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Number of NSQ drugs has declined considerably in Gujarat during the last 10 years: Dr H G Koshia
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Shardul Nautiyal, Mumbai
May 07 , 2025
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A review of drug quality data from 2011–12 to 2023–24 reveals a striking trend in Gujarat’s pharmaceutical landscape. While the number of drug samples tested has fluctuated, the number of Not of Standard Quality (NSQ) drugs has seen a consistent and dramatic decline.
Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr H G Koshia, informed, “From the peak of 463 NSQ drugs out of 5,796 samples tested in 2011–12, the number plummeted to just 349 in 2023–24 out of 14,373 samples tested, marking around a 69.6% reduction in failure rates over a decade.”
In 2011–12, regulatory authorities tested around 5796 drug samples, and of these, 463 were found to be NSQ, either due to failing chemical composition requirements, improper storage conditions, or manufacturing defects. In the years that followed, testing increased steadily. The number of samples tested peaked at 16, 076 in 2020-21, and in some years, hovered around 11, 068 to 12, 282 in 2021-22 and 2022-23 respectively. Despite this expansion in testing, the number of NSQ cases did not follow the same upward path.
By 2013–14, NSQ cases had surged briefly to 567 out of 9,713 samples tested, but since then, there has been a notable and steady decline. In 2016–17, only 535 NSQ samples were reported out of 11, 071 tested. By 2019–20, that number fell even further to 220 NSQ samples out of over 13,241. Most striking was the data from 2022–23, when just 142 substandard drugs were identified out of 10,282 tested, which is a record low.
The most recent data from 2023–24 shows 349 NSQ drugs in 2023-24 out of 14,373 samples tested. This means that approximately 2.43% of drug samples tested in 2023–24 were found to be NSQ, which is down sharply from failure rates seen a decade ago.
This dramatic shift points to deeper improvements in the Gujarat drug regulatory pharmaceutical system. Regulatory enforcement has been tightened, especially with the Gujarat FDCA stepping up its monitoring protocols. The introduction of stricter Good Manufacturing Practice (GMP) guidelines and more frequent inspections has likely pressured manufacturers to adhere more closely to quality standards.
“Technological advancements have also contributed. Modern testing equipment, automated analysis, and digital traceability systems have made it easier to identify and isolate poor-quality drugs before they reach the market. Additionally, national programs focusing on pharmacovigilance and quality control have brought both government and private players into alignment with global best practices,” Dr Koshia concluded.
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