News Digest 16.01.2026 — 23.01.2026
Regulators
The Russian Ministry of Health has cancelled the registration of 71 drugs
The registration certificates (RCs) of 71 drugs and 14 pharmaceutical substances have been removed from the State Register of Medicines. These include the antibiotic Kirin (spectinomycin), the herbal remedy Sinuforte for sinusitis, the lipid-lowering drug Medostatin (lovastatin), and the nonsteroidal anti-inflammatory drug Revmonn (etofenamate) in spray form. None of these drugs have analogues in the State Register of Medicines.
The Russian Ministry of Health has cancelled the state registration of 71 drugs and 14 pharmaceutical substances. Of these, 15 registration certificates (RCs) belonged to Medochemie. Nine more drugs from this company remain in the State Register of Medicines.
Cancellation of state registration of drugs is a routine procedure that may be related to drug re-registration, including under the rules of the Eurasian Economic Union (EAEU), or updating a company's portfolio in accordance with its development strategy. "FV" monitors only the revocation of state registration of drugs in accordance with the State Register of Medicines. The presence of analogs under international nonproprietary names (INNs) is analyzed using the EAEU registry. However, dietary supplements or medical devices containing the same active ingredient may remain on the market; they are not included in the drug analysis.
Source: https://pharmvestnik.ru/content/news/minzdrav-otmenil-registraciu-72-lekarstvennyh-sredstv.html
Market news
Manufacturers of medical devices and reagents have requested government support
Largest manufacturers of medical devices and laboratory reagents have asked the Russian Ministry of Health and the Ministry of Industry and Trade to consider additional support measures for the industry (MV has a copy of the minutes of the meeting "Development of a Strategy for the Production of Domestic Reagents to Ensure Import Independence of the Biotechnology Industry," dated December 9, 2025). In addition to representatives of federal ministries and state technology corporations, the meeting was attended by representatives of companies such as NPO TN-Biotech, Invitro, Helix, Promomed, Alkor Bio Group of Companies, KhimMed JSC, and Olvex Diagnosticum.
This involves a consumer subsidy mechanism covering up to 70% of the costs of comparative testing and method revalidation when switching to a domestic equivalent from a special register maintained by the Ministry of Industry and Trade of the Russian Federation, along with a legislatively guaranteed demand for import-substituted products for at least five years from the date of registration.
Due to the lack of access to industrial equipment, the agency is also being asked to consider the need to create a full-cycle production and R&D infrastructure (engineering and technology centers of excellence for fine chemical synthesis based on existing research institutes and chemical-pharmaceutical clusters, equipped with modern pilot and industrial equipment meeting GMP standards), including the provision of services to small and medium-sized companies on preferential terms.
To control access to support measures, it is proposed to create a unified digital register of domestic reagents (EDRR), which would include only manufacturers who have confirmed localization and consistent product quality. It would also introduce end-to-end monitoring of the quality and traceability of raw materials and finished products through an industry-wide digital platform. Industry participants also note the virtual absence of domestic production of high-performance and multifunctional analyzers, including those for biochemical, enzyme-linked immunosorbent assays, and immunochemiluminescent assays.
The protocol lists the areas that most require protection to expand production capacity. These include hematology, biochemistry, and blood gas analyzers, PCR systems, sequencers, chromatographs, and bacteriological analyzers; and critical components of in vitro diagnostic medical devices, such as reagents, antibodies, and biochips.
The Federal Agency for Technical Regulation and Metrology, together with relevant agencies, has been asked to prepare proposals on the possibility of harmonizing GOST standards for reagents with the requirements of leading global pharmacopoeias (EP, USP) and ISO standards, as well as on the development and approval of national standards for "Biopharmaceutical Reagents" and the introduction of an "accelerated registration" mechanism for domestic products. This could also include creating a "regulatory sandbox" for domestic reagents for which the manufacturer has provided data on chemical and functional equivalence to imported analogues. For such products, the market launch period could be reduced from 1-2 years to six months.
Amid ongoing sanctions, the simplified registration of drugs in Russia has been extended until 2036, and for medical devices until 2028. According to the Cabinet of Ministers' press service, this decision will help maintain market stability in the face of external sanctions. The simplified registration procedure allows for the rapid processing of documents for introducing products to the market, as well as avoiding shortages and supply disruptions to pharmacies, clinics, and hospitals. For the same purpose, in January, the Russian government extended for another two years the special procedure for importing and distributing drugs in foreign packaging in the event of defects.
