As many as 11 fixed doses combination (FDC) drugs involving paracetamol will be among the 28 FDCs that the industry has agreed to withdraw voluntarily from the market as part of the amicable settlement reached between the DCGI and the industry on the contentious FDC issue recently.
The FDCs that will be going off the market also include at least six combinations of dicyclomine. The meeting between the industry and the DCGI had arrived at consensus at revising the contentious list from 294 to 156, after removing the duplications and already banned combinations. The industry players had got approval for as many as 28 combination drugs after the former DCGI asked them to get them approved by the Central authority.
Now the new list of FDCs which need to be cleared by the DCGI for marketing would be placed before the DTAB and DCC before formally releasing them and assessing the rationality one by one.
The 15 combinations which were already banned but appeared in the list released by the former DCGI were analgin + dextripopoxyphene, analgin + diazepam, analgin + diazepam + diphenhydramine, analgin + diazepam + paracetamol, analgin + diazepam + propylene glycol, analgin + dicyclomine + diazepam, analgin + dihydroethaverine chloride, analgin + ketoprofen, analgin + KET-P-PIPER.ETH-O-CARB M, dicyclomine + paracetamol + analgin, fenpiverinium bromide + analgin + pitofenone hydrochloride, ibuprofen + paracetamol + oxyphenbutazone + phenylisopropyl pyrazolon, mebeverine + alprazolam, paracetamol + alprazolam, and paracetamol + analgin.
The FDCs that the industry has agreed to take back from the markets are:
1) chlorzoxazone + ibuprofen + paracetamol + diclofenac + oxyphenbutazone + magnesium pyrazolon;
(2) dicyclomine + paracetamol + phenylisopropyl pyrazolon,
(3) activated charcoal + fungal distae + lactic acid,
(4) allobarbitone + phospho-dimethyl-isopropyl-pyrazolone,
(5) artesunate + arteether + artemether,
(6) chlorzoxazone + paracetamol + ibuprofen + diclofenac sodium,
(7) norfloxacin + tinidazole + loperamide,
(8) paracetamol + diclofenac sodium + amoxicillin + cloxacillin + pantoprazole + lactic acid bacillus + serrapeptase,
(9) paracetamol + diclofenac sodium + magnesium trisilicate + chlorphenamine maleate
(10) ranitidine + omeprazole,
(11) 5-bromisalicy-4-chloranilide + salicylic acid,
(12) actorvastatin + acetyl salicylic acid + caffeine,
(13) chlormezanone + paracetamole + diclofenac sodium,
(14) chlormezanone + paracetamole + ibuprofen,
(15) ciprofloxacin + tinidazole + dicyclomine,
(16) diclofenac + paracetamol + chlormezanone,
(17) dicyclomine + dextromethorphan + paracetamol,
(18) dicyclomine + paracetamol + chlordiazepoxide,
(19) dicyclomine + serrartiopeptidase,
(20) ibuprofen + colchicine,
(21) ibuprofen + paracetamol + colchicine,
(22) ibuprofen + paracetamol + magnesium triscilicate,
(23) ibuprofen + paracetamol + magnesium trisilicate,
(24) mecobalamine + methenamine mandelate,
(25) norfloxacin + tinidazole + dicyclomine,
(26) ondansetron + paracetamol,
(27) ranitidine + cisapride,
(28) ranitidine + dicyclomine + clidinium bromide
(Source: www.pharmabiz.com)
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