Soon: Trial At AIIMS to test efficacy of Cannabis on Epilepsy patients

IIIM Director Ram Vishwakarma said they want to conduct clinical trials of the cannabis based drugs on terminally ill patients at the Tata Memorial Hospital for cancer, at AIIMS for epilepsy and Sickle Cell Institute Chhattisgarh (SCIC) for sickle cell anemia.

New Delhi: In another six months, Indian researchers will launch the country's first set of clinical trials with medicines derived from hemp or cannabis that is more popular as a recreational drug or intoxicating agent.

Research to develop cost-effective cannabis-based drugs for the treatment of cancer, epilepsy and sickle cell anemia is being conducted by Council of Scientific and Industrial Research - Indian Institute of Integrative Medicine (CSIR - IIIM) in collaboration with Bombay Hemp Company (BOHECO).

Currently, hemp is being cultivated at the Jammu-based IIIM research station which has obtained the license from the state government to grow cannabis to study their medicinal properties so that drugs can be developed for the Indian population.

Cannabis-based formulations which have been approved in other countries are being imported for fast-tracking clinical approvals in India and also trials on animals are being conducted as of now.

IIIM Director Ram Vishwakarma said they want to conduct clinical trials of the drugs on terminally ill patients at the Tata Memorial Hospital for cancer, at AIIMS for epilepsy and Sickle Cell Institute Chhattisgarh (SCIC) for sickle cell anemia.

Vishwakarma said that they are in talks with the Drug Controller General of India's office to acquire approval for conducting trials to see the utility of cannabis as medicine in India.

Also the IIIM, Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT) will soon sign an agreement to conduct a study on the efficacy of seven drugs out of which three are cannabis-based drugs, he said at an event which saw experts including scientists calling for liberal regulatory regime for cannabis-based medicines in India

The CSIR-IIIM was given the first-ever license to grow and study the medicinal properties of cannabis in collaboration with the Mumbai-based firm - the Bombay Hemp Company (BOHECO) - around a year back.

At the conference titled 'Cannabis R&D in India: A Scientific, Medical & Legal Perspective', experts said that India needs to tweak its legal regulatory system on the lines of countries like Canada and the Netherlands to expand the interpretation and definition of cannabis and its by-products so that cannabis-based medicines become more widely available.

Speaking at the event, Minister of State for Prime Minister's Office Dr Jitendra Singh noted that since ancient times, cannabis-based products like 'bhang' have been a part of Indian culture, social customs and festivals and research into cannabis-based medicines is going to be very important for the management of chronic diseases like diabetes which cause excruciating neurological pain and for which currently there is hardly any relief.

"There is a very thin line between use, misuse, and abuse of a substance, and it is our responsibility to draw that line," the minister said.

"Now, as the incidence of non-communicable diseases increases in India, we need to conduct pioneering research on drugs originating from plants and herbs.

"In the middle of the last century, such research gave us mint, which has now become an internationally used product. We need to replicate this kind of success by exploring the full medicinal potential of cannabis for the treatment and management of pain and health conditions for which there is currently no effective cure," he said.

According to Jahan Peston James, Co-founder, Bombay Hemp Company, chronic diseases are on the rise in India and existing medical solutions are not proving adequate.

In this scenario, hemp-based medicines can offer a high-quality, cost-effective solution for patient populations across urban and rural India, he said.

The geriatric population of India is poised to reach 100 million people by 2020-2025. Unfortunately, R&D work with other forms of medicine for several critical conditions afflicting the elderly has plateaued, he said.

"Health conditions like mental disorders, rheumatism, osteo-based ailments and heart diseases can be greatly alleviated with the use of cannabis which has almost negligible side-effects, as shown by a range of global regulatory and research work," he said.

The cannabis plant and its commonly used forms like ganja, bhang, charas etc. contain many chemicals which are not psychoactive, and are seen to have opposite actions to that of THC (Tetrahydrocannabinol), Dr. Vivek Benegal, Professor, Centre for Addiction Medicine, NIMHANS said.

"One such chemical, Cannabidiol, is arousing interest in the scientific community due to its medical and therapeutic capabilities.

"The molecule must be subject to stringent and scientifically rigorous testing. This is difficult due to its current ambiguous position under the law in India, especially the NDPS Act," he said.

The panelists recounted several "myths" surrounding cannabis-based medicinal products.

They said that it is wrong to think that the major method for ingestion and consumption of hemp-based medicine is through smoking. In fact, there are multiple forms of administration of cannabis with considerably lesser health risks, such as capsules, oils, tinctures, patches, sublingual sprays, and vaporizers.

Talking about the main challenges in the production and consumption of cannabis-based modern medicines, Dr. Dhiraj Vyas, Head of Department, Plant Biotechnology, CSIR-IIIM, said there are no standard varieties or seeds of cannabis to cultivate in India.

As cannabis is considered a narcotic commodity under the NDPS Act, research is restricted due to non-availability of research-grade material.

Research projects to produce standard varieties of cannabis have only recently begun in India by CSIR-IIIM in collaboration with the Bombay Hemp Company, and there are no standard extracts from which medicines can be produced, he said.