An AI system for mass screening of heart failure has been registered in Russia
I.M. Sechenov First Moscow State Medical University has registered software for remote screening and monitoring of hemodynamic parameters using single-channel electrocardiogram and pulse wave data. The development is designed for the early detection of heart failure and other hidden cardiac disorders and can be used in outpatient clinics, telemedicine centers, and for routine follow-up, according to the medical school's press service.
Approval for the development was received for the most complex, third-class, medical devices with artificial intelligence (MD with AI). The technology allows for the calculation of parameters typically obtained from cardiac ultrasound using single-channel ECG data. According to Professor Filipp Kopylov, Director of the Institute of Personalized Cardiology at Sechenov University, this opens up opportunities for mass screening and remote patient monitoring.
Patented algorithms can detect systolic dysfunction, when the heart's contractions weaken and eject an insufficient volume of blood, and diastolic dysfunction, when the heart's ability to fill with blood between contractions is impaired, an early sign of heart failure. They are integrated into a portable single-channel electrocardiograph no larger than a credit card.
To conduct the test, the patient simply places two fingers on the device for one minute. After recording the signal, the neural network analyzes the data, and the physician receives a report assessing the patient's individual risks. The technology allows the initial diagnostic stage to be moved to primary care—for example, to first-aid stations—which could significantly simplify access for patients to the initial examination, the report emphasizes.
Scientists are working on a new version of the algorithm that will be able to detect additional conditions, including heart defects and coronary artery disease, as well as signs of diabetes and anemia.
The Dubna Special Economic Zone (SEZ) will establish a 200 million ruble production facility for medical needles
The Ministry of Investment, Industry, and Science of the Moscow Region announced that V-Mlab will manufacture disposable medical needles and infusion systems in the Dubna Special Economic Zone (SEZ). Investment in the project will exceed 200 million rubles.
According to Ekaterina Zinovieva, Deputy Prime Minister and Minister of Investment, Industry, and Science of the Moscow Region, the company plans to create over 90 jobs. Butterfly needles, double-ended needles, and infusion systems, which are in high demand in laboratories, will be manufactured on high-performance automated equipment in cleanroom conditions, adhering to quality and sterility standards.
The project is part of Eiliton LLC, a company specializing in the production of irradiation electrotherapeutic equipment, and is focused on the development and commercialization of new, modern medical devices and components for clinical laboratory diagnostics.
In December 2024, Eiliton launched its fourth automated production line for vacuum tubes for venous blood collection, costing 60 million rubles. At the time, it was reported that the new production line would have a capacity of approximately 5 million tubes per month. Following the launch, the overall capacity of the entire enterprise increased to 12 million tubes per month, increasing production volume by almost 70%.
Other
Weight-loss drugs could impact the US airline industry
The growing popularity of weight-loss drugs could save the largest US airlines up to $580 million on fuel this year, according to a study by Jefferies cited by CNBC.
The four largest US carriers—United Airlines, Delta Air Lines, American Airlines, and Southwest Airlines—will collectively burn approximately 16 billion gallons of fuel this year, costing $39 billion, or nearly 19% of their operating costs. Calculations suggest that if passengers lose an average of 10% weight, the weight of each aircraft would decrease by 2%. This would reduce fuel consumption by 1.5% and boost earnings per share: 2.8% for Delta Air Lines, 3.5% for United Airlines, 4.2% for Southwest Airlines, and 11.7% for American Airlines, the airline most sensitive to fuel costs.
"A leaner society means lower fuel consumption. For years, the aviation industry has been looking for ways to reduce the weight of aircraft—from eliminating olives to switching to lighter paper," the investment bank's report notes. This refers to two iconic cases: in the 1980s, American Airlines cut annual costs by $40,000 by removing olives from business-class meals, and United Airlines cut costs by $290,000 by using lightweight paper for its Hemispheres in-flight magazine since 2018.
The obesity rate among adults in the US has fallen from a peak of 40% in 2022 to 37% in 2025—a reduction of 7.6 million people. Over the past year, the proportion of Americans using GLP-1 agonists has doubled, reaching 12%. Jefferies believes that the transition to pills will attract many people who have previously rejected these medications, unwilling to take injections for various reasons.
Changing passenger eating habits could also lead to a reduction in airline revenue from in-flight snack sales. Appetite suppression has already changed consumption patterns for millions of people: grocery chains are reporting reduced revenue, and clothing retailers are revising their sizing in favor of smaller sizes. Read more about this in the article "The Economy Has Gone on a Diet" — FV No. 9 (1168) dated April 15, 2025.
