Legal & Regulatory > India > Cannabinoid Drugs, Medicinal Cannabis & Opioid Drugs

Cannabinoid drugs, medicinal cannabis & opioid drugs in India – a comprehensive legal overview. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.

CANNABINOID DRUGS

Global Comment: For the purpose of this chapter, we will assume that Cannabinoid Drugs are preparations made out of extract or tincture of Cannabis. If a drug contains cannabinoids which have been synthetically manufactured, they would be regulated as drugs, except for drugs containing Tetrahydrocannabinol (THC). THC is regulated as a psychotropic substance in India. We have assumed that a drug that that contains only, or mostly, THC that is synthetically manufactured will not be called as a Cannabinoid Drug.

1. Are Cannabinoid Drugs authorized in your country?

Cannabinoid Drugs can be sold in India in accordance with the requirements laid down by law. Cannabinoid Drugs which are an extract or tincture from cannabis require a licensed under Narcotic Drugs and Psychotropic Substances Act 1985 (“NDPS Act”), Narcotic Drugs and Psychotropic Substances Rules 1985 (“NDPS Rules”), Drugs and Cosmetics Act,1940 (“D&C Act”) and the Drugs and Cosmetics Rules, 1945 (“D&C Rules”) for sale in India.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The following authorities have jurisdiction with respect to all narcotic drugs including Cannabinoid Drugs:

1. Central Bureau of Narcotics (“CBN”) operates under the Department of Revenue, Ministry of Finance and is in charge of enforcement of the NDPS Act, which is India’s primary anti-drug abuse legislation. The CBN is headed by the Narcotics Commissioner.
2. Narcotics Control Bureau (“NCB”) operates under the Ministry of Home Affairs and exercises the function of the Central Government under the NDPS Act. The NCB is also in-charge of coordinating between various government authorities under the NDPS Act, Customs Act 1962 and Drugs & Cosmetics Act 1940 (“D&C Act”).
3. Central Drugs Standard Control Organisation (“CDSCO”) headed by the Drugs Controller General of India (“DCGI”) under the Ministry of Health and Family Welfare regulates clinical trials import, manufacture, marketing and clinical trials, biologics and medical devices in the territory of India.
4. State-level Licensing Authorities (“SLA”) are established in each Indian state and independently regulate the manufacture and sale of drugs, biologics and medical devices within the territory of their respective state.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

There is no specific regulatory framework regulating the authorization, pricing and reimbursement of Cannabinoid Drugs.

AUTHORIZATION

As indicated in the first response, a Cannabinoid Drug can be sold after  obtaining appropriate licenses under the NDPS Act and NDPS Rules, as well as D&C Act and D&C Rules.

PRICING

There is no specific pricing framework for Cannabinoid Drugs in India. However, since cannabinoids drugs would be regulated under the larger framework applicable to medicinal drugs in India, they would be subject to price control.

Under the Drugs Price Control Order,2013 (“DPCO”) the National Pharmaceutical Pricing Authority (“NPPA”) is empowered to fix prices of drugs that qualify as ‘essential’. As of now, to our knowledge, no Cannabinoid Drug has been listed as an essential drug. However, even non-essential drugs are subject to price control, as they are not permitted to increase prices by more than 10% in any 12-month period.

REIMBURSEMENT

There is no specific regulatory framework for the reimbursement of drugs, including cannabinoid drugs, in India.

4. Which are the cannabinoid drugs that have received market approval to date?

So far, to our knowledge, no cannabinoid drugs have received market approval.

5. Who can prescribe Cannabinoid Drugs?

The persons who are permitted to prescribe cannabinoid drugs vary from state to state. But, at the least, the following persons can prescribe cannabinoid drugs:

1. A person who holds a qualification recognized under National Medical Commission Act, 2019 and is registered with a medical council;
2. A person registered as a dentist under the Dentists Act, 1948 (in some States with approval of the government);
3. A person who is registered in the practice of veterinary medicine and who possesses qualifications approved by the government (in some States with approval of the government)

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No. There is no such list of doctors authorized to prescribe Cannabinoid Drugs.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

At the minimum, the following authorizations are required to sell Cannabinoid Drug in India –

1. License from the Narcotics Commissioner to manufacture the Cannabinoid Drug
2. License from State Licensing Authority to manufacture Cannabinoid Drug
3. Marketing Permission from DCGI, if the Cannabinoid Drug has not been used in India to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognised as effective and safe by the DCGI.

