Alarming Study Reveals Over 70% of Indian Antibiotics Were Unapproved or Banned

In a recent analysis of the Indian pharmaceutical market, a staggering 70.4% of fixed-dose antibiotic formulations were discovered to be either unapproved or banned in 2020. This concerning revelation comes from a research paper titled 'Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics,' published in the Journal of Pharmaceutical Policy and Practice on November 10.

The study further disclosed that these unauthorised antibiotics accounted for a significant 15.9% of Fixed Dose Combination (FDC) antibiotic sales. Despite two regulatory initiatives in 2007 and 2013 aimed at removing unapproved systemic antibiotic FDCs from the market, the researchers found that these drugs persist, even being sold over the counter.

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Experts involved in the study concluded that regulatory enforcement has been slow and weak, allowing numerous unapproved and banned FDCs to remain in circulation. This revelation has raised serious concerns within the medical community, particularly as Antimicrobial Resistance (AMR) continues to escalate. AMR poses a significant threat as it renders pathogens less responsive to medications, making infections increasingly challenging to treat.

Coincidentally, these findings coincide with World AMR Awareness Week, observed from November 18 to 24, emphasising the urgency of addressing the critical issue of antibiotic misuse and the need for strengthened regulatory measures to combat AMR effectively.