English text of G.S.R. 175(E), Ministry of Health and Family Welfare (Department of Health and Family Welfare), dated , published in the Gazette of India, Extraordinary, No. 136, . The draft was G.S.R. 835(E) of .
1. (1) These rules may be called the New Drugs and Clinical Trials (Amendment) Rules, 2023. (2) They shall come into force on the date of their publication in the Official Gazette.
2. In the New Drugs and Clinical Trials Rules, 2019, in the First Schedule, in paragraph 3, in sub paragraph (1), for clause (b), the following shall be substituted, relating to development methodology namely: —
“(b) (I) The general requirements of non-clinical studies have been specified in the Second Schedule.
(II) The non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug include the following, namely: – (i) Cell-based assay; (ii) Organ chips and micro physiological systems; (iii) Sophisticated computer modeling; (iv) Other human biology-based test methods; (v) Animal Studies.”.
Note: The New Drugs and Clinical Trial Rules, 2019 were published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i) vide Notification Number G.S.R. 227(E), dated the 19th March, 2019 and last amended vide notification number G.S.R. 778(E), dated the 14th October, 2022.
