NEW DELHI : The country’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has issued a fresh advisory warning the public, doctors and pharmacists against indiscriminate use of painkillers and antibiotics, citing the risk of chronic kidney disease, avoidable adverse drug reactions and antimicrobial resistance.
In a circular dated 21 September, the regulator said non-steroidal anti-inflammatory drugs (NSAIDs), commonly used to relieve pain and inflammation, and antibiotics must be used only when clinically indicated, at the appropriate dose and for the prescribed duration, under medical supervision.
The advisory comes amid concerns over the repeated use of painkillers for common ailments and the tendency to take antibiotics without a prescription, including for illnesses where they offer no benefit.
Most NSAIDs fall under Schedule H of the Drugs Rules, 1945, while most antibiotics are classified under Schedule H1. These medicines are subject to prescription requirements and cannot be sold at retail without a registered medical practitioner’s prescription, in accordance with applicable rules.
KIDNEY RISKS FROM MISUSE
NSAIDs are widely used for headaches, body aches, joint pain and fever. But repeated, indiscriminate or prolonged use can harm the kidneys, potentially leading to chronic kidney disease, the CDSCO cautioned.
These medicines can reduce blood flow to the kidneys, affecting their ability to filter waste. The risk is particularly concerning for people with pre-existing kidney disease, dehydration or cardiovascular conditions, as well as those taking other medicines that may affect kidney function.
The regulator has advised doctors to consider a patient’s age, existing illnesses, other medications and kidney-related risk factors before prescribing NSAIDs. They should use the lowest effective dose for the shortest appropriate duration, with additional precautions for patients at risk of renal impairment.
The CDSCO has also urged people to seek medical advice if pain, fever or other symptoms persist or recur, instead of repeatedly reaching for painkillers or antibiotics.
Antibiotics, meanwhile, should not be used for self-medication or illnesses where they are not clinically indicated, including most uncomplicated viral infections.
Antibiotics do not work against viruses. Their unnecessary use can contribute to antimicrobial resistance (AMR), in which bacteria evolve to withstand medicines designed to kill them. This can make common infections harder to treat and increase the risk of complications.
The CDSCO has directed patients to take prescribed antibiotics exactly as advised, and not share them with others or use leftover medicines. Doctors have been asked to avoid inappropriate antibiotic selection, incorrect dosing, unnecessary combinations and excessively long treatment courses.
PHARMACIES UNDER SCRUTINY
The advisory also puts the onus on pharmacists, retailers and distributors to enforce prescription requirements, warning them against facilitating self-medication with antibiotics or prescription-only NSAIDs.
Schedule H and H1 medicines must not be sold over the counter in violation of the Drugs Rules, 1945. The regulator has asked pharmacists to comply with statutory sale requirements and ensure that prescribed warnings and conditions of sale on medicine labels are followed.
Hospitals and healthcare institutions have also been asked to strengthen prescription reviews, monitoring systems, patient counselling and antimicrobial stewardship practices.
State drug control authorities have been directed to create awareness among doctors, pharmacists, retailers and the public, while ensuring compliance with the law.
The CDSCO’s advisory calls for coordinated action across the drug supply chain to promote the rational use of medicines and prevent avoidable kidney complications and antimicrobial resistance.
