Over 47% of antibiotics used in India’s private sector in 2019 were not approved by a central drug regulator, a study published in medical journal The Lancet has found. The number is particularly concerning as 85% to 90% of all drugs are prescribed by the private sector.

The study, published in the September edition, called for “significant policy and regulatory reform” to monitor and regulate the sale of antibiotics while improving access to them through the public health system,” recommended the study.

The researchers used the World Health Organization’s AWaRE (Access, Watch and Reserve) classification to analyse the consumption of antibiotics.

Narrow-spectrum antibiotics recommended as first-line or second-line antibiotics are categorised as Access, while Watch includes broad-spectrum antibiotics with a high chance of resistance. Watch antibiotics are to be prescribed only in response to specific symptoms. Reserve antibiotics are prescribed as the last resort.

The study found that antibiotics in the Watch category comprised 54.9% doses consumed in 2019, while those in the Access category comprised 27.0%.

Azithromycin and cefixime, used to treat bacterial infections such as pneumonia, were the most consumed antibiotics without a prescription.

The study noted that inappropriate usage of antibiotics was a significant driver of resistance to the medicines in India. Inappropriate use of antibiotics contributes to the emergence of multidrug resistant bacteria, making the cure of many infections more expensive and, in some cases, impossible, said the study.

“Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many fixed-dose combinations and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country,” said the study.

In India, the Central Drugs Standard Control Organization and State Drug Regulatory Authorities are responsible for drug regulation.