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Russia’s newly introduced speedy process for registration of drugs augurs well for India
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Laxmi Yadav, Mumbai
May 24 , 2022
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The Russian government has expedited procedures for registration of drugs facing shortage in the domestic market which augurs well for Indian drug manufacturers.
Indian companies with business operations in the Russian market and the ones planning for business expansions can take advantage of the expedited procedure for registration of drugs. It has reduced the time frame for registration of drugs from 1-2 years to 60 days, said Uday Bhaskar, director general, Pharmaceuticals Export Promotion Council of India (Pharmexcil).
Pharmexcil has received communication from the department of commerce, government of India wherein Indian mission in Moscow has shared the new decree towards expedited procedure for registration of generic and new medicines in Russia.
Russia is India's fourth-largest drugs export destination. India exported medicines worth more than USD 591 million to Russia in fiscal year 2021, a 7 per cent rise from a year ago. Russia accounts for 50 per cent of CIS pharma market for India. No Indian company has rolled back operations from Russia and India has refused to criticise Moscow's invasion of Ukraine, despite pressure from the United States to do so.
Russia is facing shortage of vital medications including anti-inflammatory, gastrointestinal, antiepileptic and anticonvulsant drugs, as well as antidepressants and antipsychotics following western sanctions after it invaded Ukraine.
To overcome the shortage, Russia on April 5, 2022 adopted Decree No. 593 introducing temporary rules for speedy registration of generic and new medicines in the domestic market till the end of year 2023.
With this, 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 nonproprietary 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.
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