Government Takes Bold Step: Ban on Etodolac + Paracetamol FDC

New Delhi – In a significant move aimed at safeguarding public health, the Central government has put an immediate halt to the manufacture, sale, and distribution of the fixed dose combination (FDC) of Etodolac and Paracetamol. This decision was fueled by concerns over a lack of therapeutic justification for these drugs, alongside potential risks to human health.

Expert Committee Recommendations

An expert committee from the government has permitted restricted human use of two other FDC drugs that combine Naproxen IP and Antacid medications, but only under specific conditions. These combinations are primarily used as pain relief.

Understanding Fixed-Dose Combinations

Fixed-dose combination drugs, often referred to as “cocktail drugs,” contain a mix of two or more active pharmaceutical ingredients (APIs) in a pre-determined ratio, designed to optimize efficacy and patient compliance.

A Long Journey to the Ban

The prohibition of the Etodolac + Paracetamol FDC was initially flagged back in 2018; however, drug manufacturers contested the ban in the Delhi High Court. After the court’s intervention, the Central government’s Drugs Technical Advisory Board (DTAB) established a sub-committee to revisit the case. Their findings deemed the drug as “irrational,” leading to a recommendation for its ban in the interest of public health.

Government Notification

On 12 August, a government notification confirmed this ban, stating: “The Central Government hereby prohibits the manufacture, sale, and distribution for human use of the drug fixed dose combination of Etodolac + Paracetamol with immediate effect as the said drug is found to have no therapeutic justification and may involve risk to human beings,” as reported by Mint.

Expert Insights

An official from the state drug regulatory body noted, “This combination of Etodolac and Paracetamol has been completely banned. Both are painkillers, and there doesn’t seem to be any benefit in using them together.”

Conditional Approval for Other FDCs

In a related matter, the Central Government has also imposed restrictions on the manufacture, sale, or distribution of Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg and Naproxen IP 250/500mg + Pantoprazole IP 20mg. These FDCs will only be permissible under specific conditions to address certain medical needs.

Strict Guidelines Ahead

The guidelines stipulate that Naproxen must be in an enteric-coated form, indicated for adults suffering from conditions like osteoarthritis and rheumatoid arthritis, or for patients who might be prone to NSAID-associated gastric issues. Additionally, proof of bioequivalence with internationally recognized products must be demonstrated within a year.

Ongoing Commitments to Safety

The DTAB emphasized that these drugs could pose risks to human health, but noted that safer alternatives are available. Furthermore, for Naproxen combined with Pantoprazole, bioequivalence must align with the standard package insert within the same timeframe, ensuring that both efficacy and safety remain paramount.

A History of Drug Regulation

Last year, the Union Health and Family Welfare Ministry also banned human use of 14 other fixed-dose combination drugs. This latest decision echoes the central government’s earlier actions in 2016 when it prohibited the manufacture and sale of 344 drug combinations after expert panels highlighted the lack of scientific support for their effectiveness.