M K Bhan, Secretary To India’s Department Of Biotechnology On Creating Indian Biopolis Akin To Singapore: An Interview With PharmAsia News

Dr. Maharaj Kishan Bhan, secretary to the department of biotechnology, government of India, is perhaps the best known biotechnology scientist in the country. He is also known to have connected science and technology with the primary healthcare needs of India's rural population through many programs. Bestowed with a number of responsibilities, Bhan tells PharmAsia News he is working on a plan to change the Indian biotechnology landscape.

PharmAsia News: Multinational companies that have expressed interest in conducting clinical trials in India say lack of clarity about regulatory systems here for biotech products hold them back. What are your views on that?.

M. K. Bhan: If outsiders are to talk to someone on such important issues, the big question always is who they should go to. So, we have created BIRAP or Biotechnology Industry Research and Development Program so that whatever is related to biotech or pharma, we can direct them to the right people for the right approach and assistance. Now, those who have doubts can engage in discussions directly.

We do need a government-industry partnering organization and we hope BIRAP can fulfill that objective for a transparent and proactive system. With the Association of Biotech Led Enterprises and the government together we should have a meaningful progress. In another 12 to 18 months we will have the people and then we can train them to facilitate investments and other programs in India.

PharmAsia News: Biotech drugs are a different ball game altogether [ (Also see "Indian Govt. Plans Booster Dose For Indian Biotech Industry Through Cost-sharing Scheme" - Scrip, 13 Nov, 2008.). Will there be a different set of regulations and policies to be followed?

Bhan: The government clearly wants a separate set of regulations for biotech drugs and we are headed in that direction. Our prime minister is very clear about that move. But until that time comes, the drug controller general of India is providing all the support. According to me, there are less differences in Phase I or Phase II and Phase III trials than with the preclinical stages of a biotechnology-based drug in the way that the data you require, for example, in biomolecular characterization. These requirements are vastly different from new chemical entities.

So we are opening centers where such services will be available to companies and in that process the biotech authorities will also get the desired trained people. The first center has already been approved to be opened in Bangalore and they will provide services to the industry like characterization of bio-molecules. These centers will be within the oversight of the National Center for Biological Sciences. I am sure it will be a superb place. Therefore, you would understand that we are building the infrastructure to support the preclinical programs for biological drugs.

PharmAsia News: We have heard from sources that a mega biotech university is in the works. Could you please elaborate?

Bhan: There is a UNESCO University that we are making in New Delhi and this will be part of a health science cluster spread over an area of 200 acres. This university will have partnerships with recognized establishments like MIT, Stanford, Boston and a whole lot of others. So the university will draw from academics and medical science attachments and encompass diverse areas like nanoscience, chemical engineering, biological engineering and also clinical medicine. We have a large international group which is helping us in designing the project. Between New Delhi and Bangalore, we will create something like the Biopolis of Singapore so that there will be many clusters of institutions in the Indian healthcare space.

PharmAsia News: How has the progress been on this project so far?

Bhan: We have just bought the land for the 200-acre university. We are anchoring all of these new projects near the existing successful research institutions. One would be the National Institute of Immunology in New Delhi. The idea is to use these brands so that we have experts handling the projects professionally. We have partnered with MIT for helping us manage and train young faculty members in New Delhi.

Similarly, there is a partnership being worked out at Bangalore with a research establishment from Japan. There will also be high-end projects like the protein science center, National Center for Biological Sciences, stem cell institutes and biomaterial institutes. We are taking up these projects with the future in mind. We also want to have hospitals involved in these new projects and we have selected Christian Medical College as the first to be involved in our work. So all of these put together will be what we would like to call the Biotechnology Gateway of India. It's a very ambitious program.

PharmAsia News: How do you intend to put this entire grand plan together?

Bhan: We will be paying the international institutions for their services and for the entire cluster - the funding approved is upwards of 1500 crore rupees [$300 million].

PharmAsia News: Accountability of government-sponsored projects is always a big question in India. How do you plan on tackling that problem?

Bhan: We need young people of quality who are well mentored and well funded to create a brand of excellent people. So we have started a partnership with the Wellcome Trust of UK to make a serious effort. We want to put in considerable amounts of government money but let some other people manage it.

PharmAsia News: The Indian biotech industry has been critical about the multiple agencies involved in clearing biotech drugs. Drug Controller General of India Surinder Singh announced a series of measures last year to overhaul regulatory and administrative functions of his office [ (Also see "India’s Drug Watchdog DCGI Speeds Up Regulatory Overhaul; Single Window Clearance to Precede Central Drug Authority" - Scrip, 11 Sep, 2008.)]. Is the proposed single-window clearance on track?

Bhan: The Indian regulatory systems still do not have A-class procedures. The regulatory staff are however helpful and they do give approvals but they are not world class. And this will not change unless we put new people into those important positions. There will be a need for adequate training. As such this is more an HR issue like every company [faces]. There is no government issue; it is more an institutional challenge. How do you find a new breed of people? The government staff are the ones who have been deficient in IT skills and that's something that has to be sorted out smartly by using technology. A new HR approach is needed for the government.

PharmAsia News: What is your sense of multinational drug companies' approach to India?

Bhan: There are many parameters on which multinational companies are judging us. I really do not worry about which companies are coming to India or not than to worry if my homework is right to make India attractive to them. They will all come if India is prepared.

PharmAsia News: Do you think Indian companies are doing quality research in biotech drugs?

Bhan: I don't think Indian companies are doing enough and that is by my own admittance. They must definitely do work in areas like biosimilars, but discovery research should be taken up in a way that risks are adjusted with the benefits of such research. Leadership in discovery is lacking and that's where Indian companies should ramp up with a pool of committed scientists.

- Vikas Dandekar ([email protected])