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India, EU to ink pact on pharma exports soon

Following Brexit, India and the European Union (EU) are likely to finalise the Broad Based Trade and Investment Agreement (BTIA) for free trade of pharmaceutical exports.

By: | Hyderabad | Updated: September 23, 2016 7:03 AM
India had deferred FTA talks with EU in August last year as it was disappointed over the EU banning sale of around 700 pharma products, clinically tested by Hyderabad-based GVK Biosciences. (Reuters) India had deferred FTA talks with EU in August last year as it was disappointed over the EU banning sale of around 700 pharma products, clinically tested by Hyderabad-based GVK Biosciences. (Reuters)

Following Brexit, India and the European Union (EU) are likely to finalise the Broad Based Trade and Investment Agreement (BTIA) for free trade of
pharmaceutical exports.

The negotiations are at an advanced stage and both countries are expected to sign an agreement soon. The high-level talks resumed after Prime Minister Narendra Modi insisted on ironing out differences between both countries and pitched for removing the non-tariff barriers on Indian pharma exports to the European markets.

“We are on the verge of finalising the FTA with the new EU and are in an advanced level of negotiations for pharmaceutical exports. We hope to revive and expedite the relationship between Indo-EU as both need a strong bilateral trade regime,” Anice Joseph Chandra, director, ministry of commerce and industry, said.

The revival of talks follows from the recent high-level meetings of the commerce ministry officials, EU drug regulators and the industry. “We are also in talks with the UK as well and are exploring bilateral trade opportunities with the UK as well,” she said.

India had deferred FTA talks with EU in August last year as it was disappointed over the EU banning sale of around 700 pharma products, clinically tested by Hyderabad-based GVK Biosciences. Negotiations for the India-EU FTA was launched way back in 2007. In July 2015, the EU banned 700 generics tested by GVK Biosciences, following charges of manipulation of clinical trials for bio-equivalence testing by French standards agency ANSM.

The ban was based on the allegation that the electrocardiogram (ECG) data of volunteers examined by GVK between 2008 and 2014 had been doctored. The drugs tested by GVK during the period were withdrawn from all EU markets in August 2015 despite the lack of evidence against, or complaints regarding, the quality or efficacy of the medicines.

“The FTA negotiations were slated to restart in August 2015, but India deferred them, saying it was disappointed and concerned over the EU imposing a ban on sale of around 700 pharmaceutical products clinically tested by GVK Biosciences. Both sides have since held talks to separately resolve the GVK issue,” said an official from the Pharmaceuticals Export Promotion Council (EPC), promoted by the ministry of commerce and industry, to focus on healthcare and pharmaceutical products.

“The process of finalising the Broad Based Trade and Investment Agreement (BTIA), to draw up a free trade pact, has just begun and an agreement will be in place soon,” the official pointed out. Meanwhile, the Indian government is still working on its payment proposal with the Venezuela government for ‘drugs for oil’ scheme. “The issue with the Venezuelan government is still uncertain and the commerce ministry is working with the ministry of external affairs, RBI and other banks to bring an amicable solution for the pharma industry,” she said.

Indian pharmaceutical companies are still keeping fingers crossed as they are yet to receive payments from exports worth Rs 2,000 crore to Venezuela, Russia, Nigeria and Angola countries.

Further, the commerce ministry and the Department of Pharmaceuticals are working to revive sick IDPL units in the country. “We are looking at all options to revive both Hindustan Antibiotics (HAL) and Indian Drugs And Pharmaceuticals (IDPL). This would also include a private-public-partnership (PPP),” Anice Joseph Chandra said.

The central government had earlier decided to revive IDPL units and prepared a revival package with an investment of over Rs 1,000 crore and monetise even the land parcels around the IDPL units. IDPL has manufacturing plants at Rishikesh, Gurgaon and Hyderabad and two subsidiary units at Chennai and Muzaffarpur. “We are looking at various strategies which can bring in enough capital infusion without selling the assets,” she said, accepting the fact that the whole process is delayed and more of an endless wait.

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