Medicinal Cannabis: A Brief History
Cultivation, possession, consumption, and trade in cannabis has been criminally prohibited in India by the Narcotic Drugs and Psychotropic Substances Act, 1985 (‘NDPS Act’) that was enacted by the 8th Lok Sabha in August, 1985. Historically, the cannabis plant has been a key part of Indian culture and rural economy. In the recently published book Cannabis Indica: Perception v. Potential (2022) (‘Cannabis Indica’) medicinal aspects of this healing herb are noted. Cannabis was recognized as a therapeutic agent across many cultures for over 5000 years and was used in ancient ‘Indian Ayurvedic medicine,’ and neighboring China’s claim that their use of medicinal cannabis goes back 2700 BC. In 2019, Prof. Lewis Grossman noted: “Cultures around the world have used marijuana therapeutically for millennia. They have taken it orally, smoked it, and applied it topically. … If occasional marijuana smoking over [decades] carried substantial health risks, the evidence should have started to come in by now.”
The use of cannabis (or bhanga, vijaya, or as plainly and popularly known ganja) is mentioned as a medicine in the work of Maharishi Sushruta written before the 8th century A.D. (Cannabis Indica, p. 41). In 1984 the British Parliament appointed Indian Hemp Drugs Commission (IHDC) gave its report, which noted that the use of cannabis for medicinal purposes went back to the 5th and 12th century. It was used to destroy phlegm, to heal loss of appetite, general digestive aid, to prevent insomnia, relieve anxiety, treat diabetes, impotency, spermatorrhoea, etc. It was found particularly helpful during the cholera epidemics and was recommended to use during the malaria epidemic to counteract the effects of bad air and water. After a very thorough and detailed investigation, the IHDC concluded that: “Cannabis Indica must be looked upon as one of the most important drugs of Indian Materia Medica.” (Cannabis Indica, p. 41-42).
Medicinal Cannabis Defense Under Indian Drug Laws
Unfortunately, none of this was discussed by the 8th Lok Sabha or was otherwise brought to their attention in August, 1985. In 1996, the citizens of California enacted the famed Proposition 215 (also called the Compassionate Use Act, 1996) that allowed Californians to consume medicinal cannabis. This law also introduced the ‘medicinal cannabis’ defense to charges of illegal cannabis cultivation, possession, consumption, and trade etc. According to the ‘medicinal cannabis’ defense, an accused person cannot be declared guilty under a possession, or consumption, or cultivation charge under the drug laws if the accused person can establish that their possession, consumption, or cultivation was for medicinal reasons and authorized by a prescription for medicinal cannabis given by a licensed physician. However, several leading US lawyers and law professors have noted that even after the enactment of Prop. 215 the prosecutors and judges and many times even defense lawyers were totally unaware of what the medicinal cannabis defense is, and how to argue it in courts. It took a lot of time, patience, and a determined collective judicial will to unlearn old rules and master new ones.
Unfortunately, there is no medicinal cannabis defense expressly provided in the NDPS Act or any other union or state legislation that can be pled in defense of cannabis possession, cultivation, or consumption charges. There are no clear Supreme Court decisions to offer guidance as well.
This raises an extremely important question of law of significant public importance: is the medicinal cannabis defense available under Indian Cannabis Law? In our attempt to answer this question today, after going through the analysis offered below, it will be seen that:
- Medicinal cannabis is legal in India.
- Physicians licensed to practice Indian Systems of Medicine (viz. Ayurvedic, Siddha, Unani Tibb, and Sowa-Rigpa systems of medicine) are legally authorized to prescribe cannabis.
- There is a very complicated, multi-tiered licensing mechanism that regulates the entire medicinal cannabis industry. Finally, it will also be seen that the Indian drug laws lack an express ‘medicinal cannabis’ defense. However, such a defense does, by implication, flow from the existing legal regime.
