FDC's

[Guest guest]

Dear members,

Thanks for your valuable inputs in the current topic of discussion.

As per Schedule Y [ Drug and Cosmetic act (II amendment) rules, 2005] FDCs can

be divided into the following groups and data required for approval for

marketing is described below:

(a) The first group of FDCs includes those in which one or more of the active

ingredients is a new drug. For such FDCs to be approved for marketing data to be

submitted will be similar to data required for any new drug (including clinical

trials)

( (i) The second group FDCs includes those in which active ingredients already

approved/marketed individually are combined for the first time, for a particular

claim and where the ingredients are likely to have significant interaction of a

pharmacodynamic or pharmacokinetic nature. If clinical trials have been carried

out with the FDC in other countries, reports of such trials should be submitted.

If the FDC is marketed abroad, the regulatory status in other countries should

be stated. .

(ii) For marketing permission, appropriate chemical and pharmaceutical data will

be submitted. In case such a combination is not marketed anywhere in the world

but these drugs are already in use concomitantly (not as an FDC but

individually) for the said claim, marketing permission may be granted based on

chemical and pharmaceutical data. Data showing the stability of the proposed

dosage form will also have to be submitted.

(iii) For any other such FDCs, clinical trials may be required. For obtaining

permission to carry out clinical trials with such FDCS a summary of available

pharmacological, toxicological and clinical data on the individual ingredients

should be submitted, along with the rationale for combining them in the proposed

ratio. In addition, acute toxicity data (LD 50) and pharmacological data should

be submitted on the individual ingredients as well as their combination in the

proposed ratio.

© The third group of FDCs includes those which are already marketed, but in

which it is proposed either to change the ratio of active ingredients or to make

a new therapeutic claim. For such FDCs, the appropriate rationale including

published reports (if any) should be submitted to obtain marketing permission.

Permission will be granted depending upon the nature of the claim and data

submitted.

(d) The fourth group of FDC includes those whose individual active ingredients

(or drugs from the same class) have been widely used in a particular

indication(s) for years, their concomitant use is often necessary and no claim

is proposed to be made other than convenience. It will have to be demonstrated

that the proposed dosage form is stable and the ingredients are unlikely to have

significant interaction of a pharmacodynamic or pharmacokinetic nature.

No additional animal or human data are generally required for these FDCs, and

marketing permission may be granted if the FDC has an acceptable rationale.

Regards,

Dr. Sonali Pimpalkhute

Lecturer, Pharmacology

GMC, Nagpur