High percentage of unapproved antibiotic formulations raises questions on regulatory effectiveness in India

Even as India's drug pricing authority, the National Pharmaceutical Pricing Authority (NPPA) last week brought 33 fixed-dose combination (FDC) drugs under its price regulation, in an initiative to make these drugs more cost-effective, a recent comprehensive analysis reveals a concerning trend, that the Indian government's efforts to eliminate centrally unapproved and banned antibiotic FDC drugs have experienced limited success, reports The Pharma Letter’s India correspondent.

Despite the regulatory intervention, the study jointly conducted by researchers from India, the UK, and Qatar, calls into question the efficacy of these governmental initiatives. In 2020, most antibiotic formulations available in the Indian market were either unapproved or banned, signalling a persistent challenge.

The sale of FDCs comprised a significant 37.3% of total antibiotic sales in 2020, reflecting an increase from 32.9% in 2008.