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Position as on: 04 January, 2021
1. Legal definition of “Cannabis” and its indigenous variants
According to Section 2(iii) of the Narcotics Drugs and Psychotropic Substances Act, 1985 [1] (“NDPS Act”) "cannabis (hemp)" means-
(a) charas, that is the separated resin, in whatever form, whether crude or purified, obtained from the cannabis plant and also includes concentrated preparation and resin known as hashish oil or liquid hashish; )
(b) ganja, the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops), by whatever name they may be known or designated; and
(c) any mixture, with or without any neutral material, or any of the above forms of cannabis or any drink prepared therefrom.
This essentially makes the resin, flowering or fruiting tops of the cannabis plant a narcotic drug. It is important to note here that the leaves and the seeds have been excluded from the above definition. Additionally, edible preparation of cannabis made out of leaves and stem (“Bhang”) has also been exempted from being interpreted under the definition of “cannabis” under the NDPS Act.
2. History
India’s ban on the 'narcotic drug' was heavily shaped by the US’ war on drugs — linking it to “insanity, criminality and death” and “the most violence-causing drug in the history of mankind” among African-American and Hispanic population.
The US was the driving force behind the global prohibition of drugs. This came into effect via the United Nations’ 1961 Convention on Narcotic Drugs ("Convention") which subsequently led to the enactment of the NDPS Act in 1985. The Convention [2] created several international obligations to curb traffic, cultivation, use etc. of narcotic drugs, including cannabis. India is one of the members of three United Nations drug conventions -1961 Single Convention on Narcotic Drugs, 1971 Convention on Psychotropic Substances and 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic. The NDPS Act mainly prohibits cultivation, manufacture, possession, sale, transport etc, of these drugs and substances except for medical and scientific purposes as provided in the Act. The only provision for non-medical legal use within the Act was provided for Bhang. The drugs included under the NDPS Act are cannabis, coca, opium and other narcotic substances.
Reclassification of cannabis- United Nations’ Convention on Narcotic Drugs & World Health Organization
Recently, the reconvened 63rd session of the Commission on Narcotic Drugs (“Commission”) took place in Vienna, Austria from 2nd to 4th December 2020 in which 53 countries took part. The session was organized to discuss the recommendations of the World Health Organization (“WHO”) given to its Secretary General on 24th January 2019. These recommendations came up in the 41st meeting of the WHO Expert Committee on Drug Dependence which was held in Geneva from 12 to 16 November 2018.
Some of the recommendations were as follows [3] :
1. Delete cannabis and cannabis resin from Schedule IV of the 1961 Convention, but to maintain it in Schedule I of the 1961 Convention.
2. Delete extracts and tinctures of cannabis from Schedule I of the 1961 Convention.
3. 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.”
4. Add certain preparations of dronabinol to Schedule III of the 1961 Convention
From the above-mentioned recommendations, the Commission accepted only the first recommendation and rejected the others with comments.
Cannabis was included in Schedule IV of the 1961 Convention and with its removal from the strictest control schedule, consequently, allowing it to be used for medicinal and therapeutic purposes which was not permitted earlier. Recently, the use of cannabidiol (CBD) a non-intoxicating compound, has been increased for wellness therapies. In this session, the Commission further clarified that the use of CBD is not in contravention of international laws.The decision to delete cannabis and related substances from Schedule IV of the 1961 Convention was supported by 27 countries with 25 countries opposing and one abstention. India among other countries, also voted in favour of the recommendation. With this, the position of cannabis which used to come at par with dangerous drugs like heroin as per the NDPS Act will be relaxed. The decisions in the said session could lead to further scientific research into the long-heralded medicinal properties of the plant and the countries would now be required to legalize the use of this drug for medicinal purposes and reform the relevant laws governing the use of cannabis for recreational purposes.
3. Uses of cannabis [4]
Industrial Use- Industrial cannabis is a variety of cannabis that is used for the purposes of extracting fibres, seeds and stalks with an intention to supply raw materials to make many bio-products. It also has lesser psycho-active compounds as compared to medical varieties of cannabis. This is generally done out of wildly growing cannabis and is permissible by law.
Medicinal Use- Medical cannabis refers to the usage of cannabis to treat health problems. It is not used for its psychoactive effects, as the main cannabinoid used in medicinal cannabis is CBD (Non-Psychotropic component). The body also produces its own cannabinoid chemicals. These chemicals play a role in regulating pleasure, memory, thinking, concentration, body movement, awareness of time, appetite, pain, and the senses (taste, touch, smell, hearing, and sight). CBD is a non psychoactive cannabinoid used primarily for its therapeutic and medicinal benefits. Under section 8 of the Narcotic Drugs and Psychotropic Substances Act cultivation of cannabis is permitted under a licence for medicinal and research purposes.
