The Central Drugs Standard Control Organization (CDSCO) has cautioned against the indiscriminate use of non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics, citing the risk of avoidable adverse drug reactions, renal complications and antimicrobial resistance.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), issued a circular on September 21 advising all concerned stakeholders, including the public, healthcare professionals, pharmacists, retailers, wholesalers, hospitals and healthcare institutions, to ensure that these drugs are used only when clinically indicated, at the appropriate dose and for the appropriate duration, under the supervision of a Registered Medical Practitioner (RMP).
The regulator noted that the import, manufacture, sale and distribution of drugs in India are regulated under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
Based on their applicability and risk profile, various drugs, including NSAIDs and antibiotics, are placed under Schedules G, H, H1 and X of the Drugs Rules and require appropriate medical supervision. Such drugs are also required to bear the prescribed warnings, cautions and conditions of sale.
Most NSAIDs are included under Schedule H and cannot be sold by retail without a prescription from a Registered Medical Practitioner.
Similarly, most antibiotics are covered under Schedule H1 and are required to be labelled with warnings stating that the preparation is dangerous to take except in accordance with medical advice and that it should not be sold by retail without an RMP’s prescription.
Advice for the Public
The CDSCO advised the public not to take NSAIDs/painkillers and antibiotics indiscriminately, repeatedly or for prolonged periods without medical advice.
“Antibiotics should not be used for self-medication or for conditions where antibiotic treatment is not clinically indicated, such as most uncomplicated viral infections,” it said.
Patients have also been advised to take prescribed antibiotics strictly as advised and not share them with others or use leftover medicines.
Individuals with pre-existing kidney disease or other risk factors for renal impairment should inform their healthcare professional before using NSAIDs.
The regulator further 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.
Guidance for Healthcare Professionals
Healthcare professionals have been advised to prescribe NSAIDs and antibiotics only when clinically indicated, after considering the patient’s clinical condition, age, co-morbidities, concomitant medicines and relevant risk factors.
For NSAIDs, the CDSCO recommended considering the lowest effective dose for the shortest appropriate duration, particularly for patients at increased risk of renal impairment.
“Appropriate precautions should be taken in patients with renal impairment, dehydration, cardiovascular disease or other conditions that may increase the risk associated with NSAID use,” it said.
While prescribing antibiotics, healthcare professionals have been advised to follow 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.
The CDSCO also advised avoiding unnecessary combination therapy, inappropriate antibiotic selection, incorrect dosing and unnecessarily prolonged antibiotic treatment.
Directions for Pharmacies and Healthcare Institutions
Pharmacists, retailers and distributors have been directed to strictly comply with statutory requirements governing the sale and distribution of Schedule H, H1 and other prescription medicines.
“Schedule H/H1 drugs shall not be sold at retail except in accordance with the applicable provisions of the Drugs Rules, 1945,” the CDSCO said.
Pharmacists and retailers have also been advised not to encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs and to comply with the warnings and conditions of sale specified on medicine labels.
Hospitals and healthcare institutions have 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 CDSCO has also requested State and Union Territory Drugs Control Authorities to create awareness among healthcare professionals, pharmacists, retailers and the public about the risks associated with indiscriminate use of NSAIDs and antibiotics and to ensure compliance with applicable drug laws.
All concerned were advised to take necessary steps to promote the rational, safe and responsible use of NSAIDs and antibiotics and to prevent avoidable adverse drug reactions, renal complications and antimicrobial resistance.
