The Indian pharmaceutical landscape is undergoing a massive shift, driven by regulatory harmonization and a digital-first approach to R&D. In an exclusive conversation with Dr. Mahesh Bhalgat, Industry Consultant and Former CEO & MD of Veeda Life Sciences, Elma Fatima and Shruti Agarwal from Elets News Network (ENN) discuss on how CROs are navigating these changes, the rising influence of regional hubs like Telangana, and why technology is the ultimate game-changer for drug development. Edited excerpts 

With the CDSCO pushing for global regulatory harmonization, how do you see the role of Indian CROs evolving, especially regarding complex genetics and biosimilars?

Indian CROs have a very critical role to play. They are the ones with the practical, hands-on experience in executing studies for a global clientele with global awareness. While the CDSCO is providing the necessary push toward harmonization, they need to partner with CROs to actually implement that direction. CROs bridge the gap between regulatory intent and global execution standards.

Hyderabad has emerged as a global hub for pharma R&D. From an industry vantage point, what unique advantages does the Telangana ecosystem offer for end-to-end drug development?

While I am now associated with the industry in a consulting and supporting capacity, I can speak broadly to the conducive environment in Telangana. 

The state has built a very strong ecosystem that is highly attractive for investments. However, it is important to note that CRO presence is diverse; while the government is making significant strides, including substantial budget allocations for life sciences, it is about creating an environment where CROs can thrive through infrastructure and a collaborative regulatory framework.

Also read: The Digital Transformation of Pharma and Clinical Research in India

Technology, including AI-driven bioanalytical tools and paperless labs, is becoming standard. How will this transform the speed and accuracy of clinical trials over the next 3 to 5 years?

The most dramatic change will be the speed of delivery to customers. Beyond speed, I see a massive opportunity for improving compliance. As more technology platforms are implemented, the margin for error decreases and the transparency of data increases.

This digital transformation is what excites me most – the ability to deliver high-quality, compliant results faster than ever before.

Edited by: Dr. Asawari Savant | ENN

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