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.