New Delhi: Days after issuing a gazette notification prohibiting 156 fixed dose combination (FDCs) medicines, including antibiotics, painkillers and multivitamins, the health ministry on Friday said that these drugs were licensed by the State Licensing Authority even without prior approval of the Drug Controller General of India (DCGI).
“The FDCs were licensed by the State Licensing Authority even without prior approval of the Drug Controller General of India (DCGI) which poses severe health risk,” the health ministry said.
“As per the first assessment report of Prof Kokate Committee, a number of FDCs were declared as irritational and the same were prohibited by the central government, However, these notifications were challenged in the court of law and the matter was referred to the Drugs Technical Advisory Board (DTAB),” the ministry said.
Based on the recommendations of the DTAB sub-committee, the central government has recently prohibited 156 FDCs vide Gazette Notification no 3285 (E) to 3440 (E).
“The Central Government is satisfied that the use of the drug Fixed Dose Combination of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain is likely to involve risk to human beings whereas safer alternatives to the said drug are available,” the notification stated.
It further said that the use of FDC drug of Antimony Potassium Tartrate + Dried Ferrous Sulphate is likely to involve risk to human beings whereas safer alternatives to the said drug are available.
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.
