India Reports Progress Over EU Drug Ban

New Delhi says Indian and European regulators have made headway in discussions over an EU ban on certain Indian pharmaceutical products.

NEW DELHI - India has reported progress in discussions with European Union regulators over a ban by Brussels on hundreds of Indian generic equivalents of off-patent drugs due to testing quality issues.

The EU last July told its 28 member countries that some 700 generic products must be pulled from retail shelves following a recommendation by the European Medicines Agency (EMA) to suspend their sale amid concerns over the reliability of studies conducted on the behalf of several drug makers by a leading Indian clinical research firm, gvk bioSciences Private Ltd. (Also see "EU Confirms Suspension Of 700 Generics But Indian Impact Unclear" - Scrip, 29 Jul, 2015.).

“As we speak our delegation is already in Brussels and there is a meeting [going on] between the regulators to discuss the GVK matter,” Commerce Secretary Rita Teaotia said in New Delhi. There has been "progress," Teaotia was quoted as saying by The Press Trust of India, the largest news agency in the country, although she gave no further details.

The EU ban has been one of a string of problems besetting India's pharmaceutical industry, which has been increasingly in the headlights of overseas regulators over quality concerns. The US FDA has issued warning letters to various Indian generic drug makers over the past few years and in some instances banned products from Indian plants being shipped to the US.

The Brussels talks on the GVK row were scheduled in tandem with a resumption of free-trade discussions between India and the European Union following a gap of some 30 months.

After the EU ban, India responded by calling off the resumption of these free-trade talks that have been going on since 2007. New Delhi later relaxed its stand and said it would hold an initial "stock-taking" meeting with the EU on the proposed pact, and agreed that the GVK issue should be split from the trade liberalization discussions.

Concerns have been expressed that failure to reach a deal with the EU could leave India isolated on the trade front, as Europe seeks Trans-Atlantic Trade and Investment Partnerships (TTIPs) with the US and Japan, and a number of regional and bilateral FTAs are being signed across the world. Underlying India's concerns over the issue is the fact the country's exports have fallen for 13 straight months.

‘Extremely Positive’ Free Trade Discussions

Teaotia described the latest free-trade discussions with the EU, India's largest trading partner, as “extremely positive,” and said EU negotiators had proposed holding secretary-level talks.

India is “keen to go ahead and work toward a balanced agreement,” said Teaotia, noting that since the last round of talks in 2013, India had implemented many demands that the EU had urged be included in the free-trade pact, such as higher foreign investment caps in telecoms, banking and insurance.

Indian pharmaceutical industry officials said they would be watching the talks closely and were optimistic a resolution could be reached.

"When German Chancellor Angela Merkel was here in Bangalore [in October 2015] she did indicate to the prime minister [Narendra Modi] that 'we will sort this out' and when the commerce minister, Nirmala Sitharaman, was in Paris for the climate talks this same indication came from the French president," Dilip Shah, secretary-general of the Indian Pharmaceutical Alliance, an industry lobby representing major local firms, told PharmAsia News.

Modi had asked the German chancellor "to ensure that the right decision was made by regulators in this regard," Foreign Secretary S. Jaishankar said in October 2015.

While the EU import ban was not on the formal agenda of the Delhi talks, commerce ministry officials had said that the tenor of the talks would be important.

The EU-wide suspension was unprecedented in scale and came after European inspectors said they found data manipulations of electrocardiagrams dating back at least five years. The regulators concluded the "systematic nature of the deception" cast doubt on the integrity of the conduct of trials at the GVK Hyderabad site generally (Also see "EMA Acts To Freeze GVK Drugs, Guard Against Shortages" - Scrip, 28 Jan, 2015.).

The medicines affected by the EU ban are sold by over a dozen firms including Mylan Laboratories Ltd., Teva Pharmaceutical Industries Ltd.,Dr. Reddy's Laboratories Ltd. and several other Indian companies, and the Sandoz Inc. division of Novartis AG. There was no evidence the drugs, which include common painkillers and antihistamines, could cause harm, the EMA said, but it had sought the suspension as a “precautionary” step.

Estimated Losses of $1bn-Plus

The Pharmaceutical Export Promotion Council of India or Pharmexcil, which falls under India’s commerce ministry, has estimated India's business loss arising from the EU ban could total $1.0bn to $1.2bn.

GVK Bio had conducted the tests to determine whether the generics had the same therapeutic impact as the original branded drug. The company, part of infrastructure-to-energy giant GVK Group, was not immediately available for comment on the Commerce Ministry spokeswoman’s comments.

GVK earlier said the suspension was highly disproportionate given that European regulators have stated that ECGs are “not essential” to establish bioequivalence with the original product. It also noted the Indian government and GVK Bio had presented data from “eminent cardiologists” that showed different conclusions from those of European regulators.

In October, India’s commerce ministry set up a six-member panel of experts from various departments, including drug regulators and cardiologists, to examine the data and reported that the panel found no irregularities. “We are very clear in our assessment that there was nothing wrong with the ECGs…we hope to convince them [the EU] of that,” a government official told India’s Business Line newspaper in December.

Also, a joint audit by regulators including the US FDA passed the ECG checkouts red-flagged by the EMA with only a few minor observations (Also see "U.S. FDA Cleared GVK Bio With Few Minor Observations" - Scrip, 11 Jun, 2015.).

Business Line quoted the government official as saying in December 2015 that, “While there is not much chance of the ban on the drugs getting revoked soon, the January meeting will serve to set things straight for the future and ensure that bans are not enforced on the same grounds again.”

EU officials have argued that the ban is a technical matter but some Indian drug makers have regarded it as protectionist backing for European drug manufacturers. Last April, the Indian government said the problem arose from a “few big multinationals…driving an agenda” against India’s $15bn pharmaceutical industry, a key provider of affordable generic medicines to the world.

MSF Tells India To Hold Firm

Separately, the international medical humanitarian organization Médecins Sans Frontières (MSF) on Jan. 18 urged New Delhi to hold firm against EU pressure to include “harmful provisions” on intellectual property in the free-trade talks that could restrict the production, sale and export of affordable life-saving medicines made in India, upon which millions of people in developing countries rely.

India requires companies seeking patents on their drugs to demonstrate that their compounds show novelty and inventiveness and not be obvious - as well as perform better than current compounds.

The country's huge generic drug industry has been a major supplier of generic medicines to treat diseases such as cancer, tuberculosis and AIDS for those who cannot afford expensive branded versions. But global drug manufacturers say India's generics industry inhibits pharmaceutical innovation and reduces the commercial incentives to produce cutting-edge medicines.

The EU has demanded that India adopt a patent protection regime.

MSF said that after fierce pressure from groups of people living with life-threatening diseases, some of the worst provisions such as extensions to patent terms and data exclusivity have been removed from the negotiating text.

Still, the group said it was still concerned about a range of “intellectual property enforcement” measures proposed in the FTA, ranging from legitimate medicines being blocked from leaving India on their way to people in developing countries if a multinational company claims that their intellectual property is being infringed upon, to third parties - such as treatment providers - being embroiled in court cases simply for buying or distributing generic medicines.

“As the Indian government considers resuming trade negotiations with the EU, we urge both sides to think about the lives that hang in the balance if access to affordable generic medicines is shut down or blocked due to IP enforcement measures,” said Leena Menghaney, who heads India MSF’s Access Campaign.

The Indian Pharmaceutical Association has also long resisted pressures from multinational companies seeking a tighter intellectual property framework which would mirror regimes in developed markets.