CDSCO flags indiscriminate use of painkillers and antibiotics

The Central Drugs Standard Control Organisation (CDSCO) on Tuesday issued an advisory to curb the indiscriminate use of painkillers and antibiotics, highlighting their association with the risk of chronic kidney disease.

In a circular, Drugs Controller General of India Dr Rajeev Singh Raghuvanshi noted that all non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics must be sold and distributed only on the prescription of a registered medical practitioner or specialist.

The country’s apex drug regulator stated that, based on applicability and potential risks, these medicines are placed under Schedules G, H, H1 and X of the Drugs Rules, 1945, requiring medical supervision. Most NSAIDs fall under Schedule H, meaning they cannot be sold at retail without a prescription from a registered medical practitioner, as mandated under Rule 97.

Similarly, most antibiotics fall under Schedule H1, requiring labels warning that it is dangerous to take the preparation except in accordance with medical advice and prohibiting retail sale without a prescription.

The circular said it is mandatory to ensure these drugs are used only when clinically indicated, in the appropriate dose and duration, and under medical supervision. The advisory outlines specific directions for patients, doctors, chemists, healthcare facilities, and state regulators.

Dos and don'ts

The regulator said antibiotics must not be used for self-medication or for conditions where they are not indicated, such as uncomplicated viral infections. Patients must take prescribed antibiotics strictly as advised, avoid sharing them, and refrain from using leftover medicines.

People with pre-existing kidney disease or other risk factors for renal impairment must inform doctors before taking NSAIDs, and individuals should seek medical advice when pain, fever, or other symptoms persist rather than self-medicating.

For healthcare professionals, the directive states that NSAIDs and antibiotics must be prescribed after assessing clinical condition, age, co-morbidities, concomitant medicines, and risk factors. When prescribing NSAIDs, doctors should consider the lowest effective dose for the shortest duration, particularly for patients at risk of renal impairment, dehydration, or cardiovascular disease.

Antibiotics must be prescribed judiciously following stewardship principles, accounting for the causative organism, infection site, severity, microbiological tests, and susceptibility patterns. Doctors must avoid unnecessary combination therapies, incorrect dosing, and prolonged treatment durations.

Pharmacists, retailers, and distributors must comply with statutory requirements for Schedule H and H1 drugs, observe label warnings, and avoid encouraging or facilitating self-medication. Hospitals and healthcare institutions have been asked to strengthen systems for prescribing, monitoring, prescription reviews, and patient counselling.

State and Union territory drug control authorities have been directed to raise public and professional awareness and enforce compliance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, to prevent adverse drug reactions, renal complications, and antimicrobial resistance.

About the Author

Priyanka Sharma is a journalist at Mint, where she covers the Union Ministry of Health and the pharmaceutical industry. Her work focuses on explaining government policies and how they impact healthcare and the medicine market in India. With 12 years of experience in journalism, she has built a reputation for providing clear and honest news on important health topics that affect the entire country.<br><br>Her educational background includes a journalism degree from the prestigious Indian Institute of Mass Communication (IIMC) and specialized training in public health from the Public Health Foundation of India. Before her current role at Mint, Priyanka worked with India Today, The Pioneer, and ANI. She also served as a lead consultant for the National Health Authority, which gave her firsthand knowledge of how the government manages large-scale health programmes.<br><br>Priyanka is based in New Delhi and is an avid traveller who loves visiting the mountains. She has a great interest in regional flavours, particularly South Indian food.