Overview The Ministry of Health and Family Welfare , via the CDSCO , has launched a multi‑pronged regulatory drive to safeguard drug quality across India, including medicines sold at Jan Aushadhi outlets. Key Developments (2022‑2026) Risk‑Based Inspections of more than 960 drug manufacturing premises (Dec 2022‑Mar 2026) by CDSCO and State Drugs Controllers ( SDCs ). Over 860 regulatory actions – show‑cause notices, stop‑production orders, suspensions, licence cancellations and warning letters – were issued. Intensive audits of > 1,100 cough‑syrup manufacturers and 380 blood centres in coordination with state authorities; enhanced market‑surveillance sampling of syrup formulations. Amendment of the Drugs & Cosmetics Act (G.S.R. 922 (E), 28 Dec 2023) to revise Schedule M . The revised norms apply to manufacturers with turnover > ₹250 crore from 29 Jun 2024 and to smaller firms from 1 Jan 2026. February 2024: CDSCO issued uniform guidelines for sampling of drugs, cosmetics and medical devices, standardising the methodology for inspectors. Launch of the SUGAM Labs portal (Sept 2023) to automate testing workflows and provide real‑time status of laboratory analyses. Mandatory inclusion of QR Code or bar‑code on primary/secondary packaging of the top 300 formulation brands (Schedule H2) and on every bulk‑drug package to enable electronic authentication and traceability. Regular coordination through the Drugs Consultative Committee (DCC) and extensive capacity‑building programmes: 22,854 officials trained in FY 2023‑24 and 20,551 in FY 2024‑25 on GMP compliance. Important Facts & Statistics Annual drug‑sample testing exceeds 1 lakh specimens across states and Union Territories. More than 860 enforcement actions have been taken against non‑compliant units since December 2022. Digital tracking via QR/Bar‑codes is now compulsory for the top 300 formulation brands and all bulk‑drug imports. UPSC Relevance Understanding the regulatory architecture of the pharmaceutical sector is essential for GS III (Health) and GS II (Governance). Questions may focus on (i) the role of CDSCO and state bodies, (ii) the significance of Schedule M amendments, and (iii) the impact of digital traceability (QR/Bar‑codes) on curbing counterfeit medicines. Way Forward To consolidate gains, the government should (i) expand the QR‑code mandate to all drug categories, (ii) integrate the SUGAM Labs system with state‑level databases for real‑time surveillance, (iii) increase the frequency of risk‑based inspections for small‑scale manufacturers, and (iv) strengthen public awareness campaigns on reading QR‑codes for product authentication.