India now has the highest number of market authorisations granted by the US Food and Drug Authority (USFDA) so far along with a steady increase in the registration of manufacturing sites registered with the US regulator. Market authorisations are approvals given to Abbreviated New Drug Applications (ANDAs) that allow companies to launch a product in the US market.
As per the latest industry data of the USFDA, market authorisations granted to Indian formulations companies with USFDA approvals stood at 6,316, which is highest in comparison to any other country as of April 2023. This includes authorisations granted to India subsidiaries situated overseas.
There were 107 market authorisations granted by the US agency for First Time Generics out of which Indian origin companies bagged 41 which shows the `primacy’ of the Indian drug industry, according to R Uday Bhaskar, Director-General. Pharmaceutical Export Promotion Council (Pharmexcil). “There has been a steady increase in the overall percentage of market authorisations granted to Indian companies over the last year despite the challenges posed by Covid-19 to the Industry,’‘ a senior official of a Hyderabad-based drug major told businessline.
During the calendar year of 2022, USFDA has granted 1,181 market authorisations of ANDAs. Out of these, Indian companies bagged 493 which accounted for 41.74 per cent of total authorisations. This had gone as 36 per cent of total market authorisation granted by the US Food and Drug Administration (USFDA) in 2020 was to drug makers from India.
There has been an increase in the number of USFDA recognised sites in India too. As as April 2023, India has 703 manufacturing sites which constitutes almost 20 per cent of the total manufacturing sites registered with it and situated outside India which exports almost 30 per cent of its total pharma exports to the US. Indian pharmaceutical exports stood at $25.4 billion in FY23.
