Growing recognition of a beneficial role for cannabinoids, especially CBD, in human health has been driving their growing demand and legalization in the United States as well as around the world, and with it the opening of untapped markets of immense size.
Several States have crafted laws to allow the medicinal use of cannabinoids. Meanwhile, the United States Agricultural Act of 2014 sets the stage for commercial hemp cultivation around the United States. These developments are in balance with work by ANANDA Scientific to grow CBD-rich hemp plants, to sell chemistry and medicinal products rendered from them and to otherwise make cannabinoids desirable medicine by healthcare providers. The work of ANANDA Scientific is complemented by the high likelihood of cannabinoid rescheduling by the United States Department of Justice in the near future (which will finally permit US Food and Drug Administration scrutiny and approval of medicines containing cannabinoids), the Department of Justice’s position to not interfere with States’ that have legalized cannabinoids, and the Drug Enforcement Agency’s willingness to issue research permits to those doing bona fide medical research on cannabinoids.
To further the progression to sensible legalization and regulation, ANANDA Scientific has been providing its expertise on a State-by-State basis to legislatures, healthcare professionals and other germane entities. ANANDA Scientific considers this effort important to fostering a sincere, positive image as the most advanced and forward seeking professional enterprise concerned with making cannabinoids real human medicine.
Israel has been the world center of cannabinoid research for over 50 years, a circumstance fueled by the country’s strong medicine and technology research base coupled with encouragement and support from the government.
ANANDA Scientific centers its Israeli activities at major universities known for their groundbreaking cannabinoid discoveries, accredited hospitals and biotechnology concerns with expertise and accomplishments appropriate to ANANDA Scientific’s needs. The Company closely coordinates what it does in Israel with the Medical Cannabis Unit in the Ministry of Health.
Human clinical trials on cannabidiol (CBD) pharmacokinetics (how these are absorbed, distributed, metabolized, and eliminated by the body) by ANANDA Scientific, along with formal affirmation of its safety, are in process at a major Israeli medical center. Subsequent trials on cannabinoids for treating specific medical conditions have already been arranged. Essentially unique with respect to any cannabinoid research so far done, clinical work in Israel is being done under institutional review board (IRB) auspices. An IRB is a professional ethics committee that approves and monitors human medical research. IRB involvement in all clinical activities is requisite for achieving regulatory approval of a therapeutic or medicinal product in Israel and virtually anywhere else. In that regard, the US Food and Drug Administration, the China State Food and Drug Administration (SFDA) and regulatory agencies elsewhere consider the results of IRB-sanctioned clinical trials in Israel acceptable for “regulatory approval” application.
ANANDA Scientific is distinctively partnered in China with a large producer of hemp to process and sell cannabinoids. Until now, cannabinoids have not been manufactured in China, even though the country is the world’s largest hemp grower. To facilitate the production of what are considered controlled substances there, the Company has established crucial working relationships with the Health Ministry and Public Security on both Provincial and Central Government levels. ANANDA Scientific is building the first large-scale factory of its kind for extracting and refining cannabidiol (CBD) as well as other cannabinoids for both domestic and international sales.
A growing number of officials in China are recognizing the therapeutic potential of CBD, and maybe other cannabinoids, for resolving conditions of immense public health significance. The immensity of health problems in China that could tentatively be positively addressed with CBD cannot be understated, and this makes for one of the largest patient (customer) populations anywhere that could merit from CBD therapies. ANANDA Scientific is leading the way in making CBD-based medicines a reality there by uniquely pursuing government-sanctioned clinical work for the regulatory approvals required for this market. Related to such efforts, the Company is also partnering with the China government to establish an industry first in Asia and maybe anywhere else, a “National Cannabinoid Research Center”. Members of ANANDA Scientific are well experienced in China medical, governmental & business matters.
Second only to China in hemp production for food and fiber (with 55,000 acres, or about 22,260 hectares, grown in 2013), Canada has yet to approve the research and development of medicinal products containing cannabinoids acceptable to healthcare professionals. Nevertheless, regulations on cannabinoids for medical purposes from Health Canada have been in place since 2001, and key court decisions have invalidated the outlawing of cannabinoids based on the need for their legitimate medical use.
ANANDA Scientific has been working with Health Canada, the Office of Controlled Substances and the Industrial Hemp Section in changing medical cannabis and industrial hemp regulations to allow the cultivation of appropriate hemp plants, cannabinoid extraction and medicinal product development.. The Company anticipates pertinent Health Canada licensing to soon be in place, unique and the first of its kind in Canada.
Based on clinical trial results from Israel and work done elsewhere around the world, ANANDA Scientific will engage with the Therapeutics Directorates and the Office of Clinical Trials for fast-track clinical trials and then product approval of its cannabinoid therapies.
The Canadian Medical Association (CMA) does not support cannabinoids as currently instituted in Canada on account of (1) its principally smoked nature, (2) lacking evidence-based scientific and clinical studies on therapeutic use, and (3) the psychedelic nature of tetrahydrocannabinol (THC) in virtually all extant preparations. In desirable contrast, the CMA is favorably disposed to what ANANDA Scientific is doing.