[Ip-health] Livemint: India cancels EU trade talks over pharma ban

Thiru Balasubramaniam thiru at keionline.org
Thu Aug 6 02:24:05 PDT 2015


Last Published: Thu, Aug 06 2015. 01 06 AM IST

India cancels EU trade talks over pharma ban

Government says it is ‘disappointed’ with EU for imposing an import ban on
700 drugs made by GVK Biosciences

Asit Ranjan Mishra

Photo: Bloomberg

New Delhi: India has cancelled a meeting with the European Union’s (EU’s)
chief trade negotiator in protest against an import ban on 700 of its
generic drugs for alleged manipulation of clinical trials, dealing a blow
to the proposed free-trade accord between the European trade bloc and
Asia’s third-largest economy.

The decision was taken as the government is “disappointed and concerned by
the action of EU in imposing legally binding ban on the sale of around 700
pharma products clinically tested by GVK Biosciences, Hyderabad” on 16
July, the commerce ministry said in a statement on Wednesday. The meeting
between chief trade negotiators of the two sides was scheduled for 28

The cancellation of talks is only the latest setback to the proposed
free-trade agreement (FTA) that the two sides have been negotiating since
2007. Differences over the lack of access for Indian professionals to EU’s
labour market and high taxes imposed on liquor and car imports from Europe
have thwarted efforts to reach an accord that is expected to boost trade
between India and the EU.

D.G. Shah, secretary general, Indian Pharmaceutical Alliance, a lobby of
domestic drug makers, said the government seems to be sending a strong
signal to the EU against the arbitrary decision to ban some Indian generic
medicines. “EU has acted unfairly and without any proof.”

The ban follows the recommendation of the European Medicines Agency’s
(EMA’s) Committee for Medicinal Products for Human Use to suspend the
licences for some medicines in the EU that were based on clinical trials
conducted at GVK Biosciences’ site in Hyderabad.

EMA’s recommendation was based on an inspection by the French medicines
agency (ANSM) in 2014 of GVK Biosciences’ Hyderabad facility. The
inspection cast doubt on the way clinical trials were performed at the site
and therefore the reliability of data used to support the granting of a

“While the drug inspector sent by the French authorities claimed ECG
(electrocardiogram) data of clinical trials were manipulated, the inspector
was not competent to vet such data. It is only a cardiologist who can
verify such data,” Shah claimed, terming the ban on 700 generic drugs,

The UK government on Tuesday said the ban on the drugs was being imposed
only as a precautionary measure. “There is no evidence of safety concerns
or loss of efficacy with these products. People should continue to take
their medicines as prescribed,” it said.

India could lose about $1-1.2 billion worth of drug exports because of the
decision taken by the European Commission to ban the drugs, according to
Pharmaceuticals Export Promotion Council (Pharmexcil).

The country exported $15.4 billion worth of pharmaceutical products in
2014-15, with Europe accounting for $3 billion, or 20% of the total. Out of
the $3 billion, exports of generic medicines constituted about $1 billion
and drug ingredients accounted for the rest, according to Pharmexcil.

“Pharmaceutical industry is one of the flagship sectors of India which has
developed its reputation through strong research and safety protocols over
the years and, therefore, government of India will examine all options in
this regard. It is pertinent to mention that most of these drugs are
already in EU market for many years without any adverse pharmaco-vigilance
report from any member state,’ the commerce ministry statement said.

India and the EU have missed at least four deadlines to clinch a free-trade
accord, called Broad Based Trade and Investment Agreement, even after 15
rounds of talks.

A prolonged recession in the EU, and its focus on concluding the
Transatlantic Trade and Investment Partnership agreement with the US, also
delayed the progress.

Trade minister Nirmala Sitharaman met her counterpart, EU trade
commissionerCecilia Malmström, on the sidelines of an informal meeting of
trade ministers in Paris in June and decided to revive talks at the chief
negotiators’ level.

Accordingly, India’s chief trade negotiator J.S. Deepak and his EU
counterpartIgnacio Garcia Bercero were scheduled to meet in Delhi.

India’s exports to the EU contracted 4.4% to $49.3 billion in 2014-15 while
imports contracted 2.2% to $48.8 billion.

India and the EU have a long history of tussle over generic drugs. India
initiated dispute settlement consultations in May 2010 at the World Trade
Organization with the EU on the issue of detention of Indian generic
medicines while in transit. The dispute was triggered by repeated instances
of seizure at EU ports, particularly in the Netherlands, of Indian generic
drugs meant for export to Latin American and other countries in 2008.
However, both sides reached a settlement to the dispute in 2011 and EU
agreed not to seize generic drugs consignments in transit through its

The EU also banned the import of Alphonso mangoes, brinjal, taro, bitter
gourd and snake gourd starting May 2014 citing the presence of pesticides.
However, after a strong protest by India, EU lifted the ban on Alphonso
mangoes in January though the ban on vegetables still continues.

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