Express Pharma

Looking back, moving forward

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20141215ep01Sometimes, the more things change, the more they remain the same. Express Pharma Pulse was launched in December 1994. Change was in the air: a new edition of the Drug Price Control Order (DPCO) was in the making and companies were also gearing up to evolve from the process to the product patent era, in line with India’s commitment to becoming TRIPS-compliant. The Indian government had started taking the first steps towards reviewing the Indian Patent Act of 1970. The turnover of the industry was an estimated Rs 8200 crores in 1993/94, which grew to Rs  35000 crores in 2003/04.

Fast forward to 2014. Change is once again in the air. Even before Prime Minister Modi and his team took charge, a fresh edition of pricing norms, DPCO 2013, and subsequent orders of the National Pharmaceutical Pricing Authority (NPPA), have changed the dynamics of the pharma industry in India, by increasing the span of price control.

While MNC and Indian pharma unite to protest pricing norms, they are on opposite sides of the fence when it comes to intellectual property rights (IPR). Landmark decisions like the Supreme Court’s rejection of Novartis’ challenge to Intellectual Property Appellate Board’s (IPAB) interpretation of section 3(d) of Indian Patent Act in the imatinib mesylate (Glivec) case, India’s first compulsory license for kidney cancer drug, sorafenib tosylate (Bayer’s Nexavar) mark the evolution of the nation’s patent system.

On one hand Indian companies are acquiring global assets, the latest example being Aurobindo Pharma’s acquisition of Natrol Inc, which is still pending approval. But on the other hand, they continue to be hauled up by the US FDA for GMP non-compliance issues. The strategy to buy US assets to ease entry into world’s largest pharma market is a response to this backlash from global regulators, but this need not be foolproof: the US regulator withdrew approvals given to Ranbaxy for generic Valcyte and Nexium even though it has a facility in the US which is GMP compliant.

The Indian growth story still endures. To be on not to be in India, is no longer a choice, inspite of regulatory roll backs and seemingly populist pricing and clinical trial policies. A PricewaterhouseCoopers (PwC) report projects that the Indian pharma market will touch $74 billion sales by 2020. Thus Abbott chose India as the second emerging market (after Brazil) to launch its new corporate identity, underlining the importance the MNC places on this country. (See interview with Paul Magill, Senior Vice President, Chief Marketing Officer, Abbot on page 26)

On the IPR front, the pressure to change India’s patent laws continues on various fronts. For instance, lobby groups like the US-based Intellectual Property Owners Association (IPO) arranged an Innovation Dialog Trip to India from November 16-21, touching first Chennai and then Delhi, reportedly meeting members of the Indian judiciary, IPAB and Intellectual Property offices.

These meetings were obviously laying the groundwork for US Trade Representative Michael Froman’s visit on November 25, when he will lead a US delegation to the US-India Trade Policy Forum (TPF) to be hosted by India’s Ministry of Commerce and Industry (MOCI) in Delhi. Both Froman and Nirmala Sitharaman, Minister of Commerce and Industry, are co-chairs of the US-India TPF. On the face of it, the TPF is a ‘follow-through on Prime Minister Modi and President Obama’s commitment … to deepen our trade and investment relationship’. But discussion and resolution of trade and investment issues as well as IP issues would most certainly top the list. The USTR’s has already launched an ‘out-of-cycle’ review (OCR) of Indian IPR laws and these meetings are clearly using trade as a lever to change Indian patent laws. The first report of the OCR is due to be filed on November 30, and several members of the US Congress are already lobbying for a second investigation in 2015. Will our policy makers succumb?

In our 20th anniversary issue, we invited industry experts to retrospect on some of these issues which we featured in our inaugural issue. While celebrating our successes, they’ve also analysed our failures and missteps. More importantly, they’ve suggested the path forward for industry chiefs as well as policy makers. (See pages 36-47; followed by a special section on clinical trials from pages 48-57) The retrospective theme will continue over selected issues going into 2015 as well. How long will these shadows from the past continue to dim the path future?

Viveka Roychowdhury
Editor

[email protected]

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