The United States Food and Drug Administration (US FDA) has reportedly said it intends to conduct more unannounced inspections at pharmaceutical manufacturing facilities in India.
What Happened: U.S. FDA Commissioner Robert M. Califf stated in an interview with CNBC-TV 18 on September 29 that a combination of announced and unannounced inspections is crucial, and more unannounced inspections will be implemented to create a system with no surprises.
Califf emphasized that the U.S. FDA aims to reward companies that demonstrate a commitment to quality and integrity. He stressed the importance of a bottom-up approach within organizations, highlighting the significance of staff members exhibiting deep integrity and honesty, even if it means reporting issues.
Why It Matters: During the COVID-19 pandemic, inspections of Indian pharmaceutical manufacturing facilities by the U.S. FDA decreased. However, a US House panel expressed concerns in July regarding the FDA’s oversight of manufacturing facilities in India and China and its reliance on foreign drug manufacturers. Subsequently, there has been an increase in inspections conducted by the FDA in India.
It was reported in June that Indian pharma companies, including giants like Sun Pharma, Cipla, and Lupin had been pulled up by the US drug regulator for failures in drug manufacturing practices, Bloomberg reported.
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Califf anticipates that India will continue to be a major supplier to the US, the world’s largest drug market. He also noted that countries should strive for self-reliance in drug production rather than depending heavily on China.
The Indian Pharmaceutical Alliance, an association of 25 leading pharmaceutical manufacturers in India, estimates that India exports approximately 40% of all drugs consumed in the US.
Califf praised Indian companies that have worked closely with the FDA for several years and have met global standards. With the influx of new entrants into the industry, he emphasised the need for comprehensive training on all aspects of the pharmaceutical sector.
Disclaimer: Artificial intelligence was used as a secondary aid in the writing of this story.
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