Govt bans 156 fixed dose combination drugs over health risk concerns

The government on Thursday banned 156 fixed dose combination (FDCs) medicines, which included antibiotics, painkillers and multivitamins, after a review found that they posed health risks.

The Union Ministry of Health and Family Welfare issued a gazette notification, prohibiting the manufacture, sale and distribution of these medicines.

The banned FDCs include antibiotics, anti-allergics, painkillers, multivitamins and combination doses for fever and hypertension among others. 

According to the notification, this decision was taken after the recommendations of the Drug Technical Advisory Board (DTAB) and an expert committee formed by the central government. 

“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.  

Major FDC drugs in the list include a combination of Mefenamic Acid and Paracetamol Injection, which is used to reduce pain and swelling in various conditions, and a combination dose of Omeprazole Magnesium and Dicyclomine HCl, which is used to treat abdominal pain.

Prominent brands with Omeprazole Magnesium and Dicyclomine HCl combination include Mankind Pharma’s Ranispas and Xenspas from Zoic Lifesciences. 

Other FDCs include Ursodeoxycholic Acid and Metformin HCl combination used to treat fatty liver in people with diabetes, and a combination dose of Povidone Iodine, Metronidazole and Aloe used to prevent and treat skin infections.  

Prominent brands for the Ursodeoxycholic Acid and Metformin HCl FDC includes Hepexa M tablets manufactured by Eris Lifesciences, whereas Makdin AM ointment from Maksun BIotech and Medcure Pharma’s Poviol M ointment are commonly available examples of a combination dose of Povidone Iodine, Metronidazole and Aloe. 

The ministry stated that the use of the said FDCs is 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.