The Gazette of India

CG-DL-E-08082026-275299

EXTRAORDINARY

PART II—Section 3—Sub-section (ii)

PUBLISHED BY AUTHORITY

No. 649] NEW DELHI, FRIDAY, AUGUST 7, 2026/SHRAVAN 16, 1948

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 6th August, 2026

G.S.R. 713(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945 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. 299(E), dated the 21st April, 2026, 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 22nd April, 2026;
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 sections 12 and 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 Drugs Rules, 1945, namely: —

1. (1) These rules may be called the Drugs (Twelfth Amendment) Rules, 2026.
(2) They shall come into force from the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, in rule 89, for the words and figures “Form 25 or Form 28” the words, figures and letters
“Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA or 28E or
Form 28F” shall be substituted.

[F. No. X.11014/03/2026-DR]
HARSH MANGLA, Jt. Secy.

Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45H (1), dated the
21st December, 1945 and last amended vide notification number G.S.R. 706 (E), dated the 30th July, 2026.

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The Gazette of India

CG-DL-E-07082026-275267

EXTRAORDINARY

PART II—Section 3—Sub-section (ii)

PUBLISHED BY AUTHORITY

No. 4164] NEW DELHI, THURSDAY, AUGUST 6, 2026/SHRAVAN 15, 1948

MINISTRY OF HEALTH AND FAMILY WELFARE
NOTIFICATION
New Delhi, 23rd July, 2026.

S.O. 4340(E).— In exercise of the powers conferred by sub-sections (1) and (2) of section 3 read with
section 4 of the National Commission for Allied and Healthcare Professions Act, 2021 (14 of 2021), the
Central Government hereby makes the following amendments further to amend the notification of the
Government of India in the Ministry of Health and Family Welfare number S.O.1248 (E), dated the 11th
March, 2024, published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (ii), dated the
11th March, 2024, namely:-

In the said notification, in paragraph (2) relating to the heading “Members under clause (c) of sub-section
(3) of section 3″, in the Table,-

(a) for serial number (viii) and the entries relating thereto, the following shall be substituted, namely:-

(b) for serial number (ix) and the entries relating thereto, the following shall be substituted, namely:-

[F. No. Z-28016/03/2023-AHS-Part (1)]
A. MUTHUKUMAR, Jt. Secy.

Note: The principal notification was published in the Gazette of India, Extraordinary, Part II, section 3, subsection (ii), vide notification number S.O. 1248 (E), dated the 11th March, 2024 and was last amended vide
notification number 850 (E), dated 17th February, 2026.

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The Gazette of India

CG-DL-E-09072026-274311

EXTRAORDINARY

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 549] NEW DELHI, THURSDAY, JULY 9, 2026/ASHADHA 18, 1948

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 8th July, 2026

G.S.R. 607(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 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. 760 (E), dated the 16th 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 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 18th October, 2025;
And whereas, no objections and suggestions received from the public on the said draft rules;

Now, therefore, in exercise of the powers conferred by sections 12 and 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
Drugs Rules, 1945, namely: —

1. (i) These rules may be called the Drugs (Tenth Amendment) Rules, 2026.
(ii) They shall come into force after the 6 months of publication of these rules in the Official Gazette.

2. In the Drugs Rules, 1945, ─

(i) in Schedule K, under the heading Extent and Conditions of Exemptions, against the serial no. 10, after the
words “Act and rules thereunder”, the words, figures, symbols, letters and brackets “except for all oral
formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles
of more than 30 milliliters.”, shall be inserted;

(ii) in Schedule H1, after the entry “51. Pregabalin”, the following entry shall be inserted, namely: ─
“52. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in
packings or bottles of more than 30 milliliters.”.

[F. No. X.11014/07/2025-DR-Part(3)]
HARSH MANGLA, Jt. Secy.

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Notification for consideration of Navi Mumbai International Airport (NMIA) as authorized Airport for Drug Import, under the provision of Rule 43A of Drugs Rules, 1945

Notification Designating Navi Mumbai International Airport for Drug Importation Under Drugs Rules

The Gazette of India

CG-DL-E-07072026-274223

EXTRAORDINARY

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 503] NEW DELHI, FRIDAY, JULY 3, 2026/ASHADHA 12, 1948

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd July, 2026

G.S.R. 561(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 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. 66(E), dated the 28th January, 2026 published in the Gazette of India, Extraordinary,
Part II, section 3, sub-section (i) dated the 28th January, 2026, 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 Official
Gazette containing the said notification were made available to the public;

And whereas, copies of the said Official Gazette were made available to the public on the 28th January, 2026;
And whereas, no objections and suggestions were received from the public in respect of the said draft rules;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government, after consultation with Drugs Technical Advisory Board, hereby makes the
following rules further to amend the Drugs Rules, 1945, namely:-

1. (1) These rules may be called the Drugs (Ninth Amendment) Rules, 2026.
(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Drugs Rules, 1945, in rule 43A, for the words “Cochin and Thiruvananthapuram”, the words, “Cochin,
Thiruvananthapuram and Navi Mumbai” shall be substituted.

[F. No. X.11035/131/2022-DR]
HARSH MANGLA, Jt. Secy.

Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st
December, 1945 and last amended vide notification number G.S.R. 530(E), dated 29th June, 2026.

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The Gazette of India

CG-DL-E-02072026-274000

EXTRAORDINARY

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 477] NEW DELHI, TUESDAY, JUNE 30, 2026/ ASHADHA 9, 1948

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 29th June 2026

G.S.R. 530(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 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. 758 (E), dated the 16th 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 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 18th October, 2025;
And whereas, no objections and suggestions received from the public on the said draft rules;
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 Drugs Rules, 1945, namely: —

1. (1) These rules may be called the Drugs (Eighth Amendment) Rules, 2026.
(2) These rules shall come into force on the date of their publication in the Official Gazette.

2. In the Drugs Rules, 1945, ─
(i). in rule 75, in sub-rule (3), after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”,
the words “Cell or Stem Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted;
(ii). in rule 75A, in sub-rule (1A), after the words, letters and brackets “Recombinant DNA (r-DNA) derived
drugs”, the words “‘Cell or Stem Cell derived products’, ‘Gene therapeutic products or Xenografts’” shall be
inserted;
(iii). in rule 76, for the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs” wherever may
occur, the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs, Cell or Stem Cell derived
products, Gene therapeutic products or Xenografts,” shall be substituted;
(iv). in rule 76A, for the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs”, the words,
letters and brackets “Recombinant DNA (r-DNA) derived drugs, Cell or Stem Cell derived products, Gene
therapeutic products or Xenografts,” shall be substituted;
(v). in SCHEDULE A, ─
(a) in Form 27D, ─

(A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”,
the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM
CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” shall be
substituted;

(B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem
Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted;
(b) in Form 27DA, ─
(A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”,
the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM
CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” shall be
substituted;
(B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem
Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted;
(c) in Form 28D, ─
(A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”,
the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM
CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” shall be
substituted;
(B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem
Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted;
(d) in Form 28DA, ─
(A) in the heading, for the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS”,
the words, letters and brackets “RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM
CELL DERIVED PRODUCTS, GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS,” shall be
substituted;
(B) after the words, letters and brackets “Recombinant DNA (r-DNA) derived drugs,”, the words “Cell or Stem
Cell derived products, Gene therapeutic products or Xenografts,” shall be inserted;

[F. No. X.11014/07/2025-DR-Part(2)]
HARSH MANGLA, Jt. Secy.

Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45H(1), dated the
21st December, 1945 and last amended vide notification number G.S.R. 506(E), dated 22nd June, 2026

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