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Approval pathways of Fixed dose combination (FDC) in India

Fixed dose combination (FDC) approval process is a little different from the drug approval process in India.
FDC can be divided into 5 major parts:

Category 1: FDC  which are not marketed in India and one or more active ingredient(s) is a new drug not approved in India.

It may be further divided into two parts:
Sub Category I: One of the ingredients of the FDC is an Investigational New Drug (IND). 

Sub Category II: One or more of the active ingredients of the FDC is a New Drug not approved individually in India but they are approved in other countries. 

In simplest terms we can say that, at least one active ingredients of proposed FDC should not be approved in India.

Category  2:
FDC which is not marketed in India but the active ingredients are approved/ marketed individually and there is possibility of  PK/PD interactions among ingredients if given as FDC.

It can be divided into three parts:
Sub Category I: FDC which is approved in other countries

Sub Category II: FDC, which is not marketed anywhere but individual active ingredients used concomitantly.

Sub Category III: FDC, which is not marketed and individual active ingredients are not used concomitantly
In simplest terms, all the active ingredients of FDC should be approved individually in India.
Category 3 :  FDC which are marketed in India but some changes are sought.

Category 4: FDC which are Only for convenience (no significant changes from clinical point of view)

Category 5: Approvals of a FDC already approved in the country.
Documents needs to be submitted as per proposed FDC category, Indication and nature of drugs etc.

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Requirements of Clinical and Non Clinical Data

  • If the Fixed dose combination is not marketed in India, and one or more of its active ingredients are not approved in any country:  In this case first applicants for each proposed FDCs must conduct a full, four-phase clinical trial.
  • If the FDC is marketed in other countries. In this case only the Phase III clinical trial (‘bridging studies’) is needed.
  • If  active ingredients of FDCs are approved and marketed in India and FDC is approved in other countries, then regulatory authority asks for in vitro studies.
  • If FDC is not marketed in any other country but has a history of concomitant use in India; then only ‘adequate evidence’ of their safe and effective concomitant use may be necessary for approval ( if published data is not available).
  • If applicant is seeking minor changes for the FDCs marketed in India, then regulatory authority asks for in vitro studies. BA/BE study is necessary if regulatory authority is not satisfied with the claim.

 The same guidelines are applicable to FDCs which are combined only to bring convenience, and whose individual ingredients have been in concomitant clinical use.

Follow the link for List of approved FDCs (Fixed Dose Combinations) Approved by DCG (I) Since 1961 Till February, 2013:



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