Permission for clinical trial

  • Act/Rule/Legislation

  • Online Link to Act/Rule/Legislation

  • Initial Setup or Ongoing Maintenance

    Initial Setup only

  • Filing and Maintenance Requirements

    Permission in Form 45/45A/46/46A, as the case may be, is required from the licensing authority, prior to carrying out clinical trials for any new drug, as required under Rule 122-DA.

  • Penalty

    Whoever having been convicted of an offence—
    (a) under clause (b) of section 27 is again convicted of an offence under that clause, shall be punishable with
    imprisonment for a term which shall not be less than two years but which may extend to six years and with fine
    which shall not be less than ten thousand rupees:
    Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a
    sentence of imprisonment for a term of less than two years and of fine of less than ten thousand rupees;
    (b) under clause (c) of section 27, is again convicted of an offence under that clause shall be punishable with
    imprisonment for a term which shall not be less than six years but which may extend to ten years and with fine
    which shall not be less than ten thousand rupees;
    (c) under clause (d) of section 27, is again convicted of an offence under that clause shall be punishable with
    imprisonment for a term which shall not be less than two years but which may extend to four years or with fine
    which shall not be less than five thousand rupees, or with both

  • Application Guidelines / Responsible Persons / Comments

    The clinical trial sponsor is required to
    submit application (Form 44) for the purpose of conducting clinical trial in India
    and submit documents as per Schedule Y of the Drugs and Cosmetics Act
    1940 and Rules there in. The sponsor is also responsible for implementing
    and maintaining Quality Assurance system to ensure that the clinical trial is
    conducted and data generated, documented and reported in compliance with
    the protocol and Good Clinical Practice Guidelines issued by CDSCO,
    Directorate General of Health Services, Govt. of India as well as all applicable
    statutory provisions of Drugs and Cosmetics and Rules there under. Standard
    operating procedures should be documented to ensure compliance with GCP
    and applicable regulations.