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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-21012026-269489
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
No. 46]
NEW DELHI, TUESDAY, JANUARY 20, 2026/PAUSHA 30, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 20th January, 2026
G.S.R. 46(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. 588 (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;
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 (Amendment) Rules, 2026.
(ii) They shall come into force after forty five 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 52, —
a. in the marginal heading, for the word "permission", the words "permission or prior intimation" shall be
substituted;
b. for the sub-rule (1), the following sub-rule shall be substituted, namely: —
"(1) No person shall manufacture a new drug or an investigational new drug to conduct clinical
trial or bioavailability or bioequivalence study or for examination, test and analysis without
obtaining permission, by making an application in Form CT-10 to the Central Licencing Authority
to manufacture such new drug or investigational new drug, from the Central Licencing Authority:
Provided that in case of manufacture of new drug or investigational new drug for
analytical and non-clinical testing (excluding the new drug and investigational new drug of
category of sex hormones, cytotoxic, beta lactum, biologics with live microorganism and narcotics
and psychotropic drugs) an online application in Form CT-10 to the Central Licencing Authority
shall be submitted as prior intimation and the applicant may manufacture such drugs based on the
acknowledgment of such intimation.";
c. sub-rule (2) shall be omitted;
d. in sub-rule (3), for the word, brackets and figure "sub-rule (2)", the word, brackets and figure "sub-rule (1)"
shall be substituted.
3. In the said rules, in rule 53, —
a. in the sub-rule (1), for the words "ninety working days" wherever they occur, the words "forty-five working
days" shall be substituted;
b. in the sub-rule (2), for the words "ninety working days", the words "forty-five working days" shall be
substituted;
c. in the sub-rule (3), in clause (ii), for the words "ninety working days", the words “forty-five working days"
shall be substituted.
4. In the said rules, in rule 54, —
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 “permission granted under rule 53 in Form CT-11", the
words, brackets and figures “or the acknowledgement of prior intimation under the proviso of sub-rule (1) of
rule 52 as the case may be," shall be inserted;
c. in sub-rule (2), for the words "permission granted", the words "permission granted or the validity of
acknowledgement issued under the proviso of sub-rule (1) of rule 52, as the case may be," shall be
substituted.
5. In the said rules, in rule 55, —
a. in the marginal heading, for the words "Conditions of permission", the words "Conditions of permission or
prior intimation" shall be substituted;
b. in the opening paragraph, after the words, figures and letters “permission under rule 53 in Form CT-11", the
words, brackets and figures “or the acknowledgment under the proviso of sub-rule (1) of rule 52" shall be
inserted;
c. for the clauses (i) to (iii), the following clauses shall be substituted, namely: —
"(i) the holder of the permission or acknowledgment of prior intimation under the proviso of sub-
rule (1) of rule 52, as the case may be, shall make use of new drugs manufactured only for the
purposes of conducting clinical trial or bioavailability and bioequivalence study or for
examination, test and analysis and no part of it shall be sold in the market or supplied to any other
person or agency or institution or organisation;
(ii) the holder of the permission or acknowledgment of prior intimation under the proviso of sub-
rule (1) of rule 52, as the case may be, shall manufacture new drugs only for the purposes of
conducting clinical trial or bioavailability and bioequivalence study or for examination, test and
analysis in small quantities in accordance with the provisions of these rules and at places specified
and in accordance with the principles of Good Manufacturing Practices;
(iii) the holder of the permission or acknowledgment of prior intimation under the proviso of sub-
rule (1) of rule 52, as the case may be, shall keep a record of new drugs manufactured and persons
to whom the drugs have been supplied for specified purposes; ".
6. In the said rules, in rule 56, —
a. in sub-rule (1), after the words and figures “permission under rule 53", the words, brackets and figures "or
the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 52" shall be inserted;
b. in sub-rule (2), after the words, figures and letters "permission under rule 53 in Form CT-11", the words,
brackets and figures "or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 52,
as the case may be," shall be inserted.
