Government expert committee bans fixed combination preparation with etodolac + paracetamol

New Delhi: The central government has banned the manufacture, sale and distribution of fixed dose combination (FDC) of etodolac and paracetamol with immediate effect, saying that “there is no therapeutic justification for these drugs and they may pose risks to humans”.

The Government's Expert Committee has approved the restricted use of two FDC drugs, namely Naproxen IP and antacids, in humans under certain conditions. These drugs are painkillers.

Fixed-dose combination medicines or drug cocktails are medicines that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.

The ban on Etodolac + Paracetamol FDCs was announced in 2018, but was challenged by the drug manufacturers in the Delhi High Court.

Following the Delhi High Court's directions, the central government's Drugs Technical Advisory Board (DTAB) formed a sub-committee to investigate the case. It said the drug was “irrational” and recommended its ban in the public interest.

On January 25 of this year, the matter was further discussed at a DTAB meeting, where it was recommended that its manufacture, sale and distribution for human use be banned.

“Based on the recommendations of the Drugs Technical Advisory Board, the Central Government hereby prohibits the manufacture, sale and distribution of the drug combination Etodolac + Paracetamol in fixed dose for human use with immediate effect as there is no therapeutic justification for the said drug and it may pose a risk to humans,” said the government notification published on August 12 and seen by Mint.

“This etodolac + paracetamol composition has been completely banned. Both are painkillers and there seems to be no benefit in administering this combination together,” said one of the state drug regulators.

Meanwhile, the Central Government has restricted the manufacture, sale and distribution of the medicines FDC Naproxen IP 375 mg + Esomeprazole Magnesium Trihydrate IP 20 mg (capsule or tablet) and Naproxen IP 250/500 mg + Pantoprazole IP 20 mg (hard gelatin capsules or tablets) under certain conditions.

These conditions include that naproxen must be in enteric-coated form and that the FDC is indicated in adults for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or in patients at risk of developing gastric or duodenal ulcers in association with nonsteroidal anti-inflammatory drugs (NSAIDs), or to reduce the risk of developing gastric or duodenal ulcers and in accordance with treatment guidelines.

It states that the bioequivalence of Naproxen IP 375 mg + Esomeprazole Magnesium Trihydrate IP 20 mg capsule or tablet with the innovator’s internationally available FDC shall be demonstrated within one year.

It was said that these drugs probably pose a risk to humans, but there are safer alternatives to the drug in question.

However, bioequivalence of Naproxen IP 250/500 mg + Pantoprazole IP 20 mg hard gelatin capsules or tablets must be demonstrated with naproxen and pantoprazole separately according to the standard package leaflet within one year. Efficacy and safety equivalence must be demonstrated with the FDC of the international innovator Naproxen Esomeprazole for the indication within one year.

“Government committees review the use of the drug from time to time. Naproxen is a high-quality drug and its acid-suppressant compounds are approved only under certain conditions,” said the official mentioned above.

Last year, the Indian Ministry of Health and Family Welfare banned the use of 14 fixed-dose combination drugs in humans.

In 2016, the central government banned the manufacture, sale and distribution of 344 drug combinations after a government expert panel suspected that these drugs were being sold to patients without scientific data.