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India’s lifescience starts-ups see regulatory compliance as a key hurdle for growth
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Nandita Vijayasimha, Bengaluru
December 16 , 2025
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Indian lifesciences start-ups are increasingly viewing regulatory compliance as a significant hurdle to their growth and innovation. As the sector experiences rapid expansion, navigating complex regulatory frameworks becomes a major challenge, especially for early-stage companies with limited resources.
Gangotri Naik, AVP, Idea stage entrepreneurship and mentoring, NSRCEL, an incubation hub at IIM-Bangalore said that regulatory compliance is a major hurdle for healthcare start-ups. We make this easier by connecting founders with regulatory experts from the CDSCO (Central Drugs Standard Control Organisation), to help them understand medical device classifications, documentation expectations, and requirements related to clinical trials and ethical approvals.
The government is also building an enabling environment to address challenges across regulatory through CDSCO reforms and key funding schemes like the Biotechnology Ignition Grant (BIG), which offers up to Rs. 50 lakh for early-stage biotech and healthcare ideas. The production linked incentive (PLI) scheme for medical devices rewards domestic manufacturing with financial incentives. These, alongside medical device parks and state-level subsidies, are the policy and capital backbone for the next generation of Indian lifescience entrepreneurs, she added.
Deep healthcare innovation demands patient capital and long timelines. Researchers often spend 2-7 years in labs before commercialisation, so sustained support and funding are critical. Researchers need capital inflows to keep their work moving that ultimately drives economic growth, Gangotri told Pharmabiz in an email.
When it comes to investors, funding is undoubtedly critical especially for capital and research-intensive healthcare innovations. Equally important is investor readiness. NSRCEL helps founders understand how much equity to dilute, evaluate cap tables, interpret term sheets, and prepare for investor conversations with clarity and confidence. We help create a softer landing for healthcare start-ups not just into the market, but into the ecosystem, said Gangotri.
In the last 12 months, NSRCEL has worked with about 80 ventures and over 120 founders across healthcare pharma, biotech, diagnostics, monitoring, precision medicine, and curative therapies, among others. Through its partnerships with MSMF (Mazumdar Shaw Medical Foundation) and Cytecare, it was able to open access to hospital networks and connect founders directly with clinicians. This helped them access user feedback, understand procurement, decision-making cycles, and validate both clinical and market viability.
According to Gangotri, mentors play a critical role not just by sharing knowledge, but also by challenging assumptions, exposing blind spots, and bringing contextual clarity. Our mentor network includes healthcare practitioners, entrepreneurs, and investors who help founders understand clinical workflows, market dynamics, and fundraising realities. An example is Sangrah Innovations, which began with a B2G (business-to-government) model for its portable defibrillator. Mentor feedback helped them expand into B2B and B2C segments like housing societies and educational institutions—opening new revenue pathways and improving scalability.
Through the Healthcare Incubation Programme, NSRCEL helps founders focus on market & customer validation, business & product roadmap and operational readiness. Our partnership with DailyRounds to support early-stage healthcare start-ups may not immediately attract traditional investment but has the potential to transform healthcare. Through its CSR initiative, DailyRounds provides funding support of Rs. 1 crore per cohort. Together, they support nearly 70 healthcare startups each year with the potential to scale, create social impact, and build sustainability into their core models, said Gangotri adding that streamlined regulatory frameworks will be crucial to allow start-ups contribute to global health advancements.
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