The USFDA's FY23 State of Pharma Quality Report highlights significant trends and developments in the pharmaceutical industry. India experienced a 16% net increase in USFDA sites, adding 146 new sites in FY23 for a total of 585, while 54 sites were removed and 438 were maintained.
Foreign inspections made up 59% of all USFDA drug quality assurance inspections in FY23. In India, 25% of USFDA sites were inspected, significantly higher than China's 6% and the US's 20%. Of the 500 sites inspected in India, 444 (89%) received favourable outcomes, categorised as No Action Indicated (NAI) or Voluntary Action Indicated (VAI).
There were more drug quality-related import alert additions in FY23 (93) than during FY21 and FY22 combined (77). India was responsible for 16% of these 93 import alerts, highlighting ongoing challenges in maintaining quality standards. However, China had the highest number of import alerts at 33%, followed by South Korea at 18%.
In FY23, 17% of recalled products were associated with ophthalmic drug products. The number of recalls was 26% less than in FY22 but similar to the five-year average. India recorded the second-highest number of drug recalls after the US, accounting for 33% of all recalls compared to the US's 58%. A notable incident involved the USFDA advising consumers in February 2023 to stop using eye drops manufactured by India's Global Pharma Healthcare due to microbial contamination.
The report also noted that the US, China, Germany, and Italy, alongside India, had the most USFDA sites in FY23. India's higher inspection coverage was partly due to for-cause inspections, indicating stricter regulatory oversight in response to quality concerns.
Foreign inspections made up 59% of all USFDA drug quality assurance inspections in FY23. In India, 25% of USFDA sites were inspected, significantly higher than China's 6% and the US's 20%. Of the 500 sites inspected in India, 444 (89%) received favourable outcomes, categorised as No Action Indicated (NAI) or Voluntary Action Indicated (VAI).
There were more drug quality-related import alert additions in FY23 (93) than during FY21 and FY22 combined (77). India was responsible for 16% of these 93 import alerts, highlighting ongoing challenges in maintaining quality standards. However, China had the highest number of import alerts at 33%, followed by South Korea at 18%.
In FY23, 17% of recalled products were associated with ophthalmic drug products. The number of recalls was 26% less than in FY22 but similar to the five-year average. India recorded the second-highest number of drug recalls after the US, accounting for 33% of all recalls compared to the US's 58%. A notable incident involved the USFDA advising consumers in February 2023 to stop using eye drops manufactured by India's Global Pharma Healthcare due to microbial contamination.
The report also noted that the US, China, Germany, and Italy, alongside India, had the most USFDA sites in FY23. India's higher inspection coverage was partly due to for-cause inspections, indicating stricter regulatory oversight in response to quality concerns.
First Published: Jun 13, 2024 9:22 AM IST
Check out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!
