Industry will see more unannounced inspections: USFDA Commissioner Dr.Califf  Watch Interview

In an Interview to CNBCTV18 during visit to India, USFDA Commissioner touched on different topics concerning the Pharma Industry. On inspections Dr.Califf said there will be more unannounced inspections; “if you always observe good practices it shouldn’t matter when an inspector comes”. FDA Commissioner also said Data Integrity or compliance issues are not unique to India. Lot of companies in India have come up in standards and have very high quality and for others there is a learning curve to come through. Dr.Califf also understands the challenges in generics industry – low margins, economics of investments required in technology and people, competition for talent. Dr.Califf stressed on the importance of designing processes correctly and demonstrating (to oneself and others) manufacture of drugs reliably. Inspections are not to punish the industry but (help to) develop a system where there are no surprises. Dr.Califf recognised the role of India in the global drug supply chain and mentioned the world is depending on India for inexpensive lifesaving generics. India has largest number of FDA approved facilities outside of US. Dr.Califf was in India to celebrate 15 years of USFDA in India.

Link to the interview