Russia introduces a speedy process for the registration of drugs.

Friday May 20, 2022 at 4:44 pm

The Russian government has now expedited procedures for registering drugs, facing a shortage in the domestic market. It is going to be suitable for Indian drug manufacturers.

Indian pharma companies with business operations in the Russian market and those planning for business expansions can now take advantage of the expedited procedure for registering medicinal drugs. It has already reduced the time frame for the registration of medicinal drugs from 1-2 years to 60 days, claimed Mr. Uday Bhaskar. He is the director-general at India’s Pharmaceuticals Export Promotion Council (Pharmexcil).

Pharmaceuticals Export Promotion Council of India (Pharmexcil) has already received communication from the department of commerce of the union government of India wherein the Indian mission in Moscow had shared the new decree regarding the expedited procedure for registration of various generic and unused medicines in Russia.

Russia is India’s fourth-largest drug export destination. India has exported medicines worth more than USD 591 million to Russia in the fiscal year 2021, which was a significant 7 percent rise from a year ago. Russia accounts for 50 percent of the CIS pharma market for India. No Indian company has rolled back its operations from Russia, and India has refused to criticize Russia’s invasion of Ukraine, despite the pressure from the United States to do so.

After the Western sanctions imposed, Russia is now facing a shortage of vital medications, including anti-inflammatory, gastrointestinal, antiepileptic, and anticonvulsant drugs, including antidepressants and antipsychotics.

To overcome this shortage, the Russian government of Russia, on April 5, 2022, adopted Decree No. 593, which introduced temporary rules for speedy registration of generic and new medicines for the domestic market until the end of the year 2023.

With that, a special interdepartmental commission was also created by the ministry of health that will determine a list of medicines and shortages which is faced or might be faced in the Russian market.

Suppose this special interdepartmental commission acknowledges the shortage of a particular drug. In that case, the therapeutic analog of the said drug in short supply can be registered as part of an accelerated procedure. That is expected to take up to 60 business days instead of 1-2 years earlier. This concept of a therapeutic analog established by this document is broader than the concept of a generic drug, that drugs that are copies of the original drug, and may include not only medicinal drugs registered under one international nonproprietary name (INN) with other trade names but also drugs with other international nonproprietary names (INNs).

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

In addition, this decree will allow the newly registered medicines to the Russian market even in non-Russian packaging, whereas till now, Russian packaging was legally mandatory)  provided that they have at least a sticker in the Russian language till the end of 2022. These measures, which the Russian government is taking because of the current war-like position it finds in due to the ongoing war and the sanctions imposed by the West, will help Indian pharma companies boost their markets in the country.