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 The Karnataka Food and Drug Administration (FDA) and the United States Food and Drug Administration (FDA) held a strategic meeting to strengthen cooperation in food and drug regulation, with a focus on enhancing regulatory standards, ensuring the safety, quality of medicines and food products, and sharing global best practices. The discussions centred on capacity building, regulatory innovation, and collaborative efforts to promote public health through a robust and transparent regulatory framework.
The high-level delegation from the US FDA India Office visited the Food and Drug Administration (FDA), Karnataka office in Bengaluru. The visit culminated in a comprehensive interactive meeting aimed at elevating regulatory standards, quality assurance, audit systems, and capacity-building programs across the food and pharma sectors.
The US FDA India Office was represented by Greg Smith, Country Director, Dr. Jacquin Jones, International Relations Specialist, and Dhruv Shah, Senior Technical Advisor. The Karnataka FDA delegation was led by. Srinivas K, Commissioner, alongside Vijaya E Ravikumar, Joint Commissioner, Dr. Umesh S, Additional Drugs Controller, Dr. B R Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka Drugs Controller, Dr. Bhaskaran, Headquarters Deputy Drugs Controller, and Dr. Kempaiah Suresh, Headquarters Deputy Drugs Controller.
During the high-profile exchange, both regulatory bodies discussed strategic frameworks to align enforcement with global benchmarks. The bilateral discussions yielded several key agreements and actionable milestones. These includes the Educational Enforcement with an objective to implementing technical training frameworks that actively promote industry education alongside strict regulatory enforcement.
Under the Observer Programme, there was a discussion on selecting Karnataka FDA inspectors to participate as observers in future US FDA facility inspections conducted within the state. On the Joint Workshops, it was deliberated that organizing specialized training workshops for inspectors and manufacturing units, would focus mainly on Good Manufacturing Practices (GMP), data integrity, Corrective and Preventive Actions (CAPA), and advanced laboratory controls. Interest was evinced on annual collaborations. Here is was suggested to establish a Karnataka-US FDA regulatory collaboration program, highlighted by annual forums to review global compliance trends. Also a setting up a specialized US FDA Coordination Cell within the Karnataka FDA was proposed to seamlessly manage training modules, observer placements, and collaborative follow-up actions.
Following the detailed deliberations, the visiting US FDA delegation highly commended the various progressive regulatory reforms initiated by FDA Karnataka to safeguard public health and boost manufacturing compliance, said the communication note from the Karnataka FDA.
Concluding the meeting, the Commissioner of FDA Karnataka, Srinivas K, expressed appreciation for the valuable global insights shared by the US FDA team. He emphasized that this collaboration would significantly enhance the technical capabilities of the state's inspectors and help ensure that products manufactured in Karnataka meet world-class quality standards.
The global regulatory authority US FDA, has been collaborating state Drugs Control Departments in Telangana and Gujarat through specialized Regulatory Forums and Memorandum of Understandings (MoUs). Now Karnataka is the third state for the same.
India has the highest number of US FDA-approved manufacturing plants pegged around 750 outside the United States. In Karnataka, the 49 US FDA approved plants include Apotex Pharmachem India, Biocon, Strides Pharma Science, One Source Speciality Pharma, Micro Labs, Kemwell Biopharma, Mylan Laboratories now Viatris, Jubilant Pharmova, Hikal, Cipla, Hetero, RL Fine Chem to name few.
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