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How Open Source Drug Discovery Is Helping India Develop New Drugs

Left to fend for itself, India is now finally developing new drugs on its own

Published: Apr 9, 2012 06:36:29 AM IST
Updated: Apr 3, 2012 02:41:15 PM IST
How Open Source Drug Discovery Is Helping India Develop New Drugs
Image: Mallikarjun Katakol for Forbes India
OPTMISTIC T Balganesh, the chief of the OSDD drug development unit, is looking for a big shift in the drug discovery process

Crowdsourcing can boast of many success stories today, but in 2008, when the Council for Scientific and Industrial Research (CSIR) launched such an effort for drug discovery, there weren’t many. Four years on, its Open Source Drug Discovery (OSDD) network is emerging as a cyber platform to garner resources for developing drugs that pharmaceutical companies don’t find attractive enough.

On World TB Day on March 24, when OSDD and the Global Alliance on TB (GATB) in New York announced that a new TB molecule will undergo Phase IIb trial in India, even as it is being tested in Brazil and Africa, it was a sign of serious commitment from CSIR. If the molecule shows promise, it can advance into further studies and be included in treatment more quickly. India detects 1.7 million new cases of TB every year.

“Realistically speaking, open innovation is the future of drug development,” says Samir Brahmachari, director general, CSIR. He got OSDD off the ground with a seed fund of Rs 50 crore in September 2008 and has sought Rs 1,700 crore in the 12th Plan. “I am sure even with the revised economic growth rate, we’ll get Rs 800-1,000 crore,” he says.

Hopefully, the funds will arrive soon. CSIR is yet to spend its seed money since substantial free help poured in during the initial phase, including assistance from Infosys to build the portal. But it’s the human capital that Brahmachari and the heads of six business units of OSDD are more preoccupied with. There’s limited drug development expertise in the industry, let alone research institutions. In December 2011, in one of the five newly created posts, CSIR appointed T Balganesh, former head of R&D and managing director of AstraZeneca India, as the chief of the OSDD drug development unit.

Now the programme is set to steamroll. With the GATB molecule, there will be immense learning for India in the next 12-16 months, says Balganesh. Having spent 25 years in AstraZeneca, he knows how drugs are developed, but more importantly, he has seen first-hand how the big pharma model of drug discovery has been falling apart. He says he is convinced that if India has to have drugs for neglected diseases, it has to develop them on its own. China has moved on similar lines, investing over $500 million in domestic programmes.

As a mentor for all CSIR drug discovery efforts, Balganesh is positioning OSDD as the de facto “application” platform for the country. “We need to break away from the big pharma mould and try risky routes… look for a big shift in the discovery process,” he says.

If OSDD participants manage to develop a molecule to reduce sputum bacteria, even in a week’s time it will have enormous public health benefit. Then, in another big shift, the drug could be delivered through aerosols, like asthma inhalers. “This may not cure the disease, but it will impact the public health system. I am asking people to come up with novel ways of hitting the [TB] bacteria,” says Balganesh.

So far, the network has crowd-pulled some 5,500 participants in 130 countries, 80 percent of whom are in India. From the “healthy-looking front end”, two anti-TB molecules are in advance stages of research, though they are still two to three years away from clinical study. The malaria and Leishmaniasis programmes have just taken off. However, it’s the late stage research that needs strengthening where molecules, proverbially, die like flies.

It’s for this purpose that an innovation centre is being built in Mumbai. It will do pre-clinical work, says Ram Vishwakarma, director of the Indian Institute of Integrative Medicine (IIIM) in Jammu. His institute developed, in partnership with Cadila Pharmaceuticals, a new combination drug for TB in 2009. With the antibiotic rifampicin dose almost halved, the new drug risorin is much safer.

How Open Source Drug Discovery Is Helping India Develop New Drugs
Vishwakarma, who was earlier with Piramal Life Sciences in Mumbai, is now using OSDD to file an Investigational New Drug application with the US Food and Drug Administration so that risorin could be taken to other markets. “I am driving such programmes as it would be driven in the industry—even outsourcing to contract research organisations,” he says.

Meanwhile, Balganesh wants to groom OSDD as an institution which life sciences companies can effectively use to drive common goals such as biomedical breakthroughs. All this would require more than just capital investment. Researchers today file patents only to be able to publish. They often don’t use the 18 months that it takes for the patent application to become public for bulwarking their patent. Consequently, the patents remain weak and unfit for commercialisation, a reason why companies don’t make a beeline to commercialise them. Balganesh and Vishawakarma believe this hole can be plugged with OSDD resources.

In drug research, the network effect is multiplying (see graphic). The medicines of the future will come from innovation networks which will comprise of numerous stakeholders, says Kenneth Kaitin, professor and director, Tufts Center for the Study of Drug Development at Tufts University School of Medicine in Boston.

