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India’s regulatory framework should cover emerging areas such as digital solutions, according to Badhri Srinivasan, Head, Global Development Operations, Novartis, Switzerland.
Srinivasan told BusinessLine here that there was a ‘healthy collaboration’ between the pharma industry and regulators at present. However, a mechanism to take cognisance of emerging digital innovative solutions and their regulation will augur well for the industry, he said.
Clinical trials in India
The use of software to detect a disease and informing consent in electronic form are some examples.
Asked about the state of affairs in clinical trials in India, he said: “The potential and ability to conduct clinical trials is huge but barrier is very high and it should be brought down.”
Though a lot of clinical trials are happening in major hospitals, they are not nearly enough. “There is some friction over legacy issues, among others. New methods such as decentralised trials might help bridge this gap,” he said.
Novartis is now using the decentraslised method for early trial phases in the US and is likely to examine the same in India.
Investments
On investments, he said: “Novartis will continue to invest.” While the number of trials being conducted by the global major in India could fluctuate, the operations in India have moved away from transactional activities to support the company in leading areas.
“Apart from clinical trials, we also take up many operations here such as advanced high-level analytics,” the executive said. Novartis now has 4,000 employees in India.
On the means to popularise R&D in pharma and basic sciences, he said strengthening curriculum around basic sciences and integrating computer-based or IT-based courses with new frontiers in pharma and life-sciences research should be taken up.
“There is excellent future for drug discovery as the science fiction is now becoming a science reality as human biology is understood better now,” he said.
Drug research
Asked whether Novartis had any plans to take up drug discovery research in India, he said: “There is drug discovery appetite in India. Some maturity is coming in the industry. But basic science infrastructure should be strengthened. We will wait and watch.”
Globally, main research focus of Novartis is on more cutting-edge technologies such as cell therapy and gene therapy. It is currently engaged in over 500 clinical trials.
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