Understanding ‘Medicinal Cannabis’
The first important thing to note is that ‘medicinal cannabis’ is not a concept that is foreign to Indian drug laws. ‘Medicinal cannabis’ is defined in section 2(xii) of the NDPS Act itself to mean any extract or tincture of cannabis. Cannabis, per section 2(iv), means any plant of the genus cannabis. Earlier, we have seen that the section 2(iv) definition offers botanically the most accurate perspective. Similarly, the Medicinal and Toilet Preparations (Excise Duties) Act, 1955 is also based on the premise of medicinal cannabis. In fact the definition of ‘Indian Hemp’ given in section 2(e) of the 1955 Act is more exhaustive and useful as compared to the one in NDPS Act. It includes:
- The leaves, small stalks, flowering or fruiting tops of all forms of cannabis plant (also known as bhang, siddhi, or ganja)
- The pure resin minus any manipulations obtained from the plant (also known as charas)
- Any mixture or drink prepared from Indian hemp (presumably the reference is to the bhang drink)
- Any extract or tincture of any form of Indian hemp. Bhang, ganja, and charas are all recognized for their medicinal value under the Ayurvedic, Siddha, and Unani Tibb systems of medicine and accordingly physicians licensed to practice these systems of medicine are allowed to prescribe them as medicine.
Legal Regime Governing Medicinal Cannabis: Six Parties to One Transaction
Medicinal cannabis is simultaneously governed by at least four sets of legal regulations. These are:
- The NDPS Act, 1985
- The Drugs and Cosmetics Act, 1940
- The National Commission for Indian Systems of Medicine Act, 2020 (‘NCIMS Act’)
- The relevant and applicable state excise legislations. In addition to these four sets of laws, there are a plethora of subordinate legislations that further govern medicinal cannabis. These include the NDPS Rules, 1985, the Drug Rules, 1945, the Code of Professional Ethics in the medical profession as prepared by the National Commission for Indian Systems of Medicine (NCISM), under section 10(1)(h) of the NCISM Act, and lastly, the relevant state excise rules that vary from state to state. In addition to this, multiple licenses have to be obtained at union as well as state levels in order for any person or a body corporate to trade in medicinal cannabis.
If we think about medicinal cannabis strictly from a logistical perspective, we would see that there are six possible parties involved in one medicinal cannabis transaction. These are:
- The Cultivator, or the Procuror
- The Manufacturer
- The Distributor
- The Prescribing Physician
- The Patient
- The State.
The Cultivator or the Procuror is primarily responsible for either growing or procuring the raw material that the Manufacturer then converts into the end product. The Distributor facilitates the seamless distribution of this end product from the manufacturer to either the Prescribing Physician or the Patient. The Prescribing Physician prescribes medicinal cannabis to the patient on the basis of their practice experience and medical discretion. The Patient, of course, is the end consumer who consumes the medicinal cannabis as prescribed by their physician and as manufactured by the Manufacturer.
Here we may note that the manufacture for sale of Ayurvedic, Siddha or Unani drugs on which a general prohibition has been imposed under section 33EEC of the D&C Act has been relaxed by the Drug Rules, 1945. Part XVI of the Drug Rules (rule 151-161B) regulates the manufacture for sale of these drugs. The State Government appoints a licensing authority under rule 152. Application for license may be made under rule 153, whereas an application for a ‘loan license’ may be made under rule 153A.
A ‘loan license’, essentially, is a license issued by the licensing authority to an applicant who does not have their own arrangements for manufacturing but intends to use the existing manufacturing arrangements of another producer. In addition to this, a certificate for good manufacturing practices has to be obtained (rule 153B). A license or a loan license issued under Part XVI of the Drug Rules remain valid perpetually, unless canceled by the government.
The State is everywhere. To begin with, in order to be able to cultivate or procure the raw material required to manufacture medicinal cannabis, the cultivation license or a Wild Growth Procurement License is necessary. After that, a manufacturing license is required to manufacture medicinal cannabis preparations. There is no need for a manufacturing license for a physician licensed to practice medicine under the NCISM Act or its precursor, the Indian Medical Central Council Act, 1970.
Thereafter, a distribution license is required in order to be able to freely distribute the preparations so prepared throughout the territory of India. Luckily, physicians licensed to practice Indian Systems of Medicine (ISMs) require no additional license to prescribe cannabis.
Medical Ethics and Medicinal Cannabis
The phrase ‘Indian System of Medicine’ has been defined under section 2(h) of the NCISM Act to mean ‘Ashtang Ayurveda, Unani, Siddha and Sowa-Rigpa Systems of Medicine’ as supplemented by modern scientific and technological advances from time to time. As per section 27(1)(a) of the NCIMS Act, the Board of Ethics and Registration for ISM is responsible for maintaining a national register of all licensed practitioners of ISMs. Section 32(1) of the same Act declares: “The Board of Ethics and Registration for Indian System of Medicine shall maintain a National Register containing the name, address, all recognised qualifications possessed by a licensed medical practitioner of the Indian System of Medicine and such other particulars as may be specified by regulations.”
