The fixed dose combinations in the categories of analgesics and orthopaedics lead the list of FDCs to be withdrawn from the market following the agreement between the industry and the DCGI over the vexed issue, according to the minutes of the first meeting released recently.
The largest number of number of combinations to be banned or discontinued from the market had aspirin as a component, followed by paracetamol, according to the minutes of the meeting held on July 14, but belatedly released in the second meeting held on October 1.
"Grossly irrational FDCs should be banned and already banned FDCs should be discontinued, if available in the market," the minutes said, listing 44 in the category. As many as 31 products whose names were inadvertently repeated in the list were identified and the meeting called for ignoring the same from the original list of 294.
Besides, as many as 22 FDCs which had been approved by the office of the DCGI before the matter was brought up also would be scrapped from the list. "They also included some similar FDCs of vitamins including methylcobalamin and minerals that can be approved on case to case basis by the office of the DCGI'," the minutes said. Thus the consensus was reached on altogether 96 products (43 + 31 + 22) and would be excluded from the contentious list.
Among the remaining 198 FDCs, six were those approved by the state licensing authorities. The second meeting also cleared the list of 36 products which could be approved based on similar FDCs already approved by the DCGI. Thus balance of 156 FDCs were referred to the expert panel for scrutinising the rationality and recommending for approval in due course.
List of 96 FDCs:
Banned/logically banned
1. Analgin + Dextropopoxyphene,
2. Analgin + Diazepam,
3. analgin+diazepam+diphenhydraminc,
4. analgin+diazepam+paracetamol,
5. analgin+diazepam+propylene glycol,
6. analgin+diacyclomine+diazepam,
7. analgin+dihydrocethaverine chloride,
8. analgin+ketoprofen,
9. analgin+KET-P-pipereth-o-carbm,
10. dicyclomine+paracetamol+anlagen,
11. fenpiverinium bromide+analgin+pitofenone hydrochloride,
12. ibuprofen+paracetamol+ oxyphenbutazone+phenylisopropyl pyrazolon,
13. mebeverine+alprazolam,
14. paracetamol+alprazolam,
15. paracetamol+analgin,
16. chlorzoxazone+ibuprofen+ paracetamol +diclofenac+ oxyphenbutazone+magnesium hydroxide;
17. Dicyclomine +paracetamol + byrazolon+phenylisopropyl.
Absurd
1. Activated characoal+fungal diastase+lactic acid,
2. allobarbitone+ phosphodimethyl-isopropyl-pyrazolone,
3. artesunate+arteether+artemetther,
4. chlorzoxazone+paracetamol+ ibuprofen+diclofenac sodium,
5. norfloxacin+tinidazole+loperamide,
6. paracetamol+diclofenac sodium+cloxacillin +pantoprazole+lactic acid bacillus+serrapeptase,
7. paracetamol+diclofenac sodium+ magnesium trisilicate +chlorphenniramine maleate,
8. and ranitidine+omeprazole.
Could be discontinued
1. 5-bromosalicyl-4chloranilide+salicyclic acid,
2. atorvastatin+acetyl salicyclic acid + caffeine,
3. chlormezanone+paracetamol+diclofenac sodium,
4. chlomezanone+paracetamol+ibuprofen,
5. ciprofloxacin+tinidazole+dicyclomine,
6. diclofenac + paracetamol +chlormezanone,
7. dicyclomine+dextromethorphan +paracetamol,
8. dicyclomine +paracetamol + chlordiazepoxide,
9. dicyclomine +serratiopeptidase,
10. ibupforen +colchicines,
11. ibuprofen +paracetamol + colchicines,
12. ibuprofen + paracetamol + magnesium trisilicate,
13. ibuprofen +paracetamol +magnesium trisilicate,
14. mecobalamine +methenamine mandelate,
15. norfloxacin +trinidazole + dicyclomine,
16. ondansetron +paracetamol,
17. ranitidine +cisapride,
18. ranitidine +dicyclomine + clinidium bromide.
Duplicate FDCs
1. Amoxycillin +clavulanic acid + lactobacillus,
2. amoxyclllin +cloxacillin + lactic acid bacillus,
3. amoxycillin +cloxacillin +lacto acid bacillus,
4. amoxicillin + lactobacillus,
5. amoxicillin+ lactobacillus acidophilus,
6. amoxicillin + lactobacillus acidophilus + clavulanic acid,
7. atorvastatin +acetyl salicyclic acid,
8. cefixime + ambroxol + lactic acid bacillus,
9. cefixime +lactic acid + ambroxol,
10. cefixime +lactobacillus acidophilus,
11. cefixime + lactobacillus acidophilus + ambroxol,
12. cefixime +lactobacillus acidophilus,
13. cefpodoxime +lactic acid bacillus,
14. cefpodoxime +lactic acid bacillus,
15. cefpodoxime + lactobacillus,
16. cefpodoxime + cloxacillin +lactic acid bacillus,
17. diclofenac sodium +serratiopeptidase,
18. diclofenac +paracetamol + chlorzoxazone,
19. diclofenac + serratiopeptidase,
20. diclofenac +serratiopeptidase+ paracetamol,
21. Diclofenace sodium + serratiopeptidase,
22. diclofenace + serratiopeptidase,
23. dicylomine +paracetamol + dimethylpolysiloxane,
24. fenpiverinium hydroxide bromide + diclofenac sodium + pitofenone hydrochloride,
25. glucosamine + chondroitin + Vit C + Vit - E + magnese sulphate,
26. ibuprofen + paracetamol + dextropropoxyphene,
27. losartan + hydrochlorothiazide + atenolol,
28. losartan + hydrochlorothiazide + ramipril,
29. paracetamol + diclofenac + chlorzoxazone,
30. tiznidine + diclofenac sodium + paracetamol,
31. tramadol + paracetamol + domperidone.
Already Approved
1. Atovastatin + aspirin,
2. atovastatin + ramipril,
3. benfotiamine + pyridoxine+ mecobalamine + iositol + alpha lipoic acid,
4. diclofenac sodium + rabeprazole,
5. diclofenac + methyl salicylate + linoleic acid + menthol,
6. diclofenac + rabeprazole,
7. levocetirizine + montelukast,
8. levofloxacin + ambroxol,
9. mecobalamin + alpha lipoic acid + folic acid + vit-B6 + choline,
10. mecobalamine +alpha lipoic acid,
11. mecobalamine + alpha lipoic acid + folic acid,
12. mecobalamine + alpha liopic acid + vit B1 + folic acid,
13. mecobalamine + calcium pantothenate,
14. mecobalamine +biotine,
15. mecobalamine + carotenoid + alpha lipoic acid + chromium + vit-B1 + vit-B complex,
16. mecobalamine + folic acid,
17. mecobalamine + Vit-A + Vit E + vit -c + Vit B1 + vit -B6 + Vit-D3 + selenium,
18. mecobalamine + vitamins + minerals,
19. mecobalamine + Vit-B1 + Vit-B2 + vit-B6 + folic acid,
20. mecobalamine + vit -B1 + Vit -B6 + folic acid + alpha lipoic acid,
21. mecobalamine + vit -B1 + Vit -B6 + nicotinamide +D-panthenol,
22. meobalamine + Vit-B6 + folic acid.``