“Although India may currently lack the infrastructure for moving forward with some of these open source initiatives, I think the brain power and commitment are there, and I have no doubts that OSDD will not only succeed in India, but will eventually flourish,” he says.

(This story appears in the 13 April, 2012 issue of Forbes India. To visit our Archives, click here.)

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  • Danish

    Thanks for sharing such a nice article. Really helpful for all researchers

    on Oct 30, 2014
  • Pushpdeep

    The Open initiative stands apart unlike the profit driven research by the private pharma companies, as Open Community works for a cause. OSDD has come up strongly in the competition and shall rise up ahead as the community grows bigger and bigger, and so is the determination of its community members to solve the challenges in the society. To make the Impossible, Possible! Pushpdeep Mishra Researcher, OSDD.

    on Apr 15, 2012
  • Pushpdeep

    Today the World appreciates the Open Science and Open innovation. Scientists say that the bigger and complex problems can be solved through Open Science and research. Open Source Drug Discovery is aimed to do the same. Working for OSDD gives opportunity for young minds to give their intellectual inputs under the esteemed guidance of expert and experienced Principle investigators. The Step taken by Govt of India for Open research has been very successful so far and with more funds coming in, the positivity to achieve its goal has immensely rose. At OSDD the goal of the researchers is to work towards new drug for the tropically neglected diseases. Collaborators work day and night, not for any monetary benefits, but to save those thousands of patients who die daily due to Tuberculosis and other tropically neglected diseases which largely affects the poor. Open Science says to contribute as much as one wants for the open research. There are no time limitations; one can work for as less as for few minutes to as long as many hours together. Several Collaborators in the community have used the power of social media, open tools

    on Apr 15, 2012
  • Rakhila Nair

    Really a an inspiring thoughts thanks to Seema I am a house wife doing research at home by the help of osdd women science forum . For an educated girl student in india , how we will satisfy our passion toward science while doing our duties as a mother and wife ( forget the elite class) . for the students like me osdd is a great relief . otherwise i might have stopped my learning after Msc . rakhila research scholar Bharathiyar University coimbatore TN

    on Apr 15, 2012
  • Mobsar Ali

    Dear Friends, Finance and health are not the basic problems in research, Research's pillars are attitude, resources and epistemology. The purpose of the research is to produce new knowledge, rather than to present the existing knowledge in a new form. There are lot scientist who are getting enough financial assurance but still they are nil in research. Those kinds of researchers are just publishing papers without sense to show that they are doing research. So if we'll consider financial problem a basic one then we can earn from research but we can'€™t do research. Similar case is with health, health is also not a barrier for research, we have a best example Stephen Hawking and several more, those are not having good health but their contributions to society is unforgettable. The basic thing we need are first to change our attitude for research, and get all resources...... Mobsar Ali OSDD Rajasthan

    on Apr 15, 2012
  • Nufail Vkd

    another link from osdd which explain the right of a contributor http://scienceopenscience.blogspot.in/p/use-of-osdd-resources-terms.html for osdd team nufail vkd OSDD research@home

    on Apr 14, 2012
  • Vr Suresh

    It is true that pharma companies headquartered in (Western) foreign countries, naturally, worry about keeping THEIR investors happy by focusing on diseases that affect THEIR population. As is usually the case with Indians, Indian pharma also tends to focus its presentations on unmet medical needs of the West and presents statistics and pie charts on the incidence of diseases relevant to the West as a rationale for its programs. So from that point of view, there is no reason why we should not wake up and start taking care of ourselves. If the West doesn't care about malaria and TB, why shouldn't we embark on our research programs to help ourselves? But although it sounds nice on paper and in cyberspace, it's never this simple. Transparency and accountability are not intrinsic traits of Indian society. Dr. Brahmachari has run into such problems himself--if I have to cite a case, I would cite the one about Dr. Shiva Ayyadurai who was fired for criticizing CSIR policies. Of course, Ayyadurai's problem is not an uncommon one--most NRIs get carried away with their own self-importance when Indian agencies woo them to join them and forget the way India works (and doesn't work) and try to rock the boat as soon as they come in. And falling into a tearful embrace when one's employer has admitted their faults after a quarrel because one pointed out their flaws while one was getting paid by them is something the film industry may like but it doesn't work in real life. But my point is that open-ness is not really open-ness and there are real-world problems with this idea of "sharing all resources." I am not clear on what is meant by patenting being weak and the part about grooming OSDD as an institution which life sciences companies can use to drive common goals. Life sciences companies are usually enterprises that have to answer to investors. They have to turn in profits and give returns to those who invested in their efforts. Patenting is important to companies because it protects their intellectual property and allows them to recover the expenditure of effort, time and money by not allowing competitors to take up their invention (product/process/use) and make money out of it as soon as they release it into the market after all that hard work. OSDD, on the other hand, says that it is patent-neutral and wants to keep information and other resources open for all to use. Inherently, these two concepts (patenting by companies and OSDD) are contradictory. What do these people really want? TS Balganesh was in Astrazeneca痴 R&D for quite a while. While it is prudent to take the help of experienced people to further research and innovation, I don稚 see the sort of entrepreneurship that some people show by quitting a company when they have put in enough years learning the ropes, starting their own company to do something different, maybe sell that company when it does well, move on and help others mushroom so that many people are benefitted by the experience of this entrepreneur and knowledge is spread. So I could believe Dr. Balganesh痴 interest in furthering drug discovery and development in India if he had quit years before retirement to do this work with OSDD because he wanted to implement his own ideas. Is this the case or did he retire from Astrazeneca and like all people in India over the age of 60 years get a new lease of employment? As for Dr. Kenneth Kaitin痴 closing remarks on India lacking the infrastructure for moving forward with some of these open source initiatives and claiming to think that the 澱rain power and commitment are there, and I have no doubts that OSDD will not only succeed in India, but will eventually flourish. Most Western scientists who are willing to talk about this will tell you that an idea that sits on the fence about intellectual property protection (supporting it for companies but encouraging open access for others) is not one that will benefit the people who put effort into such an initiative. Infrastructure will come up, equipment will also be purchased, but brain power and commitment to do research will not stay for long in India after they either fly in from abroad or pass out of Indian universities. But like Indian institutions, OSDD itself may succeed and flourish葉he question is will the taxpayers who pay for such initiatives benefit and flourish from such an initiative?

