The BJP-led government at the Centre has prohibited 156 fixed-dose combinations (FDCs) that are considered to pose a risk to human health.
In a recent gazette notification, the government said, “The use of the drug FDC containing Amylase, Protease, Glucoamylase, Pectinase, Alpha Galactosidase, Lactase, Beta-Gluconase, Cellulase, Lipase, Bromelain Xylanase, Hemicellulase, Malt diastase, Invertase, and Papain is likely to involve risk to human health, whereas safer alternatives to this drug are available.”
“The Drugs Technical Advisory Board also examined the said FDC and recommended that there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human health. Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of this FDC under Section 26A of the Drugs and Cosmetics Act, 1940. In view of the above, any kind of regulation or restriction allowing its use in patients is not justifiable,” it said.
Based on the recommendations of the said Drugs Technical Advisory Board, the central government has decided that it is necessary and expedient in the public interest to prohibit the manufacture, sale, and distribution of the said drug for human use in the country, the notification said.
“Therefore, in exercise of powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the central government hereby prohibits the manufacture, sale, and distribution for human use of the drug FDC of Amylase, Protease, Glucoamylase, Pectinase, Alpha Galactosidase, Lactase, Beta-Gluconase, Cellulase, Lipase, Bromelain, Xylanase, Hemicellulase Malt diastase, Invertase, Papain with immediate effect,” it said.