Indian trial on hemp-derived medicine in 6 months

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.

To be undertaken by doctors at Tata Memorial Hospital in Mumbai and All India Institute of Medical Sciences in Delhi in association with scientists at Indian Institute of Integrative Medicine, Jammu, the trials will explore the therapeutic role of medicines made out of cannabis in cancer, epilepsy and sickle cell anaemia treatment.

The hemp to be used in the trials are being cultivated scientifically in a research farm in Jammu with approval from the state government.

“The trials would begin in another 6-8 months. We have also asked for an additional 40 acres of land from the Jammu and Kashmir government for hemp cultivation,” Ram Vishwakarma, director of the IIIM, one of the laboratories under the Council of Scientific and Industrial Research, told DH.

The Indian trials will occur within months of the US Food and Drug Administration approving its first ever medicine, derived from cannabis. The drug, Epidiolex, will be used to treat a rare form of epilepsy called Lennox-Gastaut Syndrome and a brain dysfunction called Dravet syndrome.

Vishwakarma said existing pain-relieving medicines – knows as non-steroidal anti-inflammatory drugs – are inadequate to alleviate the pain experienced by cancer patients.

The doctors currently use morphine for pain relief, but it comes with the drawback of the patient getting addicted to the drug.

As an alternative, the scientists will try a medicine that has been made using a 50:50 combination of two chemicals derived from hemp - tetrahydrocannabinol (THC) and cannabidiol (CBD).

“While THC alone is responsible for intoxicating properties of cannabis, the combination doesn't have any such attributes. The trials for cancer patients will be done in collaboration with TMH,” he said.

The role of CBD would be explored in therapies for epilepsy and sickle cell anaemia. The first one would be conducted by doctors at AIIMS whereas the second investigation would be done by the doctors of a hospital in Raipur in Chhattisgarh that specialises in the blood disorder in which there are not enough healthy red blood cells to carry adequate oxygen throughout the body.

Lack of regulatory clarity on cannabinoids other than THC (the psychoactive compound), combined with the socio-cultural stigma of cannabis consumption since 1985, has contributed towards the absence of cannabis-based medicines in the Indian market,” said Avnish Pandya, Director of Research & Development, Bombay Hemp Company, the first start-up in India to study the medical and industrial use of cannabis in partnership with CSIR.

There is also a lack of standardized cannabis plants with standard cannabinoid output derived from their flowering tops to get consistent medicine – a gap that IIIM seeks to bridge.