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

The following entities are authorized to sell/distribute cannabinoid drugs –

1. Licensed vendors and druggists;
2. Hospitals, dispensaries and veterinary dispensaries working under Government supervision;
3. Other medical institutions authorised by the state government;
4. Dispensary owned by a registered medical practitioner where no prescriptions except his own are dispensed, provided that the registered medical practitioner is registered with the State Government.

9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?

No. There is no publicly available list of retailers/distributors authorized to sell Cannabinoid Drugs.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

No. There are currently no proposals for reform or significant change to the regulation of Cannabinoid Drugs.

11. When are they likely to come into force?

The question is not applicable.

MEDICINAL CANNABIS

Global Comment: For the purpose of this chapter, we have assumed that Medical Cannabis means use of Cannabis in its original form, i.e. not in form of extracts or tinctures, for medicinal purposes.

12. Is Medicinal Cannabis authorized in the country?

No, the sale of cannabis to patients for medicinal purposes is not permitted in India.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The following authorities have jurisdiction with respect to all narcotic drugs including Medicinal Cannabis:

1. Central Bureau of Narcotics (“CBN”) operates under the Department of Revenue, Ministry of Finance and is in charge of enforcement of the
   Narcotic Drugs and Psychotropic Substances Act 1985 (“NDPS Act”), which is India’s primary anti-drug abuse legislation. The CBN is headed by the Narcotics Commissioner.
2. Narcotics Control Bureau (“NCB”) operates under the Ministry of Home Affairs and exercises the function of the Central Government under the NDPS Act. The NCB is also in-charge of coordinating between various government authorities under the NDPS Act, Customs Act 1962 and Drugs & Cosmetics Act 1940 (“D&C Act”).
3. Each Indian State has the power to regulate the cultivation of any cannabis plant, production, manufacture, consumption, transport, import inter-State, export inter-State, sale, purchase, consumption or use of cannabis.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Medicinal Cannabis cannot be prescribed as a drug for the use of Indian citizens.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

MANUFACTURE

Cultivation of Medicinal Cannabis may be done for scientific or research purposes under a license granted by the State Government and a separate license granted by the Narcotics Commissioner.

IMPORT

Cannabis, including Medicinal Cannabis, can only be imported into India for the following purposes:

i. Scientific requirements including analytical requirements of any Government laboratory or any research institute in India or abroad.

ii. Very limited medical requirements by a foreigner by a duly authorised person of a hospital or any other establishment of the Government especially
approved by that Government.

iii. De-addiction of drug addicts by Government or local body or by an approved charity or voluntary organisation or by such other institution as
may be approved by the Central Government.

iv. Restraining or immobilising wild animals by or under the authority of the Government and approved by that Government.

In order to import cannabis for above purposes, a permission from the Narcotics Commissioner is required.

Persons authorised to import cannabis for the above mentioned purposes are required to maintain records concerning the acquisition and use of the cannabis for at least two years.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Medicinal Cannabis can only be imported by duly authorised person of a hospital for very limited medical requirements of foreigners under a valid import permission granted by the Narcotics Commissioner.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Medicinal Cannabis cannot be marketed and distributed in India.

18. How can patients obtain Medicinal Cannabis?

Indian patients cannot obtain medical cannabis. However, eligible foreign patients can import medical cannabis under an import permission from Narcotics Commissioner.

19. Who can prescribe Medicinal Cannabis?

Medicinal Cannabis cannot be prescribed in India.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

There is no list of doctors authorized to prescribe Medicinal Cannabis.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Medicinal Cannabis cannot be prescribed in India.

