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Pharma companies are looking for new ways to boost drug discovery potential, reduce time to market and squeeze costs along the whole value chain- Interview with Dr. Bhavil Kumar Narola, Director – QCA Biocon Sdn. Bhd
How would you like to summarise your experience in a few lines for our readers? Coaching is the process of attending to people’s needs, experiences and feelings, and intervening so that they learn particular things, and go beyond the given. I really appreciated all the organizing team members and audience.
Dr. Bhavil, With this diverse profile would you like to share your most interesting field? Pharmaceutical manufacturing is the making of medicines on an industrial scale. For a medicine to get to the manufacturing stage, it has already gone through all research and discovery phases, and has been thoroughly tested. The manufacturing stage is about following the same “recipe” to create the same medicine again and again. For this reason, manufacturing medicines isn’t really about science, it’s about systems. It’s about following processes and checking quality. This helps to make sure that the products are the same every time they’re made so that patients can rely on their medicines. So with the diverse profile from laboratory-based research and development, technology transfer, Quality control, regulatory affairs, quality assurance & validation all the way through to patient’s centricity so each and every files is having their own importance and I am happy to be associated with all required functions. It’s really great to note that you’ve excelled major regulatory audits as a QC lead like USFDA, EMA etc.What do you think about the actual importance taken by companies in order to meet the standards? From time to time, inspectors from these regulatory agencies visit facilities to review operations and ensure compliance with applicable laws, rules and regulations. The pharmaceutical industries is ensuring to support and sustain robust, modern quality systems that are consistent with CGMP regulations. Every pharmaceutical product has established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness and in order to achieve the same pharmaceutical industries have ensured certain measures like implementing product life cycle approach, self sufficient quality model and all time audit readiness.
In your opinion what is the strength of Indian pharmaceuticals that allow it to sustain its position in the pandemic situation as well? The pharmaceutical industry’s main markets are under serious pressure. North America, Europe and Japan jointly account for 82% of audited and unaudited drug sales. Further, higher R&D costs, a relatively dry pipeline for new drugs, increasing pressure from payers and providers for reduced healthcare costs and a host of other factors are putting pressure on the global pharmaceutical companies.
Pharma companies are looking for new ways to boost drug discovery potential, reduce time to market and squeeze costs along the whole value chain. India has a growing pharmaceutical industry of its own. It is likely to become a competitor of global pharma in some key areas, and a potential partner in others. India has considerable manufacturing expertise; Indian companies are among the world leaders in the production of generics and vaccines. As both of these areas become more important, Indian producers are likely to take a large role on the world stage.
What do you find major setbacks for Indian pharmaceuticals in the past years? How can we overcome such a scenario? United States Food and Drug Administration over the last few years cited many 483s to Indian pharmaceutical industries for its failure to comply with Current Good Manufacturing Practices, is one of the biggest setback in the Indian pharmaceutical industry. The striking aspect of the multiple warnings to Indian pharmaceutical companies is the similarity in the violations cited. Automation, investment in upgrading facilities, technology enhancement and training are key area focused to overcome the scenario.
Certainly COVID-19 has severely impacted various sectors so what difficulties faced by you and your team amidst this pandemic outbreak? Yes here are few critical aspect faced by all leadership teams like supply chain to ensure consistent availability of essential medicines to patients, colleague outreach, technology like work from home execution and infrastructure, support for special employee segments who cannot work from home.