CDSCO warns against the indiscriminate use of painkillers and antibiotics Today’s news
The Central Drugs Standard Control Organization (CDSCO) on Tuesday issued an advisory to curb the indiscriminate use of painkillers and antibiotics, highlighting their link with the risk of chronic kidney disease.
In a circular, Drugs Controller General of India Dr Rajeev Singh Raghuvanshi noted that all non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics must be sold and distributed only on the prescription of a registered doctor or specialist.
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The country’s top drug regulator said that based on usability and potential risks, the drugs are listed under G, H, H1 and X of the 1945 Drug Rules requiring medical supervision. Most NSAIDs fall under Schedule H, which means they cannot be sold at retail without a prescription from a registered medical practitioner, as mandated by Rule 97.
Similarly, most antibiotics fall under Schedule H1, which requires labels warning that it is dangerous to use the product other than in accordance with medical advice and prohibits retail sale without a doctor’s prescription.
The circular states that it is mandatory to ensure that these drugs are used only when clinically indicated, at an appropriate dose and duration and under medical supervision. The advisory outlines specific guidance for patients, physicians, chemists, healthcare facilities and state regulators.
What to do and what not to do
The regulator said antibiotics must not be used for self-medication or for conditions where they are not indicated, such as uncomplicated viral infections. Patients must take prescribed antibiotics exactly as directed, avoid sharing them, and refrain from taking leftover medications.
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People with pre-existing kidney disease or other risk factors for kidney damage must tell a doctor before taking NSAIDs, and individuals should seek medical attention if pain, fever, or other symptoms persist rather than self-medicate.
For healthcare professionals, the guidelines state that NSAIDs and antibiotics must be prescribed after assessment of clinical status, age, co-morbidities, concomitant medications and risk factors. When prescribing NSAIDs, clinicians should consider the lowest effective dose for the shortest duration, especially in patients at risk of kidney damage, dehydration, or cardiovascular disease.
Antibiotics must be prescribed judiciously according to stewardship principles, taking into account the causative organism, site of infection, severity, microbiological tests, and susceptibility patterns. Physicians must avoid unnecessary combination therapies, incorrect dosing, and prolonged treatment duration.
Pharmacists, retailers and distributors must comply with the legal requirements for Schedule H and H1 drugs, comply with label warnings and avoid encouraging or facilitating self-medication. Hospitals and healthcare institutions have been asked to strengthen prescribing, monitoring, prescribing control and patient counseling systems.
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State and territory drug control authorities were directed to raise public and professional awareness and enforce compliance with the Drugs and Cosmetics Act 1940 and the Drugs Regulations 1945 to prevent adverse drug reactions, kidney complications and antimicrobial resistance.
