An eye opening study published in Lancet which highlights, India consumed 72.7 percent of unapproved antibiotics products in 2019. India has also consumed 48.7 percent of Fixed Dose Combinations discouraged by the WHO.
The study is conducted by researchers from Boston University, USA and Public Health Foundation of India, New Delhi, India which states that there is a significant volume of antibiotics in the market that the central drug regulators do not approve. More than 90% of macrolides and 61% of cephalosporins are sold in the market without the approval of the central agency. These products are permitted by the state government agencies that have limited technical capacity to decide on the merit of approval.
Studies have also shown that pharmacologically incompatible combinations are widely used in India. In 2015, the national government had banned 16 unapproved systemic antibiotics FDCs that accounted for 14% of antibiotic FDC sales following the Kokate Committee recommendations.
Inappropriate use of antibiotics is a significant driver of antibiotic resistance in India. Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many fixed-dose combinations (FDC) and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country.
Researchers used the WHO AWaRe classification system and the defined daily dose (DDD) metrics to analyze a large nationally representative private-sector drugs sales data. This study used the most recent data (2019) and examined the consumption of antibiotics using additional dimensions of essentiality (listed/not listed in national list of essential medicines), product type (fixed dose combinations, single formulations) and central regulatory approval status (approved/unapproved).
This is the first published study analyzing private-sector consumption of systemic antibiotics in India using the DDD metrics and the WHO AWaRe classification system.
This study covers only the private sector sales of antibiotics and will not reflect the antibiotics dispensed through the public system.
Authors said in a conclusion that,"With antibiotic resistance emerging as a global public health problem, it is crucial to institute new regulations and strengthen existing ones to monitor and regulate the sale and use of antibiotics while improving access to appropriate antibiotics through the public health system."
