The Ministry of Health and Family Welfare (MOHFW) has issued a prohibition of the fixed dose combination (FDC) of S(+) Etodolac + Paracetamol as a step towards ensuring patient safety and rational drug use in India. This decision was published through a notification dated August 12, 2024.
The decision, rooted in scientific evidence and regulatory oversight, highlights the a commitment to safeguarding public health.
The journey towards this ban was marked by a series of events. Initially, the Central Government had prohibited the manufacture, sale, and distribution of the FDC of Etodolac + Paracetamol in 2018. However, this decision was challenged in court, leading to a stay on the ban for the specific combination of S(+) Etodolac + Paracetamol in 2020.
Recognizing the need for a thorough evaluation, the Drugs Technical Advisory Board (DTAB) was tasked with examining the matter. After careful deliberation and considering the scientific evidence, the DTAB concluded that the FDC lacked therapeutic justification and posed potential risks to human health. This finding was instrumental in the government’s decision to impose a complete ban on the drug.
The prohibition of irrational FDCs is a crucial step in addressing the rampant problem of antimicrobial resistance. By restricting the availability of drugs without proven therapeutic benefits, the ministry aims to promote rational prescribing practices and reduce the risk of adverse drug reactions.
This decision sets a precedent for future actions against irrational drug combinations and reinforces the need for a vigilant regulatory system to protect consumers from harmful and ineffective medications.
