Clinical Trials - Drug development and Approval

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.

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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.