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
Last Updated: Friday 07 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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  • It is very surprising to know how the EU drug regulatory agency can be so arbitrary in their action of banning around 700 "GENERIC" formulations with one single stroke of an order! It is further surprising to know that they first approved these 700 odd formulations of various drugs manufactured by several Indian Pharmaceutical companies over a period of 10 long years ( 2004 to 2014 ) and then with a single order ban these all together, because they all were tested in the same lab over the period 2004 to 2014! Does this mean that all those millions of patients who received these "APPROVED" medicines over 10 long years should actually have not received them in the first place? These patients deserve to know from the regulators, what harm they might have caused to them so that they could claim compensation from the regulators because without their approval they could have not received these. The Drugs Controller general of India should take a proactive step and grant an immediate "BLANKET" approval to all these 700 odd formulations for sale at reduced prices to Indian patients. It is these millions of poor Indian patients who need cheaper "GENERIC" versions of drugs and not the patients in the European countries or USA.. This step will help reduce the monetary losses suffered by the concerned Indian Pharma companies. This step also gives the DCGI and the Indian Government an opportunity to introduce cheaper "GENERIC" formulations of drugs in India and get rid of the hundreds of expensive "BRANDED" formulations being sold in India.

    Posted by: Shriram Mahajani | 4 years ago | Reply