Executive Summary:
This notification from the Ministry of Health and Family Welfare announces a draft of amendments to the Drugs and Cosmetics Rules, 1945. It invites objections and suggestions from the public regarding these amendments, which will be considered after a period of ten days from the date the draft rules are made available. The amendments concern the Drugs and Cosmetics Rules, 1945.
Key Points / Main Content:
* **Purpose:** To amend the Drugs and Cosmetics Rules, 1945.
* **Authority:** The amendments are proposed by the Central Government, exercising powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940, and in consultation with the Drugs Technical Advisory Board.
* **Public Consultation:**
* The draft rules are published for public information.
* Objections and suggestions are invited and will be considered by the Central Government.
* Comments 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 upon their final publication in the Official Gazette.
* **Amendment Details:**
* Schedule H of the Drugs and Cosmetics Rules, 1945, is amended.
* A new paragraph 5 is inserted after paragraph 4 in the Note appended to Schedule H.
* Rule 65 and Rule 97 will be on a voluntary basis from the date of notification until March 31, 2019 for drugs specified from serial number 538 to 551, and thereafter shall be mandatory.
Impact Analysis:
Healthcare Professionals and Pharmaceutical Industry:
Impact: Pertaining to Schedule H drugs serial number 538 to 551, rule 65 and 97 compliance is voluntary until March 31, 2019, after which it becomes mandatory.
Action Required: Stakeholders should note the temporary voluntary status of compliance with rules 65 and 97 for specific drugs and prepare for mandatory compliance after March 31, 2019.
General Public:
Impact: The public is given an opportunity to provide feedback on the proposed changes to drug regulations, potentially influencing the final rules.
Action Required: Interested individuals can review the draft rules and submit objections or suggestions to the Ministry of Health and Family Welfare within the specified timeframe.
Key Entities Referenced
Drugs and Cosmetic Rules, 1945: A set of rules in India governing the import, manufacture, distribution, and sale of drugs and cosmetics.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture and distribution of drugs and cosmetics.
Drugs Technical Advisory Board: A board consulted by the Central Government in making rules regarding drugs and cosmetics.
Central Government: The Union Government of India.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy.
New Delhi: The capital of India.
Schedule H: A schedule within the Drugs and Cosmetics Rules, 1945, likely pertaining to specific regulations or classifications of drugs.
Dr. Mandeep K. Bhandari: Joint Secretary, as indicated by the signature in the notification.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 10th December, 2018
G.S.R. 1190(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), 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 ten 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 their final publication in the Official Gazette.
2. In the drugs and Cosmetics Rules 1945, in the Schedule H, in the Note appended thereto, after
paragraph 4 the following paragraph shall be inserted, namely,-
“5. Notwithstanding anything contained in these rules, the provisions of rule 65 and rule 97 in
respect of drugs specified from serial number 538 to serial number 551 inserted vide Notification
number G.S.R. 277(E) dated 23rd March, 2018 published in the Gazette of India, Extraordinary,
Part-II - Section (3) - Sub-section (i) shall be on voluntary basis for a period commencing on the day
on which this notification shall come into force and ending on the 31st March, 2019 and thereafter
shall be mandatory.”.
[F. No. X.-11014/14/2017-DRS]
Dr. MANDEEP K. BHANDARI, 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. ……., 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.