India has the talent and ambition to be a global biotech leader, but slow and complex regulations are holding it back. According to Dr. Raches Ella, Chief Development Officer at Bharat Biotech, the biggest hurdle is the long approval process for new biologic drugs. He believes a single-window regulatory system could dramatically speed things up and help India compete with global innovation hubs.
Speaking in Hyderabad, Dr. Ella explained that India’s multi-layered regulatory system delays progress, especially for first-in-human clinical trials. He pointed out that while countries in the West and China can clear approvals in about 90 days, India often takes close to two years. Reducing this timeline to even one year, he said, would remove a major barrier to innovation.
At the ETPharma Biotech Leadership Symposium, Dr. Ella shared his belief that the next wave of pharmaceutical breakthroughs will be driven by biology rather than chemistry. Advances such as genome sequencing, CRISPR-Cas9 gene editing, and artificial intelligence are transforming how medicines are discovered and developed.
Dr. Ella noted that these biological and digital advances align perfectly with India’s strengths. Lower research costs, a large and skilled scientific workforce, and the return of experienced researchers to India are creating a strong foundation for homegrown and globally relevant innovation.
He emphasized that new medical products must first prove their safety and effectiveness before pricing and access are discussed. While price caps are reasonable for generic drugs, applying the same approach to novel therapies could discourage investment. Stable financial returns, he said, are essential to support high-risk research and development.
Vaccines continue to be the backbone of Bharat Biotech’s strategy. Although much of today’s global research focuses on cancer and autoimmune diseases, Dr. Ella believes this focus will shift as new health threats emerge.
Dr. Ella warned that antimicrobial resistance could become one of the leading causes of illness and death by 2050. He believes preventive vaccines will play a crucial role in addressing this challenge. Bharat Biotech is developing a robust pipeline of vaccines targeting drug-resistant bacteria such as MRSA, Klebsiella, Pseudomonas, and Clostridium difficile.
Concluding his remarks, Dr. Ella said that with faster regulations, better funding, and a supportive innovation environment, India has the potential to emerge as a global leader in next-generation biotech, serving both domestic and international markets.
Holding M.Pharm in Pharmaceutical Chemistry, Chandni crafts cutting-edge, research-driven healthcare news for Towards Healthcare, combining scientific depth with innovative storytelling to simplify complex topics for global readers.
