India's Drug Regulatory Landscape: Facing the Quality Challenge

In the period of 2024-25, over 1.16 lakh drug samples in India were tested for quality with 3,104 found below the standard and 245 deemed spurious. Efforts by CDSCO and regional regulators focus on rigorous inspections and enhancement through the Strengthening of States' Drug Regulatory System (SSDRS).

In a detailed parliamentary session, Union Health Minister J P Nadda disclosed that between 2024-25, over 1.16 lakh drug samples in India were scrutinized, out of which 3,104 did not meet quality standards, while 245 were spurious or adulterated.

In response to inquiries, Nadda highlighted intensified surveillance by the Food Safety Standard Authority of India (FSSAI), including regular inspections and random sampling by state and union territory food safety departments.

Risk-based inspections by the Central Drugs Standard Control Organisation (CDSCO) have led to significant regulatory actions, including the construction of new laboratories as part of efforts to fortify the country's drug regulatory framework.