Executive Summary:
This notification announces the Drugs and Cosmetics Eighth Amendment Rules, 2018, further amending the Drugs and Cosmetics Rules, 1945. It addresses objections and suggestions received from the public regarding a previous draft. The rules come into force on the date of their publication in the Official Gazette, with a transition period for voluntary labeling requirements until March 31, 2019, after which they become mandatory.
Key Points / Main Content:
Amendments to Drugs and Cosmetics Rules, 1945:
* These rules are called the Drugs and Cosmetics Eighth Amendment Rules, 2018.
* Effective Date: The rules come into force on the date of publication in the Official Gazette.
* Amendment to Rule 96: In rule 96, subrule 1, clause i, subclause A, the words in the same font but shall be omitted
* Voluntary Labeling: Additional labeling requirements specified in notification G.S.R. 222E, dated March 13, 2018, are voluntary from September 13, 2018, to March 31, 2019.
* Mandatory Labeling: After March 31, 2019, the additional labeling requirements become mandatory.
Impact Analysis:
Manufacturers/Stakeholders:
Impact: Must be aware of the new amendments to the Drugs and Cosmetics Rules, 1945, specifically regarding labeling requirements.
Action Required: Implement the additional labeling requirements on a voluntary basis until March 31, 2019, and ensure mandatory compliance thereafter.
Regulatory Bodies (Ministry of Health and Family Welfare, Drugs Technical Advisory Board):
Impact: Responsible for enforcing the amended rules and ensuring compliance.
Action Required: Oversee the implementation of the new rules, monitor compliance, and provide guidance to stakeholders.
Public:
Impact: Affected by changes in drug labeling, which aims to improve information and safety.
Action Required: Be aware of the updated labeling requirements on drug products.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules governing the regulation of drugs and cosmetics in India. The notification pertains to 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.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
New Delhi: The capital city of India, where the notification was issued.
G.S.R. 1161E: Notification number related to amendment of Drugs and Cosmetics Rules, 1945.
Drugs Technical Advisory Board: A board that the Central Government consults with to amend the Drugs and Cosmetics Rules.
Drugs and Cosmetics Eighth Amendment Rules, 2018: The title of the specific amendment rules being introduced.
G.S.R. 222E: Notification number specifying additional requirements of labeling.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 3rd December, 2018
G.S.R.1161(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was
published as required under section 12 and 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. 764(E), dated the 10th August, 2018, 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 Official Gazette containing the said notification were made
available to the public;
And whereas, copies of the Gazette were made available to the public on the 14th August, 2018;
And whereas, objections and suggestions received from the public on the said rules have been considered by the
Central Government;
Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics
Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby
makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:-
1. (1) These rules may be called the Drugs and Cosmetics (Eighth Amendment) Rules, 2018.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, in rule 96, in sub-rule (1), in clause (i),-
(1) in sub-clause (A), the words “in the same font but” shall be omitted.
(2) at the end of sub-clause (A) the following sub-clause shall be inserted, namely,-
“(AA) Notwithstanding anything contained in these rules, the additional requirements of labeling specified
vide notification number G.S.R. 222(E) dated the 13th March, 2018 published in the Gazette of India,
Extraordinary, Part-II - Section (3) - Sub-section(i) shall be on voluntary basis for a period beginning on
the 13th September, 2018 and ending on the 31st March, 2019 and thereafter shall be mandatory.”.
[F.No. X.11014/5/2017-DRS]
DR. MANDEEP K BHANDARI, Jt. Secy.
Note: The principal rules were published in the Gazette of India vide notification number F.28-10/45-H (1), dated
21st December, 1945 and last amended vide notification number G.S.R. 795(E), dated 21st August, 2018.
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.