India must move beyond its success in generic medicines and build an innovation-led pharmaceutical industry, according to Kiran Mazumdar-Shaw, Executive Chairperson of Biocon and Syngene International. She called for stronger research capabilities, faster regulatory approvals and sustained investment in new drug development to help India compete with global pharmaceutical leaders.
India Must Move Beyond Generic Medicines
Mazumdar-Shaw highlighted India’s potential to become a global pharmaceutical innovation hub. Although the country has established a strong position in generic medicines, she believes the next phase of growth must focus on developing innovative treatments. “Generics is a great success story for India but we need to follow this with innovation and an innovation led strategy,” she said. Furthermore, she urged India to benchmark its progress against China and strengthen the ecosystem required to translate scientific discoveries into commercially successful medicines.
Sustained R&D Investment Is Critical for Drug Development
Mazumdar-Shaw emphasised that consistent investment in research and development (R&D) is essential to strengthen India’s pharmaceutical innovation capabilities. Rather than treating research spending as a one-time commitment, companies must continuously invest in developing new medicines and replenishing their drug pipelines. “In bio pharma and in pharma in general, the pipeline is the lifeline,” she said. Consequently, she called on the industry to move from a volume-driven business model towards a value-driven approach. This transition could help Indian pharmaceutical companies develop differentiated treatments, strengthen their global competitiveness and address unmet medical needs more effectively.
Quality and Clinical Development Must Remain Priorities
As India expands its focus on innovative medicines, Mazumdar-Shaw stressed that quality must remain central to research, clinical development and pharmaceutical manufacturing. She also highlighted the need to strengthen India’s ability to advance new treatments from laboratory research to clinical trials and commercial markets. By improving these capabilities, the country could participate earlier in the global drug development process and provide patients with access to innovative therapies sooner.
Faster Regulatory Approvals Could Accelerate Innovation
In addition to research investment, Mazumdar-Shaw identified regulatory reform as a key factor in accelerating pharmaceutical innovation. While she acknowledged positive changes in India’s regulatory environment and improved alignment between regulators and industry, she called for faster progress. “This is the time for really deep diving into what regulatory reforms can be done fast,” she said.
Moreover, she suggested that artificial intelligence (AI) and other digital technologies could help reduce regulatory review timelines and accelerate approvals for new medicines. She also encouraged India to study regulatory approaches adopted by countries such as China and Australia to improve the efficiency of clinical development and approval processes. At the same time, closer collaboration between pharmaceutical companies and regulators would help ensure that reforms support innovation without compromising quality and safety.
Biocon Advances Innovative Drug Development
Highlighting Biocon’s efforts in innovative drug development, Mazumdar-Shaw said the company had advanced one of its drug assets into Phase III clinical development in the United States. She also referred to another cancer drug programme, underscoring the company’s focus on developing new treatments. Meanwhile, she noted that research and development incentives were encouraging companies to invest in innovation, describing this trend as a positive development for the sector.
India Has an Opportunity to Become a Global Innovation Hub
India has the scientific talent and technical capabilities needed to strengthen its position in the global pharmaceutical industry. However, realising this potential will require sustained R&D investment, efficient regulatory processes, high-quality clinical development and stronger collaboration between industry and regulators. As reported by The Economic Times, shifting from generic medicines towards innovation-led growth could help India develop higher-value treatments, address unmet medical needs and establish a stronger presence in the global pharmaceutical market.
