Only a few dozen medicines are tested for bioequivalence each year, due to insufficient facilities. However, this shortage will become a magnet to draw investors in the Vietnamese pharmaceutical market. Vietnam Business Forum interviewed Mr Nguyen Dang Lam, Deputy Director of the National Institute of Drug Quality Control, on this issue. Giang Tu reports.
Currently, Vietnam has started studying bioequivalent production. How do you assess the quality of medicine bioequivalence and how is the quality control process carried out?
In principle, medicine quality process in Vietnam is licensed by the Ministry of Health and ratified by specialised councils, as well as specialists of patent, quality, preparation and clinical physics. To put it another way, the process is specified in Circular 44 of the Ministry of Health on drug registration. Quality will certainly meet minimum criteria for circulation in Vietnam. Or, it must meet standards of the United States, the United Kingdom, Europe and Japan. In principle, both domestic and foreign medicines must satisfy technical barriers to be circulated in Vietnam. Producers may raise their medicine quality above criteria to assert their positions.
How do assess the interest of pharmaceutical companies in bioequivalence testing, as well as the development pace of bioequivalence testing in Vietnam?
We now have only two test rooms, but a great number of companies registered for bioequivalence testing at the National Institute of Drug Quality Control. Hau Giang Pharma (DHG), Traphaco and CPC1 Hanoi tested bioequivalence quite early. Test registration contracts signed have provided enough work for the institute until the end of 2016 and pharmaceutical companies have continued to register for tests. Even some companies of South Korea and India also want to have their products tested in Vietnam to have official data when they enter the Vietnamese market. The fee for testing a medicine ranges from hundred millions of Vietnamese dong to billions of Vietnamese dong, and not all companies can afford the fee.
Vietnam has 12 mandatory active substances according to the Regulation 08 of the Ministry of Health, and products that have prolonging or slowing attributes must be tested. Companies test products on their own if such products are not required for mandatory tests, aimed to confirm quality and used for tendering and marketing. Currently, only a few dozen medicines are tested for bioequivalence each year due to insufficient facilities. Vietnam will encourage companies to invest in this field in the coming time. The State may invest in facilities, but companies must pay fees for testing.
In reality, although domestic medicines have similar quality to foreign ones, the latter are more popularly used by hospitals. How can domestic medicines of bioequivalence gain more use by hospitals?
Data vary. For example, central hospitals use more foreign drugs and the use of domestic medicines increases in lower-level hospitals. There are two reasons for this. Firstly, central hospitals are located in big cities where residents have better incomes. Secondly, patients hospitalised to central hospitals usually carry more serious diseases. So far, many Vietnamese products have registered, but not many actually have bioequivalence. A few hundred medicines have been tested for bioequivalence, while hospitals are using tens of thousands of medicines. Indeed, the rate of registered medicines is not significant. According to development orientations, domestic drugs will be used more in the future. But, drug makers must prove that their medicine quality is very high. Moreover, central hospitals are specialised units and specialised drugs are now mainly foreign. In fact, there are not many domestic specialised drugs in circulation. And, we cannot find domestic ones even though we want to use them.
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