Pharmaceutical companies are asking the government to give them extra time to comply with the GMP standards.
At present, good manufacturing (GMP) and distribution (GDP) practices are introduced in only a few companies, whereas about 70 companies are operating on the pharmaceutical market. All of them are obliged to move to the new standards from January 1, 2022. Otherwise, non-compliance with the standards will lead to the suspension of their activities.
It should be noted that pharmaceutical companies did not hear recently that they had to move to the GMP standards. They were given extra time several times to meet the new requirements, but as Levan Gogiberidze, head of the Pharmacists Association, explained to BMG, the government had an action plan. The relevant agency started taking steps in this direction only 2 years ago. One of the main obstacles for the private sector was the fact that the relevant standards have not even been translated into Georgian. Accordingly, the business says they are not ready to move to a new standard, which requires a solid investment on their part and asking the government to postpone the regulation.
"GMP does not mean only modernization of existing enterprises. It requires technical maintenance Equipment imports become very difficult due to the pandemic. Engineering is very weak with us, hence companies have to invite them from abroad, although travel is also difficult. That's why it takes time and money. The manufactures cannot do that within the given time. When the active steps were taken in 2019, an inspectorate was formed and the government took that issue seriously. Two years is very little time.
The export of local medicine is up to 60 million USD, the domestic turnover is up to 200-240 million GEL. Consequently, this is a serious economic direction, and we cannot close the production so, it will be a crime. I, therefore, believe that consensus will be reached and manufacturers who have a plan to move to a new standard will be given so-called buffer time to meet the new requirements”, Levan Giorgobiani declares.
According to him, the problem is that the standard, that is required by local producers, is not required by importers, so Georgian companies find themselves in a non-competitive environment.
"This also hinders the businesses from investing here. We are talking about quite large sums, up to 1-15 million Euros, no business will start investing in such an environment. There should be a change in this direction, because I believe that creating such good conditions for them at the expense of closing our production will not be justified," - said the head of the Georgian Pharmacists Association.
According to him, there are 10 enterprises that are ready to gradually move to a new standard in case of giving the so-called buffer time.
"It can be said that the enterprises are divided into two parts, because in addition to these 10 enterprises, there are also 25 enterprises that addressed the Prime Minister and asked for time to move to a new standard until 2025," said Giorgobiani.
The business hopes that the negative effects of the pandemic will be taken into account because only in the case of a medium-sized enterprise, investments of about 5 million EUR are needed in the infrastructure sector.
