Srinagar, June 20: The Union Ministry of Health and Family Welfare announced complete ban on manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs) citing public health concerns, officials said on Saturday.
“Union Ministry of Health and Family Welfare Prohibits Manufacture, Sale and Distribution of 16 Fixed Dose Combinations (FDCs) in Public Interest,” an official spokesperson said, adding “the decision aimed at safeguarding public health and ensuring availability of only scientifically justified drug combinations.”
According to the Ministry, the action follows a comprehensive review of FDCs conducted in compliance with Supreme Court directions. The Drugs Technical Advisory Board (DTAB) had constituted an Expert Committee to examine various drug combinations and identify those considered irrational, therapeutically unjustified or potentially harmful.
Based on the committee’s scientific assessment, the government found that 16 FDCs lacked therapeutic justification and that their continued use did not offer benefits commensurate with the risks involved.
The Ministry said the move is part of the government’s ongoing efforts to ensure that only safe, effective and scientifically validated medicines remain available in the market.
The banned Fixed Dose Combinations include Acetyl Salicylic Acid + Ethoheptazine; Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Panthenol + Vitamin A; Aloe Extract + Vitamin E + Dimethicone + Glycerine; Aloe Vera + Jojoba Oil + Vitamin E; Aloe Vera + Orange Oil; Aloe Vera + Jojoba Oil + Wheat Germ Oil + Tea Tree Oil; Aloe Vera + Vitamin E + Herbal; Dicyclomine + Paracetamol + Clidinium Bromide; Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide; Gliclazide + Chromium Picolinate; Paracetamol + Lignocaine; Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes; Amoxicillin + Cloxacillin + Lactic Acid Bacillus + Serratiopeptidase; Amoxicillin + Serratiopeptidase; Cefadroxyl + Probenecid; and Cefuroxime + Serratiopeptidase. These combinations were found to lack adequate therapeutic justification and were prohibited in the interest of public health.
