Full Breakdown
CDSCO Warns Against Indiscriminate Use of NSAIDs and Antibiotics Over Kidney-Health and Resistance Risks
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CDSCO Issues Advisory on Painkillers and Antibiotics
In a circular dated September 21, the Central Drugs Standard Control Organisation (CDSCO) instructed doctors, pharmacists and the public to limit the use of non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics to situations where they are clinically indicated, at appropriate doses and for the prescribed duration. The regulator emphasized that both drug classes can contribute to chronic kidney disease (CKD) and antimicrobial resistance (AMR) when misused.
Background: Growing Burden of CKD and AMR in India
India faces a substantial CKD challenge, with an estimated 138 million adults affected in 2023, according to a Lancet-based study. Simultaneously, the country carries a high global burden of AMR, prompting heightened scrutiny of antibiotic prescribing practices.
Key Figures Steering the Advisory
- Rajeev Raghuvanshi — Drug Controller General of India (DCGI): Authored the circular and urged healthcare professionals to discourage repeated or prolonged NSAID and antibiotic use without medical supervision.
- Vikram Kalram — Consultant Nephrologist, CK Birla Hospital, Delhi: Highlighted that NSAIDs can reduce renal prostaglandins, lowering kidney blood flow and precipitating acute kidney injury, especially in dehydrated, elderly, or heart-failure patients.
Data & Statistics Highlighted in the Advisory
- CKD prevalence: 138 million Indian adults (2023).
- Antibiotic sales trend: Recent declines noted, partly attributed to changes in pack sizes (e.g., shift from 10-tablet to 15-tablet packs) rather than a proportional drop in doses sold, according to a Delhi-based drug wholesaler.
- Regulatory classifications: Most NSAIDs fall under Schedule H of the Drugs Rules 1945; most antibiotics are under Schedule H1, which requires red-bordered warning labels and, for H1 drugs, a three-year retention of sales registers documenting patient, prescriber and quantity details.
Implementation Measures Across the Drug Supply Chain
- Doctors: Must assess patient age, comorbidities, concurrent medications and renal risk factors before prescribing NSAIDs; use the lowest effective dose for the shortest necessary duration.
- Pharmacists and retailers: Required to enforce prescription-only sales of Schedule H and H1 medicines, display statutory warnings, and refrain from facilitating self-medication.
- Hospitals and health institutions: Asked to strengthen prescription reviews, patient counselling and antimicrobial-stewardship programs.
- State drug control authorities: Tasked with creating awareness among healthcare professionals, pharmacists, retailers and the public, and ensuring compliance with the Drugs Rules.
The coordinated push aims to curb avoidable kidney damage and curb the rise of drug-resistant infections by promoting rational medicine use throughout India’s healthcare system.