World Monitor Mag, Industrial Overview WM_November_2018_WEB_Version - Page 36

EXPERT OPINION will be implemented next year. We hope that the new laboratory complex will also become a unique object for Kazakhstan, because it is initially designed to meet the requirements of good laboratory practice. Pharmacists have standards for GDP, GMP, GLP, even good agricultural practices for collecting medicinal raw materials, which have not yet been implemented in Kazakhstan. This project will take us even a step higher in terms of competitiveness and export potential. The investment program is developing and gaining momentum in response to market demand, modern realities. Because of our leading positions in the market, we can use opportunities for further development, increase export potential, implement innovative ideas and solutions in production. Let me remind you that in addition to production sites, we have a modern warehouse complex that meets the standards of good distribution practices. Our factory is the most “’smart’ from the point of view of digitalization. We are the only farm enterprise in Kazakhstan who participated in the pilot project ‘Model Digital Factories’, implemented within the state programs ‘Digital Kazakhstan’, ‘Industry 4.0.’. We underwent a rather complicated and serious audit of the German Fraunhofer Institute, commissioned by the Ministry for Investment and Development, the Ministry of National Economy and the administrators of the Digital Kazakhstan project. The company’s level of digitalization was determined to be at a fairly high level. Only seven manufacturing enterprises participated in the pilot project. I think that we are comparable to the giants of heavy engineering, given that their ‘digit’ level of penetration is much higher than that assumed in the pharmaceutical industry. That is, we secured leadership in automation. A separate investment aspect, which is 34 world monitor not included in the previously announced figures - these are our digital projects. This is our present and our future. Biotechnology is a complex and multi- step process. You mentioned generics and biosimilars. Please tell us about their role in modern medicine. We talked about the fact that SANTO is both a domestic manufacturer and a supplier of generics, including from the sites of our investor - Polpharma Group. Generics is a non-patent version of the original drug product, in which patent protection is completed, and manufacturers have the opportunity to reproduce this drug that meets the requirements for quality, efficacy and safety. As you know, pharmaceuticals is a highly regulated industry, respectively, all generic drugs comply with the requirements of the national regulator. In turn, the national regulator justifies its requirements, referring to the British, European Pharmacopoeia. Thus, generic drugs meet the requirements for quality. The professional level of the domestic regulator, expert body – the National Centre of Examination – is very high. Recently, they successfully passed the qualifications of the World Health Organization, that is, a kind of audit of an expert body in the field of pharmaceutics. Kazakhstan has established itself as a country with good regulatory practice. According to the data of the National Centre of Expertise, generic products that enter the country's markets comply with international, European quality requirements. The regulatory requirements in force in Kazakhstan correspond to those in the EU. Concerning us, as a domestic producer, there are higher requirements for the release of products to the market than for foreign importing companies. For us testing is obligatory in laboratories. If, for example, generic products supplied from countries of the ICH region (countries with high regulatory practices, such as the EU, the USA, Japan, Canada) do not have to undergo laboratory tests during drug registration, then domestic manufacturers confirm the quality of the generic with laboratory testing. This is about domestic generics versus imported ones. We believe that, on the one hand, it puts domestic producers in unequal conditions, because the ICH countries do not check, and domestic producers check. This puts an extra burden on us. On the other hand, for us it is another opportunity to prove that domestic generics meet the same requirements. This should dispel the myth that our generics, in particular, produced by SANTO, are somehow different from foreign ones. There are many myths, some of them are based on associations with crisis periods in the 90s and early 2000s. Today, because of the investor and the potential that our plant has, we have created an innovative and modern production site. It’s not so easy to get rid of old myths, but we continue to work on it. In addition, we play an important role as a leader – supplier of generics in terms of national security in the healthcare system. If you look at the list of our drugs, it becomes clear that basic medicines, which are in our portfolio, are classified as vital. In Kazakhstan, formally, there is no definition of ‘life-saving drugs’, but those drugs that are included in the National Formulary actually reflect the concept of ‘life-saving drugs’. Our drugs, as well as others from the National Formulary, are the basis for the treatment of diseases in both hospital and polyclinic or outpatient settings. This characterizes our role as a pillar of safety and reliability as a drug supplier in the country. Generics in our portfolio are presented from different generations, which means it can be basic drugs or drugs with a well-studied