FDA Perspective on Generic drugs: Low Cost and same quality medicines as Branded drugs

Let’s find out Similarities and Differences between Brand Name and Generic Drugs

Brand Name Drugs

Also called “innovator drugs those have Patent Rights to Innovator Company”
Initially marketed by innovator as new chemical entities (NCE) after Performing Clinical Trails.

Generic Drugs

Generic drugs have same Active ingredient, dosage form and same route of administration.
These are Similar in Quality Strength identity, strength, quality, purity, and potency of brand name drugs. However, some variability can and does occur during manufacturing, for both brand name and generic drugs.
It has met rigorous Standards Given by Regulatory Bodies (FDA, EMA, and MHRA)
Generic Drugs Produced only after the original patent expires

Criteria to Evaluate Generic drug Effectiveness in Body:

One of the key parameters for bioequivalence is the area under the curve (AUC)
The AUC of a generic formulation must be not less than 80% or not more than 125% of the brand name formulation

What makes generic drugs price less?

Generic drug companies don’t spend on the researching and developing a new chemical entity and marketing promotional activies.so there is no Clinical Trials for Generic Drugs it saves lot of money to Generic drug makers.
Therefore multiple Pharma Manufacture’s Produce Generic Drugs, it makes Competition among Generic Drug makers and reduce availability price to Patients.

Some Facts Should Know about Generic Drugs:

Cheaper Generic drugs does not mean lower quality.
Generic drugs also monitored vigorously for adverse drug reaction after Post market approval.
FDA does not allow a 45 percent difference in the effectiveness of the generic drug product.
Generic drug Price are 80-85% less to Branded drugs.
Please be careful when switching to generic drugs these have difference composition of excipients, which may trigger allergic reactions.

How to find Alternative Low cost medicines to Branded drugs

Ausodhyatmika: Health & Safety: It is an android app freely available, very handy to find low cost or substitute medicines
MyDawaai.com – Another iOS and Android app that will help you quickly find equivalent medicines along with their prices. It has small drug manufactures in India