The Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, has issued a comprehensive regulatory circular addressing the growing health hazards linked to the indiscriminate use of non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics, with a primary focus on preventing drug-induced Chronic Kidney Disease (CKD) and antimicrobial resistance (AMR).
Signed by Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi, the directive mandates strict compliance across all healthcare tiers with the statutory provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. Under these regulations, the majority of NSAIDs and antibiotics are categorized under Schedule H and Schedule H1, legally prohibiting retail sale without a valid prescription from a Registered Medical Practitioner (RMP).
The circular outlines actionable mandates for key stakeholders across the health ecosystem.Clinicians are directed to prescribe NSAIDs and antibiotics strictly when clinically indicated, using the lowest effective dose for the shortest necessary duration, while exercising heightened caution in patients with baseline renal impairment or cardiovascular risks. Hospitals are instructed to enforce robust antimicrobial stewardship, prescription audits, and patient counseling protocols.
Dispensers are barred from encouraging or facilitating over-the-counter self-medication and must strictly observe mandatory Schedule H/H1 labeling warnings and sales documentation. Consumers are advised against self-medicating with painkillers or sharing leftover antibiotics, with explicit warnings that antibiotics are clinically ineffective against uncomplicated viral infections.
CDSCO has called upon State and Union Territory Drugs Control Authorities to launch targeted compliance inspections and public awareness campaigns to ensure adherence and protect public health nationwide.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
