Government stand against EU ban on Indian drugs much needed, says industry

Standing against the arbitrary ban on 700 drugs, India has decided to defer the proposed talks on the free trade agreement between India and the EU

By Kundan Pandey
Published: Thursday 06 August 2015

The Indian pharma industry has decided to stand together against the EU's "arbitrary" action against generic drugs made in India.

In a statement on Wednesday, the commerce ministry said, "The Government of India is disappointed and concerned by the action of EU in imposing a legally-binding ban on the sale of around 700 pharma products clinically tested by GVK Biosciences, Hyderabad."

The government had been in touch with various EU regulators over the issue for the past eight months. However, the EU went ahead and banned these medicines last month. The ban is expected to come into force August 21. The government has decided to examine all options to resolve the issue.

Most of these drugs have been available in the EU market for many years without any adverse pharmaco-vigilance report from any member state.

Pharmaceutical Alliance Secretary General D G Shah said that the action against the drugs is "a clear case of vendetta" and that the industry cannot fight it alone. "Government did the right thing by taking a tough stand against the EU. Now, someone has to explain the reason for taking action against these drugs. The EU agency has not followed the standard and it will be tough for them to explain," he said.

This ban follows a recommendation by the European Medicines Agency (EMA) committee to ban a few medicines in the EU due to alleged manipulation of trial data of 40 drugs. The clinical trials were conducted at GVK Biosciences in Hyderabad.

Shah explained that the inspector sent by the French medicines agency (ANSM) was not a cardiologist, as was required in the case of those drugs, and hence was not qualified to interpret the data correctly.

GVK Biosciences has denied any wrongdoing.

In this case, the EU should have also sent a third party, like in the Ranbaxy case a couple of years ago, added Shah. After the US complaint about Ranbaxy drugs, experts from World Health Organization and other countries were sent. They concluded that things were in order and, thus, the drugs in question continued to be sold in the US market.

The EU conducted checks on 40 drugs but recommended a ban on 1,000 drugs. Later, they finalised a list of 700 drugs which, Shah alleged, is a case of "mischievous attitude". 

The generic drugs produced in India are hurting their interests, said Shah.

In 2010, India had initiated dispute settlement consultations at the World Trade Organization (WTO) when the EU repeatedly seized Indian generic medicines meant for Latin America and other countries. In 2011, India and EU reached a dispute settlement.

Last year, the EU also banned the import of Alphonso mangoes citing the presence of pesticides. After strong protests, the ban was lifted. 

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