More Unannounced Inspections in India: Califf
FDA commissioner Robert Califf says the agency will be increasing a mix of announced and unannounced drug company inspections in India. Califf was interviewed on CNBC-TV18’s The Medicine Box while on his first official visit to the country.
Asked about the largest challenge facing India, he said expectations are high for the country’s generic drug industry and it is a challenge for all the players. He noted that the compliance issues that FDA finds in some Indian companies are not unique to that country. Making drugs that meet regulatory standards all the time is hard work that is difficult to get right, he said.
When asked how much compliance issues in India have contributed to drug shortages in the U.S., Califf demurred, saying India is a leading drug manufacturer and has a bright future. He said that generic drugs are sold at a low margin and when the economics of the business are not right, companies find it hard to invest in the technology they need. He also referenced the competition for the best workers to do the available jobs.
“The U.S. does not want to be too reliant on India,” Califf said. “You hear discussions about on-shoring drug manufacturing. We believe there needs to be an equilibrium and that we shouldn’t bring all production back to the U.S.”
Asked about a U.S. government report that said the country has too much manufacturing reliance on India and China, Califf noted that his agency has little control over company economic issues and decisions. “The pie is getting bigger,” he said. “India will always be a dominant component.”
Asked about drug company inspection frequency, Califf related that at a company visit as part of his trip, he asked a company executive how often the agency should inspect his firm. “Come any time you want to,” the executive replied, earning Califf’s approval for an attitude of always expecting to do a good job that can be inspected at any time.
“There should be one standard for all drugs, no matter what company is making them,” he said…. “It’s not just for the U.S., since India has 1.5 billion people who need high-quality drugs.”
Asked if the data integrity issues that several Indian companies experienced a few years ago have abated, Califf said some companies are doing very well, but also said there are many new companies entering drug manufacturing and there is a need for training.