The government’s expert committee prohibits drugs 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 that “there is no therapeutic reason for this medicine and it is may involve danger to people.”

A federal expert committee has approved the restricted human use of two FDC drugs that include Naproxen IP and Antacid under certain conditions. These drugs are pain killers.

Fixed compound 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 introduced back in 2018 but is being challenged by drug manufacturers in the Delhi High Court.

Following the orders of the Delhi High Court, the government’s Central Drugs Advisory Board (DTAB) has formed a sub-committee to look into the matter. It said the drug was “senseless” and recommended its ban in the public interest.

On January 25 this year, the issue was discussed again at the DTAB meeting which recommended banning its manufacture, sale and distribution for human consumption.

“Now, therefore, on the basis of the recommendations of the Drug Technology Advisory Board, the Central Government prohibits the manufacture, sale and distribution for human use of the unchanged drug combination of Etodolac + Paracetamol by the immediate effect of the said drug is found to have no therapeutic effect and may involve harm to humans,” a government notification said on August 12 seen by Mint.

“This model of Etodolac + Paracetamol is completely prohibited. Both are painkillers and there does not seem to be any benefit to combine this combination,” said one of the government’s drug authorities.

Meanwhile, the Central Government has banned the manufacture, sale or distribution of drugs FDC Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet and Naproxen IP 250/500mg + Pantoprazole IP 20mg hard gelatin Capsules or Tablets respectively depend on certain conditions.

These conditions include that Naproxen will be in an enteric form that FDC will be indicated in adults for the treatment of symptoms of rheumatoid arthritis, ankylosing spondylitis, or in patients at risk of developing other drugs anti-inflammatory (NSAID). )- associated with gastric or duodenal ulcers, or to reduce the risk of developing gastric and duodenal ulcers and follow treatment guidelines.

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

It said that these drugs can cause harm to people while other types that are safer than the said drug are available.

However, the bioequivalence of Naproxen IP 250/500mg + Pantoprazole IP 20mg hard gelatin Capsules or Tablets, will be demonstrated with Naproxen and Pantoprazole separately according to the standard package inserted within one year. Efficacy and safety adequacy will be demonstrated with the FDC of the international developer of Naproxen Esomeprazole for the exhibition, during the year.

“The government committee reviews the use of the medicine from time to time. “Naproxen is a highly effective drug and its anti-acidity ingredients will be allowed only for certain conditions,” the official quoted above said.

The Department of Health and Family Welfare had last year banned the use of 14 non-volatile drugs.

In 2016, the central government had banned the manufacture, sale and distribution of 344 drug compounds after a government expert group recommended that these drugs be sold to patients without scientific information.