Written by José Alejandro Abusaid with contributions by Isabela Ramirez
The national regulation of cannabis in Colombia was one of the first in Latin America, giving the country a competitive and regulatory advantage that would catapult the internal and external market for medicinal cannabis. Various decrees and regulations around this have been focused on tracing the way in order for entrepreneurs to take full advantage of the benefits of this plant. However, in the last two years, the national government has put aside the interest to continue with a regulation on par with the evolution and has generated lags on the industry; therefore, cannabis growers have high production volumes without a structured market to sell to.
Although this industry can be developed through 3 main approaches: 1) the production of medicines and cosmetics endorsed by INVIMA; 2) The development of foods or derivatives based on cannabis and 3) the elaboration of cannabis-based compounding pharmacy products, the regulation is mainly focused on magisterial formulas elaborated from cannabis.
Through Resolution 315 of 2020, the lists of narcotics, psychotropics, and drug precursor substances under control in Colombia were updated; within them, cannabis. Moreover, the national government established the parameters for the production of cannabis-based compounding pharmacy products.
What is cannabis-based compounding pharmacy products?
Cannabis-based compounding pharmacy are medicines intended for an individualized patient, complying with a prescription that clearly details the active principles that include it. Unlike drugs, these formulas cannot be mass-produced and sold freely to the consumer; rather, the components are determined one by one by the treating physician to be consumed exclusively by the patient.
In principle, if the THC content is less than 2 mg within the formula, it is not subject to special control. The opposite happens if the amount of THC is equal to or greater than 2 mg depending on the dosage form of the formula. It is important to clarify that not being subject to special control implies that the substance is not controlled by the National Narcotics Fund.
Through resolution 315, a key overview is given to know how these cannabis-based compounding pharmacy products will be sold to the public and produced by pharmaceutical establishments certified in Good Manufacturing Practices. According to this standard, certified pharmaceutical establishments may prepare cannabis-based compounding pharmacy products, adapt and adjust the dose concentration or repackage them as long as they, as an establishment, are registered in the Special Administrative Unit of the National Narcotics Fund when the substance has to be subject to special control. This allows the opening of the domestic market for this formula and an overcoming the limitations of marketing cannabis-based products in the country.
What are the benefits of the draft decree that is being processed in the Colombian Congress?
With current Colombian regulations, it is not possible for entrepreneurs to export dried flowers to the rest of the world; limiting the competitive capacity that Colombia has to offer related to a high-quality product with a competitive price in the market. However, through the draft decree, this prohibition will be lifted with the aim that national entrepreneurs and producers can export dried flowers to the rest of the world without incurring penalties for it.
On the other hand, INVIMA must issue the corresponding regulation for the elaboration of phytotherapeutic products, foods and beverages based on cannabis. Likewise, this entity must try to carry out agile procedures that allow more medicine to be authorized for their manufacture and marketing in Colombia as long as they meet the minimum standards set by that entity.
In conclusion, the Colombian domestic cannabis market revolves around cannabis-based compounding pharmacy products; limiting the field of action of entrepreneurs and producers. However, it is expected that the National Government, through its different entities, issue the necessary regulations for the efficient manufacture and marketing of cannabis-based foods and medicine.