Is India about to become the next hotbed for original pharma research?

Pass the paracetamol.

The Indian pharmaceutical industry could be about to step up to the big league with the launch of a new original diabetes drug, Lipaglyn, developed by homegrown pharma group Zydus Cadilla. With annual revenues of $1bn, Zydus’ chairman and managing director Pankaj Patel, expects the new drug, which tackles both high blood sugar and cholesterol in a single pill, to more than double that amount, calling it a potential “blockbuster”.

Due to be released in the coming months in India, it will take another 3-5 years of clinical trials before being cleared for sale in the more tightly regulated western markets. After years of the Indian pharma industry producing cheap knock-offs of western medicines, it is “time for India to give back,” according to Patel, “(having) benefited for years from the research and development efforts in other countries.”

This reputation for a culture of imitation drug production has led to repeated accusations from western pharma companies of poor IP protection by Indian authorities. US giant Pfizer, among others, have called on lawmakers to do more to protect the millions spent on R&D, which will not be turned into revenues if the Indian generics market is allowed to continue churning out cheaper alternatives. This culminated in US Secretary of State John Kerry discussing the issue with Indian policymakers during his recent visit to the country.

But that has still not stopped some companies falling foul of the Indian system, with the Supreme Court rejecting Novartis’ bid to protect its new leukemia drug with a patent in January, paving the way for India’s pharma companies to produce generic versions at a fraction of the cost. Gleevec, which can cost up to $31,000 a year in India is now being undercut by the generic version, which costs just $2,100 a year.

Still, Zydus’ Lipaglyn could be the start of a move from generics manufacture to original research across the rest of the Indian pharma industry. G. Shah, secretary-general of the Indian Pharmaceutical Alliance, sees this latest development as critical if Indian pharma companies, such as Glenmark and Biocon are to compete on the world stage; “Our credibility is at stake now… People have been branding us as a copycat industry, and this is a departure from that,” he said. “We are not just copycats, but we are transforming into creating original research products also.”

Zydus have spent close to $450m developing new drugs since 2001, while Glenmark spent nearly $1billion on R&D in the last year alone. However, not everyone shares this enthusiasm, with Gayatri Saberwal of the Institute of Bioinformatics and Applied Biotechnology, Bangalore, last year voicing his concern over the Indian pharma sector’s R&D abilities. Based on analysis of the patents being granted in the sector, he found a tiny minority were for genuinely original research, thus making the “prospects for original drug discovery in India poor,” he said. “There is probably a long way to go for Indian companies to undertake highly innovative work”.

Just what success the Indian industry is able to achieve internationally will not become apparent on these shores for some time yet, with the development of news drugs taking years. So we will have to stick to our tried and tested remedies in the short term at least, just as the Indian generics industry will also continue to cause a headache for western pharma companies until their original research starts to bear fruit. Pass the parcetamol.

Photograph: Getty Images

Mark Brierley is a group editor at Global Trade Media

Photo: Getty
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Like it or hate it, it doesn't matter: Brexit is happening, and we've got to make a success of it

It's time to stop complaining and start campaigning, says Stella Creasy.

A shortage of Marmite, arguments over exporting jam and angry Belgians. And that’s just this month.  As the Canadian trade deal stalls, and the government decides which cottage industry its will pick next as saviour for the nation, the British people are still no clearer getting an answer to what Brexit actually means. And they are also no clearer as to how they can have a say in how that question is answered.

To date there have been three stages to Brexit. The first was ideological: an ever-rising euroscepticism, rooted in a feeling that the costs the compromises working with others require were not comparable to the benefits. It oozed out, almost unnoticed, from its dormant home deep in the Labour left and the Tory right, stoked by Ukip to devastating effect.

The second stage was the campaign of that referendum itself: a focus on immigration over-riding a wider debate about free trade, and underpinned by the tempting and vague claim that, in an unstable, unfair world, control could be taken back. With any deal dependent on the agreement of twenty eight other countries, it has already proved a hollow victory.

For the last few months, these consequences of these two stages have dominated discussion, generating heat, but not light about what happens next. Neither has anything helped to bring back together those who feel their lives are increasingly at the mercy of a political and economic elite and those who fear Britain is retreating from being a world leader to a back water.

Little wonder the analogy most commonly and easily reached for by commentators has been that of a divorce. They speculate our coming separation from our EU partners is going to be messy, combative and rancorous. Trash talk from some - including those in charge of negotiating -  further feeds this perception. That’s why it is time for all sides to push onto Brexit part three: the practical stage. How and when is it actually going to happen?

A more constructive framework to use than marriage is one of a changing business, rather than a changing relationship. Whatever the solid economic benefits of EU membership, the British people decided the social and democratic costs had become too great. So now we must adapt.

Brexit should be as much about innovating in what we make and create as it is about seeking to renew our trading deals with the world. New products must be sought alongside new markets. This doesn’t have to mean cutting corners or cutting jobs, but it does mean being prepared to learn new skills and invest in helping those in industries that are struggling to make this leap to move on. The UK has an incredible and varied set of services and products to offer the world, but will need to focus on what we do well and uniquely here to thrive. This is easier said than done, but can also offer hope. Specialising and skilling up also means we can resist those who want us to jettison hard-won environmental and social protections as an alternative. 

Most accept such a transition will take time. But what is contested is that it will require openness. However, handing the public a done deal - however well mediated - will do little to address the division within our country. Ensuring the best deal in a way that can garner the public support it needs to work requires strong feedback channels. That is why transparency about the government's plans for Brexit is so important. Of course, a balance needs to be struck with the need to protect negotiating positions, but scrutiny by parliament- and by extension the public- will be vital. With so many differing factors at stake and choices to be made, MPs have to be able and willing to bring their constituents into the discussion not just about what Brexit actually entails, but also what kind of country Britain will be during and after the result - and their role in making it happen. 

Those who want to claim the engagement of parliament and the public undermines the referendum result are still in stages one and two of this debate, looking for someone to blame for past injustices, not building a better future for all. Our Marmite may be safe for the moment, but Brexit can’t remain a love it or hate it phenomenon. It’s time for everyone to get practical.