He further said that the banned formulations include a number of therapeutic categories, including certain dermatological preparations, analgesic (pain reliever) and antispasmodic (muscle relaxant) drugs and antibiotic-based combinations.
Among the prohibited formulations are combinations such as Acetyl Salicylic Acid with Ethoheptazine; Dicyclomine, Paracetamol and Clidinium Bromide; Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide; Gliclazide with Chromium Picolinate; and Paracetamol with Lignocaine.
Several antibiotic-based combinations are also prohibited, including Amoxicillin with Serratiopeptidase, Amoxicillin with Serratiopeptidase and Lactobacillus Sporogenes, Amoxicillin with Cloxacillin, Lactic Acid Bacillus and Serratiopeptidase, Cefadroxil with Serratiopeptidase, and Probeefiopeptidase.
The banned list also includes some dermatological and skin care formulations that contain combinations of Aloe Vera or Aloe Extract with ingredients such as vitamin E, jojoba oil, orange oil, wheat germ oil, tea tree oil, Allantoin and D-Panthenol.
The ministry banned FDC in notifications issued under Section 26A of the Drugs and Cosmetics Act, 1940.
The ministry noted that the action is part of the government’s efforts to promote the rational use of drugs and strengthen patient safety. He recalled that some irrational FDCs had been banned in previous years after detailed scientific reviews.
All state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation of the notifications.
Manufacturers, importers, distributors and other interested parties are also advised to take the necessary corrective measures to comply with the law.
