Warning against the indiscriminate, repeated or prolonged use of painkillers and antibiotics, the central drugs standard control organisation (CDSCO) has flagged the risk of renal complications and antimicrobial resistance. The advisory comes with specific directions for the public, doctors, pharmacists, retailers, distributors, hospitals and state and Union Territory (UT) drug control authorities.
In a
circular issued on 21 September 2026, drugs controller general of India, Dr Rajeev Singh Raghuvanshi, said non-steroidal anti-inflammatory drugs (NSAIDs), commonly used as painkillers, and antibiotics must be used only when clinically indicated and under the supervision of a registered medical practitioner (RMP).
CDSCO said the import, manufacture, sale and distribution of medicines are regulated under the Drugs and Cosmetics Act, 1940 and the rules framed under it. Most NSAIDs are covered under Schedule H and cannot be sold at retail without a prescription from a registered medical practitioner, the regulator said.
It pointed out that drugs, including NSAIDs and antibiotics, are subject to prescription requirements depending on their classification under the Drugs Rules, 1945. Various medicines are placed under Schedules G, H, H1 and X because of their potential risks and, therefore, require appropriate medical supervision.
Similarly, most antibiotics are covered under Schedule H1. Their labels are required to carry warnings that the medicines are dangerous to take except in accordance with medical advice and that they cannot be sold at retail without an RMP's prescription.
CDSCO said these requirements mean such medicines should be used only when clinically indicated, at the appropriate dose and for the appropriate duration.
The regulator has specifically advised people not to take NSAIDs or antibiotics indiscriminately, repeatedly or for prolonged periods without medical advice.
It has also warned against using antibiotics for self-medication or for illnesses where antibiotic treatment is not clinically indicated, including most uncomplicated viral infections.
Patients who have been prescribed antibiotics should take them strictly as advised by their healthcare professional. CDSCO said antibiotics should not be shared with others or taken from leftover medication.
The circular also singles out people with pre-existing kidney disease or other risk factors for renal impairment. They have been advised to inform their healthcare professional before taking NSAIDs.
The regulator has asked people to seek medical advice if pain, fever or other symptoms persist or return instead of repeatedly treating themselves with painkillers or antibiotics.
CDSCO has asked healthcare professionals to prescribe NSAIDs and antibiotics only when clinically indicated, after considering factors such as the patient's condition, age, co-morbidities, other medicines being taken and relevant risk factors.
For NSAIDs, doctors have been advised to consider the lowest effective dose for the shortest appropriate duration, particularly when treating patients who face a higher risk of renal impairment.
The circular also calls for appropriate precautions when prescribing NSAIDs to patients with renal impairment, dehydration, cardiovascular disease or other conditions that could increase the risks associated with their use.
Regarding antibiotic use, CDSCO has called for judicious prescribing in line with antimicrobial stewardship principles.
Doctors have been asked to consider the likely causative organism, the site and severity of infection and, wherever appropriate, microbiological investigations and local susceptibility patterns.
Unnecessary combination therapy, inappropriate antibiotic selection, incorrect dosing and unnecessarily long courses of antibiotics should be avoided, the regulator said.
CDSCO has also reminded pharmacists, retailers and distributors that statutory requirements governing the sale and distribution of Schedule H, H1 and other prescription medicines must be strictly followed.
Schedule H and H1 medicines should not be sold at retail except in accordance with the applicable provisions of the Drugs Rules, 1945.
Pharmacists and retailers have been specifically told not to encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs.
They have also been asked to comply with the warnings and conditions of sale printed on the labels of such medicines.
Hospitals and healthcare institutions have been advised to strengthen systems for the rational prescribing and monitoring of NSAIDs and antibiotics.
CDSCO has called for greater focus on antimicrobial stewardship, prescription review and appropriate patient counselling.
The advisory also places a responsibility on state and UT drug control authorities to create awareness among healthcare professionals, pharmacists, retailers and the public about the risks associated with indiscriminate use of these medicines.
The authorities have been asked to ensure compliance with the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
CDSCO said the overall objective of the measures is to promote the rational, safe, and responsible use of NSAIDs and antibiotics, and to prevent avoidable adverse drug reactions, renal complications, and antimicrobial resistance.
The regulator's warning places particular emphasis on the risks associated with unsupervised and prolonged use of commonly available medicines used to manage pain, fever and infections.
