A New Era Of Treatment: Medicinal Cannabis In India

by Anurit Kanti
Source: businessworld.in

Cannabis is something which brings up many thoughts in the Indian mind. A subject of intense debate globally, cannabis is finding increasing acceptance in the medical community, with major developments abroad in terms of policy and society for accepting medicinal cannabis. With the use of cannabis for medical use thoroughly ingrained in the Indian Ayurveda and Atharvaveda system, it is high time that there is a consensus about its huge medicinal potential. In an exclusive interview with BW Businessworld, Dr. Arno Hazekamp, scientific advisor to Bombay Hemp Company (BOHECO) and global cannabis expert, Avnish Pandya, Director of Research and Development at BOHECO and Siddhant Mistry, Associate Scientist at BOHECO discuss the various facets of medicinal cannabis, its use in Indian medical history, its medicinal benefits and the policy changes in India set to take place with respect to medicinal cannabis. Edited excerpts: 

How deeply imbibed is the medicinal use of cannabis in Indian medical history? Why is it's medicinal use shunned in contemporary Indian society?

The cannabis plant has been used in India since the dawn of time, based on written sources and archeological findings. In old times, the plant was used not only for medicinal use but also for cultural, religious and spiritual reasons. Moreover, hemp seeds were a common, and nutritious, food. In short: cannabis played many roles for different groups of people. The medicinal use became increasingly shunned only in the 20th century, not only in India but worldwide. The reason was that cannabis has medicinal uses, but can also be used as a narcotic drug. When cannabis plants became more potent as a result of breeding and selection, and the medical use became more obsolete as a result of opiates and other modern drugs, there was no more practical need for cannabis. Since 1961, cannabis has been banned worldwide, including in India. In recent times, it has become clearer that opiates may be more dangerous than initially believed, while cannabis turns out to be more medicinally useful that believed. Now the medicinal use of cannabis is increasingly embraced by other countries, India can surely not stay behind to claim back one of its most authentic medicinal plants.

Can you briefly describe some of the proven medical uses of cannabis? What is the comparison between the medical properties of cannabinoids vs the medical properties of opioids in treating pain?

The problem with ‘proven’ medicinal effects is that such claims are based on the gold standard of modern clinical research: the placebo-controlled, double-blind, randomized clinical trial. Such trials have been hard to do over the last few decades, as a result of the cost (who is going to pay for such expensive trials when you can not patent the cannabis plant to be yours), and the lack of pharmaceutical grade cannabis in most countries. The lack of clinical trials does not reflect the fact it does not work, but it reflects how hard it is to set up and execute such trials. Nevertheless, studies are increasingly being done around the world, and the following effects of the main cannabis components THC and CBD are most proven, based on a recent meta-analysis.

There is conclusive or substantial evidence that cannabis or cannabinoids are effective:

• For the treatment of chronic pain in adults

• As antiemetics in the treatment of chemotherapy-induced nausea and vomiting

• For improving patient-reported multiple sclerosis spasticity symptoms

There is more moderate evidence that cannabis or cannabinoids are effective for:

• Improving short-term sleep outcomes in individuals with sleep disturbance associated with obstructive sleep apnea syndrome, fibromyalgia, chronic pain, and multiple sclerosis

• Increasing appetite and decreasing weight loss associated with HIV/AIDS

• Improving clinician-measured multiple sclerosis spasticity symptoms

• Improving symptoms of Tourette syndrome

• Improving anxiety symptoms, in individuals with social anxiety disorders

• Improving symptoms of posttraumatic stress disorder

Please note that THC and CBD have different therapeutic effects that can sometimes overlap and sometimes work synergistically.

Opiates have been gold standard for use in pain alleviation not only in the end of life care but also in a variety of other ailments. Over a period of time, the most abundant painkiller or analgesic to come to light has been opiates. Opium has been used so predominantly in the west and the upcoming eastern part of the world as a successful analgesic in the pharmaceutical industry where it is used abundantly till date for.

1. Reducing pain scores

2. Inducing sleep

3. Analgesic

Even though it fulfills the requirements of a painkiller the drawbacks/ side-effects during or post-treatment harbor potential negative consequences such as:

1. Opioid overdose morbidity

2. Opioid analgesic overdose mortality

3. Constipation

4. Physical dependence

The most common side effect of opiates are constipation and nausea.

As of today itself, opiates and its derivates cause the death of 91 American individuals daily due to opioid analgesic overdose morbidity. Hence we can conclude that, in the battle of Cannabinoids vs Opioids, Cannabinoids are safer analgesic as even at high concentration dosage and administration of Cannabinoids to humans does not cause death as compared to opiates which are also highly addictive. 

