New Delhi, September 23: The Central Drugs Standard Control Organisation (CDSCO) has issued an advisory circular to healthcare professionals, pharmacists, retailers, distributors, hospitals and the general public regarding the indiscriminate use of painkillers, particularly Non-Steroidal Anti-Inflammatory Drugs ( NSAIDs), and antibiotics, highlighting the associated risks of Chronic Kidney Disease (CKD).
According to the Directorate General of Health Services (DGHS), the circular dated September 21 stressed that NSAIDs and antibiotics should only be used when clinically indicated, in the appropriate dose and for the appropriate duration, and under the supervision of a Registered Medical Practitioner.
The DGHS said that the import, manufacturing, sale and distribution of drugs are regulated under the Drugs and Cosmetics Act, 1940 and the rules framed thereunder.
It further noted that various drugs, including NSAIDs and antibiotics, are placed under Schedules G, H, H1 and X of the Drugs Rules, 1945, depending on their applicability and potential risks, and are required to carry prescribed warnings, cautions and conditions of sale.
“Most of NSAIDs are included in the Schedule H of Drugs Rules, 1945. Thus, are not to be sold by retail without the prescription of a Registered Medical Practitioner’ as is required in Rule 97 of Drugs Rule, 1945,” the circular stated.
Similarly, the DGHS said that most antibiotic drugs are included in Schedule H1 and are required to carry specific warnings.
“It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner,” the circular stated.
The advisory said NSAIDs and antibiotics should not be taken indiscriminately, repeatedly or for prolonged periods without medical advice.
It also advised the public against using antibiotics for self-medication or for conditions where antibiotic treatment is not clinically indicated, including 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,” it said.
The DGHS further advised individuals, particularly those with pre-existing kidney disease or other risk factors for renal impairment, to inform their healthcare professionals before using NSAIDs.
The public has also been advised to seek medical advice if pain, fever or other symptoms persist or recur, instead of repeatedly using painkillers or antibiotics on their own.
For healthcare professionals, the circular called for NSAIDs and antibiotics to be prescribed only when clinically indicated, after considering the patient’s clinical condition, age, co-morbidities, concomitant medicines and relevant risk factors.
It said the lowest effective dose for the shortest appropriate duration should be considered when prescribing NSAIDs, particularly for patients at increased risk of renal impairment.
The advisory also called for appropriate precautions in patients with renal impairment, dehydration, cardiovascular disease or other conditions that may increase risks associated with NSAID use.
On antibiotics, the DGHS called for judicious prescribing in accordance with applicable antimicrobial stewardship principles, taking into account 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,” the circular stated.
The DGHS also directed pharmacists, retailers and distributors to strictly comply with statutory requirements relating to the sale and distribution of Schedule H, H1 and other prescription drugs.
It said Schedule H and H1 drugs should not be sold at retail except in accordance with the applicable provisions of the Drugs Rules, 1945, and advised pharmacists and retailers not to encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs.
Hospitals and healthcare institutions have also been advised to strengthen systems for rational prescribing and monitoring of NSAIDs and antibiotics, while promoting antimicrobial stewardship, prescription review and appropriate patient counselling.
The State and Union Territory Drugs Control Authorities have been requested to create awareness regarding the advisory.–(ANI)
