SAHPRA Open to Changing CBD Scheduling Status: Tells Daily Maverick ‘Anyone Can Submit A Request'
The South African Health Products Regulatory Authority (SAHPRA) says it’s open to changing the 0,2% THC restriction in CBD products but that any request must be “supported by relevant backing information”.
17 November 2022 at 04:00:00
The Daily Maverick has published the first part of a four-part series: ‘A tale of marijuana charlatans, corruption, collusion and exploitation’ in which it takes a swipe at “cannabis charlatans – new and old – who are trying to construct corporate empires, some of which appear to be based on corruption, collusion and exploitation”.
The DM warns that “without transparency, credibility and integrity from the get-go, the equitable growth and sustainability of the South African cannabis community stands to be sacrificed purely for the sake of profit.
It does not name names but says “the wealthier and well-connected – many corporations, conglomerates and even philanthrocapitalists – are lending legitimacy to their practice by using targeted terminology alongside the granted and paid-for approval from entities like Sahpra, DALRRD and individual authorities.
Investment and venture opportunities of all sorts abound, and those who possess the money, connections and means are able to fully exploit the unregulated market under the guise of “legal cannabis”, a legal construct that does not yet fully exist in South Africa.
However, from a Cannabiz Africa perspective, the most interesting part of the article was the response from SAHPRA to queries around the 0,2% THC limit in CBD products. The Authority says its open to changing this as long as the motivation is evidence-based.
“Anyone can submit a request for review of scheduling status and limits for any scheduled substance, this must be supported by relevant backing information (e.g. evidence-based) and the Minister of Health with Sahpra will review and provide the outcome.”
The DM says Sahpra’s control of licensing – thanks to the glaring contradictions in the law – to cultivate, produce, procure and distribute for their selected medicinal and scientific research markets, comes with exorbitant fees and onerous and often impossible requirements for traditional cultivators from poor communities.
It says SAHPRA has become a tool used by cannabis “charlatans” with access to capital to keep others out of the cannabis market.
“They are simply emblematic of the rot, corruption and collusion that run through every facet of our rainbow nation. The game is rigged, folks, and it is time we learn the how, why and by who – as well as how to change the rules to positively shape the future of cannabis in South Africa”.
Statement from SAHPRA 17 November 2022
The international control framework for the medical and scientific use of cannabis and cannabis-related substances is established by the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances, 1971, as well as relevant resolutions of United Nations Economic and Social Council and the Commission on Narcotic Drugs.
The Conventions are overseen by the International Narcotics Control Board (INCB) and provisions are enacted within domestic legislation and regulations permitting licenced activities and use of narcotic drugs 1 and psychotropic substances 2 for medical and scientific use.
The application of the provisions of international drug control treaties allows for appropriate monitoring by the INCB and Competent National Authorities who, in South Africa, is Sahpra. This is to ensure that accurate data on licenced activities (e.g. cultivation) and the production of controlled substances accurately reflect the national estimates and Assessments are reported to the INCB by Sahpra/Competent National Authorities.
The medical and scientific control framework control and reporting requirements among member states includes licensure of cultivation, manufacture, distribution, monitoring process in preventing diversion to illicit market, reporting, and ensuring compliance with the international conventions by member states.
Sahpra is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. Sahpra’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) and Sahpra reports to INCB on all controlled substances.
Therefore, Sahpra through its schedules, in line with the above-mentioned, regulates cannabinoids such Tetrahydrocannabinol (THC) and Cannabidiol (CBD) for medical and scientific purposes. These control measures are aligned to international requirements and reporting requirements as committed to by the Republic.
The manufacturing (includes cultivation) of scheduled substances requires a Section 22C(1)(b) licence, supported by Regulation 23 of the Medicines Act and the licence holder must comply with good practices as determined by the Authority.
In conclusion, anyone can submit a request for review of scheduling status and limits for any scheduled substance; this must be supported by relevant backing information (e.g. evidence-based) and the Minister of Health with Sahpra will review and provide the outcome.
Regulatory Uncertainty Bites SA's Biggest CBD Brand, Goodleaf Temporarily Pulls It Range From The Shelves
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