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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-27012026-269595
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 50]
NEW DELHI, THURSDAY, JANUARY 22, 2026/MAGHA 2, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 21st January, 2026.
G.S.R. 50(E).—Whereas a draft of certain rules further to amend the New Drugs and Clinical Trials
Rules, 2019 was published, as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the
Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health
and Family Welfare (Department of Health and Family Welfare) number G.S.R. 587 (E), dated the 27th August, 2025,
in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from
persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of
the Gazette containing the said notification were made available to the public;
And whereas, copies of the said Gazette were made available to the public on the 28th August, 2025;
Further, a corrigendum to the notification number G.S.R. 587(E), dated the 27th August, 2025, was published vide
notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health
and Family Welfare) number G.S.R. 810 (E), dated the 31th October, 2025 in the Gazette of India, Extraordinary, Part
II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the
expiry of a period of fifteen days from the date on which the copies of the Gazette containing the said notification
were made available to the public;
And whereas, copies of the said Gazette were made available to the public on the 3rd November, 2025;
And whereas, objections and suggestions received from the public on the said draft rules have been considered
by the Central Government;
Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the said Act, the Central
Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to
amend the New Drugs and Clinical Trials Rules, 2019, namely:—
1. (i) These rules may be called the New Drugs and Clinical Trials (Second Amendment) Rules, 2026.
(ii) They shall come into force after ninety days from the date of their publication in the Official Gazette.
2. In the New Drugs and Clinical Trials Rules, 2019 (hereinafter referred to as "the said rules"), in rule 31, after
sub-rule (2), the following proviso shall be inserted, namely:—
"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
с. the samples size shall be more than or equal to eighteen.".
3. In the said rules, in rule 33, —
a. in the marginal heading, for the word "permission", the words "permission or prior intimation" shall be
substituted;
b. in sub-rule (1), the following proviso shall be inserted, namely:—
"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.".
с. for sub-rule (2), the following shall be substituted, namely:
"(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.".
4. In the said rules, in rule 35, —
a. in the marginal heading, for the word "permission", the words "permission or prior intimation" shall be
substituted;
b. 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;
с. 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.
5. In the said rules, in rule 36, —
a. in the marginal heading, for the word "permission", the words "permission or acknowledgement of prior
intimation" shall be substituted;
b. 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;
с. for the sub-rule (2), the following sub-rule shall be substituted, namely:—
"(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.".
6. In the said rules, in 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," shall be inserted.
7. In the said rules, in rule 38, —
a. in the marginal heading, for the word "permission", the words "permission or acknowledgement of prior
intimation" shall be substituted;
b. in sub-rule (1), —
i. after the words, figures and letters "permission has been granted under rule 34 in Form CT-07", the words,
brackets and figures "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;
ii. in clause (iii), after the words, figures and letters "permission 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;
с. in sub-rule (2), after the words, figures and letters "permission has been granted under rule 34 in Form CT-
07", the words, brackets and figures "or holder of acknowledgment of prior intimation under the proviso of
sub-rule (2) of rule 31" shall be inserted;
8. In the said rules, in the Eighth Schedule, —
a. in Form CT-05, —
A. in the heading, after the words "FOR GRANT OF PERMISSION", the words "OR OF PRIOR
INTIMATION" shall be inserted;
B. in the opening paragraph, after the words "apply for grant of permission", the words “or as prior intimation"
shall be inserted.
[F. No. X.11014/06/2025-DR]
HARSH MANGLA, Jt. Secy.
Note: The New Drugs and Clinical Trials Rules, 2019 were published in the Gazette of India, Extraordinary, Part-II,
section 3, sub-section (1) vide notification number G.S.R.227(E), dated the 19th March 2019 and last amended
vide notification number G.S.R. 46(E), dated 20th January, 2026.