The Central Government has prohibited the manufacture, sale and distribution of 16 Fixed-Dose Combinations (FDC) drugs under Section 26A of the Drugs and Cosmetics Act, citing a lack of therapeutic justification and concerns regarding patient safety. The list includes antibiotics, pain-relief medications, antispasmodic combinations, and certain cosmetic and topical products.
16 drug combinations include :
- Acetyl Salicylic Acid + Ethoheptazine
- Aloe Extract + Allantoin + Alpha Tocopherol 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 Preparation
- 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
- Cefuroxime + Serratiopeptidase
Earlier, we also witnessed regulatory actions against certain OTC cough syrups. These measures appear to reflect an increasing emphasis on rational drug use, medication safety, and evidence-based medicine.
Source article : Centre bans 16 drug combos found to lack medical justification | India News - The Times of India
Do you think these regulatory actions indicate that the government is moving towards a stronger patient-safety and pharmacovigilance framework? Or do you believe enforcement remains the bigger challenge?
MBH/DB