Drug regulator warns against prolonged use of painkillers, antibiotics

New Delhi: India’s drug regulator has issued an advisory cautioning against the indiscriminate, repeated or prolonged use of painkillers and antibiotics, highlighting the risk of avoidable renal complications and chronic kidney disease associated with inappropriate use.

The advisory said such medicines should be used only when clinically indicated, at the appropriate dose and for the appropriate duration and under the supervision of a registered medical practitioner.

It specifically advised the public not to take NSAIDs or antibiotics indiscriminately, repeatedly or for prolonged periods without medical advice.


“Antibiotics should not be used for self-medication or for conditions where they are not clinically indicated, including most uncomplicated viral infections,”it said.

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Patients have also been advised to take prescribed antibiotics strictly as directed and not share them with others or use leftover medicines. Those with pre-existing kidney disease or other risk factors for renal impairment have been asked to inform their healthcare professionals before using NSAIDs.

The advisory gains significance given the fact that antibiotics market has seen a continued growth. According to data by pharma research firm PharmaTrac the antibiotics market rose from 23,045 crore in August 2022 to 28,513 crore in August 2026, recording a five-year CAGR of 5%.

The regulator has also advised people to seek medical advice if pain, fever or other symptoms persist or recur rather than repeatedly using painkillers or antibiotics on their own.

For healthcare professionals, the advisory calls for NSAIDs and antibiotics to be prescribed only when clinically indicated, after considering the patient’s clinical condition, age, co-morbidities, concomitant medicines and other relevant risk factors.

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Doctors have been advised to consider the lowest effective dose of NSAIDs for the shortest appropriate duration, particularly in patients at increased risk of renal impairment. Appropriate precautions should also be taken in patients with renal impairment, dehydration, cardiovascular disease and other conditions that could increase the risks associated with NSAID use.

For antibiotics, the drug controller has called for judicious prescribing in line with antimicrobial stewardship principles. Doctors have been advised to consider the likely causative organism, site and severity of infection and, wherever appropriate, microbiological investigations and local susceptibility patterns.

The advisory also calls for unnecessary combination therapy, inappropriate antibiotic selection, incorrect dosing and unnecessarily prolonged antibiotic treatment to be avoided.

Pharmacists, retailers and distributors have been directed to comply with the statutory requirements governing the sale and distribution of Schedule H, H1 and other prescription medicines. They have also been asked not to encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs and to observe the prescribed warnings and conditions of sale on medicine labels.

Hospitals and healthcare institutions have been advised to strengthen systems for rational prescribing and monitoring of NSAIDs and antibiotics, besides promoting antimicrobial stewardship, prescription review and appropriate patient counselling.

State and UT drug control authorities have been asked to create awareness among healthcare professionals, pharmacists, retailers and the public about the risks associated with indiscriminate use of NSAIDs and antibiotics and ensure compliance with the applicable provisions of the Drugs and Cosmetics Act and Rules.

The advisory comes with the government stressing the need to promote the rational, safe and responsible use of the two categories of medicines and prevent avoidable adverse drug reactions, renal complications and antimicrobial resistance.

“All concerned are advised to take necessary steps to promote rational, safe and responsible use of NSAIDs and antibiotics and to prevent avoidable adverse drug reactions, renal complications and antimicrobial resistance,” it further said.