What is Clinical Trial, New Drug, Cosmetic and Medical Device?

First we will discuss about meaning and definition of clinical trail. After that we will discuss about why these are compulsory to conduct before manufacturing, sale, distribute and market a new drug.

What is Clinical Trial?

Clinical Trial is a process of systematic study or bioavailability or bioequivalence study of new drug or investigational new drug or new cosmetic or new medical device in or on human participants to find out whether it is safe and effective for use of human or not.

According to Drug and Cosmetic Act:

Clinical Trial” means

(i) In respect of drugs, any systematic study of new drug or investigational new drug or bioavailability or bioequivalence study of any new drug in human participants to generate data for discovering or verifying its clinical, pharmacological, including pharmacodynamic and pharmacokinetic, or adverse effects with the objective of determining safety, efficacy or tolerance of the drug;
(ii) In respect of cosmetics, the systematic study, including dermatological study of any new cosmetic on human participants to generate data for discovering or verifying its adverse effects with the objective of determining safety, efficacy or tolerance of the cosmetic;
(iii) In respect of medical devices, the systematic clinical investigation or study of an investigational medical device or a new medical device in, or on human participants to assess the safety or performance or effectiveness of the medical device;

“ A New Drug” means-
(i) A drug, including bulk drug substance, which has not been used in the country to any significant extent under the specified conditions, recommended or suggested in the labelling thereof and has not been recognised as effective and safe by the Central Licensing  Authority for the expected claims and its limited use, if any;
(ii) A drug approved by the Central Licensing Authority for certain claims, which is proposed to be marketed with modified or new claims, namely, indications, route of administration, dosage and
dosage form, including sustained release and novel drug delivery systems;
(iii) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in a marketed combination is proposed to be changed,
with certain claims, namely, indications, route of administration, dosage, dosage form, including sustained release and novel drug delivery systems;
(iv) vaccines, recombinant Deoxyribonucleic Acid (r-DNA) derived products, living modified organisms, monoclonal anti-bodies, stem cells, gene therapeutic products and xenografts which are  intended to be used as drugs;

Read: Difference between Drug and Medicine

“A Investigational New Drug” means

New chemical entity or substance which is under investigation in a clinical trial regarding its safety and efficacy;

“A New Cosmetic” means

Any cosmetic containing ingredients which have not been established as safe for use in cosmetics;

“A New Medical device” means

A device which has not been approved by the Central Licensing Authority;

“A Investigational New Medical Device” means

A new device which is an object of a clinical investigation or research or development involving one or more human participants to determine the safety and the effectiveness of a device

Why Clinical Trials are necessary?

When a research institute or company discover a molecule that may have potency to cure, prevent, treat or provide symptomatic relief against particular illness or disease. First its efficacy and bioavailability or bioequivalence study are tested at animals.

After passing trials at animals, we need to find out its result and side effects at human. So clinical trail has been conducted to find out its actual response at human body.


Preclinical Phase: Testing of Drug at non human subjects

Phase 0: Testing of Drug at Healthy Human at 10 people for pharmacokinetic study

Phase I: Testing of drug at 20-100 healthy volunteers for checking dose ranging

Phase II: Testing of drug at 100-300 patients of particular disease to check efficacy and side effects

Phases III: Testing of drug at 300-3000 patients of particular disease to check efficacy, effectiveness and safety.

Phase IV: It is done after marketing of drug to doctor for checking drug use in public for long term effects of drug.

Hope above information is helpful to you….


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