioid Drugs.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
No, any qualified doctor can prescribe Opioid Drugs.
31. What approvals or notifications are required to prescribe Opioid Drugs?
There is no approval or notification required for any qualified doctor to prescribe Opioid Drugs.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Distribution of Opioid Drugs may only be conducted by the specially licensed pharmaceutical manufacturers, pharmaceutical wholesalers, and state pharmaceutical supply storage facilities (sarana penyimpanan sediaan farmasi pemerintah).
Further, the selling and dispensing of Opioid Drugs to the patient may only be conducted by:
- hospitals;
- public health centers (pusat kesehatan masyarakat or puskesmas);
- pharmacies; and
- clinics.
In certain cases, doctors may dispense Opioid Drugs directly to patients, for example, when doctors treat patients with injections or in rural areas where no pharmacies are available.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
No, there is no such list of authorized distributors/retailers of Opioid Drugs. Any pharmacies can sell and dispense Opioid Drugs based on prescriptions issued by doctors.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
To the best of our knowledge, there is no proposal to reform the regulation on Opioid Drugs.
35. When are they likely to come into force?
To the best of our knowledge, there is no proposal to reform the regulation on Opioid Drugs.
