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<h2 style="text-align: left" id="contextualising-cannabis-regulations">Contextualising Cannabis Regulations</h2><p style="text-align: left" class="null">“Is this even legal? What are the rules and regulations governing cannabis?” These are often the first questions that arise whenever someone comes across cannabis medicine in India. In this brief explainer, we break-down what the current laws governing cannabis are, and their likely evolution in years to come.</p><p style="text-align: left" class="null">In India, cannabis is a restricted substance, governed by the draconian Narcotics Drugs and Psychotropic Substances (NDPS) Act. It is pertinent to note that prior to the enactment of the NDPS Act in 1985, cannabis was legal in India. But as a founding member of the United Nations, and as signatory to the United Nation’s Single Convention on Narcotics Drugs which it signed in 1961, India was obliged to ratify into its local laws its international obligations under this UN Convention, which outlawed cannabis. It is thus that the NDPS Act was born.</p><p style="text-align: left" class="null">However, due credit must be given to the mandarins in New Delhi who, when drafting the NDPS Act, recognised that cannabis was widely cultivated across the country, and had been for millennia. Furthermore, India’s classical medicine systems, primarily Ayurveda and Unani, classified cannabis as a therapeutic herb, and cannabis was widely used as an ingredient in many classical medical formulations. Furthermore, large parts of the Indian population, especially persons residing in rural areas, often relied on these traditional medicine systems for primary care. Keeping all this in mind, while ensuring India did not fall foul of its international commitments, the government of the day enacted the NDPS Act, but carved out exceptions, which remain in force today, and which make India a uniquely interesting and uniquely positioned country with respective to cannabis medicine regulations.</p><h2 style="text-align: left" id="legality-under-ndps">Legality Under NDPS</h2><p style="text-align: left" class="null">The first thing to note is that cannabis cultivation is banned in India. However, the NDPS Act allows State governments to enact Rules for the cultivation of cannabis for scientific, medical and industrial purposes. In other words, cultivation for recreational use is expressly forbidden, but enabling provisions in the Act exist to allow for cultivation for scientific/industrial uses. It is under these provisions that various State governments, such as Uttarakhand, Uttar Pradesh, Orissa, Madhya Pradesh, Jammu &amp; Kashmir, Himachal Pradesh and others have enacted, or are contemplating enacting cannabis cultivation regulations.</p><p style="text-align: left" class="null">The other interesting facet to note is that while the NDPS Act disallowed cannabis cultivation, it defined only the flower/bud of the cannabis plant as <em>ganja</em>. Thus, only the fruiting top of the cannabis plant and resin extracted from this fruiting top (<em>charas</em>) are expressly prohibited. All other parts of the plant, that is the seed, leaf, stem, stalk and roots are allowed to be used for various purposes, including medical/horticultural/industrial uses. Now it is anyone’s guess how one part of a plant can be legal and another part illegal, but it is this unique legal definition that actually sets India apart from many other countries that have explored deregulating or legalising cannabis for industrial/medical/recreational use.</p><h2 style="text-align: left" id="cannabis-medicine">Cannabis Medicine</h2><p style="text-align: left" class="null"></p><p style="text-align: left" class="null">Cannabis is listed as a therapeutic herb in the Ayurvedic Pharmacopoeia of India (API). The API is a book of standards listing all therapeutic herbs, minerals, metals (single drugs) that can be manufactured, sold and marketed across India. Thus, classical formulations, listed in reference texts of Ayurveda and Unani systems of medicine, and even novel, proprietary formulations, made using single drugs listed in the API, can be manufactured and sold as medicine across the country.&nbsp;</p><p style="text-align: left" class="null">Given that Ayurveda is the science of “whole-plant” medicine, cannabis formulations approved under India’s Ayurveda regulations must necessarily be made using “whole-plant” extracts. Another common reference to “whole-plant” extract is “full-spectrum” extract, which refers to an extract of the cannabis plant (‘cannabis leaf’ in India) that retains <em>all</em> the cannabinoids, terpenes and flavonoids found in the cannabis plant, that is over 500 unique compounds. It is pertinent to note that even in countries around the world conducting “modern” pharmacological research, “full-spectrum” extracts are proving more efficacious than any single cannabis compound in isolation.</p><p style="text-align: left" class="null">Which brings us to the fact that isolated cannabis compounds, in other words, single compounds such as THC or CBD, or even their combination in any ratio, are illegal in India. This is because modern drug rules require that any compound which is used in a medical preparation must first undergo a series of tests to establish the safety and efficacy of that compound – which is a long and expensive exercise wherein India’s allopathic drug regulator needs to sanction each stage of this clinical testing process. Only once a compound has successfully undergone these tests/trials does it get listed in the Indian Pharmacopoeia (IP) – which is like the API, but lists all single molecules/compounds used in modern allopathic formulations. No cannabinoid, whether THC or CBD or any other, is listed in the IP – thus anyone selling any product marketed just as CBD or THC or any ratio thereof is technically operating in a regulatory grey-zone. Furthermore, isolated THC is specifically illegal in India, as the Central Bureau of Narcotics has listed THC as a narcotic substance; whereas CBD is neither legal nor illegal.</p><p style="text-align: left" class="null">For this reason, any patient accessing cannabis-based medicines in India should be cautious only to purchase medicines approved by India’s traditional medicine regulator, that is the AYUSH Department of the Govt. of India; and these medicines should be “whole-plant” extracts and not simple THC or CBD.</p><h2 style="text-align: left" id="oral-vs-topical-medicine">Oral vs. Topical Medicine</h2><p style="text-align: left" class="null">One further distinction to be understood is the difference in regulations governing oral versus topical cannabis medicines. As cannabis-based medicines fall under “Schedule E(1)” of the Drugs &amp; Cosmetics Rules, any formulation containing substances listed under Schedule E(1), and meant for oral consumption, should be “taken under medical supervision”. Given the vagueness of this official guidance, it is better to interpret the same strictly and equate “should be taken under medical supervision” as “prescription medicine”. Technically, only drugs listed under “Schedule H” of the Drugs &amp; Cosmetics Rules require a doctor’s prescription – but given the potential for abuse of drugs containing cannabis, it is prudent to equate Schedule E(1) with Schedule H and allow access to oral cannabis medicines only post a prescription from a Registered Medical Practitioner.</p><p style="text-align: left" class="null">No such restriction is applicable to topical medicines. These can be sold over the counter, thus any formulations in form factors such as oils, creams, gels, balms, and patches can be bought and used by persons as per need. Such topical formulations typically target localised pain relief, inflammations and dermatological use cases.</p><p style="text-align: left" class="null">Explore from our wide range of plant based medicine <a target="_blank" rel="noopener noreferrer nofollow" href="https://shop.savikalpa.com/collections/shunyata">here</a>.</p>