22. Where is Medicinal Cannabis available?

Medicinal Cannabis can only be imported in India for specific uses. Please refer to Question 15 above for more information.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

There is no publicly available list of retailers authorized to sell Medicinal Cannabis.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

There are currently no proposals for reform or significant change to the regulation of Medicinal Cannabis.

OPIOID DRUGS

25. Are Opioid Drugs authorized in your country?

Yes, opioid drugs are authorized for marketing in India. Any person intending to market opioid drugs must obtain a license under the Narcotic Drugs and Psychotropic Substances Act 1985 (“NDPS Act”), Narcotic Drugs and Psychotropic Substances Rules 1985 (“NDPS Rules”), Drugs and Cosmetics Act, 1940 (“D&C Act”) and Drugs and Cosmetics Rules, 1945 (“D&C Rules”).

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The regulatory authorities that have jurisdiction over Cannabinoids have jurisdiction over Opioid Drugs as well.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

There is no specific regulatory framework regulating the authorization, pricing and reimbursement of Opioid Drugs.

AUTHORIZATION

An Opioid Drug can be sold after obtaining appropriate licenses under the NDPS Act and NDPS Rules, as well as D&C Act and D&C Rules.

PRICING

There is no specific pricing framework for Opioid Drugs in India. However, since Opioid Drugs would be regulated under the larger framework applicable to medicinal drugs in India, they would be subject to price control under the Drugs Price Control Order, 2013 (“DPCO”). The DPCO gives power to the National Pharmaceutical Pricing Authority (“NPPA”) to fix prices of drugs that qualify as ‘essential’. Some opioids such as morphine and fentanyl have been dentified as essential medicines and their prices are now fixed by NPPA. The drugs that do not qualify as essential are not permitted to increase prices by more than 10% in any 12-month period.

REIMBURSEMENT

There is no specific regulatory framework for the reimbursement of drugs, including opioid drugs, in India.

28. Which are the Opioid drugs that have received market approval to date?

The following Opioid Drugs can be marketed in India:

1. Methyl Morphine (commonly known as Codeine) and Ethyl Morphine and their salts (including Dionine), all dilutions and preparations except those which are compounded with one or more other ingredients and containing not more than 100 milligrams of the drug per dosage unit and with a concentration of not more than 2.5 % in undivided preparations and which have been established in therapeutic practice.
2. Fentanyl and its salts and preparations, admixtures, extracts or other substances containing any of these drugs.
3. Dihydrocodeinone (commonly known as Hydrocodone), its salts esters, salts of its esters, and preparations, admixtures, extracts or other substances containing any of these drugs.
4. Methadone, its salts, and all preparations, admixtures, extracts or other substances containing any of these drugs.
5. Morphine , its salts and all preparations containing more than 0.2 per cent. of Morphine.
6. Dihydroxy Codeinone (commonly known as ‘Oxycodone and Dihydroxycodeinone), its salts, its esters, salts of its esters and all preparations, admixtures, extracts or other substances containing any of these drugs.

29. Who can prescribe Opioid Drugs?

Opioid Drugs that have been identified in the response above fall under the Essential Narcotic Drug (“END”) list and can be prescribed by any medical practitioner who is:

1. registered as a medical practitioner or a dentist; and
2. has undergone training in pain relief and palliative care for prescription of ENDs for pain relief and palliative care or training in opioid substitution therapy for prescription of ENDs for treatment of opioid dependence.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

No. There is no such list of doctors authorized to prescribe Opioid Drugs.

31. What approvals or notifications are required to prescribe Opioid Drugs?

No. There are no specific approvals or notifications that are required to prescribe Opioid Drugs.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Dealers and chemists who have obtained a license from the State Government to sell narcotic drugs on the END list can sell/distribute Opioid Drugs.

33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?

No. There is no public list of retailers/distributors authorized to sell Opioid Drugs.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There are currently no proposals for reform or significant change that have been made to the regulation of Opioid Drugs.

35. When are they likely to come into force?

This question is not applicable.