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( )FIXED DOSE COMBINATIONS FDCs( )FIXED DOSE COMBINATIONS FDCs
Presentation by:
Rahul shroti
MBA(Pharma) 1ST SEM
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o or more active ingredients combined in a single dosage form in certain fixed
ed unless there are no alternative single drug available for treatment or no al
- —
( )co packaged products two or more products drugs in their final dosage form pa
, , - , ,comprise vitamins cough suppressants anti diarrhoeal iron preparations antaci
Fixed dose( )combinations FDCs
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Advantages of FDCs
Advantages of FDCs
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Disadvantages ofFDCs
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S PER WHO FOR ACCEPTABILITY OF FDCs
Clinical documentation justifies the .concomitant use of more than one drug
Therapeutic effect is greater than th.sum of the effect of each
The cost of combination product is
less than the sum of individual.products
Compliance is improved
Any fixed dose combination which does not satisfy the above mentioned guidelines is considered irrational
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7
ot ves o compan es behind manufacturing of
FDCs
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.r motive of generating prescription and making profits only There is a
alcium). ,While Norvasc is used to treat high blood pressure angina and
re patient compliance is improved or Oral contraceptives, where a combi
companies incentive for introducing FDCs is to sell them as comparativ
Ethical concerns
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there is corrective action
two or more drugs have a synergistic action
olecules are normally needed and taken by the patient concurrently
prescribing two or more drugs separately could result in one of the
Circumstances under which FDC iallowed
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tionale for Combination The
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:Drug control issues Indian scenario
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:Drug control issues. .Contd
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rrat ona xe dose combinations
in India • CIMS, year 2006 lists more than 100
irrational combinations
• MIMS, June 2007 has listed 136 irrationalcombinations
• Pediatric formulations of Nimesulide +Paracetamol.
• FDCs of Diclofenac + Serratiopeptidase.
• FDCs of quinolones and nitroimidazoles (e.g.
Norfloxacin + Metronidazole, Ciprofloxacin+ Tinidazole, Ofloxacin + Ornidazole).
• Combining two NSAIDs or NSAID withanalgesics like paracetamol.
•Multivitamin combinations & cough and coldremedies.
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d or marketed individually ,are combined for the first time for a particular cla
Those in which one or more of the active ingredients is a new drug
,ich are already marketed but in which it is proposed either to change the rati
, &ave been widely used for years their concomitant use is necessary no claim i
-APPENDIXVI
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-Case Study Weeding of irrational combinations
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16
.Contd
: ,Source Logistics issue in Indian Pharmaceutical Industry EXPRESSPHARMA , - ,march 16 31 2008
D d CDSCO S
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Drug under CDSCO Scanner
Companies No. of Brands
Cipla 37
Alkem Labs 37Nicholas Piramal 36
Emcure Pharma 30
Ind-Swift 40
Zydus Cadila 30Mankind Pharma 45
Lupin 21
Intas Pharma 30
Sun Pharma 12
Wochardt 12Ranbaxy Labs 15
Blue Cross Labs 15
Elder
Pharmaceuticals
15
CadilaPharmaceuticals
28 : . .Source www livemint com
B d hi h F th
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Brands which may Face theaxeBrands Company
Aciloc Rd Cadila pharmaceuticals
Alprax forte Torrent pharmaceuticals
Amlodac –I Zydus Cadila
Anxit plus Micro Labs
Amlopress Cipla
Aztec –d Ind-Swift Pharma
Ciprogyl susp. Mankind pharma
Conaz Wochardt
Cz cold Lupin pharmaceuticals
Diaba Tab. Sun pharmaceuticalsEmsulide – Fen Emcure pharmaceuticals
Gramoneg Tn Ranbaxy Laboratories
Ranidom Tab. Mankind Pharma
Lupril-Am Lupin Laboratories : . .Source www livemint com
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Outcomes of DCGIs Move
Ø DCGI have classified the FDCs in the-market broadly into four categories
, , - -absurd rejected banned and to be
.examined
Category No. of FDCs
Absurd 16
Banned 15
Rejected 83
Need for examination
156
Decision taken 19
Approved 5
Total 294
: . .Source www businessline c
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.Contd
• ,The country's leading drug makers including, ,Ranbaxy Laboratories Cipla Cadila
,Pharmaceuticals Nicholas Piramal and,Wockhardt will soon withdraw about 60 drug
.combinations from the market
• ,Currently three cases are pending in the.Madras High Court
•General consensus among most of the industry representatives on the FDC issue in the
, .recent past except with the CIPI• CIPI talking with new DCGI to have a.'settlement' on FDC issue
•
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www.businessstandard.com
.Contd
• -Pharmaceutical units in tax exempt areas like Baddi may soon become the only ones that can legally manufacture
- ( ) ,over 150 fixed dose combination FDC medicines which, .have combined sales of Rs 3 000 crore in the country
• -Since most units in these tax free zones came up in the
, -last three to four years the five year validity of the’licences which they secured just before the regulator s
ban on fresh licences allows them to continue producing these medicines for at least two more years.
•On the other hand, 80 per cent of the older units in
other parts of the country have been compelled to stop producing these medicines after the authorities.refused to renew their licences
•The ultimate fate of these 156 FDCs depends on the recommendations of an expert group that is looking
“ ” .into the irrational nature of these medicines
•Expert group submit its report by 2010.
C l di R k
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Concluding Remarks
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Future of upcoming FDCs