New Delhi: The number of drug samples declared as Not of Standard Quality (NSQ) by the drug regulators in the country has registered over two-fold growth during the 12 months of the year 2025, primarily owing to the increased participation from the states, as compared to the previous year.
Reporting of NSQ samples from the routine drug sample tests by the drug regulators of states and Union Territories (UTs) across the country to the Central Drugs Standard Control Organisation (CDSCO) has seen over three-fold increase during the year 2025, as against the year 2024, according to data from the central drug regulator.
The NSQ reported by the CDSCO, with the data collected from both the states and the central drug testing laboratories across the country, was 1,879 samples during the year 2025, as compared to a total of 877 samples during the year 2024.
Out of the 1,879 samples reported as NSQs during the year, 1,163 samples (almost 62%) were from the states. This is compared to the 339 samples (almost 39%) reported by the States during the year 2024.
According to data from the CDSCO, the NSQs reported by the State and UT drug regulators started to show significant growth from the last quarter of the year 2024. The last three months of 2024 witnessed reporting of 192 NSQs from the states and UTs (out of the total 341 samples declared by CDSCO), which was higher than the 147 NSQs reported by the states (out of a total of 536 samples declared by CDSCO) in the first nine months of the year.
The NSQs reported by the states and UTs to the CDSCO in 2019 was a meagre 125, which has grown almost three -fold to 339 in the year 2024. The NSQs reported by the states and UTs in 2020 was a total of 140, which went down to 114 in 2021, grew to 228 in 2022, and again went down to 189 in 2023 before growing to 339 in 2024.
The increased participation from the states is despite the fact that several states and UTs fail to share the monthly NSQ report with the
Central drug regulator almost every month. The CDSCO has been listing out the State and UT licensing authorities from whom the routine data is pending each month.
The CDSCO and the Drugs Consultative Committee (DCC) has repeatedly urged the drug regulators to share the data on time, in order to bring out comprehensive NSQ data for the country.
It may be noted that the CDSCO, while announcing the NSQs, have been stating, “Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. The failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market”.
“This action of identifying NSQ and spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market,” it adds.
The CDSCO has also recently made the NSQ and spurious drug alerts, from the result of its routine monthly testing of drug samples across the country, digital and searchable.
