Mazumdar-Shaw said lengthy regulatory processes had prompted companies to conduct early-stage clinical studies overseas. She called for accredited research hospitals with strong ethics committees to conduct first-in-human trials and for faster regulatory reviews without compromising standards.
“Because I know that even in our case, we have tended to really offer other countries to do clinical trials because it is so tedious and long drawn out to do anything in India,” she said.
She added that artificial intelligence and other digital technologies could speed up data review and regulatory decisions. India also needed to establish global confidence in its clinical development and regulatory systems to compete with China, which has built a stronger position in biopharmaceutical innovation.
Saldanha said government research incentives, including the Promotion of Research and Innovation in Pharma-MedTech (PRIP) scheme, were a step forward. However, he called for government-backed reimbursement programmes for medicines treating life-threatening diseases and significant unmet medical needs. “Most of the western world has a reimbursement system for life-saving products. In India, we don't have that,” he said.
Such programmes could improve patient access while giving companies greater incentive to develop treatments for serious diseases, where research costs are high, timelines are long and commercial success is uncertain.
Shanghvi said India's pharmaceutical industry had reached a scale that allowed it to develop and launch innovative products globally, but companies needed to be willing to commit capital to projects whose returns could take years to materialise. “It is important for us to leverage this capability to find a way to deliver,” he said, calling on Indian promoters and chief executives to invest with greater confidence in research.
Shanghvi cited Sun Pharma's $11.75 billion acquisition of Organon as a means of strengthening its ability to commercialise medicines globally. The acquisition would improve the company's registration and launch infrastructure in international markets, addressing gaps it had encountered while licensing products.
The deal would raise innovative products' contribution to Sun Pharma's business from about 22% to 30%, he said.
Glenmark, meanwhile, is pursuing licensing partnerships to develop and commercialise new medicines. Saldanha cited its agreement with AbbVie for a Phase I oncology asset, which involved a $700 million upfront payment and potential milestone payments, taking the total deal value to nearly $2 billion.
He said Indian companies could expand their research-led businesses through licensing, acquisitions and internal drug development over the next five to ten years, although strategies would vary across companies focused on generics, biosimilars and innovative medicines.
Mazumdar-Shaw stressed the need to maintain a steady flow of drug candidates, rather than rely on individual successes. “The pipeline is the lifeline. And therefore, we have to consistently invest in innovation. It cannot be a one-off. It has to be a continuous replenishment of that pipeline,” she said.
The panellists also stressed the importance of manufacturing quality in building global partnerships. Shanghvi said pharmaceutical companies could learn from engineering and aviation, particularly their approaches to consistency, defect prevention and operational efficiency.
“It's important for us to learn and adopt, because what works for them will not directly work for us, but we can adopt and learn,” he said.
Saldanha added that leading pharmaceutical companies were investing in manufacturing technology, automation and artificial intelligence to remain competitive, although smaller firms could take longer to adopt these technologies because of resource constraints.