Recreational Use- Recreational use is often described as the non medical and the non industrial use of cannabis. Although regulated or criminalized in certain international jurisdictions, the statistical evidence indicates that the recreational use of cannabis is a cultural phenomenon. The presence of high levels of THC (Psychotropic component) makes it psychoactive in nature. The psychoactive effect created by recreational cannabis is why the overall perception towards cannabis is not well received. It is illegal to recreationally cultivate, consume or procure cannabis in India. Such possession, consumption is punishable under the NDPS Act, based on the quantity possessed/consumed.
4. Legislation- Central and State
A. Narcotic Drugs and Psychotropic Substances Act, 1985
The Narcotic Drugs and Psychotropic Substances Act, 1985 and Narcotic Drugs and Psychotropic Substances Rules, 1985 [5] (“NDPS Rules”) was passed with a view to consolidate and amend the laws and regulations relating to narcotic drugs and psychotropic substances, and also to uphold India’s commitment to international anti drug conventions and treaties. It primarily pertains to the possession, sale, purchase, production and use of narcotic or psychotropic substances.
The NDPS Act clearly lists cannabis as a narcotic drug under section 2(iii) of the NDPS Act. It, however, only prohibits the consumption of certain parts and preparations of the cannabis plant like the flower and resin created from the plant or its buds, namely “Charas” and “Ganja”. Whereas the production of products made with cannabis seeds, leaves and Bhang are left out from the definition.
While Section 8 of the NDPS Act does permit the use of cannabis for medicinal purposes, there are no further provisions regulating the use of this drug. Moreover, punishments for contravention of this Act as given under Section 20 prescribes a stringent and non rehabilitative punishment for anyone who cultivates, produces, manufactures, possesses, sells, purchases, transports, imports inter-state, exports inter-state or uses cannabis.
1. Punishment for small quantity- Maximum of 1 year rigorous imprisonment or a fine up to Rs 10,000 or both.
2. Punishment for commercial quantity- Rigorous imprisonment from 10 years (min) to 20 years (max) and a fine from Rs 1 lakh to 2 lakhs.
3. Punishment for quantity greater than small but lesser than commercial (Intermediate)- Rigorous imprisonment that may extend to 10 years & fine that may extend to Rs 1 lakh.
4. Repeat offenders- One and half times the punishment for the offence. Death penalty in some cases. (Sec. 31A)
The Government of Punjab has even recommended to the central government that a mandatory death penalty be initiated for those convicted of drug peddling or smuggling, including first time offenders. While the Mumbai High Court has ruled against the mandatory death penalty in the Indian Harm Reduction Network vs The Union Of India case.
Section 10 of the NDPS Act empowers the State Governments to permit and regulate possession and inter-state movement of opium, poppy straw, the manufacture of medicinal opium and the cultivation of cannabis. The psychoactive parts (THC) of the cannabis plant are generally regulated or prohibited for use. Individual states are at liberty to issue their own guidelines on the same with varying thresholds of such psychoactive substances. Among the three states (Uttarakhand, UP and MP) which have permitted cultivation of cannabis, only Uttarakhand has set a threshold for acceptable THC levels at 0.3%.
Section 14 of the NDPS Act provides that the government has the power to allow cultivation of cannabis for industrial purposes for obtaining fibre or seed or for horticultural purposes only. There is a meager mention of cultivation being allowed for medicinal purposes in Section 8 of the NDPS Act.
Enforcement Directorates of the NDPS Act:
• Directorate of Revenue Intelligence
• Central Bureau of Narcotics
• NCB
• Customs
• Excise (central & state)
• BSF, para military forces or other designated officers
• Police including Anti Narcotic Cells
Landmark Judgements under the NDPS Act:
i. Abdul Aziz v. State of U.P. [6]; Shaji v. State of Kerala [7]; Stefan Mueller v. State of Maharashtra [8] A person arrested under the Act for minor offences like consumption and those involving small quantities of narcotic drugs and psychotropic substances is entitled to bail.
ii. E. Michael Raj v. Intelligence Officer, Narcotic Control Bureau [9]
The Supreme Court held that for drugs mixed with ‘neutral substances’, only the actual content of the pure content of the narcotic drug is relevant for determining whether it constitutes a small or commercial quantity. Despite such precedent, the government declared that in calculating the quantity, the total weight of the seized product must be considered and not the pure drug content (via- Notification through S.O.2941 (E), dated 18 November 2009)
iii. Indian Harm Reduction Network v Union of India [10]
A constitutional challenge was brought before the Bombay High Court on whether the death penalty given under the NDPS Act is mandatory? The Court declared the provision unconstitutional and read the same as discretionary, that is, in a manner where the sentencing court will hear the offender on punishment and have the power to impose a prison sentence instead of death.
iv. State Of Rajasthan vs Parmanand And Anr [11]
The Supreme Court held that “a joint communication of the right available under Section 50 (1) of the NDPS Act to the accused would frustrate the very purport of Section 50. Communication of the said right to the person who is about to be searched is not an empty formality. It has a purpose. Most of the offences under the NDPS Act carry stringent punishment and, therefore, the prescribed procedure has to be meticulously followed...”. Hence, if the recovery of illicit contraband took place from the bag carried by the accused, Section 50 of the Act would apply, and non-compliance therewith would impair the trial.
B. Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
The Drugs and Cosmetics Act, 1940 [12] and Rules, 1945 [13] govern the import, manufacture, distribution and sale of every drug in India including those of the Ayurvedic, Unani, Siddha and Homeopathic ("ASU") systems of medicine. It sets down specific standards of toxicity tests, composition, standardization, labelling etc. that each drug must comply with. It is under the interpretation of this Act that a drug can be deemed spurious, adulterated or misbranded and therefore, illegal within the territory of India.
As enumerated in “the National Policy on Narcotic Drugs and Substances”, Bhang made from cannabis leaves is not covered in the definition of cannabis and State governments have power to make rules for the same. Several states permit the production and sale of Bhang by licensed shops only. Whoever is so licensed to produce Bhang is allowed to produce it from the leaves of the wildly grown cannabis plants only. [14] Each state has its own rules and regulations regarding the ingestion, ownership, distribution and acquisition of cannabis in the country.
C. Pharma-Legal: Ayurvedic drugs and regulatory compliance
Labelling/ Packaging
As per Rule 161(2) of Drugs & Cosmetics Rules, the container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E(1), be labelled conspicuously with the words ‘Caution: to be taken under medical supervision’ both English and Hindi languages. Cannabis is a Schedule E(1) drug under the Drugs & Cosmetics Rules, 1945.
Import
1. Ordinarily, as per Rule 53, NDPS Rules, Narcotic Drugs (which includes cannabis) may not be imported into and exported out of India, however, under Rule 56, the Narcotics Commissioner may issue an import certificate, on an application being made.
2. The application must be accompanied by the excise certificate issued by the State Government.
3. As per the Plant Quarantine Order, 2003, issued by the Directorate of Plant Protection, Quarantine and Storage, Ministry of Agriculture and Farmers Welfare, Government of India, cannabis is a Schedule VII item, which means that an import permit is not required for the same, and import is permissible on the basis of ‘phytosanitary certificate’ issued by the exporting country, and the inspection conducted by the Plant Protection Adviser or officers authorized by him, and fumigation, if required.
4. A Pest Risk Analysis or a Plant Quarantine Clearance is not required for cannabis.
Manufacturing Licence
1. According to Rule 153 of Drugs & Cosmetics Rules,1945, an application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24D to the Licencing Authority.
2. Rule 154 of Drugs & Cosmetics Rules, 1945 states that- subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25D. The licence shall be issued within a period of three months from the date of receipt of the application licensing authority along with a fee of rupees one thousand.
3. Rule156 of Drugs & Cosmetics Rules,1945 lays down rules for procurement of original license in Form 25D or a renewal licence in Form 26D. The licence shall be valid for a period of three years from the date of its issue if not suspended or cancelled before time.
4. Rule 157 of Drugs & Cosmetics Rules, 1945 enumerates the following conditions to be fulfilled before a licence is granted-
The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out in such premises and under such hygienic conditions as are specified in Schedule T.
For getting a certificate of Good Manufacturing Practices of Ayurveda-Siddha-Unani drugs, the applicant shall make an application providing the information on existing infrastructure of the manufacturing unit, and the licensing authority shall after verification of the requirements as per Schedule T, issue the certificate within a period of three months in Form 26 E-I
It shall be conducted under the direction and supervision of competent technical staff consisting at least of one person, who is a whole-time employee and who possesses the qualifications mentioned in this sub clause.
For patent or proprietary medicine under section 3(h) of the Drugs and Cosmetics Act- As a regulatory requirement, evidence regarding efficacy for the ASU drug needs to be supported by textual rationale, published literature and pilot study. Pilot study is only required when textual rationale, published literature and textual indications based on authoritative ASU books are not provided in support of indication for intended ASU drug.(Rule 158B)
5. There are two types of manufacturing licences. One is issued for manufacturing in one's own premises with one's own resources, the other is called a loan licence, in which the resources of a third party are utilized to manufacture the products. Both have a similar application process under the Drugs and Cosmetics Rules. The other way to retail ASU products is by third party manufacturing, white labelling or contract manufacturing in which the process of manufacturing is outsourced but the retail is done in one's own brand name.
