Clinical Trials - Drug development and Approval

5
Written by Vanessa Jones, B.A  | Medically Reviewed by Dr. Sunil Shroff, MBBS, MS, FRCS (UK), D. Urol (Lond) on Oct 31, 2016
Average
4.2
Rating : 12345
Rate This Article : 1 2 3 4 5
RSS Email Print This Page Comment bookmark
Font : A-A+

Drug Development and Approval process

The drug development process is an extremely complex one. It goes through various processes before it could come out into the market. The various steps include:

India

  • Pre - clinical research , here the new chemicals are discovered in laboratories and tested in animals for safety and biological activity.
  • All new drugs for marketing or sale have to be approved by the Licensing Authority of India ( DCI ).
  • For granting approval to manufacture the new drug and its formulation a form with a fee has to be submitted to the Licensing Authority ( DCI).
  • After The Licensing Authority gives its initial approval for manufacturing of the drug another form has to be submitted for approval to conduct the various phases of the clinical trial.
  • On completion of the 3 phases of the trial , the manufacturers should submit information pertaining to the results of the clinical trials carried out in the country in accordance with the countries specified guidelines.
  • The Licensing Authority issues its approval after it is satisfied that the drug if approved to be manufactured shall be effective and safe for use in the country.

Abroad

  • Pre - clinical research , here the new chemicals are discovered in laboratories and tested in animals for safety and biological activity.
  • If the compound is thought to be safe , the pharmaceutical company submits a New Drug Application ( NDA) to the FDA.
  • After it is approved for Clinical studies, the safety and efficacy are assessed by a three phase process (Phase I, II & III).
  • After Phase III studies are completed another (NDA) application is submitted to the FDA.
  • Finally the FDA validates the claim and approves or rejects the drug accordingly.

Clinical Trials - Reference

Post a Comment

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
Notify me when reply is posted
I agree to the terms and conditions

Hello I’m the son of a Cancer patient. I’ve 2 boxes of Inj Iscador available for cancer treatment which I could not use for my father. Iscador is a recognized therapy for Cancer treatment to balance the side effects of Chemo and other standard treatment options. Researched and manufactured in Europe, the Injections are normally prescribed by most Cancer specialist Homeopaths and a few Oncologists. These injections have to be taken regularly over a period of 2-3 months for the desired effects. But one can consult a fellow Homeopath for the exact medications. In India, these inj have to be imported from Waleda and are available only at a few select places. The available medications are 2 boxes each of Iscador Q Series 0 and 1 @ Rs. 4500/- per box. Please read : http://www.iscador.com for more details. Also consult Dr. Kasad [Mumbai] or Dr. Navneet Rastogi (Delhi) for more info. Mail me : sniphadkar@gmail.com for more details

I want to start a cancer support group here at a village near Madurai, to conduct free medical check-ups, guide cancer patients like where they to go for treatment, whom to contact, how to go there, where they can get free treatment or where assistance could be got etc. Those who are already doing this kind of help to cancer patients can please guide me how to run a similar cancer support group in this village near Madurai. Please contact Gurumoorthi, thanks.

guest

We are a group of anti- cancer healers and counsellors , our mission being , allow the fullest co-operation of the patient with the Specialists/Physicians for reducing the side-effects, reduce pains , ease digestion etc. All that we need is a photogragh of the patient and theh details of treatments and updations to our mail i d. Don belive us until you see the effects of our hard work . 'Service to patients with big C is service to God ' our motto .

guest

my dad has been diagonised with stage 3 lung cancer he is undergoing radiation n chemo he is 63 years,please give me some tips about what has to be done treatment was started on 2nd august 2010.

guest

What are the side effects that occur as a result of the new treatment/ drug

Diabetes Premium Membership Benefits

Health Topics A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Medindia Health Topics Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Doctor Search

Stay Connected

  • Available on the Android Market
  • Available on the App Store