EU’s ban of 700 pharma products will impact Indian pharma export by $1 bn

Indian govt defers FTA talks with EU

Usha Sharma-Mumbai

Countering European Union’s ban of over 700 pharmaceuticals products clinically tested by the Hyderabad-based GVK Biosciences, the Government of India has announced that it was deferring the proposed trade talks. The impact of the ban will hit Indian pharma exports, and incur a loss of less than $ 1 billion. The talks with the European Union on the proposed free trade agreement was earlier scheduled for August 28, 2015.

In a communication dated February 20, 2015, the European Medicines Agency had intimated other EU member states of the GVK Bio products for which they recommended suspension of marketing authorisations, based on an investigation at GVK Biosciences’ Hyderabad site. Of around 1000 generic formulations from around 100 companies, spanning over 50 APIs, around 300 of them had enough data from other sources to support approval.

Commenting on the impact of the ban on the Indian pharma industry, Dr PV Appaji, Director General, Pharmexcil said, “Earlier this year, we received a request from the company and escalated the issue to the Ministry of Commerce and Industry, Government of India. Along with Drug Controller General (India) (DCGI) and Commerce Secretary we took a delegation of four to five persons to the French regulatory authorities. DCGI was in dialogue with its counterpart and clarified the doubts.”

Appaji says, “However, the issue is being raised again which is likely to have an adverse impact on the industry. During our earlier visit, the EU authorities had put 1000 products under the scanner, which now has been reduced to 700. Companies accounting for the remaining 300 odd products are conducting repeat tests from other CROs. Now, we are identifying the Indian companies and their products which are in the list of remaining 700 formulations, and are yet to arrive at a conclusion. Based on the 1000 products, we had indicated that the loss to Indian pharma industry would be to the tune of nearly $1.2 billion, but now we are anticipating it to be less than $ 1billion.”

In reply to a query on the steps to be taken by India’s Commerce Ministry, Appaji said that the Ministry is reviewing the action taken by the EU authority.

Dr GN Singh, DCG(I) said, “We are strengthening our BA and BE studies. We monitor the quality process pattern which is required within the country. Companies need to follow the guidelines based on the importing countries requirements. On this ban concerning 700 products, the required steps will be taken up through diplomatic channels.”

The Government of India has engaged itself with various EU regulators over the past eight months. It has taken a decision to defer the talks between chief negotiators of India and the EU on the India –EU Broadbased Investment and Trade Agreement (EU-BTIA) planned for later this month.