India’s apex drug regulator has warned people against repeatedly reaching for painkillers and antibiotics without medical advice, flagging risks ranging from kidney complications to antimicrobial resistance and calling for tighter adherence to prescription rules across pharmacies and healthcare institutions.
In a circular dated September 21, the Central Drugs Standard Control Organisation (CDSCO) said non-steroidal anti-inflammatory drugs (NSAIDs), commonly used for pain and inflammation, and antibiotics should be used only when clinically necessary, at the appropriate dose and for the appropriate duration under medical supervision. The advisory covers patients, doctors, pharmacists, retailers, distributors, hospitals and state drug regulators.
Why painkillers pose a risk
The warning is particularly significant for NSAIDs, a widely used class of painkillers. Repeated, prolonged or inappropriate consumption can affect kidney function, with the risks higher among people who already have kidney disease or other conditions that make the kidneys more vulnerable.
CDSCO has advised doctors to assess a patient’s age, clinical condition, co-morbidities, other medicines being taken and relevant risk factors before prescribing NSAIDs. For patients at increased risk of renal impairment, doctors should consider the lowest effective dose for the shortest appropriate duration.
Extra precautions have been advised for people with renal impairment, dehydration and cardiovascular disease or other conditions that may increase the risks associated with NSAID use. People with existing kidney disease or other risk factors have been asked to inform their doctor before taking these medicines.
The regulator has also advised people not to repeatedly treat persistent or recurring pain and fever themselves. If symptoms continue or return, they should seek medical advice rather than repeatedly taking painkillers or antibiotics.
Antibiotics not for viral infections
The circular separately targets the widespread misuse of antibiotics, particularly self-medication for illnesses where these drugs provide no benefit.
CDSCO said antibiotics should not be taken without medical advice or used for conditions where antibiotic treatment is not clinically indicated, including most uncomplicated viral infections. Patients who have been prescribed antibiotics should take them strictly as advised and should neither share them with another person nor use medicines left over from an earlier prescription.
Unnecessary and inappropriate antibiotic use is also a major driver of antimicrobial resistance (AMR), in which bacteria become resistant to medicines designed to treat them. This can make infections increasingly difficult to treat.
Doctors have consequently been asked to prescribe antibiotics in accordance with antimicrobial stewardship principles, taking into account the likely organism causing an infection, its site and severity and, where appropriate, microbiological tests and local susceptibility patterns.
The regulator specifically advised against unnecessary combinations of antibiotics, inappropriate selection of drugs, incorrect doses and unnecessarily prolonged treatment.
Prescription rules already exist
Importantly, the September 21 circular does not amount to a new blanket ban on commonly used painkillers or antibiotics. It reinforces prescription and sale restrictions that already exist under India’s drug regulations.
CDSCO noted that medicines are placed under Schedules G, H, H1 and X of the Drugs Rules, 1945, depending on their applicability and potential risks. Most NSAIDs fall under Schedule H, while most antibiotics are covered by Schedule H1. These categories carry prescription and other conditions governing their retail sale.
The regulator has asked pharmacists, retailers and distributors to strictly follow these statutory requirements and not encourage or facilitate self-medication involving antibiotics or prescription-only NSAIDs.
Hospitals and healthcare institutions have similarly been asked to strengthen systems for rational prescribing, prescription review, monitoring and patient counselling, while promoting antimicrobial stewardship.
State and Union Territory drug control authorities have been asked to spread awareness among doctors, pharmacists, retailers and the public and ensure compliance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
The regulator’s central message is straightforward: common availability does not make repeated use risk-free. Painkillers and antibiotics should be taken for the right medical reason, at the right dose and for the right duration rather than being treated as medicines that can routinely be self-prescribed.