For centuries, the plant we now identify as Cannabis Sativa L has been of great economic interest. It is a versatile plant that is cultivated for nutritional, recreational, industrial, and medical purposes. It is grown worldwide for fibre, seeds, seed oil, and medicinal products.
Hemp v. Marijuana
The Cannabis plant contains over 100 different types of phytocannabinoids including Cannabidiol (CBD) and Tetrahydrocannabinol (THC). The two main cultivars of Cannabis - hemp and marijuana - are differentiated based on their THC profile. Cannabis plants containing less than 0.3% THC are usually classified as hemp or industrial hemp, and those with more than 0.3% THC as marijuana. Hemp produces higher levels of CBD compared to marijuana. CBD is primarily found in leaves, stalks, stems, and flowers.
Interest in CBD
Lately, CBD has generated a lot of interest owing to its therapeutic potential. Unlike THC, CBD does not have psychoactive effects. CBD has shown tremendous potential in the realm of healthcare and is claimed to be safe as well. While there is emerging evidence regarding its various health benefits, it has been shown to be particularly effective in the treatment of epilepsy. In 2018, The US Food and Drug Administration approved Epidiolex (CBD oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, in patients aged two years and older. Several CBD-based products, both domestic and imported, are already available in the Indian market. But the legality and regulation of such products are still not properly understood. As a result, both the CBD industry and end-consumers are considerably affected.
Legal provisions relating to Cannabis
The cultivation, sale, and use of Cannabis in India are regulated under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act) along with the NDPS Rules, 1985.
Section 2(iii) of the Act defines “Cannabis” to include:
- charas, i.e., the separated resin, whether crude or purified, concentrated preparation and resin known as hashish oil or liquid hashish;
- ganja, i.e., the flowering or fruiting tops of the cannabis plant; and
- any mixture, with or without any neutral material, of any of the above forms of Cannabis or any drink thus prepared.
This definition specifically excludes the seeds and leaves of Cannabis.
Section 2(iv) defines “Cannabis plant” to mean any plant of the genus Cannabis. Thus, the Act does not differentiate between hemp and marijuana. Under Section 2(xii), “medicinal cannabis”, ie medicinal hemp, means any extract or tincture of Cannabis (hemp). Under the Act, “narcotic drug” includes Cannabis (hemp) and medicinal cannabis [Section 2(xiv)], and “manufactured drug” includes, among other drugs, medicinal cannabis and any drug notified by the Central government [Section 2(xi)]. The said notified drugs include preparations made from extract or tincture of Indian hemp, except those which are capable only of external use. Also, the manufacture of such drugs requires a manufacturing license.
Section 8 of the Act prohibits the cultivation of Cannabis plants and the production, manufacture, possession, sale, purchase, transportation, warehousing, use, consumption, importation, and exportation of any narcotic drug or psychotropic substance except for medical or scientific purposes. Section 10 of the Act read with Section 8 empowers state governments to regulate Cannabis cultivation and manufacture, as well as possession, transport, sale, purchase, consumption or use of Cannabis (excluding charas) and medicinal cannabis. Section 14 of the Act empowers the government to permit the cultivation of cannabis exclusively for horticultural and industrial purposes by general or special order.
Section 4 of the Act empowers the Central government to take measures for ensuring the availability of narcotic drugs and psychotropic substances for medical and scientific use.
Rule 53 generally prohibits the import and export of narcotic drugs specified in Schedule I, which includes Cannabis (hemp) and its preparation, admixtures, extracts, and other substances containing it. It is further provided that such drugs may be imported or exported subject to proper authorization for the purposes specified in Chapter VIIA.
According to Chapter VIIA, a narcotic drug may be used for scientific purposes; very limited medical requirements of a foreigner; de-addiction of drug addicts; and restraining or immobilising wild animals (Rule 67A). The quantities of various narcotic drugs and psychotropic substances to be supplied as samples are to be determined by the Central government from time to time [Rule 67B(4)]. Rule 67C also empowers the Narcotics Commissioner to permit import or export for the purpose of controlled deliveries, investigation, intelligence collection and scientific analysis.
A combined reading of these provisions seems to suggest that CBD derived from parts other than leaves and seeds (seed contains almost no CBD) fall within the purview of the Act. CBD also qualifies as a narcotic drug and a manufactured drug under the Act. Consequently, its import is permitted only for limited purposes after obtaining the necessary approvals.
Indian v. global views on cannabis regulation
In January 2019, the World Health Organization (WHO) recommended changing the scope of control of Cannabis and related substances. With respect to CBD, the WHO made the following recommendations:
- Delete extracts and tinctures of cannabis from Schedule I of the 1961 Convention. In a 27:24 vote (and 2 abstentions), the WHO decided not to adopt this recommendation.
- Add a footnote to Schedule I of the 1961 Convention to read “Preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabinol are not under international control”. The Commission decided by 43:6 votes (and 4 abstentions) not to add such a footnote.
India voted “no” on both counts.
Conclusion
There is mounting evidence of a range of medical and health benefits of CBD, and there are also no reported side-effects or psychoactive effects, as per the WHO. In this context, strict controls over CBD not only threaten to restrict the growth of an industry with tremendous potential, but also affect consumers who are either deprived of the benefits or fall prey to illegal, spurious or inferior quality products. While India’s position on CBD does not show any signs of changing in the near future, the rapidly evolving scientific and medical developments around CBD suggest that its regulatory controls should be revisited more frequently and more proactively.
Charul Yadav is a Partner at the law firm Obhan & Associates.