India’s drug regulator warns against unsupervised painkiller and antibiotic use

India’s Central Drugs Standard Control Organisation has warned against indiscriminate, repeated or prolonged use of non-steroidal anti-inflammatory drugs and antibiotics, linking inappropriate use to avoidable kidney complications and chronic kidney disease. In a September 21 circular, the regulator reminded doctors, pharmacists, hospitals and the public that these medicines are subject to prescription and other safeguards. The circular does not create a new ban on painkillers or antibiotics.

Most NSAIDs are classified under Schedule H of the Drugs Rules, 1945, while most antibiotics are under Schedule H1. They are therefore not intended to be sold at retail without a prescription from a registered medical practitioner. Schedule H1 medicines carry a warning that they should be taken only according to medical advice.

The regulator said antibiotics should not be self-medicated or used for illnesses in which they are not clinically indicated. Doctors were asked to prescribe them at the appropriate dose and for the appropriate duration, while pharmacies and healthcare institutions were reminded of their responsibilities. NSAIDs can reduce blood flow to the kidneys and are associated with acute kidney injury, particularly among people with kidney disease, diabetes or hypertension.

Longer-term use has also been associated with the occurrence or progression of chronic kidney disease. The warning concerns inappropriate choice, dose, duration and unsupervised use, not all painkillers or antibiotics. Antibiotics treat bacterial infections, not most viral illnesses such as common colds and influenza.

Unnecessary or incorrect use can allow resistant bacteria to survive and multiply, contributing to antimicrobial resistance. The supplied material cites studies indicating that self-medication remains a significant concern in India, while cautioning that they do not provide a national prevalence estimate. It also cites the World Health Organization’s estimate that bacterial antimicrobial resistance was associated with more than 4.7 million deaths globally in 2021.