Colombia is setting an example in Latin America, granting Khiron Life Science permission to manufacture the first legal medical cannabis product in the country. With this move, Colombia will position itself as a leader in the continent's cannabis scene, ahead of Brazil which can only import these kind of products. Because of the complexity of the process, Brazil cannot manufacture them.
The National Institute for Drug and Food Surveillance (Invima) has just granted the Khiron Life Sciences laboratory permission to manufacture the first legal medical cannabis product in the country, making Colombia a leader and an example in structuring secure and informed access to cannabis in Latin America, allowing its medical use in patients who require it.
This information was made known by Juan Diego Alvarez, the company’s vice president of legislative affairs, who said this process took more than three years and no less than 28 licenses, authorizations, and approvals by the country’s various authorities.
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The first pharmaceutical product available on the market will be prescribed to work as an adjuvant in the treatment of symptoms present in different pathologies such as chronic pain, anxiety, Parkinson’s disease, and refractory epilepsy.
“The authorization received from Invima is a certificate for good manufacturing practices that allows our laboratory to manufacture any medical cannabis product. It is not a specific authorization for a product, but a laboratory permit to make cannabis-derived drugs. To that extent, the products allowed to be manufactured are individualized pharmaceutical products, which can be purchased by the patient through a medical prescription from the company, the only one authorized to produce cannabis-based products,” explained the director.
He also said that, at the moment, only the Ilans clinics, located in Bogotá, are ready to receive requests from patients treated with this type of medicine and will be in charge of dispensing the pharmaceutical product. However, in the following weeks, the other channels will be announced as drugstores.
As the only company in Colombia currently authorized to manufacture these medicines, Khiron expects to serve the needs of some 10,000 patients in the next six months. However, as doctors in the country become increasingly knowledgeable about the benefits of cannabis-derived medicines, prescriptions for them are likely to rise, leading to increased demand for the products from patients who need them.
Álvarez pointed out that being the only laboratory in the country that has Invima certification, the company has a great responsibility and takes on the challenge so that patients in Colombia can access these products with complete security and confidence.
“There is no country in Latin America that has all this articulation and regulatory structure. The fact that private companies have been able to respond and meet the needs of patients is a great achievement. Brazil has permits to import cannabis-based products, but cannot manufacture them, because the process is very complex. We have the entire production chain regulated and we can guarantee access to these medicines in the country,” said Khiron’s manager.
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(Featured image by Flavia Carpio on Unsplash)
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First published in El Tiempo, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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