Process to procure licence
1. Application must be made to the State Government for a license under Rule 36(3) of the NDPS Rules for grant of license. Since only three states have started granting licenses for the cultivation of cannabis, it is not clear to whom the application shall be made in other states. The three states that presently have a policy on hemp cultivation are Uttarakhand, Uttar Pradesh, and Madhya Pradesh. In Uttarakhand the application shall be made to the District Magistrate, whereas in UP and MP, the application has to be made to the Excise Department.
2. For grant of import license, first an application shall be made to the State Government for the issue of an excise certificate. This certificate shall accompany the application being made to the Narcotics Commissioner for import.
3. For the manufacture and sale of ASU drugs containing cannabis, an application for grant of license (under Form 24-A), shall be made to the Licencing Authority [15] notified by the State Government under the Drugs and Cosmetics Act. For example, in Karnataka the application will have to be made to the Drug Controller, Drugs Control Department which is under the aegis of the Ministry of Health and Family Welfare.
4. The composition, benefits and manner of use of the medicines will have to be demonstrated. It is advisable that the opinion of an expert on ASU medicines be sought for precise instructions regarding the same.
5. The clinical trials shall be conducted to comply with Rule 158(B) of the Drugs and Cosmetics Rules. The clinical trials must be conducted in accordance with the guidelines laid down by the Indian Council of Medical Research.
GMP Certification: Good Manufacturing Practice
Good Manufacturing Practice ("GMP") for ASU Drugs is described in Rule 157 of Drugs & Cosmetics Rules 1945 with conditions as specified in its Schedule T. It’s a framework which guarantees that the items are reliably produced and controlled as per the quality principles norm as recommended in accordance with the Drugs and Cosmetics Act. The aim behind such certification is to limit the dangers associated with any pharmaceutical creation. Certificate of GMP demonstrates that the pharmaceutical manufacturing organization has gone through the examination and passed it conducted by the regulatory body of that country and is sheltered even to be traded and it guarantees that the item fulfils the guidelines of good manufacturing practices as expressed by the WHO.
5. Miscellaneous FAQs
1. Is domestic cultivation for personal use allowed?
Domestic cultivation for personal use is prohibited under the NDPS Act. Cultivation is permitted only for research and medicinal purposes under the licence issued by the respective state excise department. Such cultivation is also regulated in terms of the psychoactive substance (THC) the plant can contain. A licence to possess and cultivate cannabis is a prerequisite in all cases.
2. Can I transport cannabis from one state to another?
For intra-state cannabis transport, generally, one must procure a “Transport Permit” from the excise department from which the cannabis shipment is to be dispatched. Along with it, one must also show documentary evidence that allows them to hold, transfer cannabis and the amount thereof. This should be done in consonance with laws of the respective State to and from which such transport is to take place.
3. What other licences are required to manufacture, sell cannabis products?
A licence to hold cannabis for manufacturing medicines or for research purposes must be obtained from the state excise department of the jurisdiction in which one is to conduct the manufacturing process. Such licence/ permit shall also contain the rules of how the permitted amounts of cannabis is to be kept, used and recorded on paper.
4. Is possession of CBD isolate strains legal?
There is no specific regulation allowing the possession of CBD strains per se. As there is no proper distinction between THC and CBD in India, it is illegal to possess any type of hemp/cannabis variant as mentioned in Section 2(iii) of the NDPS Act without the requisite licence, except bhang, seeds and leaves of the cannabis plant. States like Uttarakhand have made an effort to set a threshold of the permissible THC (currently 0.3) levels in cultivation, without any mention of CBD. Moreover, no such thresholds have been established for the consumption of cannabis.
5. How are the Cannabis plants grown and allocated for legal use?
Allocation is entirely regulated and governed by the excise department of respective states. The allocation works in a contract system wherein tenders are distributed by the excise department for parts of wildly grown cannabis. Such cannabis has to be wildly grown and should be at a pre-budding stage or at a stage where the cannabis plant is still immature and hasn’t developed resins. In a case where such resins have developed, the plant has to be destroyed.The leaves and seed are then procured for allocation from the cannabis plants which are in consonance with the above rules.
Endnotes
[4] Cannabis 101
[5] NDPS Rules 1985
[6] 2002 CriLJ 2913
[7] 2004 (3) KLT 270
[8] 2010(112(7))BomLR2990
[9] (2008) 5 SCC 161
[10] 2012BomCR(Cri)121
[11] MANU/SCOR/7272/2014
This post was authored by Abhinav Goyal & Aparna Sridharan
The authors may be contacted at abhinav@sigmachambers.in.
DISCLAIMER. THIS CONTENT HAS BEEN PREPARED FOR INFORMATIONAL PURPOSES ALONE AND IS NOT A SUBSTITUTE FOR LEGAL ADVICE. PLEASE OBTAIN LEGAL ADVICE PRIOR TO ACTING ON OR RELYING ON THE CONTENTS OF THIS PAGE.
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