A signed guidance document has urged patients and healthcare providers to use non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics more carefully. It highlights the need to avoid unnecessary treatment, reduce preventable adverse drug reactions and limit renal complications and antimicrobial resistance.
The document is signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (I). It addresses patients, healthcare professionals, pharmacists, retailers, distributors, hospitals, healthcare institutions and State/UT Drugs Control Authorities.
Advice for patients
Patients are advised not to use antibiotics when treatment is not clinically indicated, including in most uncomplicated viral infections. Antibiotics prescribed by a healthcare professional should be taken strictly as directed and should not be shared or taken from leftover medicines.
People with pre-existing kidney disease or other risk factors for renal impairment are advised to inform their healthcare professional before using NSAIDs. The guidance also asks the public to seek medical advice when pain, fever or other symptoms persist or return, rather than repeatedly using painkillers or antibiotics without professional advice.
Prescribing and treatment safeguards
Healthcare professionals are advised to prescribe NSAIDs and antibiotics only when clinically indicated. The document says decisions should take account of a patient’s clinical condition, age, co-morbidities, other medicines and relevant risk factors.
For NSAIDs, the lowest effective dose for the shortest appropriate duration should be considered, particularly for patients at increased risk of renal impairment. Precautions are also advised for people with renal impairment, dehydration, cardiovascular disease or other conditions that may raise the risks associated with NSAID use.
Antibiotics should be prescribed in line with antimicrobial stewardship principles. The guidance calls for consideration of the likely causative organism, the infection site, the severity of infection, relevant microbiological investigations and local susceptibility patterns, wherever appropriate. It also says unnecessary combination therapy, inappropriate antibiotic selection, incorrect dosing and unnecessarily prolonged treatment should be avoided.
Requirements for pharmacies and institutions
Pharmacists, retailers and distributors are advised to comply strictly with statutory requirements for the sale and distribution of Schedule H, Hone and other prescription drugs. Schedule H/Hone medicines should not be sold at retail except in accordance with the applicable provisions of the Drugs Rules, 1945.
The guidance says pharmacists and retailers should not encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs. Prescribed warnings and conditions of sale on medicine labels should also be followed.
Hospitals and healthcare institutions are advised to strengthen systems for rational prescribing and monitoring of NSAIDs and antibiotics. The document also calls for antimicrobial stewardship, prescription review and appropriate patient counselling.
State/UT Drugs Control Authorities are requested to create awareness among healthcare professionals, pharmacists, retailers and the public about the risks linked to indiscriminate use of these medicines. The guidance refers to compliance with the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
Conclusion
The guidance focuses on clinically justified prescribing, careful medicine use, compliance by sellers and stronger monitoring by healthcare institutions. Its stated aim is to prevent avoidable adverse drug reactions, renal complications and antimicrobial resistance.
Frequently Asked Questions
Q. What does the guidance say about antibiotics?
It advises that antibiotics should be used only when clinically indicated, taken as directed and not shared or used from leftover medicines.
Q. What precautions are advised for NSAIDs?
The guidance recommends considering the lowest effective dose for the shortest appropriate duration and taking precautions for patients with renal impairment, dehydration or cardiovascular disease.
Q. Can patients repeatedly self-medicate for pain or fever?
The document advises people to seek medical advice when pain, fever or other symptoms persist or return instead of repeatedly using painkillers or antibiotics on their own.
Q. What are pharmacies and retailers advised to do?
They are told not to encourage or facilitate self-medication with antibiotics or prescription-only NSAIDs and to follow the applicable requirements for prescription medicines.
Q. What should hospitals and healthcare institutions strengthen?
They are advised to improve rational prescribing and monitoring, antimicrobial stewardship, prescription review and patient counselling.
Q. Which laws are mentioned in the guidance?
The document refers to the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
