The Ministry of Health has announced its intention to increase the share of generic drugs on the Georgian pharmaceutical market in order to lower the existing prices and regulate the competition.
What are generic drugs and what differentiates them from brand drugs? Are generics reliable?
The Georgian society’s knowledge regarding generic drugs is quite low. Part of experts and pharmaceutical specialists assess the introduction of the generic drugs on Georgian market positively, stressing that for successful implementation of the project it is important to inform the society on generic drugs.
While others stress that the Ministry of Health needs to introduce a controlling body that will scrutinize the quality of pharmaceuticals strictly. Also, there are those who do not rely on the effectiveness of generics and give priority to the brand drugs.
What do we need to know about generic drugs and how is their quality control done in Georgia? Pharmaceutical Companies Association’s executive director Irakli Margvelashvili spoke with CBW in this regard.
Based on the international standards, generic drugs are those drugs the active action of which is between 80-120 percent range. This is a European standard. Since a drug’s strength can be 40 percent, this is not a low range. Generally classifying generics into “good” and “bad” drugs is wrong. Products that meet the quality control requirements are safe. Another issue is how well the quality control of drugs in Georgia works and how to ensure compliance with the generic brand. That is why it is necessary, to implement the necessary mechanisms and tighten the drug quality control.
What is the recent tendency in the use of generics? Has it increased or decreased in recent years? What about their use in Europe?
Generic drugs are present quite widely in Georgia. Sometimes here generics can be even more expensive than the brand drugs. For instance, ceftriaxone, generics of which number over a hundred on the Georgian market. Ceftriaxone itself is not an expensive drug and its consumption is low also. Overall generics are used all over the world. The ratio of Generic drug consumption to brand drugs in developed countries, including the United States, is approximately 70/30 (70 in favor of the generics). This is because brand drugs are expensive in the developed countries and consumers are inclined to buy generics instead.
Recently the media reported that Indian companies are interested in entering the Georgian pharmaceutical market. What is the quality of Indian drugs?
India is the second country in the world in terms of population, it is not surprising that the pharmaceutical industry is a huge part of this country’s economy. India is famous for the production of generic medicines. Many international manufacturers from Germany, Switzerland, Austria and others have factories in India. Therefore, saying that Indian drugs are low in quality is plain wrong. In the last 2-3 months, hundreds of Indian companies have been registered as drug producers in Georgia.
A strong trend is observed. This raises the question of the quality of the drugs. Unfortunately, so far in Georgia there is no regulatory body that would ensure the quality of the medicines. In this regard, appropriate research and mechanisms need to be implemented in Georgia. We need a laboratory that meets international standards.
Registration-wise what steps do pharmaceutical brands have to go through in Georgia?
In Georgia, drug registration is made on the basis of inspection at the moment of registration, This does not mean that the quality of local drugs is low but so far the law regulating this process is far from perfect. At this stage, re-working of the law is in progress and what changes will be implemented in the legislature is unknown yet.