Executive Summary:
This notification from the Ministry of Health and Family Welfare announces the Drugs and Cosmetics Ninth Amendment Rules, 2019, which amend the Drugs and Cosmetics Rules, 1945. These rules address the modified application of labeling requirements for a specified period. The new rules came into force on March 20, 2019.
Key Points / Main Content:
* **Amendment and Authority:**
* The notification introduces the Drugs and Cosmetics Ninth Amendment Rules, 2019.
* These rules are enacted under the authority of sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
* **Effective Date:**
* The rules came into force on the date of their publication in the Official Gazette: March 20, 2019.
* **Rule 97A: Modified Application of Rules 96 and 97:**
* Rule 97A is inserted into the Drugs and Cosmetics Rules, 1945.
* Modified or additional labeling requirements specified in notification G.S.R. 408E, dated April 26, 2018, were voluntary until March 31, 2019.
* After March 31, 2019, these labeling requirements became mandatory.
Impact Analysis:
Stakeholders: Manufacturers and distributors of drugs and cosmetics.
* Impact: Manufacturers and distributors are subject to modified or additional labeling requirements.
* Action Required: Ensure compliance with the mandatory labeling requirements that took effect on April 1, 2019.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament related to drugs and cosmetics, under which the current notification is issued.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare policies and regulations.
New Delhi: The location where the notification was issued. New Delhi, Delhi
Drugs Technical Advisory Board: A board that the Central Government consults with when amending the Drugs and Cosmetics Rules, 1945.
Drugs and Cosmetics Ninth Amendment Rules, 2019: The name of the new rules introduced by this notification, amending the existing Drugs and Cosmetics Rules, 1945.
G.S.R. 408E, dated the 26th April, 2018: A notification related to modified or additional requirements of labelling.
Dr. Mandeep K. Bhandari: Joint Secretary in the relevant Ministry and the signatory of the notification.
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1815 GI/2019 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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[फा .सं. ए5स .11014/06/2016-डीएफ5 यूसी]
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1945 म/ (cid:15)कािशत (cid:4)कया गया था और अंितम संशोधन अिधसचू ना स.ं सा.का.िन. 223(अ), तारीख 18 माच,(cid:12) 2019
"ारा (cid:4)कया गया था।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 20th March, 2019.
G.S.R.231(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics 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. 1185(E), dated the 7th
December, 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 seven 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 7th
December, 2018;
And whereas, objections or 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 sections 12 and 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 (Ninth Amendment) Rules, 2019.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, after rule 97 the following rule shall be inserted, namely:―
“97A. Modified application of rules 96 and 97 for certain period.- Notwithstanding anything contained in
these rules, the modified or additional requirements of labelling as may be specified in the notification of the
Government of India in the Ministry of Health and Family Welfare number G.S.R. 408(E), dated the 26th
April, 2018, shall be on voluntary basis for a period commencing on the date of coming into force on this rule
and ending on the 31st day of March, 2019, and thereafter shall be mandatory.”.
[F.No. X.11014/06/2016 - DFQC]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note : The Drugs and Cosmetics Rules, 1945 was published in the Official Gazette vide notification number
F. 28-10/45-H (1), dated the 21st December, 1945 and last amended vide notification number
G.S.R. 223(E), dated the 18th March, 2019.
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.