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Gireesh Babu, New Delhi September 23 , 2026
The Central Drugs Standard Control Organisation (CDSCO) has advised all stakeholders including general public, healthcare professionals, pharmacists, retailers, wholesalers, hospitals and other healthcare institutions to promote rational, safe and responsible use of non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics to avoidable associate risks including chronic kidney disease (CKD).

Observing that indiscriminate use of painkillers, antibiotics and associated risk of CKD, the New Drugs Division of the CDSCO said that based on applicability, considering their potential risks various drugs including NSAIDs and antibiotics, are placed under Schedules G, H, H1 and X of the Drugs Rules, 1945 and require appropriate medical supervision.

Such drugs are required to bear the prescribed warnings, cautions and conditions of sale in accordance with Rule 97 of the Drugs Rules.

Most of the NSAIDs are included in the Schedule H, and most of the antibiotic drugs are included in the Schedule H1, that restricts the sales of these drugs through prescription of a Registered Medical Practitioner.

In a circular to the stakeholders, Drugs Controller General (India) (DCGI) Dr Rajeev Singh Raghuvanshi said, "... 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."

He advised the general public that NSAIDs or painkillers and antibiotics should not be taken indiscriminately, repeatedly or for prolonged periods without medical advice and antibiotics should not be used for self-medication or for conditions where such treatment is not clinically indicated.

For instance, antibiotics should not be used for self medication in cases of most uncomplicated viral infections. Antibiotics prescribed by a healthcare professional should be taken strictly as advised and should not be shared with other persons or used from leftover medicines.

"Individuals, particularly those with pre-existing kidney disease or other risk factors for renal impairment, should inform their healthcare professional before using NSAIDs," said the DCGI. He advised the public to seek medical advice where pain, fever or other symptoms persist or recur rather than repeatedly using painkillers or antibiotics on their own.

Healthcare professionals has been advised that NSAIDs and antibiotics should be prescribed only when clinically indicated, after considering the patient's clinical condition, age, co-morbidities, concomitant medicines and relevant risk factors.

The lowest effective dose for the shortest appropriate duration should be considered when prescribing NSAIDs, particularly in patients at increased risk of renal impairment.

Antibiotics should be prescribed judiciously and in accordance with applicable antimicrobial stewardship principles, taking into consideration the likely causative organism, site and severity of infection and, wherever appropriate, relevant microbiological investigations and local susceptibility patterns.

Unnecessary combination therapy, inappropriate antibiotic selection, incorrect dosing and unnecessarily prolonged duration of antibiotic treatment should be avoided, added the drugs regulator.

Pharmacists, retailers and distributors should strictly comply with the statutory requirements relating to the sale and distribution of Schedule H, H1 and other prescription drugs, and Schedule H, H1 drugs shall not be sold at retail except in accordance with the applicable provisions of the Drugs Rules, 1945.

Pharmacists and retailers shall not encourage or facilitate self-medication with antibiotics or prescription-only NSAIDS. The prescribed warnings and conditions of sale appearing on the labels of such medicines shall be duly observed.

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

CDSCO also requeste3d all State and Union Territory drugs control authorities to create awareness among healthcare professionals, pharmacists, retailers and the general public regarding the risks associated with indiscriminate use of NSAIDS and antibiotics and to ensure compliance with the applicable provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.

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