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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The Prevent strategy needs a rethink, not a rebrand

A bad policy by any other name is still a bad policy.

Yesterday the Home Affairs Select Committee published its report on radicalization in the UK. While the focus of the coverage has been on its claim that social media companies like Facebook, Twitter and YouTube are “consciously failing” to combat the promotion of terrorism and extremism, it also reported on Prevent. The report rightly engages with criticism of Prevent, acknowledging how it has affected the Muslim community and calling for it to become more transparent:

“The concerns about Prevent amongst the communities most affected by it must be addressed. Otherwise it will continue to be viewed with suspicion by many, and by some as “toxic”… The government must be more transparent about what it is doing on the Prevent strategy, including by publicising its engagement activities, and providing updates on outcomes, through an easily accessible online portal.”

While this acknowledgement is good news, it is hard to see how real change will occur. As I have written previously, as Prevent has become more entrenched in British society, it has also become more secretive. For example, in August 2013, I lodged FOI requests to designated Prevent priority areas, asking for the most up-to-date Prevent funding information, including what projects received funding and details of any project engaging specifically with far-right extremism. I lodged almost identical requests between 2008 and 2009, all of which were successful. All but one of the 2013 requests were denied.

This denial is significant. Before the 2011 review, the Prevent strategy distributed money to help local authorities fight violent extremism and in doing so identified priority areas based solely on demographics. Any local authority with a Muslim population of at least five per cent was automatically given Prevent funding. The 2011 review pledged to end this. It further promised to expand Prevent to include far-right extremism and stop its use in community cohesion projects. Through these FOI requests I was trying to find out whether or not the 2011 pledges had been met. But with the blanket denial of information, I was left in the dark.

It is telling that the report’s concerns with Prevent are not new and have in fact been highlighted in several reports by the same Home Affairs Select Committee, as well as numerous reports by NGOs. But nothing has changed. In fact, the only change proposed by the report is to give Prevent a new name: Engage. But the problem was never the name. Prevent relies on the premise that terrorism and extremism are inherently connected with Islam, and until this is changed, it will continue to be at best counter-productive, and at worst, deeply discriminatory.

In his evidence to the committee, David Anderson, the independent ombudsman of terrorism legislation, has called for an independent review of the Prevent strategy. This would be a start. However, more is required. What is needed is a radical new approach to counter-terrorism and counter-extremism, one that targets all forms of extremism and that does not stigmatise or stereotype those affected.

Such an approach has been pioneered in the Danish town of Aarhus. Faced with increased numbers of youngsters leaving Aarhus for Syria, police officers made it clear that those who had travelled to Syria were welcome to come home, where they would receive help with going back to school, finding a place to live and whatever else was necessary for them to find their way back to Danish society.  Known as the ‘Aarhus model’, this approach focuses on inclusion, mentorship and non-criminalisation. It is the opposite of Prevent, which has from its very start framed British Muslims as a particularly deviant suspect community.

We need to change the narrative of counter-terrorism in the UK, but a narrative is not changed by a new title. Just as a rose by any other name would smell as sweet, a bad policy by any other name is still a bad policy. While the Home Affairs Select Committee concern about Prevent is welcomed, real action is needed. This will involve actually engaging with the Muslim community, listening to their concerns and not dismissing them as misunderstandings. It will require serious investigation of the damages caused by new Prevent statutory duty, something which the report does acknowledge as a concern.  Finally, real action on Prevent in particular, but extremism in general, will require developing a wide-ranging counter-extremism strategy that directly engages with far-right extremism. This has been notably absent from today’s report, even though far-right extremism is on the rise. After all, far-right extremists make up half of all counter-radicalization referrals in Yorkshire, and 30 per cent of the caseload in the east Midlands.

It will also require changing the way we think about those who are radicalized. The Aarhus model proves that such a change is possible. Radicalization is indeed a real problem, one imagines it will be even more so considering the country’s flagship counter-radicalization strategy remains problematic and ineffective. In the end, Prevent may be renamed a thousand times, but unless real effort is put in actually changing the strategy, it will remain toxic. 

Dr Maria Norris works at London School of Economics and Political Science. She tweets as @MariaWNorris.