Califf Positive on Visit to India
FDA commissioner Robert Califf posted a positive online post-trip report on his recent official visit to India. He says he made the trip “to strengthen our collective efforts to advance the development and availability of medical products that both our countries and the rest of the world need.”
While in the country, he says, he met with government officials, drug company CEOs, academics, clinical researchers, and innovators. “I heard about and visited firms that are doing a tremendous and reliable job,” Califf writes. “And although the Indian pharmaceutical sector is best known for its generic drug production today, the industry is also keenly interested in the development and manufacture of novel therapeutics, vaccines, and digital health technologies.”
He says that for the moment, generic drugs are of utmost importance, although the economics of the business can be challenging. He says he repeatedly heard from Indian pharmaceutical leaders that there are many critical generic products where profit margins are thin or nonexistent, making it difficult to invest in technology and people.
“And yet,” he writes, “the U.S. and indeed the world is relying on Indian pharmaceutical companies to make safe, effective, high-quality drugs that can be trusted to have their intended effects and to remain consistently available. A significant part of the solution to our drug shortages in the U.S. is to create transparent quality systems that enable investment in firms that are reliable and quality producers.”
Califf says India’s government has been engaged in efforts to strengthen its regulatory framework for pharmaceuticals, apply uniform enforcement, and act on non-compliant manufacturers. “I applauded these efforts,” he writes, “and encouraged further resources and strengthening of regulatory oversight to adequately support drug manufacturing capacity, increased engagement in international standards-setting organizations, and continued partnership with FDA and other regulators to establish an appropriate, clear, and consistent approach to quality.”
The post concludes that Califf’s discussions on the trip “reflected a continued willingness and enthusiasm from the government of India and industry alike to work collaboratively with FDA to ensure robust quality management for safe and effective drugs. Collaborative work towards a high-quality, resilient and financially viable supply chain will be good for both countries and for the billions of other people around the world who would benefit from ample, proven generic drugs. Thus, ensuring a secure, resilient, and high-quality pharmaceutical supply chain is a high priority for FDA, and India remains a key partner in this critical effort.”