It is submitted that the license to practice medicine that is granted upon the registration in the National Register maintained by the Board of Ethics and Registration under the NCISM Act includes within itself the legal authority vested in every physician so registered to prescribe medicinal cannabis on the basis of their medical judgment.
It is also worth noting that a general prohibition on manufacture and sale of certain Ayurvedic, Siddha and Unani drugs has been enacted by section 33EEC of the Drugs and Cosmetics Act, 1940 (‘D&C Act’). As per section 33EEC(a)(iii), no person, either by himself or by any other person, is authorized to manufacture for sale or distribution any Ayurvedic, Siddha or Unani drug in contravention of the D&C Act or any rules made thereunder. There are two important exceptions to this rule. Proviso 1 to section 33EEC lays down: “Provided that nothing in this section shall apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drugs for the use of their own patients,” and proviso 2 lays down: “Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis.”
It would therefore be seen that physicians licensed to practice Ayurvedic, Siddha or Unani systems of medicine under the IMCCA, 1970 as well as physicians licensed to practice ISMs under the NCISM Act, 2020 are legally authorized to prescribe medicinal cannabis to their patients on the basis of their medical experience and judgment. It would be also seen that such physicians do not require any additional provisions from any state authorities or professional bodies whose regulatory oversight they are subject to.
On the authority of section 33EEC, proviso 1, it can further be seen that the Vaidyas and Hakims to whom the provision applies might not require any additional manufacturing licenses to legally manufacture Ayurvedic, Siddha or Unani drugs for the use of their own patients. In any event, it would be very strange to insist that an exception to a rule that regulates manufacturing by a license itself requires an additional license.
Understanding the legal aspects of medicinal cannabis is not an easy undertaking. There is a multiplicity of statutes and administrative regulations. On top of that, there is an extremely complicated system of multiple licenses granted at the union as well as the state level that certainly adds to the compliance cost and perception-based regulation risk that the medicinal cannabis industry is currently exposed to.
Starting from the cultivator or the procuror all the way up to the patient, all parties are equally exposed to very severe criminal charges such as section 20 of the NDPS Act. In August 1985, when the NDPS Act was being debated by the 8th Lok Sabha, it was pointed out by at least four MPs that the Bill was being drafted in undue haste. It was also suggested that the Bill be sent to a select committee for further study. Even the MPs speaking in favour of the Bill were at pains to point out that this is not an urgent issue before the country, does not require urgent legislation, and that therefore, the matter should be sent to a select committee for detailed study. No such effort was made.
As per the legal regime that regulates medicinal cannabis in India today, the first five out of six parties to the transaction as noted above are potentially exposed to criminal charges, the punishment for which ranges anywhere from one year to ten years. It has been noticed by many within the Indian medicinal cannabis industry that even with all the licenses and permissions that they are legally required to obtain, there is no guarantee of immunity from criminal prosecution even though manufacturing and prescribing medicinal cannabis is completely legal and heavily regulated in India. The sword of the NDPS Act constantly hangs over the heads of anybody engaged in cultivation, procurement, manufacturing, trade, and finally consumption of medicinal cannabis.
Legal issues like these (i.e., medicinal cannabis manufacturers at the state level being prosecuted under a federal law) have presented themselves in other comparable jurisdictions as well. Issues like these arose under the US Controlled Substances Act, 1971, and most of them have been settled by the US Federal Courts. Very few issues such as these have gone up to the Supreme Court. This rich body of US case law could be extremely instructive to us in India, and Indian judges and policymakers should be apprised of this jurisprudence as soon as possible.
Disease, pain and suffering are inseparable from the human condition. Indians are just as susceptible to disease, the pain and indignities that follow it, and to human sufferings as any other population. The medicinal properties of cannabis have been known to traditional Indian systems since times immemorial, and modern day western medical sciences are rediscovering this lost knowledge. Any potential risk of abuse and addiction that is generally associated with cannabis use is mitigated by a physician’s prescription and overall medical supervision. However, the fact remains that under the NDPS Act, medicinal cannabis is not an accepted defense to a charge under Section 20. It seems that the rights and interests of the first five parties to this transaction are not adequately secured by the current legal regime, which requires substantial overhaul. Having said that, medicinal cannabis is recognized under Indian drug laws and physicians are indeed authorized to prescribe it.