    on Apr 11, 2012
  • Amit Misra

    Nitpick. The journalist who wrote this piece has got a very small bit wrong. TB drug aerosols will NOT be analogous to ASTHMA inhalers. Asthma drugs are delivered to the upper airways, so that the muscles surrounding these tubes can relax and breathe easy. The most active line of OSDD research in inhaled therapies for TB tries to deliver anti-TB drugs packed in hard, but biodegradable, particles that reach the deepest, innermost recesses of the lungs. As was successfully achieved and commercially abandoned in the case of inhaled Insulin. Further, unlike inhaled insulin, inhaled TB drugs will be formulated to stay in the lungs as far (and as long) as possible, and the 'hard particles' will be picked up by the very cells on the surface of the lungs that TB bacteria invade initially. Watch the scientific literature for developments on inhaled therapies for TB, to know more about answers to the stupid question: "If TB is primarily a LUNG disease, why is the patient SWALLOWING drugs instead of BREATHING them in?'

    on Apr 10, 2012
    • Seema Singh

      @Amit Misra: Thank you for providing the explanation but the idea in the story was not to get into scientific details, i.e. pathways, of how the inhaled drug will be delivered in the body, but to "generally" convey the new modality as you have rightly pointed out.

      on Apr 14, 2012
  • Sayantan

    I am not sure if the crowdsource people can handle this until they are given the knowledge of drug development. The webpage contains lots of big institutions and i wonder how such institutions are helping the crowdsource people.The idea is good but it needs faithful hearts to implement.i have seen the work of osdd closely and i found there are lots of issues need to be resolve. If govt of india spending money on this they should also check out how crowdsource people are helping them.i dont beleive these people are giving the right reports.

    on Apr 9, 2012
    • Jinuraj

      Dear Sayantan , OSDD is an Open forum in that you can also contribute. If the reports are wrong, why cant you contribute to this novel idea? I am a OSDD volunteer researcher working from my house. I am using GARUDA Supercomputing facility provided by OSDD. If you are ready, I will help you to support OSDD project . 1. Can you believe I am working from Pulpally,a remote tribal village in Kerala which is very far away from the city and I am a home based researcher . I could publish my work in international journals like BMC Research Notes in collaboration with CSIR based scientists. 2. Can you point out any of Indian project where a really Science activist can freely participate and contribute other than OSDD? Jinuraj, OSDD Research @Home Pulpally,Wayanad, Kerala.

      on Apr 9, 2012
      • Sayantan

        There are many projects why Indian only where you can participate open notebook science, synaptic leap, and even some computer science projects. Remember the polymath project it was started as a blog. It is not the CSIR's responsible only for doing science. If you love science then you can do research by yourself and publish. There are many places for publishing. Don't tell me village, these days if you have internet connection as some means of transport and electricity then your set to go and start you research. Some big people using the idea of open science and untilizing us without any benefits at all. The indian govt is raising the food prices each year i earn arounf 8000 rs and all of the money goes to my family . I tried to do open science but i failed because an internet would cost me around 1000 rs and computer would cost me 15000 and most important is time which i cannot give i have to work 10 hours . So keep it on , i would be happy to hear if the crowdsourced people bring some drug to clinical trials rather than a collaborated organization like TB Alliance.

        on Apr 10, 2012
      • Dr. Sharmila Rao

        I would like to know more about your working how do I get in touch with you

        on May 8, 2012
  • Ritesh Rathi

    Very Insightful Seema. You are really a well researched writer :)

    on Apr 9, 2012