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THE PHARMA REVIEW (MARCH - APRIL 2011)

Fixed Dose Combinations (FDCs) of Drugs

R.K. Rishi

Introduction
Fixed dose combinations (FDCs) of drugs are important for public health perspective and commonly used for the treatment of pain & inflammation, hypertension, diabetes, malaria, tuberculosis, HIV/AIDs etc. These ailments are considered to be the foremost threats to health in the world today. FDCs have proved to be advantageous as they are safe and effective. They increase efficiency, reduce the incidence of adverse drug effects, and improve patient compliance. The FDCs offer low cost as compared to individual components of active ingredients. On other hand if administered in unprofessional way, FDCs have given problem of drug resistance in the case of antimicrobial treatment especially in case of treatment of tuberculosis malaria. In some instances wrong understanding of FDCs have been proved to be fatal.
Advantages & disadvantages of FDC’s
FDCs offer simple dosage schedule which improves patient compliance and therefore improves treatment outcomes. This is especially important in elderly patients or patients suffering from multiple disorders. The FDCs are more economic than single ingredient drugs. Such reduced "pill burden" can greatly enhance the overall treatment outcome. However, FDCs have certain disadvantages. Multiple ingredients in an FDC can confuse the physician who may not remember the exact composition and dose of individual active ingredient in a particular FDC. The patient may not actually need all the drugs present in the combination. That may lead to therapeutic confusion of therapeutic aims and create false sense of superiority of two drugs over one especially in case of antimicrobials and painkillers. If one drug is contraindicated for a patient, whole FDC cannot be prescribed. In case of FDCs, dosing is inflexible and cannot be regulated to patient’s needs (each patient has unique characteristics such as weight, age, pharmacogenetics, co-morbidity, which may alter drug metabolism and effect).
Approval of FDCs in India
FDC in India is treated as new drug as per the Rule 122 E of Drugs and Cosmetics Rules. This is because of the fact that that by combining two or more drugs, the safety, efficacy, and bioavailability of the individual Active Pharmaceutical Ingredient (API) may change. DCGI is the licensing authority notified under section 21(b) of Drugs and Cosmetics Act. The rationality of an FDC is examined in the office of DCGI as per the provisions of Schedule Y before its market authorization in the country. The applicant pharmaceutical company is required to submit exhaustive information justifying the rationale of the FDC in question. The examination process also involves external experts in their relevant field including pharmacologists. The safety and efficacy of the FDC is later ascertained by conducting clinical trial and bioequivalence studies. Once the data from clinical studies has been found satisfactory by the DCGI, permission to manufacture and market the FDC is granted. It is pertinent to note that recently DCG(I) office has made guidelines for submission of proposals for FDCs for the purpose of market authorization in the country. These guidelines are quite exhaustive and can be accessed at www.cdsco.nic.in

 

 

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