More than $ 1 million US is the value of the Russian exports to India
At the Round table “Development of bilateral trade, banking and financial sector and industrial cooperation”, which is taking place on the sidelines of the Second Russia-India Strategic Economic Dialogue in New Delhi, the ways of collaboration between the regulators and further prospects for cooperation are being discussed.
In New Delhi (India) the Second Russia-India Strategic Economic Dialogue has commenced, within which the regulators and company representatives are discussing possibilities, benefits and perspectives of the sectoral cooperation, including in the pharmaceutical sector. India is one of the key suppliers of medicinal products – both for the private and public sector. Following 2018, Indian medicinal products on the Russian pharmaceutical market ranked 7th after Russia, Germany, the USA, France, the United Kingdom and Switzerland and 3rd place after Russia and Germany. Mostly, these are the products in the following segments: oncology, ophthalmology, anti-tuberculosis products and products for HIV treatment and cardiovascular diseases. Company-leaders in the field of import are: Dr. Reddy’s, Sun Pharma, Sentiss and Shreya Life Sciences.
According to the GRLS, as of May 2019, there are 1,297 Indian medicinal products registered in Russia. On the Russian market, there are 129 medicinal products from India, related to vital and essential drugs list, 15 orphan products and 3 – innovative.
For its part, the Russian pharmaceutical manufacturers are also interested in the Indian market and envisage good opportunities in developing exports to India. For instance, if in 2017 only one Russian medicinal product was exported to India – vaccine for prevention yellow fever from the Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of Russian Academy of Sciences, then in the last year there already was an export of further International non-property name (INN) medicinal products, such as Rituximabum and Trastuzumabum (manufacturer – Biocad). According to the form for statistical reports 2lek-prom, in 2018 the export of vaccine for prevention yellow fever from the Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products of Russian Academy of Sciences was amounted to 22,500 doses at 19,000 US dollars and 225,000 doses at 190,000 US dollars; in 2019 the export value of the International non-property name (INN) Rituximabum and Trastuzumabum from Biocad was more than 1 million US dollars.
Among the reasons of the Russian medicinal products not having a huge share in the Indian pharmaceutical market, compared to the relatively high volume of Indian exports to Russia, domestic pharmaceutical manufacturers draw attention to the following:
- Price competition (Indian market is mainly divided between the national manufacturers and suppliers from China; high import duties and tariffs, which often leads to sales at the cost price level)
- Absence of transparency rules for registration and market access (29 states, 7 union territories, each having their own legislation)
- Absence of able and competent distributors/contractors, who are in a position to provide services in facilitating the registration process
- Russian GMP certificate is not recognized by the Indian regulators
At the same time, it is worth mentioning that in February 2019 the Russian organization Pharmazyntez signed an agreement with India’s Emcure on transferring technology for manufacturing of innovative products Pharmasyntez and their sale.
“India is an important strategic partner for Russia, — emphasized Director of SID & GP Vladislav Shestakov while speaking at the Second Russia-India Strategic Economic Dialogue. — We find it necessary to develop and preserve cooperation between our countries, including in the field of pharmaceutical inspectorates cooperation. In essence, our main task is to provide our people with quality and effective medicinal products”. Among the first steps on strengthening such cooperation, the representative of the Russian Ministry of Industry and Trade subordinate organization mentioned the preparation of a Memorandum of Understanding between Russia’s Ministry of Industry and Trade, Russia’s Ministry of Health, Russia’s Federal Service for Surveillance in Healthcare and India’s regulator the Central Drugs Standard Control Organization (CDSCO).
- 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