From skincare creams to fever formulations: Why 16 drug combinations, including paracetamol mix, are banned in India
The move comes following a review of the FDCs carried out in compliance with the Supreme Court directions
The Union Health Ministry has banned the manufacture, sale, and distribution of 16 fixed-dose combination (FDC) drugs nationwide, citing a lack of therapeutic justification and potential risks to patients, a move intended to protect public health and ensure only scientifically validated medicines are available. This decision, made in compliance with Supreme Court directions, follows a review by an expert committee under the Drugs Technical Advisory Board, which identified these combinations as irrational or potentially harmful across various categories including dermatological, analgesic, antispasmodic, and antibiotic-based formulations, with specific banned examples including Acetyl Salicylic Acid with Ethoheptazine, Dicyclomine with Paracetamol and Clidinium Bromide, and several Amoxicillin and Cefadroxil combinations, all aimed at promoting rational medicine use and strengthening patient safety, with strict implementation orders issued to regulatory authorities.
The Union Health Ministry has banned the manufacture, sale, and distribution of 16 fixed-dose combination (FDC) drugs nationwide, citing a lack of therapeutic justification and potential risks to patients, a move intended to protect public health and ensure only scientifically validated medicines are available. This decision, made in compliance with Supreme Court directions, follows a review by an expert committee under the Drugs Technical Advisory Board, which identified these combinations as irrational or potentially harmful across various categories including dermatological, analgesic, antispasmodic, and antibiotic-based formulations, with specific banned examples including Acetyl Salicylic Acid with Ethoheptazine, Dicyclomine with Paracetamol and Clidinium Bromide, and several Amoxicillin and Cefadroxil combinations, all aimed at promoting rational medicine use and strengthening patient safety, with strict implementation orders issued to regulatory authorities.
The Union Health Ministry has banned the manufacture, sale, and distribution of 16 fixed-dose combination (FDC) drugs nationwide, citing a lack of therapeutic justification and potential risks to patients, a move intended to protect public health and ensure only scientifically validated medicines are available. This decision, made in compliance with Supreme Court directions, follows a review by an expert committee under the Drugs Technical Advisory Board, which identified these combinations as irrational or potentially harmful across various categories including dermatological, analgesic, antispasmodic, and antibiotic-based formulations, with specific banned examples including Acetyl Salicylic Acid with Ethoheptazine, Dicyclomine with Paracetamol and Clidinium Bromide, and several Amoxicillin and Cefadroxil combinations, all aimed at promoting rational medicine use and strengthening patient safety, with strict implementation orders issued to regulatory authorities.
The Centre has banned the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs across the country. According to PTI, these drug combinations "lack therapeutic justification" and may pose risks to patients.
The Union Health Ministry said the move is aimed at protecting public health and ensuring that only scientifically validated medicines remain available in the market.
FDC drugs contain a combination of two or more active pharmaceutical ingredients in a fixed ratio.
The move comes following a review of the FDCs carried out in compliance with the Supreme Court directions. The Drugs Technical Advisory Board (DTAB) formed an expert committee to examine various drug combinations and identify those considered irrational, therapeutically unjustified, or potentially harmful.
The committee added that the prohibited formulations cover several therapeutic categories, including certain dermatological preparations, analgesic (painkiller) and antispasmodic (muscle relaxant) medicines, as well as antibiotic-based combinations.
What are the drugs on the banned list?
Among the banned drug combinations are Acetyl Salicylic Acid with Ethoheptazine; Dicyclomine, Paracetamol and Clidinium Bromide; Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide; Gliclazide with Chromium Picolinate; and Paracetamol with Lignocaine.
Also, several antibiotic-based combinations, including Amoxicillin with Serratiopeptidase, Amoxicillin with Serratiopeptidase and Lactobacillus Sporogenes, Amoxicillin with Cloxacillin, Lactic Acid Bacillus and Serratiopeptidase, Cefadroxyl with Probenecid, and Cefuroxime with Serratiopeptidase, were also banned.
Even some dermatological and skincare formulations containing Aloe Vera or Alo Extract with ingredients like Vitamin E, Jojoba Oil, Orange Oil, Wheat Germ Oil, Tea Tree Oil, Allantoin and D-Panthenol were also prohibited.
A notification issued by the Centre under Section 26A of the Drugs and Cosmetics Act, 1940, notes that the action is part of the government's efforts to promote the rational use of medicines and strengthen patient safety.
The Health Ministry has directed the regulatory authorities and enforcement agencies to ensure strict implementation of the notifications.
Manufacturers, importers, and distributors have been advised to take corrective action to comply with the law.