Hi there...

Is it necessary to have clinical trials of cosmetics (Herbal Extracts)?
If yes, is it be in the same way as that of medicines?
What is the law?

Regards,
Dr. Abhijit

Dear Abhijit,

The word cosmetic” means any substance or preparation intended to be used, or capable or purported or claimed to be capable of being used, on the various external parts of the human body (including epidermis, hair system, nails, lips and external genital organs) or the teeth and the mucous membranes of the oral cavity for the exclusive or main purpose of cleaning, perfuming or protecting them, or of keeping them in good condition, or of changing or modifying their appearance, or correcting body odors.
The most important law pertaining to cosmetics marketed in the United States is the Federal Food, Drug, and Cosmetic Act (FD&C Act) and The drug and Cosmetics Acts and Rules, India
The Drug And Cosmetics Act and Rules: “An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.”
WHEREAS it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
AND WHEREAS the Legislature of all the Provinces have passed resolutions in terms of section 103 of the Government of India Act, 1935 (26 Geo. 5, c.2), in relation to such of the above-mentioned matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act.


Some more info......


Regards

Savitha

Hey all,
Thanks for kind support.

Is it mandatory to clinical trial of a cosmetic product in INDIA?

Please help me to get the guidelines about the topic.

DR. Abhijit

Dear Dr.Abhijit,

No matter what the cosmetic product  is, if it ha sto be released in India, then it has to mandatorily undergo clinical trial sprocess. If its an abroad product, then reapply for a clinical trial conduct in India , if its to be made and released here then also it has to undergo a trial.

And for the Info, u can login to the CDSCO link and go through. They have given it very clearly.

Any more help.......do shoot out!!!!

Regards

Savitha

Dear Savita,
Thanks for your support.
I have gone through the site CDSCO but couldent find the specific data.........
Can u plz help me finding the data?

Hi There,
We are going to start the CRO.

I need your help regarding the guidelines, requirements and project plan

Regards,

Dr Abhijit