“Is this even legal? What are the rules and regulations governing cannabis?” These are often the first questions that arise whenever someone comes across cannabis medicine in India. In this brief explainer, we break-down what the current laws governing cannabis are, and their likely evolution in years to come.

In India, cannabis is a restricted substance, governed by the draconian Narcotics Drugs and Psychotropic Substances (NDPS) Act. It is pertinent to note that prior to the enactment of the NDPS Act in 1985, cannabis was legal in India. But as a founding member of the United Nations, and as signatory to the United Nation’s Single Convention on Narcotics Drugs which it signed in 1961, India was obliged to ratify into its local laws its international obligations under this UN Convention, which outlawed cannabis. It is thus that the NDPS Act was born.

However, due credit must be given to the mandarins in New Delhi who, when drafting the NDPS Act, recognised that cannabis was widely cultivated across the country, and had been for millennia. Furthermore, India’s classical medicine systems, primarily Ayurveda and Unani, classified cannabis as a therapeutic herb, and cannabis was widely used as an ingredient in many classical medical formulations. Furthermore, large parts of the Indian population, especially persons residing in rural areas, often relied on these traditional medicine systems for primary care. Keeping all this in mind, while ensuring India did not fall foul of its international commitments, the government of the day enacted the NDPS Act, but carved out exceptions, which remain in force today, and which make India a uniquely interesting and uniquely positioned country with respective to cannabis medicine regulations.

