Califf to Put Pressure on Indian Drug Makers
While the U.S. continues to struggle with ongoing drug shortages, particularly cancer drugs, FDA commissioner Robert Califf will be heading soon to India to meet with Indian regulatory and drug industry officials, according to HHS secretary Xavier Becerra. Speaking to reporters 7/18 on the sidelines of the G20 Health Ministers Meeting in Gandhinagar, India, Becerra said Califf will deliver the message that the U.S. wants the drugs sold in the country to be safe, according to a report in The Economic Times.
“India is such an indispensable partner in helping America to have the pharmaceuticals that it needs.” Becerra told reporters, adding that he did not view FDA’s GMP expectations as a challenge for Indian companies. “It is a standard if Indian companies wish to sell products in the U.S.”, he said. “If India wants to make sure that they have companies which can meet those standards, we are absolutely willing to work with them.”
Meanwhile, the ongoing drug shortages have recently drawn unwelcome attention on Capitol Hill. Last month, bipartisan leaders of the House Energy and Commerce Committee said they are concerned about the effectiveness of FDA drug inspection efforts in India and China. In a 7/18 letter to Califf, the lawmakers said the agency’s recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China “makes having effective foreign inspection programs in these countries critical. Chinese and Indian manufacturers receive the most FDA Warning Letters. These violations have included carcinogens in medicines, destroying or falsifying of data, and non-sterile manufacturing processes.”
The letter said that given that about 32% of generic drugs and 45% of active pharmaceutical ingredients come from the two countries, “we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.”
To emphasize their concerns, the committee leaders cited a Department of Defense announcement that it will independently test the quality and safety of imported generic drugs, a 2022 Government Accountability Office report that criticized FDA foreign inspections, a 2014-15 FDA pilot program in India that appeared to be successful in exposing widespread misconduct and significant violations of FDA regulations but then was discontinued, reduced inspection levels following the Covid-19 pandemic, and inspection and political issues in China.