Researchers speculate that the government’s efforts to reduce illogical antibiotic fixed-dose combinations may have been insufficient and unenforced. Research article published in the Journal of Practice and Policy in Pharmacy.
A significant investigation conducted in 2020 revealed that the majority of antibiotic formulations distributed in India were either unapproved or outlawed. Government measures to remove centrally unapproved and banned antibiotic fixed-dose combination (FDC) medications have been mainly ineffectual.
Medications classified as FDCs are those that combine two or more APIs (active pharmaceutical ingredients) in a single medication, often produced in a fixed ratio (molecules in a specific ratio).
Researchers from India, Qatar, and the UK conducted an analysis titled “Regulatory enforcement of the marketing of FDCs in India: a case study of systemic antibiotics,” which was published in the Journal of Pharmaceutical Policy and Practice on Friday.
It was discovered that the sale of FDCs climbed from 32.9 percent in 2008 to 37.3% percent in 2020 as a percentage of all antibiotic sales.
Additionally, it was shown that while though there were 395 antibiotic FDC formulations available in 2020 compared to 574 in 2008, the majority of these formulations—278 out of 395, or 70.4%—were either prohibited or disapproved.
Aashna Mehta, a co-author of the report and a health economist affiliated with the Public Health Foundation of India in New Delhi, told ThePrint, “The Indian FDC problem is well known.”
“In order to address the issue, the regulators have taken many efforts, which have led to restrictions. Nevertheless, she stated that a number of prohibited and authorized FDCs are still available on the market despite these attempts.
Mehta claims that because antimicrobial resistance is on the rise everywhere in the world, antibiotics represent a particularly significant market.
She issued a warning, saying, “The market should be surveyed periodically and enforcement strengthened.”
When ThePrint called India’s Drugs Controller General, Rajeev Singh Raghuvanshi, to get his thoughts on the results, he was unavailable. If and when a response is obtained, this report will be updated.
The most recent analysis, which examined a variety of government records and PharmTrac data, observed that earlier research had demonstrated that India possesses the greatest quantity of antibiotic FDC drugs available globally, and that since many of them may not be suitable, the risk of rising antimicrobial resistance is a specific and global concern.
According to the research, 41.5% of the 4.5 billion standard units of antibiotic FDC medications that were marketed in India in 2020 were combinations that the World Health Organization (WHO) has classified as “not recommended.”
The Central Drugs Standard Control Organization and the government had implemented two major sets of measures to eliminate irrational FDC drugs under separate initiatives that started in 2007 and 2013, according to the researchers. However, it’s possible that these initiatives had little effect on the FDC drug market in India.
The researchers claim that India has long accepted the fact that the great majority of its largely disapproved FDC medications and their widespread sales are issues of public health concern due to the fact that the CDSCO did not evaluate the products’ safety and efficacy.
The analytical article stated, “Our study demonstrates that hundreds of unapproved antibiotic FDC formulations remained on the Indian market accounting for over 700 million of the 4.5 billion standard units sold in 2020, despite regulatory initiatives and measures to control sales since 2007.”
One-third of the standard units sold in 2020 (1.5 out of 4.5 billion) were of antibiotic FDCs that were licensed in India but were not advised by the World Health Organization. The data indicates that development in this treatment field has been slow and uneven.
It further stated that in 2020, officially licensed systemic antibiotic FDCs made up roughly 55% of sales volume, down from slightly less than 33% in 2008.
Furthermore, the researchers observed that even while the number of formulations was declining, in 2020 nearly two-thirds (239 of 395) of commercialized formulations—or more than one-sixth (16%) by volume—were still neither legally nor de facto approved by the CDSCO with a no-objection certificate.
According to the data, up to 39 formulas that were outlawed in 2018 and 2019 were still available in 2020.
“The higher overall market share of systemic antibiotic FDCs in 2020 (37%) compared to 2008 (33%), given recent research findings of high sales in 2019 of FDCs not recommended by the WHO, and 13 of the 20 top-selling systemic antibiotic FDCs being expressly not recommended by the WHO, is a cause for serious public health concern,” the researchers wrote.
The report also stated that “weak, convoluted, badly targeted and inefficient regulatory enforcement” was the cause of the sluggish and restricted progress in the removal of illogical FDC medications.
