New Delhi: The Central Drugs Standard Control Organization (CDSCO) reported that 282 out of 1,06,150 drug samples tested between April 2023 and March 2024 were found adulterated, the Ministry of Health and Family Welfare informed Parliament on Tuesday (December 17). Additionally, 2,988 samples were declared of sub-standard quality.
The number of adulterated drug cases has seen a significant decline from 424 cases reported in the previous year. Notably, the financial year ending March 2023 recorded the highest number of spurious drug samples in the preceding five years.
However, the number of drug batches recalled increased to 1,394 in FY24, up from 1,171 the previous year. Over the past five years, a total of 5,759 drug batches have been recalled.
Between 2019 and 2024, the government initiated 2,516 prosecutions for the manufacturing, sale, and distribution of spurious drugs. During this period, testing revealed a total of 1,547 adulterated drug samples.
It’s worth noting that the CDSCO does not maintain a centralized database for drugs that fail quality tests. Instead, the data is compiled based on inputs from state governments and their respective regulators.
To improve regulatory compliance, the CDSCO, in collaboration with State Drugs Controllers (SDCs), began risk-based inspections of drug manufacturing premises in December 2022. So far, over 500 inspections have been conducted, targeting firms based on risk factors such as the number of drugs failing quality tests, complaints, and product criticality.
The inspections have led to over 400 actions, including the issuance of show-cause notices, stop-production orders, and suspension or cancellation of licenses, as per the provisions of the Drugs Rules, 1945, the ministry stated in response to a parliamentary question.
