Marking of Medicines is of Great Importance for the Whole Country


Pharmstandard CEO discusses the benefits of digitalisation 


 From 1 July 2020, the law on the mandatory use of digital codes to mark all drugs for the Russian market comes into force. In an interview with Izvestia, Pharmstandard CEO Grigory Potapov spoke about the consequences for Russian manufacturers, patients and doctors, as well as about how medicines are produced during the pandemic, and why digitalisation helps streamline business processes.

 — How have your company’s workflows changed during the pandemic?  In which segments have production volumes been increased?

— The pandemic, of course, has affected all aspects of our society, and Pharmstandard is no exception. Today we all work subject to the minimisation of personal contacts. Since 16 March, Company employees who are not involved in the production process directly have been working from their homes. First of all, these measures apply to office staff.

It should be noted that before the pandemic, we were also actively involved in the automation of business processes by introducing and developing digital solutions so that Company employees could work comfortably outside the office without compromising efficiency. Online conferences and negotiations, electronic document management and remote work wherever possible became quite usual for us.

 Quarantine restrictions in our country and globally affect production processes. Many enterprises are facing an increase in delivery times of technological and laboratory equipment, since the production capacities of many suppliers are reoriented to fight COVID-2019. It is difficult to carry out installation and maintenance of equipment by suppliers, in cases where the personal presence of Russian or foreign professionals is required. But in general, the situation is not critical for us.

 — From 1 July, the law on the mandatory marking of all medicines comes into force. Are you ready for this?

— The drug marking project in Russia started several years ago. Pharmstandard took part in the pilot stage of its implementation. Together with the entire industry, we have come a long way, from the beginning of the pilot phase to the present day. It should be noted that during the implementation of the project there was a constant and proactive dialogue between the regulator, the operator of the State Information System for Monitoring the Movement of Medicines (SIS MMM) — the Centre for Advanced Technologies Development (CATD) — and businesses. One of the decisions made as a result of such a dialogue was to simplify the code printing technology and reduce the number of characters, thereby reducing costs associated with setting up and modifying installed equipment. Now each code contains 44 instead of 88 characters.

Pharmstandard uses 59 packaging conveyor lines, so we decided to construct centralised marking sites at our enterprises. The centralisation of the process allowed us not only to minimise the risks of serialisation for existing production processes as a whole, but also to reduce cost of marking.

As for our readiness for marking, we carried out the necessary work as planned and are ready to begin monitoring the movement of medicines from 1 July in full. All medicines included in the 14 Nosologies programme are already marked from 1 October 2019.

— How many drugs have you already labelled?

— Over 35 million Data Matrix digital codes were issued for Pharmstandard-Leksredstva. Now it’s difficult to name the exact amount of drugs, since work is carried out at several sites in a continuous mode, and the numbers change every day. But we can say that a significant part of the products has been marked.

— Did you encounter any problems during this work?

— We experienced significant difficulties in the course of our work with SIS MMM in order to register medicines issued by our manufacturing enterprises. The data from the Unified Structured Directory of Medicines (USDM), which is a source of information on medicines for the tracking system, contained a significant number of errors and inaccuracies in terms of our nomenclature. As a result, the System blocked applications for registration of medicines in the SIS MMM or offered to confirm incorrect data. Currently, thanks to the active support of the technical services of CATD and USDM, the number of errors and inaccuracies is minimised, and we expect the elimination of the remaining ones in the near future.

— Are you ready to offer foreign manufacturers marking and packaging using your own production facilities?

— Pharmstandard is one of the leading contract manufacturers in Russia. Our portfolio includes a significant number of projects on secondary packaging and the full cycle of production of medicines from leading international vendors. And we are also ready to offer partners our production capabilities in order to serialise and aggregate their products.

For example, we have been cooperating with Gilead since 2018. Our factory in Kursk (Pharmstandard-Leksredstva OJSC) carries out secondary packaging of this partner’s products (Sovaldi, Truvada, etc). All products will be marked in accordance with the requirements of Russian legislation.

— How has the marking process affected the selling prices of medicines?

— We will not raise selling prices for pharmaceutical products manufactured by Pharmstandard. In the future, the services of the System operator will affect the cost of production, but we are constantly working to reduce other production costs and optimise business processes, as well as introduce automated solutions. Over the past years, Pharmstandard has been gradually implementing a large-scale business project to automate production using the SAP platform. We strive for the long-term effect of optimising our supply chain and product flows, as well as digitalising many other processes.

As for changes in the prices of medicines, this year we announced a decrease in the cost of drugs for the treatment of hepatitis C. In our opinion, expanding access to innovative non-interferon therapy gives doctors and patients an additional opportunity to more effectively combat socially significant infectious diseases in our country.

It should be noted that in general we are positive about drug marking. In fact, this is part of a large-scale project to digitalise the entire healthcare system, which is of tremendous importance for such a huge country like Russia. In addition, in our opinion, in the context of the development of a common pharmaceutical market, it is important to ensure the introduction of a similar marking system within the framework of the Eurasian Economic Union.

— Did you provide any assistance to hospitals during the coronavirus pandemic?

— During the pandemic, we provided targeted assistance to those who contacted us. In particular, Pharmstandard-Leksredstva purchased a batch of personal protective equipment. Medical institutions in Kursk Region received medical masks, respirators, gloves and protective suits.



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