Invaluable system of medication quality control is one of the problematic issues on Georgian pharmaceutical market, especially in the domestic production.
Currently, medication quality control is carried out by an only responsible body State Regulation Agency for Medical Activities. The small budget of the agency does not enable to ensure valuable control over quality of medications. In 2016 the agency budget was 3.38 million GEL, while total expenditures made up 3.36 million GEL, of which 2.4 million GEL was spent on the staff salaries.
This signifies 71% of the whole budget are spent on salaries. As a result, we receive state structure and its operation is much more expensive compared to the amount of money that the staff spends on this structure. To put simply, we pay 2.4 million GEL to 180 persons so as they spend 0.96 million GEL a year.
As a rule, State Regulation Agency for Medical Activities selects the list of medications for exploration from the so-called Risk Group. However, there are more than 7000 medications on the market and less than 1% gets into this group and this factor cannot illustrate the real picture of the market.
Government cannot ensure valuable quality control on the market and the consumers remain unprotected, in practice. As a result, in the quality control process, sometimes critical outcomes are also recorded, but the policy remains the same. For example, if we analyze the 2015 results, 10.6% of the examined pharmaceutical products do not satisfy state standards, while 1% of them did not have the right of registration on the market.
Invaluable quality control over medications is combined with noncompliance of domestic companies with international standards. There are no obligations for pharmaceutical companies for satisfying quality requirements or standards. Today, there are more than 60 medication production companies in Georgia.
Only starting January 1, 2018 pharmaceutical companies will become obliged to introduce GMP standards. Consequently, consumers have to blindly trust honesty of manufacturers. As a rule, Georgian manufacturers import medication substances and unpacked pharmaceutical products from Asian countries (China, India), where falsification level is high.
According to conclusion of World Health Organization (WHO), more than 35% of Indian market is saturated by falsified medications and the Indian market is shaped as the center of production of falsified medications, where 1/3 part of the world’s falsified and unreliable medications are made. Naturally, it is not correct to assert that pharmaceutical products imported from India do not satisfy standards at all. However, the fact is that influential international organizations consider Indian market as unreliable. At the same time, medication quality control is invaluable in Georgia. Therefore, risks of penetration of falsified medications to the Georgian market grow.
Georgian doctors know from their practice that medications of Indian origin are less efficient and they frequently abstain to apply them.
Weak competition is one of the sharpest challenges on the Georgian pharmaceutical market. As a result, unclear facts frequently take place on the market, especially, when price of medications of Georgian origin, the so-called Generics, are identical to the original ones, and sometimes they are even more expensive.
One of the justification arguments for Generics is that population should be able to buy medications at comparatively lower prices. For example: Siofor (Menarini Von Heyden) 850 mg, a pack of 60 pills – 13,18 GEL. Price of one pill – 0.22 GEL; Sioral (Aversi Pharma) 850 mg, a pack of 20 pills – 7.48 GEL. Price of one pill – 0.37 GEL; Levoploxatsin (GAMA) 500 mg, a pack of 10 pills- 25.50 GEL; Levostar (GMP) 500 mg, a pack of 10 pills – 50.40 GEL; Bisoprololo-Humanity (Windlas Healthcare Pvt) 10 mg, a pack of 30 pills – 6.77 GEL; Emcor (GMP) 10 mg, a pack of 30 pills – 20.40 GEL; Atorvastatini – Humanity (Mepro Pharmaceuticals Ltd.) 20 mg, a pack of 100 pills – 37.38 GEL. Price of one pill – 0.37 GEL; Torvitin (GMP) 20 mg, a pack of 20 pills – 10.50 GEL. Price of one pack – 0.52 GEL; CardioMagnil (Nycomed – (Germany)) 75 mg, a pack of 100 pills – 11.72 GEL. Price of one pack – 0.11 GEL; Cardio Force (Aversi – Rational) 75 mg, a pack of 30 pills – 5.60 GEL. Price of one pill – 0.18 GEL; (prices are given by the situation of May 30, 2017).
In conclusion, it should be noted that Georgia cannot provide valuable medication quality control for many years. State Regulation Agency for Medical Activities examines only an unimportant part of medications and detected violations are not delivered to the society in due manner. As a result, this category of medications may be used by patients, even if they are announced as hazardous for human health.
70% of the agency budget is spent on the staff salaries. Moreover, Georgia-based entrepreneurs are not obliged to satisfy any international standard regarding medication quality control. Consequently, Georgian consumers have to rely on honesty of the market players and blindly trust quality of both imported and domestically manufactured medications.
At the same time, it is worth noting that some domestic Generics are sold for higher prices on the domestic market compared to their analogues from developed countries. And this fact cannot be explained. There is very weak competition on the Georgian pharmaceutical market, especially in terms of domestic production. As a result, major pharmaceutical companies make serious benefits.