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How do you assess the proposed measures to reduce the defects of drugs?

GxP News
Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (APhPEAEU) Alexei Kedrin came up with initiatives aimed at developing domestic pharmaceutical production, as well as reducing the risk of drug defects.

Among the proposed measures is the creation of a transparent system for assessing the effectiveness of operational measures already taken by the government to support the pharmaceutical industry in order to reduce the risks of drug defects in the near future.

The Association proposes to introduce performance evaluation criteria and monitoring measures such as simplifying the state registration of medicines, speeding up changes to the registration dossier, simplifying the re-registration of prices for vital and essential drugs, as well as implementing an import substitution program for reference samples of pharmaceutical substances and impurities, providing systemically important pharmaceutical enterprises with bank guarantees with a preferential commission rate and subsidizing lending rates for systemically important enterprises in order to obtain soft loans to replenish working capital.

How do you assess the measures proposed by the association to reduce the risk of drug defects?

If you would like to participate in the discussion, please fill out the GxP Community Expert Application.

Vilena Galkina
The initiatives proposed by AFPEAES are certainly important. We support the idea of creating and implementing a system that will allow us to evaluate the effectiveness of the support measures taken. Including this will provide an opportunity to pay attention to the "narrow" places. So, for example, despite the prompt adoption of measures at the Government level, their further implementation is often delayed, as is the case with the creation of an interdepartmental commission to determine the defect.

On the whole, in the field of defects, in our opinion, new approaches and more decisive actions are required. It is important not to complicate decision-making by complex interdepartmental mechanisms, but to follow the path of automatic recognition as defective of all drugs produced using raw materials or auxiliary agents supplied from unfriendly countries. Today, this is a necessary condition for pharmaceutical companies to be more flexible in changing production processes in order to ensure the availability of medicines for our patients.

Gelani Azirov
As a company, we support the measures proposed by the Association of Pharmaceutical Manufacturers. For our part, we want to add that it is important to make efforts to completely remove all state duties on the purchase of pharmaceutical equipment and on the purchase of imported pharmaceutical substances, as well as to abolish for pharmaceutical manufacturers within the country the payment of VAT, property tax, land and tax at a profit. Such actions will help to significantly reduce the problem of defective drugs.
In addition, in the near future it will be necessary to allow the use of instruments and measuring instruments that are not included in the state register of measuring instruments imported from India or China, which can be used for separation processes of substances (for example, for HPLC - High Performance Liquid Chromatography or GLC - Gas Chromatography) . Today, equipment from these countries is not included in the register of equipment allowed for obtaining a license, and we need to purchase it.

Another important task is to simplify and change the approach when registering maximum ex-works prices for medicines from the Vital and Essential Drugs List. Because the current methodology today implies a very complex algorithm for registering and re-registering prices.
We, as manufacturers of pharmaceuticals, purchase raw materials and consumables, the prices for which are not regulated by the state. Manufacturers are limited by the maximum selling price. Its annual indexation does not contribute to the profitable operation of the enterprise. As a result, we have the risk of defects.

I believe that the successful solution of the above problems will contribute to the stable development of the pharmaceutical industry.

Nikolay Bespalov
Frankly, it is not entirely clear why, within the framework of the implementation of the “Strategy for the Development of the Domestic Pharmaceutical Industry”, which was approved at the end of 2009, a number of measures were not provided, without the implementation of which it is simply technically impossible to count on either the effective development of the industry or import substitution. not to mention the development of export potential. Here you can name a whole scattering of facts, ranging from the absence of the industry's own standard samples, excipients and even cardboard in sufficient quantities, ending with the actually legalized process of imitation of production in the form of in-bulk packaging and, finally, the lack of guarantees for the purchase of products that should have appeared as part of the implementation of the strategy.

I don’t want to say that the strategy was absolutely useless, even in this format it became a serious incentive for attracting investments and the overall development of the pharmaceutical industry, in the end, the emergence of a number of domestic products critical for the healthcare system became possible, incl. thanks to this document. Although it must be admitted that most of the goals of the "Strategy" were not achieved, and not because of external pressure or economic realities, but simply because of the lack of elaboration of a whole layer of administrative issues. Incl. the technical aspects of state regulation were not detailed and the tools for monitoring the implementation of the program were not formulated.

In fact, it was not about the "Strategy", but about the declaration of intent, and, of course, the updated version of the document should take into account all of the above issues. And if at the end of the “zero” even the declaration format was already a great achievement, now it is not just an unaffordable luxury, the current state of the domestic pharmaceutical industry is quite capable of implementing much more ambitious tasks than just “closing the risk of defects”.

Philip Romanov
With regard to the unprecedented measures taken by the Government of the Russian Federation in terms of registration of new medicinal products and amendments to the registration dossiers of registered medicinal products for medical use, I would like to note that the mechanism created is intended to allow the subjects of circulation to promptly perform the necessary registration actions in order to avoid defects (the risk of its occurrence) under the economic restrictions imposed. However, these mechanisms are quite complex and require manufacturers of medicines to perform a certain sequence of actions, from federal executive authorities - resources and time to evaluate the documents and information submitted as part of the implementation of both the order of the Ministry of Health of Russia dated May 26, 2022 No. 339, and the procedures themselves. in accordance with decrees nos. 440 and 593.

In the realities of the current situation, when there are lightning-fast changes in all areas of the economic activity of the Russian Federation and the adaptation of processes, including production, time is a fundamental factor. We understand that the life and health of patients depends on the speed of our decisions.
Over the past years, the institution of authorized persons for quality has been successfully functioning with the corresponding responsibility of such persons, together with the heads of enterprises for the quality of manufactured drugs.

In this regard, it seems possible to supplement the previously issued regulatory legal acts in terms of a simplified (notification) procedure for making such changes to the registration dossiers of registered medicinal products.

With regard to the procedure for re-registration of prices for vital and essential medicines, taking into account the current internal and external economic situation, it is necessary to simplify the process of recognizing a defect (the risks of its occurrence) as much as possible, since now this is the bottleneck of the entire procedure.

Comparison of the cost of medicinal products produced in the Russian Federation and reference medicinal products of foreign production (indicative method) in some cases loses its relevance. In order to uninterruptedly provide patients with effective, high-quality and safe drugs, maintain the volume of research and development work, conduct the necessary amount of preclinical and clinical trials of new drugs, and save jobs in the field of drug circulation, it is necessary to introduce new approaches and methods in this direction.

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