Perspectives of exporting Russia’s pharmaceutical products to the country were discussed in Thailand
On August 15 in Bangkok (Thailand) a Roundtable “Pharmaceuticals, medical equipment and biotechnologies”, dedicated to the perspectives of developing the countries’ relations in the pharmaceutical field, was held within the Russian-Thai Business Forum, organized by the Ministry of Trade and Industry of the Russian Federation.
Following 2008, Thai medical products were in demand predominantly in the commercial segment – 65,30% in value terms were for the commercial segment from the aggregate supply of medical products from Thailand to Russia and 79,18% – according to the results of the first quarter of 2019. In general, Russian consumers were aware about and purchased such Thai medical product as Strepsils. With that being stated, as was noted during the Roundtable “Pharmaceuticals, medical equipment and biotechnologies”, if in Russia Strepsils is included in the list of Russia’s State Register of Medicines as a medical product, implementation of which is only possible in the pharmacy chains, in Thailand Strepsils is not classed as a medical product, but is circulated freely: it can be purchased in any supermarket”, explained Head of Biological Products Section, Pre-marketing Control Division, Bureau of Drug Control of Thai FDA Pramote Akarapanon. Russian manufacturers currently are not exporting medical products to the Kingdom of Thailand, although company Materia Medica has a representative in the region, which supplies medical product Anaferon to the Philippines, Cambodia and Vietnam. Responding to Mr. Akarapanon’s question, Director of Materia Medica Holding’s subsidiary Anton Babikov explained that despite the interest of supplying the product to the Thai market and register it in the country, the company is still unable to find a partner-representative organization, which complicates the process of launching the product to the market.
As the process of drug registration in Thailand is neither quick nor simple and the procedure itself is still not very clear for the Russian pharmaceutical manufacturers, Chief executive officer of ChemRar Elena Yakubova raised the question in connection to the status of the submitted by the company for registering a product named Elpida. Following the discussion, Director of FSI SID and GP Vladislav Shestakov proposed to colleagues from the Thai FDA to conduct a joint GMP-inspection on the site of ChemRar, whereby the Russian side will act as an observer, after the company will have submitted the corresponding application to the Thai regulator.
As part of Russia’s pharma business-mission delegation there were representatives of manufacturers of immunobiological products and insulins – Nanolek, Microgen of Nacimbio holding (Rostec state corporation), Biocad, Geropharm, – which are interested in the details of the regulatory system in the field of registering such types of products. In particular, Chief executive officer of Nanolek Mikhail Nekrasov presented – together with Chumakov Institute of Poliomyelitis and Viral Encephalitides of Russian Academy of Medical Sciences – development – inactivated polio vaccine: the Company is the fifth manufacturing site in the world that specifically manufactures this inactivated vaccine”. With that being mentioned, Nanolek specializes on the vaccines for children, which it is ready to supply to the Thai market as well. Technical director of Microgen Aleksandr Sergeev underscored: “Microgen consistently expands its presence in external markets, registering and supplying immunobiological drugs to many countries, and above all – vaccines, bacteriophages and botulinum toxin Relatox. In particular, this year we are exporting our products to 11 countries, and, naturally, we are interested to work in such perspective and dynamic market as Thailand. We are sure that we can offer to the patients of Thailand accessible products, which are capable to compete with the world’s best analogue”.
A considerable list of questions was prepared by Pharmasyntez to the Thai FDA representatives – from the current rules to registration procedures of drugs in the country, including opportunities and barriers for Russian manufacturers – them having an international GMP Certificate for manufacturing finished pharmaceutical products and active pharmaceutical substances for their launch; and also the possibility of the company’s audit with the local GMP with a subsequent access to the Thai market. Viewing the pharmaceutical market of Thailand as perspective for export of Farmasyntez products, the company was interested in the information on the structure of morbidity rates, the existing current healthcare problems and the expenditure on it, the existence and structure of governments subsidies, compensations, coverage of public expenditure for treatment and purchase of drugs.
At Roundtable “Pharmaceuticals, medical equipment and biotechnologies”, the Russian companies presented not only their medical products for export. As such, Head of section for development and strategic marketing of pharmaceutical company Sotex, which is part of Protek, Yuri Kalmykov told about the possibilities for the Thai companies to enter the Russian market with the help of establishing a partnership with Sotex and other divisions of Protec.
Another area of the Roundtable on pharmaceuticals was the subject of medical products and medical equipment. In the field of medical devices, following the results of 2018, there was a decline in imports of Thai products compared to 2017; in value terms the supplies have deскуфыув by 9,5% ($56,2 mln). In the first quarter of 2019 the amount of import of medical devices from Thailand was $22,4 mln. For its part, in 2017 and 2018 Russia has been exporting to the Kingdom of Thailand defibrillators (9,53 ths. USD and 4,76 ths. USD respectively). In the first quarter of 2019, mainly, vessels, containers for disinfection of medical devices and tonometers for ophthalmotonous pressure; were exported. In that regard, manufacturers of medical devices are ready to export to Thailand and other products. For instance, Chief executive officer of Exoplast Georgy Semenov, who was present in the Roundtable, presented a complex for the children with cerebral paralysis and Andrei Gordin Director for International Projects “Production Association “Ural Optical and Mechanical Plant named after Mr. E.S. Yalamov” (UOMZ) expressed its interest to Shvabe in relation to the export of high-tech medical products, neonatal equipment and also readiness to conduct complex equipping for perinatal centers.
In summing up the Roundtable “Pharmaceuticals, medical equipment and biotechnologies”, whose moderator was Director of FSI “SID and GP”, Vladislav Shestakov noted that in the course of preparation for the event, Russian companies had made a list of questions – that formed the basis for the expanded meeting’s agenda – on conditions and particularities of registering pharmaceutical products and also on the participation in government procurement in Thailand. According to FSI “SID and GP”, the companies in general had emphasized among the barriers for exports the following points:
- there are no transparency rules for registration and according, there is no procedure on how to the enter the market
- there is no information on distributors and specialists in the field of medical product registration
- particularities of undergoing GMP inspections, time frame, requirements, etc.
- particularities of registering medical products
“Today’s Roundtable has shown that Russia and Thailand are opened to a comprehensive dialogue between the regulators, manufacturers and distributors. We hope that after the meeting all communication barriers will be kept to the minimum, and pharmaceutical companies, that are present in the meeting can easily conquer Thai and Russian markets, – noted Deputy Head of the Russian State GMP Inspectorate Vladislav Shestakov. – The crucial task that we all must address –providing quality and effective drugs, providing access to the necessary medical devices that make the life easier.
We would like to remind that there will be a particular focus on the subject of the export of pharmaceutical products during IV All-Russia GMP Conference with international participation, which will take place between 23 and 25 September in Svetlogorsk (Kaliningrad region).
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed