BioAsia 2024

It was a pleasure to be on the Regulatory discussion panel at the BioAsia 2024 at Hyderabad with my esteemed panelists – Sai Prasad, Gary Dubin, @Lokesh Kumar, Sanjiv Navangul, Priyabrata Pattnaik, and Dr. Harshavardhan.
 
India manufactures more than 60% of the world’s vaccines. The Indian regulatory authority, as the NRA of record, has the primary responsibility to audit and govern this entire ecosystem for the World. Indian NRA has to test and release every batch of vaccine that is manufactured in India and then sent across the world. No other NRA has more responsibility than the Indian NRA ecosystem. With so much responsibility, it is no doubt that we must strive to be better every day – not just for India but the world. 
 
In the panel, we discussed the need to harmonize the regulatory norms by integrating our multiple systems of State, Central, RCGM, etc. to emerge as a single regulatory body and then with other countries like PIC/S and ICH so that we are faster and better not just for the problems that we face in India but also for other countries. In an example: we have to create accelerated review pathway for rare diseases, tropical diseases, emerging diseases, etc. so that if there is a medical emergency anywhere, we can respond faster and better. This will also enable the Indian industry to respond to every unmet medical need in-line with our Prime Minister’s vision for India for the World.
 
We should have regular two-way dialogue among regulator and industry on regulatory procedures and reforms. Just like we request the Indian NRA to reform, the Indian NRA should also help the industry to be better – by sharing their feedback on our regulatory submissions, technology development process, etc. What is good, bad, and ugly? What are the common reasons for applications not moving ahead? How can the industry be better to avoid unnecessary queries?
 
The Indian NRA should also communicate about its workload and share performance metrics – on the number of applications that were reviewed and in which time frame; number of applications per person in the Indian NRA, etc. As we strive to be better every day, such metrics will help them get appropriate budgets, resources for the work and also highlight their contribution to India, its industry, and Indian aspirations!
 
The industry’s investments enable the regulator take the important position in the world for vaccines and pharmaceuticals. They should also reward the industry – for example: awards for best submissions, most innovative product of the year, most impactful product of the year, etc. to motivate and continuously encourage capacity and capability building.
 
Finally, more interactions with Academia are well needed so that rising talent, entrepreneurs, etc. are taught about the right practices and expectations to create technologies/dossiers, and enable ease of business, faster translational research, and adoption of productivity enhancing technologies.