Centre bans 156 fixed dose combinations found having health risks

New Delhi: The centre has decided to put a ban on 156 fixed dose combination (FDCs) medicines, which included 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.

The announcement states that an expert group appointed by the central government as well as the Drug Technical Advisory Board (DTAB) made recommendations that were considered in making this decision.

“The matter was examined by an expert committee appointed by the central government and the DTAB, with both bodies recommending that there is no therapeutic justification for the ingredients contained in the said FDCs,” the notification stated.

The ministry added that two committees — including one under the Central Drugs Standard Control Organisation’s (CDSCO) Drugs Technical Advisory Board (DTAB) — 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.

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,” the ministry added.