The Medicines Control Council (MCC) has published draft guidelines for the cultivation and processing of cannabis for medical use, proposing strict controls at every step from the field to the patient’s bedside, reports Business Day. Interested parties have until 31 March to comment on the guidelines that were published in the Government Gazette last week.
The report says the guidelines set out the standards researchers and manufacturers will need to meet to ensure patients get a product that is safe and reliable, and contain extensive details on the security requirements for sites growing or processing medical marijuana. The guidelines also say cannabis cannot be grown on the same site as hemp, in order to protect the integrity of the plants.
Prospective cannabis growers will have to obtain a licence from the MCC, as well as a permit from the Department of Health, as cannabis is classed as a narcotic drug, said MCC registrar Joey Gouws. There is no limit on the number of licences the MCC will grant for the production of cannabis for medical purposes, but the overall quantities grown in South Africa cannot exceed the quota set by the International Narcotics Control Board, say the guidelines.
The report says the two key compounds of interest in cannabis are THC (delta-9-tetrahydrocannabinol) and cannabidiol. At the moment, the MCC had registered only one medical marijuana product, which contains a synthetic version of cannabidiol, Gouws said. In order to prescribe it to a patient, a doctor must apply for permission from the MCC and keep detailed patient records.
Doctors can also apply for permission to import products not yet registered in South Africa.
The report says the Central Drug Authority was not immediately available but published a position paper in 2016 in the South African Medical Journal in which it said: "Products based on ingredients of the cannabis plant should undergo standard evaluation by the MCC to assess their benefits and risks for the treatment of particular medical conditions."
The South African Medical Association’s (SAMA) chair Mzukisi Grootboom said in the report there was limited scientific evidence for many of the therapeutic claims made about cannabis, but there were studies suggesting it was helpful for pain relief and nausea, particularly in patients with cancer or HIV. SAMA supported the legalisation of the cultivation of cannabis for medical purposes.
[link url="https://www.businesslive.co.za/bd/national/health/2017-03-08-cannabis-for-medical-use-draft-published/"]Business Day report[/link]