India has tested nearly 5 lakh drug samples over the past five years as part of efforts to ensure the safety and quality of medicines, according to the Ministry of Health and Family Welfare. The data, released by the ministry, highlights the scale of testing and regulatory actions taken to maintain standards in the pharmaceutical sector.

Testing Trends and Quality Concerns

According to the ministry, a total of 5,02,806 drug samples were tested between 2020-21 and 2024-25, with a significant portion found to be of substandard quality or adulterated. In 2020-21, 84,874 samples were tested, of which 2,652 were found not of standard quality (NSQ) and 263 were spurious or adulterated.

The numbers rose in subsequent years, with 88,844 samples tested in 2021-22, of which 2,545 were NSQ and 379 were spurious or adulterated. In 2022-23, the testing increased further to 96,713 samples, with 3,053 NSQ and 424 spurious or adulterated cases.

During 2023-24, the number of samples tested reached 1,06,150, with 2,988 declared NSQ and 282 spurious or adulterated. In 2024-25, the number rose to 1,16,323, with 3,104 samples found NSQ and 245 reported as spurious or adulterated.

Risk-Based Inspections and Regulatory Actions

To ensure compliance with quality standards, the Central Drugs Standard Control Organization (CDSCO) initiated risk-based inspections of drug manufacturing and testing firms in December 2022. These inspections are based on risk criteria such as the number of drugs declared as NSQ, complaints, and the criticality of the products.

As of now, CDSCO, in collaboration with state regulators, has conducted risk-based inspections of more than 960 premises since December 2022. Based on the findings, over 860 actions have been taken by states and union territories, including issuance of show cause notices, stop production orders, suspension, cancellation of licenses, and warning letters.

Additionally, more than 1,100 cough syrup manufacturers and 380 blood centres have undergone intense audits in coordination with state authorities. Central and state drug regulators have also increased market surveillance sampling of syrup formulations.

Infrastructure Development and Funding

To enhance the drug testing infrastructure, the Ministry of Health and Family Welfare has implemented the Centrally Sponsored Scheme, ‘Strengthening of States’ Drug Regulatory System (SSDRS). Under this scheme, funds totaling Rs. 756 crore have been released to states and union territories.

As part of the scheme, 19 new drug testing laboratories have been constructed, and 28 existing labs have been upgraded. The initiative aims to improve laboratory capacity and ensure better compliance with drug quality standards across the country.

The Union Minister of State for Health and Family Welfare, Anupriya Patel, mentioned these developments in a written reply to the Rajya Sabha on Tuesday, highlighting the government’s commitment to pharmaceutical safety and quality assurance.

The ministry’s efforts reflect a broader regulatory framework established under the Drugs & Cosmetics Act, 1940, which governs the manufacture, sale, and distribution of drugs through a system of licensing and inspection. These measures are critical in protecting public health and ensuring that medicines available in the market are safe and effective.

While the ministry has made significant strides in testing and regulatory actions, challenges remain in ensuring complete compliance across all regions. Continued monitoring and investment in infrastructure are essential to maintain high standards of drug quality in India.