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

GETTY
Show Hide image

Cabinet audit: what does the appointment of Andrea Leadsom as Environment Secretary mean for policy?

The political and policy-based implications of the new Secretary of State for Environment, Food and Rural Affairs.

A little over a week into Andrea Leadsom’s new role as Secretary of State for Environment, Food and Rural Affairs (Defra), and senior industry figures are already questioning her credentials. A growing list of campaigners have called for her resignation, and even the Cabinet Office implied that her department's responsibilities will be downgraded.

So far, so bad.

The appointment would appear to be something of a consolation prize, coming just days after Leadsom pulled out of the Conservative leadership race and allowed Theresa May to enter No 10 unopposed.

Yet while Leadsom may have been able to twist the truth on her CV in the City, no amount of tampering will improve the agriculture-related side to her record: one barely exists. In fact, recent statements made on the subject have only added to her reputation for vacuous opinion: “It would make so much more sense if those with the big fields do the sheep, and those with the hill farms do the butterflies,” she told an audience assembled for a referendum debate. No matter the livelihoods of thousands of the UK’s hilltop sheep farmers, then? No need for butterflies outside of national parks?

Normally such a lack of experience is unsurprising. The department has gained a reputation as something of a ministerial backwater; a useful place to send problematic colleagues for some sobering time-out.

But these are not normal times.

As Brexit negotiations unfold, Defra will be central to establishing new, domestic policies for UK food and farming; sectors worth around £108bn to the economy and responsible for employing one in eight of the population.

In this context, Leadsom’s appointment seems, at best, a misguided attempt to make the architects of Brexit either live up to their promises or be seen to fail in the attempt.

At worst, May might actually think she is a good fit for the job. Leadsom’s one, water-tight credential – her commitment to opposing restraints on industry – certainly has its upsides for a Prime Minister in need of an alternative to the EU’s Common Agricultural Policy (CAP); a policy responsible for around 40 per cent the entire EU budget.

Why not leave such a daunting task in the hands of someone with an instinct for “abolishing” subsidies  thus freeing up money to spend elsewhere?

As with most things to do with the EU, CAP has some major cons and some equally compelling pros. Take the fact that 80 per cent of CAP aid is paid out to the richest 25 per cent of farmers (most of whom are either landed gentry or vast, industrialised, mega-farmers). But then offset this against the provision of vital lifelines for some of the UK’s most conscientious, local and insecure of food producers.

The NFU told the New Statesman that there are many issues in need of urgent attention; from an improved Basic Payment Scheme, to guarantees for agri-environment funding, and a commitment to the 25-year TB eradication strategy. But that they also hope, above all, “that Mrs Leadsom will champion British food and farming. Our industry has a great story to tell”.

The construction of a new domestic agricultural policy is a once-in-a-generation opportunity for Britain to truly decide where its priorities for food and environment lie, as well as to which kind of farmers (as well as which countries) it wants to delegate their delivery.

In the context of so much uncertainty and such great opportunity, Leadsom has a tough job ahead of her. And no amount of “speaking as a mother” will change that.

India Bourke is the New Statesman's editorial assistant.