How can the recreational use of cannabis be separated from its medicinal use? What are the possible steps which can be taken in ending the stigma towards cannabis in India?

In countries that have experience with introducing medicinal cannabis, separation between medicinal and recreational markets is done by taking care of the following aspects:

1. Medicinal cannabis products are made and handled by official, certified parties only (cultivation, harvest, packaging, lab research, distribution). They have to take care of proper bookkeeping and security.

2. These products are available on prescription only, for patients who have a serious and well-documented illness.

3. Cannabis as a medicine is provided after regular medicines have been tried, but fail to have sufficient therapeutic effect.

4. Medicinal use is always done under the supervision of a physician or pharmacist.

5. The cost of medicinal cannabis is not much different from the price of the black market. If medicinal cannabis is too cheap it may be resold on the black market, if it is too expensive patients will search for cheaper materials on the black market.

6. Medicinal cannabis is quality controlled, meaning there are no contaminants present and the content of cannabinoids is always the same.

The first step in ending stigma in India, and any other country, is to make cannabis available for very sick patients, and palliative patients, first. It is much easier to accept cannabis medicines for severely ill patients, than just to introduce it for large groups all at once. Every society needs to get used to cannabis medicine after so many decades of prohibition. Give those who fear it some time to readjust and see for themselves it relieves suffering.

According to the Traditional Knowledge Digital Library and the Central Council for Research in Ayurvedic Sciences, what are the pharmacological properties of Cannabis?

According to the TKDl of India, Cannabis has been used over 1000 years in our Ayurveda and other alternative systems of Medicine like Unani and Siddha e.g the use of bhang and its formulation has been known for over 1000 years. In the TKDl the use of Cannabis has mainly been for its analgesic, anesthetic properties, and a resolvent. A very well-known property of Cannabis is also appetite stimulation. Within the TKDl, Cannabis is also present as a part of many formulations which are polyherbal and have been used since many years in India for medical purposes.

Within the CCRAS ambit, Cannabis has showcased the effect of a potent analgesic, antiemetic, appetite stimulant, sleep inducer, improves reproductive capacity, strengthens the GI tract, is a diuretic, helps in dysmenorrhea, cough as well as tuberculosis.

How can an age-old medicine such as cannabis be modernized in the Indian medical context? What has been the progress so far?

The difference between traditional medicine and modern medicine is mainly in the understanding of risks versus benefits, and in the certified quality of the products. The main elements are:

-modern medicinal cannabis should be standardized (always the same chemical composition, e.g. THC and CBD content), and should be free of contaminants (such as pesticides, heavy metals, fungi and bacteria, or other toxic compounds).

-the risks (side effects) versus benefits (therapeutic effects) should be studied in well designed clinical trials, especially for vulnerable patient groups such as the elderly, children, or immunocompromised patients. For palliative care, the use of cannabis products should be much easier.

How soon can we expect cannabis-based medicines in India?

India has a well-developed pharmaceutical industry, and some world-class research institutes. They are very well capable of turning Indian cannabis into medical products for the Indian and international market. If the development of these products is seriously supported (proper funding, easy access to permits, research institutes are interested), the first products could be available in 1-2 years. In order to play on the international stage, we have to consider quality standards such as ISO, GMP, FDA etc. Also, this may take more time because of the need to do more extensive clinical trials. In that case, we are probably looking at 3-5 years. It should be noted that some products, such as CBD-oil, may also be sold as a food supplement without extensive clinical testing.

What are the different medical applications of the non-narcotic component/cannabinoid of cannabis which is CBD, as opposed to the narcotic component/cannabinoid which is THC? Can these cannabinoids be individually extracted for medicinal use?

THC and CBD are both cannabinoids that are found in cannabis plants. However, they usually do not occur in the same plant. Rather, THC is found in marijuana type cannabis, while CBD is more prominent in hemp type cannabis. There are many more cannabinoids, such as CBG or THCV, which are also found in some varieties of cannabis. One of the tasks of cannabis researchers today is to find different cannabis varieties with unique cannabinoid content, for example from the Himalayas.

Cannabinoids can be isolated individually from cannabis varieties and mixed in any combination possible. CBD is a non-psychotropic cannabinoid that can be more easily used in medicine because it does not make you high. It seems to be very good for conditions where the nervous system is affected (epilepsy, anxiety, stress, alzheimer's etc.). THC is the famous psychotropic from cannabis that makes you feel high. However, it also has strong analgesic properties and can treat the symptoms of MS or chemotherapy. Because there are so many possible combinations possible of the cannabinoids, it is still difficult to say what cannabinoids are most optimal to treat specific diseases.

Studies can be done with whole cannabis plants (more holistic, all compounds are present) but also with extracts (only some compounds are present) or with the individual, single cannabinoids.

