USFDA looks to increase unannounced inspections in India, says Dr Robert Califf

by Aditya Kumar

The US Food and Drug Administration (FDA) is planning to increase unannounced inspections of Indian sites, according to Dr. Robert Califf, the head of the USFDA. In an exclusive interview with CNBC-TV18, Dr. Califf stated that the regulator will conduct a mix of both announced and unannounced inspections.

The move comes in response to concerns raised by experts regarding advanced intimations and a lack of independent translators during inspections. Advanced intimations give companies a significant amount of time to prepare for inspections, which may hinder the inspectors’ ability to observe the plant in its normal operation.

Unannounced inspections aim to address the issue of lead times, ensuring that companies adhere to good practices consistently. The FDA’s intention is not to punish, but to strengthen the system. Dr. Califf shared an example of an Indian company during his visit, stating that the FDA can visit anytime they choose. The goal is for it to not matter when the FDA visits a company site if they are always following best practices.

India is home to over 500 USFDA compliant plants, which is the largest number outside of the US. While companies continue to face challenges in manufacturing and clinical studies, there have been improvements, particularly in data integrity. Dr. Califf mentioned that companies have reached the required standards in terms of data falsification. Additionally, issues stemming from a top-down culture have also seen improvement.

In terms of the relationship between the FDA and India, Dr. Califf stressed that it is long-standing and stronger than ever. Both economies are powerful, with strengths that complement each other. India will continue to be a critical part of the supply chain for the US.

Overall, the increased inspections by the USFDA in India aim to strengthen compliance and ensure that companies maintain high standards. The FDA recognizes the improvements made by Indian companies and remains committed to maintaining a strong relationship with India.

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