Executive Summary:
This document is a notification regarding proposed amendments to the Drugs and Cosmetics Rules, 1945, under the Drugs and Cosmetics Act, 1940. It publishes draft rules for public information and solicits objections or suggestions, which must be submitted within fifteen days of the Gazette's publication. Submissions should be directed to the Under Secretary Drugs, Ministry of Health and Family Welfare.
Key Points / Main Content:
* **Proposed Amendments to the Drugs and Cosmetics Rules:**
* The document contains draft rules to amend the Drugs and Cosmetics Rules, 1945.
* The amendments are made under the powers conferred by section 6, section 12, and section 33 of the Drugs and Cosmetics Act, 1940.
* The draft rules have been made in consultation with the Drugs Technical Advisory Board, after publication.
* **Effective Date:**
* The rules shall come into force on the date of their final publication in the Official Gazette.
* **Amendment to Rule 3A:**
* In Rule 3A of the Drugs and Cosmetics Rules, 1945, a new subrule (9) will be inserted after subrule (8).
* The testing of veterinary vaccines will be carried out at the Chaudhary Charan Singh National Institute of Animal Health, Baghpat, Uttar Pradesh.
* The Director of the said Institute will exercise the functions of the Director in respect of the veterinary vaccines.
* **Veterinary Vaccines Affected:**
* Haemorrhagic Septicaemia vaccine.
* Ranikhet Disease vaccine.
Impact Analysis:
Stakeholders Potentially Affected: All persons likely to be affected by the draft rules.
* Impact: May need to adjust practices to align with amended regulations concerning drugs and cosmetics, particularly regarding veterinary vaccines.
* Action Required: Review the draft rules, and submit any objections or suggestions to the Under Secretary Drugs within fifteen days of the Gazette's publication.
Ministry of Health and Family Welfare:
* Impact: Responsible for considering and addressing objections/suggestions received regarding the draft rules.
* Action Required: Review and address any objections or suggestions received from the public regarding the proposed amendments.
Chaudhary Charan Singh National Institute of Animal Health, Baghpat, Uttar Pradesh:
* Impact: Will be responsible for carrying out the testing of Haemorrhagic Septicaemia and Ranikhet Disease vaccines. The Director will exercise related functions.
* Action Required: Prepare to undertake the testing of specified veterinary vaccines and ensure the Director is prepared to exercise the associated functions.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary legislation being amended by the notification.
Drugs Technical Advisory Board: The advisory board consulted during the rule-making process.
Ministry of Health and Family Welfare: The government ministry responsible for the notification.
Drugs and Cosmetics Amendment Rules, 2018: The title of the new rules being introduced.
Drugs and Cosmetics Rules, 1945: The existing rules being amended.
Chaudhary Charan Singh National Institute of Animal Health, Baghpat, Uttar Pradesh: The laboratory designated for testing certain veterinary vaccines, located in Uttar Pradesh, India.
Haemorrhagic Septicaemia vaccine: A veterinary vaccine that will be tested at the designated institute.
Ranikhet Disease vaccine: A veterinary vaccine that will be tested at the designated institute.
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EXTRAORDINARY
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PART II—Section 3—Section (i)
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PUBLISHED BY AUTHORITY
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4092 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(i) हमै ोरहिैजक सेि-टसीिमया टीका
(ii) रानीखेत रोग टीका ’’ ।
[फा.स.ए*स.11035/285/2018-डीआरएस]
सुधीर कुमार, संयु" सिचव
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(cid:1)कया गया और अंितम बार अिधसूचना सं0 सा.का.िन._________(अ), तारीख: ________, के तहत संशोिधत (cid:1)कया गया।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 17th July, 2018
G.S.R. 654(E).— The following draft of certain rules, which the Central Government proposes to make, in
exercise of the powers conferred by section 6, section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of
1940) and in consultation after publication with the Drugs Technical Advisory Board is hereby published for information
of all persons likely to be affected thereby and notice is hereby given that said draft rules shall be taken into
consideration on or after the expiry of a period of fifteen days from the date on which copies of the Gazette of India
containing these draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (1) These rules may be called the Drugs and Cosmetics (……Amendment) Rules, 2018.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, in rule 3A, after sub-rule (8), the following sub-rule shall be
inserted, namely :—
“(9) The functions of the laboratory in respect of testing of the following veterinary vaccines shall be
carried out at the Chaudhary Charan Singh National Institute of Animal Health, Baghpat, Uttar Pradesh
and the functions of the Director in respect of the said veterinary vaccines shall be exercised by the
Director of the said Institute :—
(i) Haemorrhagic Septicaemia vaccine
(ii) Ranikhet Disease vaccine ”.
[F.No.X.11035/285/2018-DRS]
SUDHIR KUMAR, Jt. Secy.
Note - The principal rules were published in the Gazette of India vide notification No. F.28-10/45-H (1), dated 21st
December, 1945 and last amended vide notification number G.S.R. ….. (E), dated……..
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.