CDSCO flags indiscriminate use of painkillers, antibiotics over CKD risk

Drug regulator asks healthcare professionals and pharmacists to discourage indiscriminate use of NSAIDs and antibiotics, citing risks of kidney damage and CKD

India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has asked healthcare professionals and pharmacists to discourage the indiscriminate use of painkillers and antibiotics, citing the associated risk of chronic kidney disease (CKD).

 

In a circular, Drug Controller General of India (DCGI) Rajeev Raghuvanshi said painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics should not be taken indiscriminately, repeatedly or for prolonged periods without medical advice.

 

The regulator also cautioned against antibiotic self-medication and their use for conditions where antibiotic treatment is not clinically indicated, particularly viral infections, the common cold and fever.

 

Most antibiotics are Schedule H or H1 drugs and are required to carry warnings that they should not be taken except on medical advice. While Schedule H covers prescription-only medicines, Schedule H1 is a more tightly regulated subset that includes several newer-generation antibiotics and anti-tuberculosis drugs.

 

 

These drugs carry mandatory red-bordered warning labels with an Rx symbol. For H1 drugs, pharmacists are also required to record details of the patient, prescribing doctor and quantity sold in a register, which must be retained for at least three years.

 

Raghuvanshi further asked pharmacists not to sell Schedule H and H1 drugs at retail except in accordance with the applicable provisions of the Drugs Rules, 1940.

 

“State and Union Territory (UT) drug control authorities are requested to create awareness among healthcare professionals, pharmacists, retailers and the general public regarding the risks associated with indiscriminate use of NSAIDs and antibiotics,” the circular said.

 

The circular comes amid concerns over the growing burden of CKD in India, with an estimated 138 million adults affected by the condition in 2023, according to a study published in the Lancet.

 

Vikram Kalram, consultant nephrologist at Delhi’s CK Birla Hospital, said indiscriminate use of painkillers, particularly NSAIDs, and certain antibiotics can contribute to kidney damage.

 

“NSAIDs reduce protective prostaglandins in the kidneys, which can decrease renal blood flow and trigger acute kidney injury (AKI), particularly in dehydrated people, the elderly, those with CKD or heart failure, or those taking diuretics or other medicines affecting kidney function,” he said.

 

Prolonged NSAID use can also cause chronic tubulointerstitial damage, hypertension and progressive loss of kidney function, doctors said.

 

The DCGI’s direction also comes amid growing concerns over antimicrobial resistance (AMR), with India carrying a high burden of AMR globally.

 

While antibiotic sales in India have been declining steadily, industry sources said this may partly reflect changes in packaging and prescription patterns.

 

“Several companies have changed their pack sizes, with some brands selling packs of 15 instead of 10, which can result in fewer packs being recorded even without a proportionate decline in the number of doses sold,” a Delhi-based drug wholesaler told Business Standard.

 

Kalram said patients should also be made aware that commonly available painkillers are not completely harmless.

 

“Usage of these drugs should be in the lowest effective dose and for the shortest appropriate duration, especially in high-risk patients,” he said.