7. In the said rules, in rule 57, for the words "permission holder" the words, brackets and figures "permission
holder or the holder of the acknowledgment of prior intimation under the proviso of sub-rule (1) of rule 52,"
shall be substituted.
8. In the said rules, for rule 58, the following rule shall be substituted, namely: —
"58. Suspension or cancellation of manufacturing permission or acknowledgment of prior intimation for new drug or
investigational new drugs.- (1) Subject to provisions of rule 55, where the permission holder or the holder of
acknowledgment of prior intimation, as the case may be, fails to comply with any provision of the Act and these rules,
the Central Licencing Authority may, after giving that person an opportunity to show cause and after affording an
opportunity of being heard, by an order in writing, take one or more of the following actions, namely: —
i. suspend the permission or acknowledgment of prior intimation for such period as considered appropriate;
ii. cancel the permission granted under rule 53 in Form CT-11 or acknowledgment of prior intimation.
(2) Where the permission holder or the holder of acknowledgment of prior intimation, whose permission or
acknowledgment of prior intimation has been suspended or cancelled, as the case may be, under sub-rule (1), is
aggrieved by an order of the Central Licencing Authority, he may, within sixty days of the receipt of the order, make an
appeal to the Central Government and that Government may, after such enquiry, as deemed necessary and after affording
an opportunity of being heard, pass such order in relation thereto as may be considered appropriate in the facts and
circumstances of the case.".
9. In the said rules, in rule 59, —
i. in the marginal heading, for the word "permission", the words "permission or prior intimation" shall be
substituted;
ii. after the sub-rule (1), the following proviso shall be inserted, namely: —
"Provided that where a manufacturer of a pharmaceutical formulation intends to procure new drug
or investigational new drug for analytical and non-clinical testing (excluding the new drug and
investigational new drug of category of sex hormones, cytotoxic, beta lactum, biologics with live
microorganism and narcotics and psychotropic drugs) an online application to manufacture such drug
shall be made, as prior intimation, to the Central Licencing Authority by the manufacturer of
pharmaceutical formulation in Form CT-12 and manufacturer of the active pharmaceutical ingredient in
Form CT-13 and the applicant may manufacture such drugs based on the acknowledgment of such
intimation.".
10. In the said rules, in rule 60, for the words "ninety working days" wherever they occur, the words "forty-five
working days" shall be substituted.
11. In the said rules, in rule 61, —
i. in the marginal heading, for the word "permission", the words "permission or acknowledgement of prior
intimation" shall be substituted;
ii. in sub-rule (1), after the words, figures and letters "permission granted under rule 60 in Form CT-14 or CT-
15", the words, brackets and figures "or the acknowledgement of prior intimation under the proviso of sub-
rule (1) of rule 59" shall be inserted;
iii. in sub-rule (2), for the words "permission granted", the words, brackets and figures "permission granted or
the validity of acknowledgement issued under the proviso of sub-rule (1) of rule 59, as the case may be",
shall be substituted.
12. In the said rules, for rule 62, the following rule shall be substituted, namely: —
"62. Suspension or cancellation of permission or acknowledgment of prior intimation to manufacture unapproved active
pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability and
bioequivalence study. —
(1) Subject to provision of rule 60, where the formulation manufacturer or an active pharmaceutical ingredient
manufacturer fails to comply with any provisions of the Act and these rules, the Central Licencing Authority may, after
giving an opportunity to show cause and after affording an opportunity of being heard, by an order in writing, take one
or more of the following actions, namely:
i. suspend the permission or acknowledgment of prior intimation, as the case may, for such period as
considered appropriate; or
ii. cancel the permission granted under rule 60 in Form CT-14 or Form CT-15 or acknowledgment of prior
intimation, as the case may be.
(2) Where the formulation manufacturer or active pharmaceutical ingredient manufacturer whose permission or
acknowledgment of prior intimation has been suspended or cancelled under sub-rule (1), is aggrieved by an order of the
Central Licencing Authority, such manufacturer may, within forty-five days of the receipt of the order, make an appeal
to the Central Government and that Government may, after such enquiry, as deemed necessary and after affording an
opportunity of being heard, pass such orders in relation thereto as may be considered appropriate in the facts and
circumstances of the case".
