Regulatory Harmonization:A View from India

For any drug to be marketed in a country, it must be passed by the local regulatory authorities. Different regulators have different criteria for passing a drug. Zerhouni and Hamburg in an editorial have urged greater global harmonization in the matter of drug regulations (Sci. Transl. Med., 2016, 8, 338ed6). At the time of writing their Editorial, Zerhouni was – and continues to be – head of R&D at the large pharma company Sanofi and a former head of the National Institutes of Health, USA and Hamburg was the immediate past Commissioner of the US Food and Drug Administration (USFDA). One can see that the editorial reflected Zerhouni’s current – and perhaps Hamburg’s former – problems. Given the authors’ current or past affiliations, one can also assume that their comments were somewhat US-centric.