Executive Summary:
This notification announces draft rules to further amend the Drugs and Cosmetics Rules, 1945, under the Drugs and Cosmetics Act, 1940. It invites objections and suggestions from affected parties regarding these amendments. The draft rules address the modified application of labeling requirements, making them voluntary until March 31, 2019, after which they become mandatory.
Key Points / Main Content:
* **Purpose:** To amend the Drugs and Cosmetics Rules, 1945.
* **Legal Basis:** Amendments are made under Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940.
* **Consultation:** The amendments follow consultation with the Drugs Technical Advisory Board.
* **Public Input:**
* Objections and suggestions regarding the draft rules are invited from the public.
* These must be submitted to the Under Secretary Drugs, Ministry of Health and Family Welfare.
* Submissions can be made via email or postal mail.
* **Effective Dates:**
* The Drugs and Cosmetics Amendment Rules, 2018, will come into force upon final publication in the Official Gazette.
* Modified labeling requirements are voluntary until March 31, 2019, and mandatory thereafter.
Impact Analysis:
* **Drug Manufacturers/Labelers:**
* Impact: Need to be aware of the changes to labeling requirements and prepare to implement them on a mandatory basis after March 31, 2019.
* Action Required: Voluntarily adopt the modified labeling requirements until March 31, 2019, and ensure full compliance thereafter.
* **Ministry of Health and Family Welfare:**
* Impact: Responsible for reviewing and considering public feedback on the draft rules.
* Action Required: Review and address any objections/suggestions received. Finalize and publish the amended rules in the Official Gazette.
* **General Public:**
* Impact: Affected by potential changes to drug labeling requirements.
* Action Required: Review the draft rules and submit any objections or suggestions within the specified period.
Key Entities Referenced
Drugs and Cosmetic Rules, 1945: A set of rules governing drugs and cosmetics in India, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: The Act of the Indian Parliament that provides for the regulation of the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs Technical Advisory Board: A board consulted by the Central Government in the process of amending the Drugs and Cosmetic Rules.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
New Delhi: The location where the notification was issued. Capital of India.
G.S.R. 408E: A notification number of the Government of India, Ministry of Health and Family Welfare related to modified or additional requirements of labelling.
Dr. Mandeep K. Bhandari: The Joint Secretary who signed the notification.
31st March, 2019: The date after which the modified or additional requirements of labelling shall be mandatory.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 7th December, 2018
G.S.R. 1185(E).—The following draft of certain rules further to amend Drugs and Cosmetic 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), after 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 seven
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 drugs div-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 their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945 after rule 97 the following rule shall be inserted, namely:-
“ 98 Modified application of Rule 96 and 97 for certain period.- Notwithstanding anything contained
in these rules the modified or additional requirements of labelling as the case may be specified vide
Notification of the Government of India, Ministry of Health and Family Welfare number G.S.R.
408(E) dated the 26th April, 2018 published in Part II, Section 3, Sub-section (i) of the Gazette of
India, Extraordinary, shall be on voluntary basis for a period commencing on the day this notification
shall come into force and ending on the 31st March, 2019 and thereafter shall be mandatory.”.
[F. No. X-11014/6/2016-DFQC]
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. ….(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.