|
With the September 1 deadline for implementation of digital labelling of foreign medicines and medical devices importing in the Republic of Uzbekistan approaching fast, foreign pharmaceutical companies including Indian drug firms are looking for more regulatory guidance and technical standards to implement digital labelling.
India’s pharmaceutical exports to Uzbekistan more than doubled in FY 2020-21. In order to fight Covid pandemic, India supplied HCQ, paracetamol and other essential drugs, while Uzbekistan supplied oxygen concentrators and other medical goods. According to the United Nations COMTRADE database on international trade, India’s export of pharmaceutical products to Uzbekistan was USD 137 million during 2021. Uzbekistan’s pharma market stood at US$ 1.5 billion. There is a huge scope for investment and exports in oncology and dermatology sectors in Uzbekistan.
In order to radically improve the accounting mechanisms in relation to the production, import and circulation of medicines and medical products, ensure their legal circulation, Cabinet of Ministers of the Republic of Uzbekistan in April this year approved a resolution on the phase wise introduction of a mandatory system of digital labelling of medicines and medical devices from 2022-25. It is called decree 149.
According to the decree, starting from September 1, 2022, medicines and medical devices of foreign origin can be imported into the territory of the Republic of Uzbekistan only with the presence of mandatory digital labelling (in secondary packaging). A similar requirement comes into force on November 1, 2022 for medicines in primary packaging. At the same time, the possibility of labelling by sticking stickers has been created in addition to the technology of direct application.
Also, a norm has been established according to which, after 12 months from the date of the introduction of mandatory digital labelling, a foreign manufacturer is obliged to open an official representative office in the territory of the Republic of Uzbekistan or sign an agreement with a local (Uzbek) company on the representation of interests and obligations in the field of the introduction of digital labelling in the territory of the Republic of Uzbekistan.
For these purposes, foreign manufacturers must register in the National Information System for Monitoring Labelling and Traceability of Products "Asl belgisi" by July 1, 2022, using an electronic digital signature (EDS). EDS is provided by diplomatic missions and consular offices of the Republic of Uzbekistan with the registration of a personal identification number of an individual (PINI) to representatives of foreign organizations-manufacturers of medicines who have received a taxpayer identification number (TIN) from the state tax service. The procedure for procuring the TIN, PINI and EDS is assisted by the responsible officials of the State Tax Committee.
Indian drugmakers have hailed Uzbekistan’s initiative to implement digital labelling of drugs. However, they are looking for more clarity over regulations and technical standards to implement digital labelling. Besides this, they are also looking for a transition period to migrate to digital labelling.
Said Sahas Rangan, vice president- international business, Entod International, "It is by now widely accepted that Uzbekistan is rushing to follow the lead of Russia and Kazakhstan in many (even the questionable) regulatory reforms, such as digital labelling (aka serialization). For example, a local affiliate of a Russian entity (CRPT-Turon) is promising to introduce digital labelling flawlessly and in the short term. Yet, the mandatory labelling of medicines was set to start in February 2022, while the pilot project, which was planned to commence in June 2021, has still not fully commenced in August (at least for the foreign products). With the new deadline of September 1, 2022, foreign pharma companies need more regulatory guidance and technical standards to implement digital labelling. Most importantly, without a considerable transition period to amend registered packages, there is a serious risk that certain medicines will disappear from the market.”
He further said “Implementation of the digital serialization process in Uzbekistan is a very complicated issue. Without the clear technical regulations/rules and guidelines and also without the transition period for regulatory and production aspects, there will be a huge shortage not only in local medicines but in imported medicines too. It's a great risk for local patients and the pharma market as well, because a lot of imported medicines have no analogs or generics to substitute them.”
Sharing his views on implications of Uzbekistan's mandatory digital labelling of foreign drugs from September 1 on India's drug export to the country, Rangan said “With respect to Indian manufacturers, who have been working in Uzbekistan for several years from now, it would be very difficult to comply with the regulations, unlike the fairly new players in the market, mind it, Uzbekistan is a very robust and competitive market like any other developing countries and the cost component shall be very much in the process of serialization, unlike markets like Russia where the gross margins are very much better than the other CIS countries.”
He, however, appreciated Uzbekistan’s initiative to introduce digital labelling of drugs. “The transition to digital labelling will create possibly an electronic duplicate of the country's economic life. With the help of the National Information System "Asl belgisi" and the system "Tax Partner" to form public control over counterfeit and illegal products. Legitimate companies shall survive in the process and the competition would be a bit more uniform in the process. Parallel trade will be limited too,” he added.
Chiming in with Rangan, Praveen Sikri, CEO, Ikris Pharma Network said, “The Uzbekistan government making it mandatory for imported medicine and medical devices of foreign origin to be enabled with digital labelling is certainly a welcome measure. It attests to the fact that the governments are taking the issue of counterfeit and substandard medicines today extremely seriously. While the move will force more pharma manufacturers, exporters and other associated players in the ecosystem to migrate to digital labelling and other related measures, it would also motivate other countries and their regulators to follow suit. With Indian drug exporters routing their pharma products through Russia into Uzbekistan, it would be interesting to see how they deal with this new rule. In all likelihood, they would eventually embrace digital labelling for Uzbekistan-bound products. Broadly speaking, given the scale of the counterfeit and fake medicines that exists today in the global pharma market, the move by the Uzbekistan government not only would pave the way for ‘a cleaner commerce’ in pharma, it would also be a booster shot for the health and lives of patients in Uzbekistan and other countries. Perhaps the Indian government could also consider such a step."
|