13. In the said rules, for rule 63, the following rule shall be substituted, namely: —
"63. Conditions of permission or acknowledgement to prior intimation. – The permission granted under rule 60 in Form
CT-14 or Form CT-15 or the acknowledgement of prior intimation obtained under the proviso of sub-rule (1) of rule 59
shall be subject to following conditions, namely:
i. the manufacturer of pharmaceutical formulation or the active pharmaceutical ingredient shall make use of the
unapproved active pharmaceutical ingredient manufactured on the basis of permission issued under rule 60 or
the acknowledgement of the prior intimation under the proviso of sub-rule (1) of rule 59,as the case may be,
only for the purposes specified therein, and no part of it shall be sold in the market;
ii. the holder of permission or the acknowledgement of the prior intimation obtained under the proviso of sub-
rule (1) of rule 59,as the case may be, shall manufacture such active pharmaceutical ingredient or its
pharmaceutical formulation for the purposes as specified therein, in accordance with the provisions of these
rules and at places referred to therein, and in case, the manufacture of such drugs is for clinical trial or
bioavailability and bioequivalence study, it should be manufactured in accordance with the principles of
Good Manufacturing Practices;
iii. the manufacturer of a pharmaceutical formulation and active pharmaceutical ingredient referred to in clause
(i), shall keep all necessary records to indicate the quantity of drug procured, manufactured, used, disposed of
in any manner and other matters related thereto; and
iv. where unapproved active pharmaceutical ingredient and pharmaceutical formulation manufactured in
accordance with the permission issued under rule 60 or the acknowledgement of the prior intimation under
the proviso of sub-rule (1) of rule 59 is left over or remains, unused or gets damaged or its shelf life has
expired or has been found to be of substandard quality, the same shall be destroyed and action taken in
respect thereof shall be recorded".
14. In the said rules, in rule 64, —
a. in sub-rule (1), after the words and figures "permission under rule 60", the words, brackets and figures "or
the acknowledgement under the proviso of sub-rule (1) of rule 59" shall be inserted;
b. in sub-rule (2), after the words, figures and letters "permission granted under rule 60 in Form CT-14 or CT-
15", the words, brackets and figures "or the acknowledgement of prior intimation obtained under the proviso
of sub-rule (1) of rule 59" shall be inserted.
15. In the said rules, in rule 66, for the sub-rule (2), the following sub-rule shall be substituted, namely: —
"(2) Where a new drug or an investigational new drug is manufactured by the holder of permission or acknowledgement
of prior intimation, on behalf of another person, he shall indicate on the label of the container of such drug, the name
and address of the manufacturer and the person to whom it is being supplied along with the scientific name of such drug,
if known, or the reference which shall enable such drug to be identified and the purpose for which it is manufactured.".
16. In the said rules, in the Eighth Schedule, —
a. in Form CT-10, —
i. in the heading, after the words “FOR GRANT OF PERMISSION”, the words “OR OF PRIOR
INTIMATION" shall be inserted;
ii. in the opening paragraph, after the words "apply for grant of permission", the words "or as prior intimation"
shall be inserted.
b. in Form CT-12, —
i. in the heading, after the words “FOR GRANT OF PERMISSION”, the words "OR OF PRIOR
INTIMATION" shall be inserted;
ii. in the opening paragraph, after the words "apply for grant of permission", the words "or as prior intimation"
shall be inserted.
c. in Form CT-13, —
i. in the heading, after the words “FOR GRANT OF PERMISSION”, the words "OR OF PRIOR
INTIMATION" shall be inserted;
ii. in the opening paragraph, after the words "apply for grant of permission”, the words "or as prior intimation"
shall be inserted.
[F. No. X11014/05/2025-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. 581 (E), dated 19th September, 2024.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.
GORAKHA NATH YADAVA Digitally signed by GORAKHA NATH YADAVA
Date: 2026.01.21 16:09:15 +05'30'
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