NEW DELHI: India’s drug regulator has issued an advisory warning the public, doctors, pharmacists and hospitals against indiscriminate use of painkillers and antibiotics, highlighting the risk of rising chronic kidney disease, avoidable adverse drug reactions and antimicrobial resistance.
In its September 21 circular, the Central Drugs Standard Control Organisation (CDSCO) called for rational, safe and responsible use of non-steroidal anti-inflammatory drugs (NSAIDs), used commonly to relieve pain and inflammation, and antibiotics.
The Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi in the circular said that import, manufacture, sale and distribution of drugs are regulated under the Drugs and Cosmetics Act, 1940 and the rules framed under it.
“As per the said rules, all drugs including non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics are required to be sold and distributed in the country on prescription of an RMP/specialist only,” he said.
The CDSCO said 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 of NSAIDs are included in the Schedule H of Drugs Rules, 1945. Thus, they are not to be sold by retail without the prescription of a Registered Medical Practitioner as is required in Rule 97 of Drugs Rules, 1945,” he added.
He said that most antibiotics are included in Schedule H1 and carry warnings that they are dangerous to take except in accordance with medical advice and should not be sold by retail without the prescription of a registered medical practitioner.
“In view of the above, it is mandatory to ensure that these drugs shall 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 circular said.
The circular listed detailed advisory for the public, healthcare professionals, pharmacists, retailers, distributors and hospitals and healthcare institutions.
For the general public, the CDSCO advised that NSAIDs or painkillers and antibiotics should not be taken “indiscriminately, repeatedly or for prolonged periods without medical advice.”
It also said antibiotics should not be used for self-medication or for conditions where antibiotic treatment is not clinically indicated, “such as most uncomplicated viral infections”.
The drug regulator advised people to take prescribed antibiotics strictly as advised and not share them with others or use leftover medicines.
Individuals, “particularly those with pre-existing kidney disease or other risk factors for renal impairment,” have been advised to inform their healthcare professionals before using NSAIDs.
The circular also said that 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.
For healthcare professionals, the circular said NSAIDs and antibiotics should be prescribed only when clinically indicated, after considering the patient’s clinical condition, age, comorbidities, concomitant medicines and relevant risk factors.
It advised that “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 circular also called for appropriate precautions in patients with renal impairment, dehydration, cardiovascular disease or other conditions that may increase the risks associated with NSAID use.
On antibiotic use, it said these drugs 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,” it said.
The CDSCO 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.
“Schedule H/H1 drugs shall not be sold at retail except in accordance with the applicable provisions of the Drugs Rules, 1945,” it said.
It also said that pharmacists and retailers should not encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs.
Hospitals and healthcare institutions have been advised to strengthen systems for rational prescribing and monitoring of NSAIDs and antibiotics and promote antimicrobial stewardship, prescription review and appropriate patient counselling.
The CDSCO asked the Drugs Control Authorities in the states and Union Territories to create awareness among healthcare professionals, pharmacists, retailers and the general public regarding the risks associated with indiscriminate use of NSAIDs and antibiotics, and ensure compliance with applicable provisions.
“In view of the above, 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,” the circular added.
