The New Drugs and Clinical Trials Rules, 2019 prescribe the regulatory framework for approval and conduct of clinical trials, including bioavailability and bioequivalence studies, in India. Draft amendments to these rules were published on August 27, 2025, and a corrigendum was issued on October 31, 2025, inviting objections and suggestions from stakeholders. After consideration of the objections and consultation with the Drugs Technical Advisory Board, the Central Government has notified these amendments. The rules were last amended prior to this by notification dated January 20, 2026.                                                                                                                                                                                                                                                                                                                                            Insertion of proviso to Rule 31(2):

1. After sub-rule (2) of rule 31, the following proviso has been inserted:

“Provided that in case of single-dose, two-period, two-sequence, two-treatment, bioavailability or bioequivalence studies in normal healthy adult human volunteers (for export purpose only), of oral dosage form of a drug (other than drugs of Cytotoxic, Hormone, Narcotic and Psychotropic substances categories and not a drug of Narrow Therapeutic Index or a drug having highly variable pharmacokinetics) already approved in India or any one of the countries, namely, United States of America, European Union, Japan, Australia, Canada and United Kingdom, the studies may be conducted after submission of an online application as prior intimation in Form CT-05 and its acknowledgement by the Central Licensing Authority, subject to the following conditions, namely:—
(a) the application of the prior intimation shall be accompanied with approval of the Ethics Committee registered with the Central Licensing Authority under rule 8;
(b) the Ethics Committee shall maintain a separate record of review and approval of such bioavailability or bioequivalence studies being conducted on the basis of the acknowledgement of prior intimation, which shall be reviewed by the Central Licensing Authority at the time of renewal of the Registration of the Ethics Committee; and
(c) the samples size shall be more than or equal to eighteen.”

         Amendments to Rule 33:

• In the marginal heading, for the word “permission”, the words “permission or prior intimation” shall be substituted.
• In sub-rule (1), the following proviso has been inserted:

“Provided that in case of bioavailability or bioequivalence studies as referred to in the proviso of sub-rule (2) of rule 31, such studies may be conducted by submitting an online application in Form CT-05 as specified in the proviso of sub-rule (2) of rule 31.”

• Sub-rule (2) has been substituted as follows:

“(2) An application for grant of permission to conduct bioavailability or bioequivalence study of any new drug or investigational new drug, or as prior intimation for initiation of bioavailability or bioequivalence studies specified in the proviso to sub-rule (2) of rule 31, as the case may be, shall be accompanied by a fee as specified in the Sixth Schedule and such other information and documents as specified in the Table 2 of the Fourth Schedule:
Provided that no fee shall be payable for conducting a bioavailability or bioequivalence study by an institution or organisation owned or funded wholly and partially by the Central Government or a State Government.”                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Amendments to Rule 35:

• In the marginal heading, for the word “permission”, the words “permission or prior intimation” shall be substituted.
• In the opening paragraph, after the words and figures “study under rule 34”, the words, brackets and figures “or the acknowledgment of prior intimation under the proviso of sub-rule (2) of rule 31, as the case may be,” shall be inserted.
• In clause (xiii), after the words “grant of permission”, the words, brackets and figures “or the acknowledgment of prior intimation under the proviso of sub-rule (2) of rule 31, as the case may be,” shall be inserted.                                                                                                                                            Amendments to Rule 36:

• In the marginal heading, for the word “permission”, the words “permission or acknowledgement of prior intimation” shall be substituted.
• In sub-rule (1), after the words, figures and letters “study granted under rule 34 in Form CT-07”, the words, brackets and figures “or the acknowledgment of prior intimation under the proviso of sub-rule (2) of rule 31, as the case may be,” shall be inserted.
• Sub-rule (2) has been substituted as follows:

“(2) In exceptional circumstances, where the Central Licencing Authority is satisfied about the necessity for an extension beyond one year, the said authority may, on the request of the applicant made in writing, extend the period of permission granted or the acknowledgment of prior intimation under the proviso to sub-rule (2) of rule 31 for a further period of one year.”                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Amendments to Rule 37:                                                                                                                                                                                                                                            After the words, figures and letters “study under rule 34 in Form CT-07”, the words, brackets and figures “or under the acknowledgement of prior intimation under the proviso of sub-rule (2) of rule 31, as the case may be,” have been inserted.                                                                                                                                             Amendments to Rule 38:

• In the marginal heading, for the word “permission”, the words “permission or acknowledgement of prior intimation” shall be substituted.
• In sub-rule (1), after the words “permission has been granted under rule 34 in Form CT-07”, the words “or holder of acknowledgment of prior intimation under the proviso of sub-rule (2) of rule 31, as the case may be,” shall be inserted, and similar insertions have been made in clause (iii).
• In sub-rule (2), after the words “permission has been granted under rule 34 in Form CT-07”, the words “or holder of acknowledgment of prior intimation under the proviso of sub-rule (2) of rule 31” shall be inserted.                                                                                                                                                  Amendment to Eighth Schedule (Form CT-05):

• In the heading, after the words “FOR GRANT OF PERMISSION”, the words “OR OF PRIOR INTIMATION” shall be inserted.
• In the opening paragraph, after the words “apply for grant of permission”, the words “or as prior intimation” shall be inserted.