Anti-Counterfeit Association Demands Roszdravnadzor Investigate Dangerous Eye Drops on Marketplaces
The Anti-Counterfeit Association has submitted a petition to Roszdravnadzor demanding an investigation into the mass sale of dangerous eye drops on marketplaces that are not considered medications. The regulator is reviewing 131 products. Pharmvestnik examined 27 products from the association's list (available to the publication).
In total, experts examined 131 eye drops on Wildberries and Ozon. The investigation revealed that 43 products lack state registration as medicines, declarations of conformity for 21 products have been suspended or terminated, and 21 products are sold without the required information in Russian.
During the detailed analysis, various schemes for deceiving consumers were discovered. Products sold as medications explicitly claim to treat serious conditions. For example, "Aloe Vera Extract Eye Toner" from the seller "Fitonauka" is marketed as a treatment for glaucoma and diabetic retinopathy, while "Isotine" from "EcoVybor" promises to improve vision in cases of cataracts and myopia. However, neither of these products has been registered with Roszdravnadzor.
To legitimize their products on these platforms, sellers use substitution of documents: instead of registration certificates, they provide declarations for cosmetics or even beverage concentrates. For example, "Filatov Aloe Extract" from "Tanamari" is declared as a cosmetic toner, while "Prozrenie Eye Drops" from "Zdorov" is declared as a beverage concentrate.
The average price of the products on the list is approximately 581 rubles. Despite the lack of regulatory approvals, demand for them is high. For example, "Tonic Control" sold for 6.1 million rubles. (10,601 packs), and "Tonic with Aloe Extract" for 6.6 million rubles (11,126 units).
Japanese drops are among the most expensive items. Wildberries sells Rohto drops under various names, as well as "Iridina" drops from WILDMARKET, which are the most expensive product on the list (1,281 rubles). Ozon is actively selling the Sante and LION Smile Contact lines, as well as "Rohto Vitamin Eye Drops." None of these products have a registration certificate, although their descriptions include therapeutic indications.
In its appeal, the Anti-Counterfeit Association points out direct risks to the lives and health of citizens. Following the publication of these data, marketplaces announced the blocking of some product listings and increased monitoring of sales in the medical category.
The Ministry of Health has approved a new standard of medical care for adults with influenza
The Russian Ministry of Health has approved a new standard of medical care for adults with influenza. Previously, Order No. 724 of November 9, 2012, was in effect for the treatment of moderate influenza, but it was repealed in July 2024. Now, the ministry has refused to specify the severity of the disease. Furthermore, the regulator has excluded antibiotics and diuretics from the list of medications and reduced the average treatment duration from 15 to 9 days. The updated version specifies a list of influenza treatment methods and a list of specialized physicians for consulting patients.
According to the order, the standard applies to the treatment of influenza caused by a specific identified virus, seasonal influenza, and unspecified influenza viruses. The average treatment duration will be 9 days, and medical care will be provided in both outpatient and inpatient settings. Diagnosis requires consultations with seven physicians: a gynecologist, a hematologist, an infectious disease specialist, a cardiologist, a neurologist, a pulmonologist, and a general practitioner.
The document states that drug treatment includes the use of antiviral drugs, immunostimulants, cough suppressants, and pulmonary surfactants. The list includes 29 medications (33 in the previous version), including ibuprofen, paracetamol, ambroxol, acetylcysteine, and bromhexine. The updated version excludes, among other things, azithromycin, amoxicillin, ceftriaxone (antibiotics), and furosemide (diuretic).
The patient may be prescribed 27 tests, including serum C-reactive protein levels and molecular biology testing of nasopharyngeal swabs for metapneumovirus, adenovirus, bocavirus, coronaviruses 229E, OC43, NL63, and HKUI (Human Coronavirus). For inpatient flu treatment, 24-hour observation by an anesthesiologist-resuscitator and daily checkups by an infectious disease specialist and a general practitioner will be prescribed.
In July 2025, Rospotrebnadzor approved preventive measures for the 2025-2026 epidemic season. The document provides for the prevention of influenza, as well as acute respiratory viral infections and COVID-19. To this end, large-scale vaccination of up to 60% of the population in each region is planned, including at least 75% of those in risk groups.
New registered medical devices
We publish a list of new medical devices registered from 01.16.2026 to 01.23.2026
Link to the list: [see table in the attachment]
News
