Pharmaceutical industry of Republic of Kazakhstan. Where do we go next?

Quite frequently, statements are made that Kazakhstan is an import-dependent country, and its economic development, staff growth and population employment can only be ensured by the development of its own production. But at the same time, we do not notice and do not appreciate when exactly such projects are successfully implemented in our country. For example, it is the pharmaceutical industry, where literally over the past decade and a half there have been large-scale changes. The Executive Director of “NOBEL Almaty Pharmaceutical Factory JSC” Ms. Svetlana Kiel tells about what has already been achieved and what remains to be done.

 - Ms. Svetlana Valeriyevna, why is it important that the country has a developed pharmaceutical industry?

- Drug products are socially important products necessary for the population. Of course, if possible, it should be produced domestically. Because that is how their availability to patients is ensured, especially when it is referred to generics that are cheaper than original drugs. In this case, it is very important to take into account not always foreign manufacturers are ready to immediately place the drug product on the Kazakhstani market after the patent protection term expires (especially under today's conditions of difficult and rather strict regulation), and if the drug products were supplied to our patients in full from abroad, they would become available over the years. This gap may be closed by the local pharmaceutical industry. Local factories can adjust the production of such drug products earlier, and patients will have the opportunity to be treated by them earlier too.

- The pharmaceutical industry of Kazakhstan in recent years has made a qualitative leap in its development. Tell us why did it happen?

- That is true, 20 years ago, and this is not so much time, the pharmaceutical industry in our country was represented by several enterprises that produced a limited range of products and, of course, were far from meeting international GMP standards. Almost all drug products were delivered from abroad. Then the State Program on the Development of the Pharmaceutical Industry was adopted and a number of Orders of the Government of the Republic of Kazakhstan were approved, which contributed to the investments come to the industry. Thanks to state support, modern factories were created in the country and personnel were trained according to international standards. The product range and volume are gradually increased. In parallel with this process, legislation was improved. The requirements to all stages of drug circulation, and first of all to production, were brought into line with international standards and became stricter and stricter. Today, every third package of drug products used by the citizens of our country is Kazakhstan’s package. It is important to note that this is a real import substitution when foreign products are replaced by high-quality domestic ones.

NOBEL AFF entered the Kazakhstan market in 2002, and immediately with investments and with the intention to organize production here. In fact, this is the first production that was created in our country in accordance with GMP standards. We were the first to pass an inspection and received a GMP certificate.

In general, the company has five (5) manufacturing workshops (departments) that are GMP certified. The production capacity is 750 million tablets, film coated tablets and powders; 250 million capsules; 20 million syrups and suspensions, 10 million cream tubes and gels. The product range exceeds 250 items of high-quality import-substituting drug products for the treatment of both widespread and rare diseases, as well as malignant tumors (cancers).

- How does the company monitor product quality?

- Great attention is paid to this issue. The company uncompromisingly and rigorously follows the Good Manufacturing Practice (GMP) requirements. During production, all risks that may affect the quality of drug products are taken into account. Each stage is strictly controlled. The factory has production control laboratories. All of them are accredited by authorized state bodies for compliance with international laboratory practices and are equipped with the most advanced equipment and measuring instruments. In addition, all finished products pass control in the State Laboratory of the Republican State Enterprise on the Right of Economic Use the “National Center for the Expertise of Medicinal Products, Medical Devices and Medical Equipment” of the Ministry of Health of the Republic of Kazakhstan.

- What prospects do you see in connection with the creation of a single pharmaceutical market for the EAEU member countries?

- The single pharmaceutical market was officially launched in May 2017. From that moment, it became possible to register drug products according to the EAEU rules. It should be noted that when developing legislation on the drug circulation in a single market, the most progressive world experience was taken as a basis. As a result, in terms of requirements and standards, all market participants, including Kazakhstani manufacturers, significantly approached world standards. This means that the competitiveness of local pharmaceutical manufacturers has improved. But the main benefit from this, of course, was obtained by the state and consumers, since they received a well-developing industry and high-quality drug products manufactured in Kazakhstan.

Of course, the Russian market is the most attractive for Kazakhstani companies. Nobel AFF, taking into account the development prospects, is expanding production. Recently, a new workshop (department) was put into operation, the design of which took into account all the accumulated experience. It complies with the GMP standard and the most stringent pharmaceutical manufacturing requirements. In addition, Nobel AFF has established cooperation with a transnational pharmaceutical company, which has chosen “Nobel AFF” as a contract platform for the production of its original drug products, which today are produced not only for the Kazakhstan market, but also exported to Russia.

- What is important for Kazakhstani manufacturers at this stage?

- The Kazakhstan pharmaceutical market is close to saturation. Therefore, for further development, it is necessary to master the production of new products and expand our presence in foreign markets. These are two (2) major areas without which further development of the domestic pharmaceutical industry is impossible. However, for this, of course, conditions are necessary to be created: 1) A favorable, stable economic and regulatory environment; 2) Support for these two (2) areas. This will contribute to the growth of investment in the industry.

Taking this opportunity, I want to congratulate the people of Kazakhstan from the entire NOBEL AFF team on the past holiday - Independence Day of the Republic of Kazakhstan! I also want to congratulate the citizens of our country on the upcoming New Year holidays. I wish you success, prosperity, implementation of the most daring projects! Peace and prosperity to our country!

Ms. Svetlana Kiel, Executive Director of NOBEL Almaty Pharmaceutical Factory, told about what has already been achieved and what remains to be done.