PXL/HO/Cir-014/2022-23                                                                    Date: 13.05.2022

Hyderabad

Subject: New decree (No. 593) for expedited procedure for registration of drugs in Russia

Pharmexcil is in receipt of communication from the Department of Commerce, Government of India wherein our Indian mission in Moscow has shared the new decree towards expedited procedure for registration of generic and new medicines in Russia.

The Russian Government has adopted Decree No. 593( enclosed) dated April 05, 2022, which introduces temporary rules ( till the end of year 2023) for registration of drugs facing shortage in the Russian market.

The major points of the decree are as below:

·   A special interdepartmental commission will be created by the Ministry of Health that will determine a list of medicines, shortage of which are faced or might be faced in the Russian market.

·   If this special interdepartmental commission acknowledges the shortage of a certain drug, the therapeutic analogue of the drug in short supply can be registered as part of an accelerated procedure. This is expected to take up to 60 business days, instead of 1-2 years earlier. [The concept of a therapeutic analogue established by the document is wider than the concept of a generic (copies of the original drug), and may include not only drugs registered under one international non-proprietary name (INN) with different trade names, but also drugs with other INNs].

·   Producers of such medicines are allowed not to hold separate clinical trials of such medicines in Russia. Instead of this, they can present results of trials conducted in other countries. In addition, remote mode of lab testing of medicines is also allowed including through audio or video communication, the procedure and forms of which are determined by an expert institution in agreement with the said applicants. However, producers of medicines that will be registered according to this new facilitated procedure may be obliged to conduct post-clinical studies after the release of the drug into circulation.

·   In addition, this decree allows newly registered medicines to the Russian market even in non-Russian packaging (till now Russian packaging was mandatory), provided that they have a sticker in Russian language (till end of 2022).

Member companies with business operations in the market and the ones planning for business expansions are advised to take note of this important information.

With regards,

Udaya Bhaskar

Director General