Antibiotics, multivitamins among 156 drugs banned by Health Ministry

The Central Government has banned 156 fixed-dose combinations (FDCs) medicines, which include antibiotics, painkillers, and multivitamins after a review found that they posed health risks.

On Thursday, the Union Ministry of Health and Family Welfare published a gazette notice outlawing the production, marketing, and distribution of these medications.

Antibiotics, anti-allergic drugs, analgesics, multivitamins, and combination dosages for fever and hypertension are among the prohibited FDCs.

`No therapeutic justification'

The announcement states that an expert group appointed by the government as well as the Drug Technical Advisory Board (DTAB) made recommendations to this effect.

Two committees examined the FDCs and found that “there is no therapeutic justification for the ingredients contained” in the combination drug while they may involve “risk to humans”.

The list of major FDC medicines includes a combination dose of Omeprazole Magnesium and Dicyclomine HCl which is used for treating stomach pain, as well as a combination of Mefenamic Acid and Paracetamol Injection for reducing pain and swelling in various diseases.

Additional FDCs include a combination of povidone-iodine, metronidazole, and aloe used to prevent and cure skin infections, as well as ursodeoxycholic acid and metformin HCl used to treat fatty liver in diabetics.

Risk to humans 

In the notification, the government has said that it feels that these FDCs are “likely to involve risk to human beings whereas safer alternatives to the said drug are available”.

“The DTAB did not find the claims of these combination medicines correct and took the decision considering that the harm to the patient is more than the benefit,” the gazette notification stated. “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of Drugs and Cosmetics Act 1940.” 

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