Indian biotech industry has made its mark on the world map exhibiting a phenomenal growth from $500 million to $8 billion from 2003 to 2012. With a view to further its development and chart the roadmap ahead, the Association for Biotechnology Led Enterprises (ABLE), to commemmorate its 10th anniversary, organised BIOINVEST – a series of panel discussions between members of the industry and the government to discuss the key issues and challenges plaguing the sector recently and brainstorming their way to solutions forward. The event was held in Delhi over March 11 and 12, 2013.
Building on India’s strength
Pointing out the need for creating an innovative and enabling environment for all stakeholders and a pressing need for policy implementation, Kiran Mazumdar Shaw, Chairman and Managing Director, Biocon said, “Biotechnology is going to have a huge impact on nutritional security, healthcare environment, sustainability and energy. As we try to build this bioeconomy, we need to address regulatory challenges. If we can deliver in an effective way we can bring products quickly to the market.”
She cited challenges in terms of investment and funding that need to be overcome, with the biotechnology sector presenting a long gestation period for the investor, the upside being a long-term return, which is exponential. Conveying this to the investors, along with building the right talent pool is important, she added. She also mulled on creating a manufacturing sector in biotechnology given that it has been neglected for long, emphasising that India has to focus on its natural advantages to create focused strategic investments that make it stand apart.
“We can build a global scale in generics, BioIT is a huge opportunity for India. Are we prepared to invest in genomics? While agriculture creates 50 per cent of jobs, it contributes only 15 per cent to the GDP. Services on the other hand contribute 65 per cent to the GDP but only create 30 per cent jobs. Fermentation-based manufacturing can be done. Can we do this in biologics? Can we look at going beyond generic vaccines to DNA vaccines?” said Shaw.
Dr Vijay Raghavan, Secretary DBT took the discussion a notch further by pointing that India needs to establish itself from being a vendor of biotechnology to being a leader of quality biotechnology given that the centres of innovation lie elsewhere and the country also faces the challenge of grappling with a host of diseases. This coupled with a nascent biotech industry, not so huge resources, competition in a global market, along with regulatory issues, makes the challenges formidable but they can be overcome. He called for combined efforts across all departments be it health or agriculture also underlining the collaborations that DBT is charting with nascent start ups.
Investment in chemistry- biology interface, drug interface and screening is the way to go. Raghavan said, “We need to create a high level sequencing centre, analyse data, work in big data in genomics, learning from the mistakes and success of the Genomics Institute. In the next two years this could help us hit the IT and genomics space. Growth can be exponential in these areas, but will only provide us with temporary respite unless we can come up with other innovative ideas,” he said. He also outlined the role of training scientists and engineers, as well as the management to negotiate the pipeline. Learnings from countries such as Singapore, South China and Korea who have also been facing the same issues need to be applied.
He added that DBT is investing in a platform technology centre between industry and academia. Industry utilise the current global economic situation to their advantage by enlisting talented people form start ups to join their innovation team. Talking about the recent news on clinical trials and revised guidelines, he said that the civil society harbours a fear of technology, which is okay if it is there in the early days, but needs to be addressed nonetheless, as evidence mounts, they lessen, he added. “People tend to confuse the probability of having a disaster and the impact of a disaster,” he pointed.
Regulation is the key
K Desiraju, Special Secretary, Ministry of Health and Family welfare opined that constant dialogue between science, industry and healthcare needs to continue since each player has a crucial role to play. Regulation has been a talking point in the past year and he enumerated two very big reasons why the government sees the need for an efficient regulatory system.
“Affordability is important from our point of view. We need to define universal healthcare. It involves ready and easy availability of drugs and medicines. In the 12th chapter of the 12th Plan, affordability, access and quality have been cited as the three basic principles on which we need to have healthcare globally. Affordability is crucial, administration is equally important,” he said.
He lamented the fact that regulatory institutions such as DCGI are under-resourced, and not well equipped to handle the huge body of work allotted to them, however for now, those are the resources one has to operate in, given the realities of the recent budget.
“Regulatory mechanisms in healthcare have always been flawed, it’s a vicious circle. “With everyone quick to blame the government for everything that goes wrong, one cannot also leave everything to individual good sense, the probability of misuse in such a case is 100 per cent,” he added. Nor can a system work if the entire responsibility lies with the regulator. He stressed on introspection to come up with the right answers. Citing that courts have to intervene in matters of dispute which would not arise in the first place if everyone takes up their individual responsibility seriously, he said.
“The Supreme Court is now holding the Health Ministry responsible for every clinical trial. The buck should not stop here. Government tends to over regulate because everything tends to go wrong otherwise. Let us not dispute the role of regulation,” Desiraju said. With new guidelines for clinical trials laid down recently the Ministry of Health and Family Welfare is also looking at reforms within Central Drugs Standard Control Organization, he informed.
Shaw brought out industry concerns by highlighting that a cumbersome regulatory process coupled with a trust deficit between the government and those being regulated needs to be worked upon. With regulation being a big enabler, the longer a regulatory pathway, the more expensive a product entering the market, she added.
“Is it possible to put the data on clinical trials conducted by companies publicly where the information on the sites where they are being conducted along with other relevant data is made available. Also, can we can encourage expenses as an adjunct by getting industry to pay for it, with a pool of experts who can use user fees to raise the standards?” she questioned. Raghavan made a good point by suggesting that not just getting experts but amping up the resources would help, otherwise only those with deep pockets will have access to regulatory pipelines.”
Finally, Raghavan gave a clear direction to the industry by charting its future road map. “What is needed is to harness out collective strength in chemistry and engineering and bring it into biologics. Drug discovery appears to be a formidable challenge but it can be tackled, “ he concluded.
Desiraju stressed on the availability of drugs and diagnostics at all public health centres so that people should not die for want of a drug that is well known but not available. Long-term efforts include the integration of non-physician clinicians including nurse practitioners, Ayush staff and public health professionals into the workforce, he added further. The day-long summit saw more than 250 participants from industry with a keynote address by Steven Burrill, Chief Executive Officer, Burrill and company US and Narayan Vaghul, Chairman ICICI Bank.
