Regulatory overview on New Drugs and Clinical Trials Rules, 2019

  • Neha Meshram
  • Vinita Kale
  • Dinesh Biyani
  • Milind J. Umekar


Most clinical studies were carried out in the United States, Europe, and Japan up until 1995. In 1995, the first assessment of research in India was completed. A 2004 article suggested that India lacked the ideal research environment that the majority of clinical researcher’s demand. Clinical trials carried out in India significantly increased in 2009. A public interest litigation (PIL) was filed in 2012 accusing government, non-governmental, and independent investigators of conducting clinical studies improperly. The Drugs and Cosmetics Rules of 1945's Schedule Y, which govern clinical trials, were previously followed (D&C Rules). The Drugs and Cosmetics Act, 1940 (D&C Act) is the legal framework for the New Drugs and Clinical Trials Rules, 2019, or "NDCT Rules," which put an end to the protracted process of codifying the regulations that apply to clinical trials. Clinical trials, studies on bioequivalence and bioavailability, ethics committees, and investigational novel medications for human use will all be subject to the new regulations. As of 13-01-2o22, the Union Health Ministry has published a final notification revising the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to include cell derived products as well as stem cell derived products under the definition of new medication.

Keywords: Clinical trials, Ethics committee, New Drugs and Clinical Trials (ND&CT) Rules, The Drugs and Cosmetics Act, 1940 (D&C Act), CLA, IND


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How to Cite
Meshram, N., S. Harane, V. Kale, D. Biyani, and M. J. Umekar. “Regulatory Overview on New Drugs and Clinical Trials Rules, 2019”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 1, Mar. 2023, pp. 31-42, doi:10.22270/ijdra.v11i1.578.