Executive Summary:
This document publishes draft amendments to the Drugs and Cosmetics Rules, 1945, as proposed by the Central Government in consultation with the Drugs Technical Advisory Board. It invites objections and suggestions from affected persons, which must be submitted within forty-five days of the rules being made available to the public. The amendments are issued under the authority of the Drugs and Cosmetics Act, 1940.
Key Points / Main Content:
* **Amendment Purpose:** To further amend the Drugs and Cosmetics Rules, 1945.
* **Authority:** Issued under section 12 and section 33 of the Drugs and Cosmetics Act, 1940.
* **Public Consultation:** Invites objections and suggestions from persons likely to be affected.
* The deadline for submitting feedback is forty-five days after the draft rules are made available.
* Feedback should be addressed to the Under Secretary Drugs, Ministry of Health and Family Welfare, or emailed to drugsdivmohfwgov.in.
* **Effective Date:** The rules will come into force on the date of their final publication in the Official Gazette.
* **Rule Amendment:** Rule 127 of the Drugs and Cosmetics Rules, 1945 is amended:
* In subrule 2, the following words shall be inserted: "except gelatine capsules wherein approved or permitted colour shall be used"
Impact Analysis:
Stakeholders Impacted:
* Drug Manufacturers:
* Impact: Must comply with the amended Rule 127 regarding the use of approved or permitted colors in gelatine capsules.
* Action Required: Implement the change in manufacturing processes to ensure compliance with the new rule.
* Public/Citizens:
* Impact: Affected by changes in drug manufacturing regulations.
* Action Required: May submit objections or suggestions regarding the draft rules within the specified timeframe.
* Government (Ministry of Health and Family Welfare):
* Impact: Responsible for considering feedback, finalizing, and implementing the amended rules.
* Action Required: Review submitted objections and suggestions, finalize the rule amendments, and publish the final notification in the Official Gazette.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India related to the regulation of drugs and cosmetics. This notification proposes amendments to these rules.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
Central Government: The executive authority of the Union of India, responsible for making and implementing policies.
Drugs Technical Advisory Board: A statutory body in India that advises the Central Government on technical matters related to drugs and cosmetics.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy in India.
New Delhi: The capital of India, where the notification was issued and the address for objections is located.
Drugs and Cosmetics Amendment Rules, 2018: The name given to the set of rules that amend the Drugs and Cosmetics Rules, 1945.
Official Gazette: A public journal and an authorized legal document of the Government of India, used for publishing official notifications.
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4396 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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[फा. सं. ए; स.11014/15/2018-डीआर]
सुधीर कुमार, संयु; त सिचव
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 30th July, 2018
G.S.R. 721(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945,
which the Central Government proposes to make, in exercise of the powers conferred by section 12 and section 33 of the
Drugs and Cosmetics Act, 1940 (23 of 1940), in consultation 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 will
be taken into consideration on or after the expiry of a period of forty-five 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) It shall come into force on the date of its final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, in rule 127, in sub-rule (2), at the end, the following
words shall be inserted namely:-
“except gelatine capsules wherein approved or permitted colour shall be used”
[F.No. X.11014/15/2018-DR]
SUDHIR KUMAR, Jt. Secy.
Note: The principal rules 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 GSR ..........(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.