Clinical Trial

A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans.

Legal Provisions

  • Drugs and Cosmetics Act, 1940: The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
  • Indian Medical Council (Amendment) Act, 2019: It supersedes the Medical Council of India through the Indian Medical Council (Amendment) Ordinance, 2018, promulgated on 26th September, 2018 and entrust its affairs to a Board of Governors consisting ....
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