rahul shroti fdcs final

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( )FIXED DOSE COMBINATIONS FDCs( )FIXED DOSE COMBINATIONS FDCs

Presentation by:

Rahul shroti

MBA(Pharma) 1ST SEM



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



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







7

ot ves o compan es behind manufacturing of

FDCs



.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




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






tionale for Combination The






:Drug control issues Indian scenario





:Drug control issues. .Contd




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.




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





-Case Study Weeding of irrational combinations






16

.Contd

: ,Source Logistics issue in Indian Pharmaceutical Industry EXPRESSPHARMA , - ,march 16 31 2008

D d CDSCO S




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



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



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




.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

•






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






Concluding Remarks





Future of upcoming FDCs




THANK YOU

rahul shroti fdcs final

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