Executive Summary:
This notification announces a draft of amendments to the Drugs and Cosmetics Rules, 1945, concerning drugs supplied by health functionaries and volunteers. The Central Government proposes these changes following consultations with the Drugs Technical Advisory Board. Public comments and suggestions on the draft are invited within 45 days of the Gazette of India's publication. The proposed rules will come into force upon final publication in the Official Gazette.
Key Points / Main Content:
* **Amendment Purpose:** Further amend the Drugs and Cosmetics Rules, 1945.
* **Legal Basis:** Based on subsection 1 of section 12 and subsection 1 of section 33 of the Drugs and Cosmetics Act, 1940.
* **Consultation:** Amendments proposed after consultation with the Drugs Technical Advisory Board.
* **Public Comment:** Objections and suggestions are invited within 45 days of the Gazette's publication.
* **Submission of Comments:** Comments should be addressed to the Under Secretary Drugs, Ministry of Health and Family Welfare, or emailed to drugsdivmohfwgov.in.
* **Effective Date:** The rules shall come into force on the date of their final publication in the Official Gazette.
* **Amendment Details:**
* In Schedule K of the Drugs and Cosmetics Rules, 1945, serial number 23 concerning the column Class of Drugs will be substituted with:
* Drugs supplied by Health Functionaries including Community Health Officers, Nurses, Auxiliary Nurse Midwives and Lady Health Visitors attached to Primary Health Centres SubCentres Health Wellness Centres in rural and urban areas.
* Community Health Volunteers such as Accredited Social Health Activists ASHAs under the National Health Mission.
* Anganwadi Workers.
Impact Analysis:
* **Health Functionaries and Volunteers (Community Health Officers, Nurses, Auxiliary Nurse Midwives, Lady Health Visitors, ASHAs, Anganwadi Workers):**
* *Impact:* Specifies the categories of health personnel and volunteers authorized to supply certain drugs under the Drugs and Cosmetics Rules.
* *Action Required:* Be aware of the updated classifications and how it affects the supply of drugs in their respective roles.
* **Central Government (Ministry of Health and Family Welfare):**
* *Impact:* Responsible for reviewing public comments and finalizing the amendments to the Drugs and Cosmetics Rules.
* *Action Required:* Consider and address public feedback, finalize the amendments, and publish them in the Official Gazette.
* **Drugs Technical Advisory Board:**
* *Impact:* Consulted in the drafting of these amendments.
* *Action Required:* No further action mentioned.
* **General Public:**
* *Impact:* The changes affect the availability of drugs through community health channels.
* *Action Required:* Review the proposed rules and submit any objections or suggestions within 45 days of the Gazette's publication.
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.
Drugs Technical Advisory Board: A board consulted by the Central Government in India regarding the Drugs and Cosmetics Act.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
New Delhi: The location of the Ministry of Health and Family Welfare in India.
Health Functionaries: A group of people including Community Health Officers, Nurses, Auxiliary Nurse Midwives and Lady Health Visitors attached to Primary Health Centres SubCentres Health Wellness Centres in rural and urban areas in India
National Health Mission: A national health program in India.
Accredited Social Health Activists ASHAs: Community health volunteers under the National Health Mission in India.
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EXTRAORDINARY
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[फा. सं. एdस .11014/13/2019 – डीआर]
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संशोिधत (cid:4)कए गए थ।े
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 6th November, 2019
G.S.R. 827(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 sub-
section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940)
and 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 the said draft rules shall be taken into
consideration on or after the expiry of a period of forty-five days from the date on which the copies of the
Gazette of India containing these draft rules are made available to 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, 2019.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, in Schedule K, against serial number 23, for the entries
under the column “Class of Drugs”, the following shall be substituted, namely:―
“Drugs supplied by (i) Health Functionaries including Community Health Officers, Nurses, Auxiliary
Nurse Midwives and Lady Health Visitors attached to Primary Health Centres/ Sub-Centres/ Health &
Wellness Centres in rural and urban areas, (ii) Community Health Volunteers such as Accredited
Social Health Activists (ASHAs) under the National Health Mission, and (iii) Anganwadi Workers.”
[F. No. X.11014/13/2019-DR]
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 the 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.