Given its growing role as the "pharmacy to the world," FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's) views upon his return. During his visit, Commissioner Califf met with representatives from the Indian government and pharmaceutical companies in order to express FDA's position on the importance of manufacturing quality and data integrity. Recognizing recent instances of quality failures, Commissioner Califf discussed not only the importance of CGMP requirements but the desire from FDA that companies "adopt a top-down, bottom-up culture of quality that allows for critical feedback from operator to manager on processes to ensure compliance as well as facilitate continuous improvement." Having such a culture will not only help to satisfy FDA's oversight role but will also assist in addressing public concerns about the quality of drug products exported to the United States from India.
Commissioner Califf also expressed FDA's support for the harmonization of the regulatory regimes between India and the rest of the international community. Such harmonization includes recent efforts by the Indian government to strengthen its regulatory oversight, along with improving the collaboration between FDA and Indian regulators.
FDA has long-recognized the important role that Indian companies play in the U.S. pharmaceutical market, especially in the generic pharmaceutical industry. Commissioner Califf's recent trip to India is just one step to further collaboration between FDA and Indian regulators and companies.
Throughout my time in India, I repeatedly spoke about the importance of prioritizing a culture of quality and practices that ensure the integrity of manufacturing and clinical data.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