How conducive is the current Indian policy scenario/environment for accepting the medicinal use of cannabis? What are the lessons which can be learnt from medicinal cannabis policies of other nations for India?

Globally at the moment, Cannabis is an unknown territory for a lot of countries, but there are a handful of countries which have a very well organized regulatory framework for the introduction of Cannabis-based medicines in mainstream medicine or as an alternative medicine. These countries have created an access scheme for patients who are severely in need of these medications in the areas of Chronic pain, epilepsy, Multiple Sclerosis based symptom control and chemo therapy induced nausea and vomiting. In The Netherlands, for example, there is an overlooking administration called the Office of Medicinal Cannabis which is under the Dutch Ministry of Health which takes care of all activates with respect to Cannabis products and its utilization within the country as well as the import and export of medicinal cannabis in the event other countries require this material and have the required permits. Other countries have similar controlling bodies, that oversee the production, quality control and distribution of medicinal cannabis products. Examples are Italy, Germany, Australia and Canada.  

Cannabis has been intertwined with Indian history for over 1000 years. If the Indian Government can create the right framework for the medical use of cannabis in India, for conditions like chronic pain and for symptom management in other chronic and debilitating diseases like cancer which are on the rise in India, this could go a long way in helping these people. Not only has cannabis showcased promising results in that domain but also the fact that this plant was being used in our traditional medicine and now should be reintroduced as a modern medicine for the ailing masses.

So far, opiates have been the main drug of choice for many serious diseases, but opiates are rapidly losing their appeal. Like the example of the USA where due to overdosing of prescription opiates there are 91 deaths per day. If India can understand and learn from this situation and implement Cannabis-based medicines which are softer than opiates but highly effective medicines, nonetheless, India will not only generate revenue but also have a new research stream and a new industry as well to learn and apply. If done well, we could be global leaders in this space as the origins of the plant were in the lower Himalayas itself and its about time India restores the lost glory of one of the most sacred plants of our traditional medicine.

The environment for Cannabis-based medicine has improved over recent years as there has been a lot of focus on Cannabis globally. As a matter of fact, in 2015 India launched the Phytopharmaceutical Act of India which is focused on plant-based medicines but with a modern analytical approach to the same.
Along with that in 2016, Boheco held a conference at the Indian Habitat Centre which was focused on the medicinal benefits of cannabis, called the I-CARE (India Cannabis Analysis And Research) summit, where the Chief guest was the DCGI ( Drug Controller General of India). In his speech at I-CARE he said ‘’ Yes, we want to have a lenient approach rather than a restrictive approach. You people will be thinking and working together and as a regulator and technocrat, we are with you, till you are scientifically going to prove that you will protect the people of this country. We have already worked out the phytopharmaceutical path for new product development to be used for humanity and people of this country. You can use that platform. I see huge potential in these kinds of alternative medicines in the treatment of patients and people.” --
Dr. G N Singh
Drug Controller General of India 

Since then the first Medical Cannabis license has been granted by the Government for the cultivation of medically valuable Cannabis plants by the IIIM for use in the medicine sector. Hence there has been a shift in the Government towards making these medicines available In India and it is evident from the steps they have taken to introduce the same.

Once well regulated, medicinal cannabis can yield much needed new medicines, boost the pharmaceutical industry, and create new revenue. Countries that have introduced medicinal cannabis notice that the recreational use/abuse of cannabis does not seem to go up. Instead, the general public learns a lot from the discussion about medicinal use, and even recreational use can become less problematic.

Apart from traditional Vedic texts, are there references to cannabis in any other texts like Hriday Saar Sutra?

The earliest written reference to Cannabis in India may occur in the Atharvaveda, dating to about 1500 BCE [Russo 2005; Grierson 1894]. This ancient document hails the ‘bhang’ plant as one of the five sacred plants and as a source of happiness, donator of joy, and bringer of freedom [IDHC 1894]; “We tell of the five kingdoms of herbs headed by Soma; may it, and kusa grass, and bhang and barley, and the herb saha, release us from anxiety.”

In the Sushruta Samhita (meaning: the verses of Sushruta), dating from around 500 BCE, Cannabis was recommended for phlegm, catarrh, and diarrhoea. The Sushruta Samhita is among the most important ancient medical treatises, and one of the foundational texts of the medical tradition in India. The Rajanighantu, also known as Abhidhana Cudamani, is the famous work of Narahari Pandita, son of Iśvarasuri, who was a resident of Kashmir around 1300 AD. The manuscript mentions Cannabis among various important medicinal plants. It states that “its effects on man are described as excitant, heating, astringent; it destroys phlegm, expels flatulence, induces costiveness, sharpens the memory, excites appetite, etc.”