New Delhi: Due to the indiscriminate use of painkillers, the Central Drugs Standard Control Organisation issued an advisory to healthcare professionals, retailers, hospitals, distributors and pharmacists.
The national drug controller highlighted the risk of Chronic Kidney Disease (CKD) associated with excessive painkiller use.
In its 21 September circular, the drug controller called for the rational, safe and responsible use of non-steroidal anti-inflammatory drugs (NSAIDs).
The advisory comes amid concerns over the unchecked use of painkillers, particularly NSAIDs, which can cause kidney failure when used excessively or without proper medical supervision.
The CDSCO has stressed that most NSAIDs are prescription-only medicines and called on doctors, pharmacists, retailers and hospitals to curb self-medication and ensure rational prescribing by identifying patients at risk of kidney impairment.
The latest advisory also reinforces rules governing the sale of these medicines, as repeated use of painkillers and antibiotics without medical advice remains a concern.
The circular said that the import, manufacturing, sale and distribution of drugs are regulated under the provisions of the Drugs and Cosmetics Act 1940.
“As per the said rules, all drugs including NSAIDs and antibiotics are required to be sold and distributed in the country on prescription of RMP/specialist only,” read the circular.
The regulator added that various drugs, including NSAIDs and antibiotics, have been placed under Schedules G, H, H1 and X of the Drugs Rules 1945, considering their potential risks, and require appropriate medical supervision.
“Most NSAIDs are included in Schedule H of the Drugs Rules, 1945. Thus, they are not to be sold by retail without the prescription of a Registered Medical Practitioner as required in Rule 97 of Drugs Rules, 1945,” the advisory read.
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Detailed guidelines
The CDSCO issues detailed guidelines for the public, healthcare professionals, retailers, distributors and healthcare institutions.
The latest circular advised the general public not to take painkillers indiscriminately or for prolonged periods without medical advice. It states that antibiotics should not be used for self-medication.
Those individuals with pre-existing kidney disease or other risk factors for renal impairment should inform their healthcare professional before using NSAIDs
“The public is advised to seek medical advice where pain, fever or other symptoms persist or recur rather than repeatedly using painkillers or antibiotics on their own,” said the circular.
For healthcare professionals, the drug controller advised that NSAIDs and antibiotics should be prescribed only when clinically indicated after considering the patient’s clinical condition, age, and co-morbidities.
For pharmacists, retailers, and distributors, the circular advised that the prescribed warnings and conditions of sale appearing on the labels of such medicines shall be duly observed and they shall not encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs.
“Hospitals and healthcare institutions are advised to strengthen systems for rational prescribing and monitoring of NSAIDs and antibiotics and to promote antimicrobial stewardship, prescription review and appropriate patient counselling,” the CDSCO advised.
(Edited by Insha Jalil Waziri)