The first thing to note is that cannabis cultivation is banned in India. However, the NDPS Act allows State governments to enact Rules for the cultivation of cannabis for scientific, medical and industrial purposes. In other words, cultivation for recreational use is expressly forbidden, but enabling provisions in the Act exist to allow for cultivation for scientific/industrial uses. It is under these provisions that various State governments, such as Uttarakhand, Uttar Pradesh, Orissa, Madhya Pradesh, Jammu & Kashmir, Himachal Pradesh and others have enacted, or are contemplating enacting cannabis cultivation regulations.

The other interesting facet to note is that while the NDPS Act disallowed cannabis cultivation, it defined only the flower/bud of the cannabis plant as 

. Thus, only the fruiting top of the cannabis plant and resin extracted from this fruiting top (

) are expressly prohibited. All other parts of the plant, that is the seed, leaf, stem, stalk and roots are allowed to be used for various purposes, including medical/horticultural/industrial uses. Now it is anyone’s guess how one part of a plant can be legal and another part illegal, but it is this unique legal definition that actually sets India apart from many other countries that have explored deregulating or legalising cannabis for industrial/medical/recreational use.

Cannabis is listed as a therapeutic herb in the Ayurvedic Pharmacopoeia of India (API). The API is a book of standards listing all therapeutic herbs, minerals, metals (single drugs) that can be manufactured, sold and marketed across India. Thus, classical formulations, listed in reference texts of Ayurveda and Unani systems of medicine, and even novel, proprietary formulations, made using single drugs listed in the API, can be manufactured and sold as medicine across the country. 

Given that Ayurveda is the science of “whole-plant” medicine, cannabis formulations approved under India’s Ayurveda regulations must necessarily be made using “whole-plant” extracts. Another common reference to “whole-plant” extract is “full-spectrum” extract, which refers to an extract of the cannabis plant (‘cannabis leaf’ in India) that retains 

 the cannabinoids, terpenes and flavonoids found in the cannabis plant, that is over 500 unique compounds. It is pertinent to note that even in countries around the world conducting “modern” pharmacological research, “full-spectrum” extracts are proving more efficacious than any single cannabis compound in isolation.

Which brings us to the fact that isolated cannabis compounds, in other words, single compounds such as THC or CBD, or even their combination in any ratio, are illegal in India. This is because modern drug rules require that any compound which is used in a medical preparation must first undergo a series of tests to establish the safety and efficacy of that compound – which is a long and expensive exercise wherein India’s allopathic drug regulator needs to sanction each stage of this clinical testing process. Only once a compound has successfully undergone these tests/trials does it get listed in the Indian Pharmacopoeia (IP) – which is like the API, but lists all single molecules/compounds used in modern allopathic formulations. No cannabinoid, whether THC or CBD or any other, is listed in the IP – thus anyone selling any product marketed just as CBD or THC or any ratio thereof is technically operating in a regulatory grey-zone. Furthermore, isolated THC is specifically illegal in India, as the Central Bureau of Narcotics has listed THC as a narcotic substance; whereas CBD is neither legal nor illegal.

For this reason, any patient accessing cannabis-based medicines in India should be cautious only to purchase medicines approved by India’s traditional medicine regulator, that is the AYUSH Department of the Govt. of India; and these medicines should be “whole-plant” extracts and not simple THC or CBD.

One further distinction to be understood is the difference in regulations governing oral versus topical cannabis medicines. As cannabis-based medicines fall under “Schedule E(1)” of the Drugs & Cosmetics Rules, any formulation containing substances listed under Schedule E(1), and meant for oral consumption, should be “taken under medical supervision”. Given the vagueness of this official guidance, it is better to interpret the same strictly and equate “should be taken under medical supervision” as “prescription medicine”. Technically, only drugs listed under “Schedule H” of the Drugs & Cosmetics Rules require a doctor’s prescription – but given the potential for abuse of drugs containing cannabis, it is prudent to equate Schedule E(1) with Schedule H and allow access to oral cannabis medicines only post a prescription from a Registered Medical Practitioner.

No such restriction is applicable to topical medicines. These can be sold over the counter, thus any formulations in form factors such as oils, creams, gels, balms, and patches can be bought and used by persons as per need. Such topical formulations typically target localised pain relief, inflammations and dermatological use cases.

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The Savikalpa Journal

Is Cannabis Legal in India? Here's Everything You Need to Know