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The know-how to detect fake drugs for erectile dysfunction

기사승인 2017.02.03  18:05:41

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- MFDS identifies 41% of analogue substances among drugs for erectile dysfunction

Koreans are much interested in various kinds of healthy food and stamina-related products such as prescription drugs for erectile dysfunction.

Especially after the release of Viagra (ingredient name: Sildenafil) in Korea, the domestic market of drugs for erectile dysfunction has sharply grown. Besides Viagra, Cialis (ingredient name: Tadalafil), and Levitra (ingredient name: Vardenafil) etc. were imported and then Korean pharmaceutical companies rushed to develop the drugs on their own.

The drugs that Korean pharmaceutical companies developed are Udenafil (Korean name: Zydena) developed by Dong-A ST, Mirodenafil (Korean name: Mvix) by SK Chemical, and Avanafil (Korean name: Zepeed) by JW Pharmaceutical etc.

The patent periods of Viagra and Cialis expired in 2012 and 2015 respectively. After that, dozens of generics were on the Korean market.

Korean pharmaceutical companies released different types of generics for erectile dysfunction such as powder, tablet, and film. They thought demands on the drugs exist.

With the market of drugs for erectile dysfunction getting bigger and bigger, the black market to sell the fake drugs without doctor’s prescriptions is also getting bigger.

The fake drugs distributed in the black market have too small amount of or too high amount of Sildenafil and Tadalafil that are ingredients to treat erectile dysfunction. And also foods with substances that have similar chemical structures of drugs for erectile dysfunction are distributed in the black market.

This isn’t the problem only for Korea. Pharmaceutical companies estimate the black market is approximately twice as big as the world’s market of drugs for erectile dysfunction.

The governments in each country crack down on the fake drugs, but have trouble in regulating analogue substances whose chemical structures are slightly modified. Therefore, countries update data after they identify new analogue substances.

Korea seems to be more interested in drugs for erectile dysfunction. MFDS (Ministry of Food and Drug Safety) has detected 41% of the analogue substances found in the world.

The advanced analysis team at Toxicological Evaluation and Research Department of NIFDS (National Institute of Food and Drug Safety Evaluation) under the MFDS found 7 analogue substances of Tadalafil among 17 analogue substances.

The team found ‘Isopropyl nortadalafil’ that has the similar chemical structure with Tadalafil for the first time in the world. The newly-detected Isopropyl nortadalafil has similar chemical structure with Tadalafil, but the structure is slightly modified. The health functional food with Isopropyl nortadalafil is being sold like hotcakes on the market because people believe the ingredient is good to strengthen sexual performance. The case to detect Isopropyl nortadalafil appeared in the international journal ‘Food Additives and Contaminants’ on December 2016.

NIFDS has investigated 1,854 foods and medical supplies that are suspected to include illegal ingredients from 2014 to 2016 for 3 years. Among them, illegal ingredients were found in 493 products. 111 of 493 products had illegal ingredients for drugs for erectile dysfunction that are the largest portion. The analogue substances of Sildenafil (the main ingredient for Viagra) were detected much in 2014. And the analogue substances of Tadalafil (the main ingredient for Cialis) were found much from 2015 to 2016.

Scientific officer Hyoung-Joon Park at the advanced analysis team said “new analogue substances of drugs for erectile dysfunction are slightly modified in chemical structure. Therefore, they may not be detected in the analysis test. Generally, we analyze the substances based on the existing substance list, but are trying to find new ones. Korean analysis technology is better than other countries.”

Hyeseon Lee lhs@docdocdoc.co.kr

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