Given its rising function because the “pharmacy to the world,” FDA Commissioner Robert Califf, M.D., not too long ago took a visit to India and provided a few of his (and FDA’s) views upon his return. During his go to, Commissioner Califf met with representatives from the Indian authorities and pharmaceutical corporations so as to categorical FDA’s place on the significance of producing high quality and knowledge integrity. Recognizing latest situations of high quality failures, Commissioner Califf mentioned not solely the significance of CGMP necessities however the need from FDA that corporations “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 tradition is not going to solely assist to fulfill FDA’s oversight function however can even help in addressing public considerations concerning the high quality of drug merchandise exported to the United States from India.

Commissioner Califf additionally expressed FDA’s assist for the harmonization of the regulatory regimes between India and the remainder of the worldwide neighborhood. Such harmonization consists of latest efforts by the Indian authorities to strengthen its regulatory oversight, together with enhancing the collaboration between FDA and Indian regulators.

FDA has long-recognized the necessary function that Indian corporations play within the U.S. pharmaceutical market, particularly within the generic pharmaceutical trade. Commissioner Califf’s latest journey to India is only one step to additional collaboration between FDA and Indian regulators and corporations.

“Throughout my time in India, I repeatedly spoke concerning the significance of prioritizing a tradition of high quality and practices that make sure the integrity of producing and medical knowledge.

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