The impact of Brexit is finally set to be felt by the global drug industry, more so our own generic drug industry.
CMDh, a group working under the aegis of European regulator EMA has put out a notice that will require drug companies to comply with certain tests to gain marketing authorisations in member nation’s post-2019.
CNBC-TV18 has accessed the notice from the European drug regulator and Archana Shukla has more on details on its impact on Indian pharma industry.
Experts say the change will be necessary where the products are common for the UK and the European Union. As of now, a filing in the UK is valid for several European markets but that will change post-March 2019.
CMDh the agency that harmonises market authorisations for EU member state has sent out notice dated May 2, stating that the EU law requires that marketing authorisation holders are established in EU and that some of the activities must be performed in the EU for example related to pharma covigilance, manufacturing, import etc. Now, this could mean duplication of tests, trials for 100s of products and that could lead to higher cost for drug makers.
The European Agency has also called for advance action by drug companies to check the validity of these approvals to avoid any impact on the continuous supply of medicines in the EU post-Brexit.
This is a move that applies to all products – generics and innovative.
Europe, including UK, is the world’s second largest drug market after the US.
From the Indian context, this move will be very significant. In FY16, Indian drug exports to EU stood to USD 2.5 billion and 22 percent of this export was for the UK. Although not all exports to EU will be impacted because there are certain products, which will have separate filings but a large section of common authorisation products will be impacted.
To access the impact, CNBC-TV18 reached out to seven of the top EU exporters – Sun, Lupin, Glenmark, Cipla, Dr Reddy’s and Unichem. Sun denied to comment and others did not respond.
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