Government Expert Committee Banned Fixed Dose Combination (FDC) Medicines Containing Etodolac + Paracetamol | Mint

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 “there is no therapeutic license for this drug and it may pose a risk to humans.”

A government expert committee approved the limited human use of two FDC drugs under specific conditions, including naproxen IP and antacid drugs. These drugs are pain relievers.

Fixed-dose combination drugs or cocktail drugs are those that contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.

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

On the directions of the Delhi High Court, the central government’s Drug Technical Advisory Board (DTAB) constituted a sub-committee to look into the matter. It said the drug was “irrational” and recommended banning it in the public interest.

On January 25 this year, the matter was further discussed in a meeting of the DTAB, which recommended a ban on its production, sale and distribution for human consumption.

“Therefore, now, based on the recommendations of the Technical Advisory Board on Drugs, the Central Government hereby recalls with immediate effect the manufacture, sale and distribution of fixed dose combination of Etodolac + Paracetamol for human use. The drug is not found to be therapeutically justified and may pose a risk to humans,” said a government notification published on August 12 seen by Mint.

“This combination of Etodolac + Paracetamol is completely banned. Both are pain killers and there is no benefit seen in giving this combination,” said one of the state drug regulators.

Meanwhile, the central government has restricted the manufacture, sale or distribution of the drugs FDC Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet and Naproxen IP 250/500mg + Pantoprazole IP 20mg Hard Gelatin Capsule or Tablet respectively. Subject to special conditions.

These conditions include that naproxen must be in an intravenous formulation that the FDC must use in adults with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or in patients at risk of developing a nonsteroidal anti-inflammatory drug (NSAID). It is shown in adults. – associated with gastric or duodenal ulcers, or to reduce the risk of developing gastric or duodenal ulcers and according to treatment instructions.

It said that the bioequivalence of Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet should be demonstrated with the internationally available innovator FDC within one year.

It is said that these drugs are dangerous for humans while there are safer alternatives to these drugs.

However, bioequivalence of Naproxen IP 250/500mg + Pantoprazole IP 20mg Hard Gelatin Capsules or Tablets should be demonstrated within one year of standard package insert with Naproxen and Pantoprazole separately. Efficacy and safety balance should be demonstrated within one year with naproxen esomeprazole international innovator FDC.

“The state committee reviews the use of drugs from time to time. Naproxen is a high-end drug and antacid combinations will be allowed only for certain conditions,” said the official quoted above.

The Union Ministry of Health and Family Welfare had banned the human use of 14 fixed-dose combination drugs last year.

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