Executive Summary:
This notification from the Ministry of Health and Family Welfare publishes draft amendments to the Drugs and Cosmetics Rules, 1945. These amendments, made under the Drugs and Cosmetics Act, 1940, include revisions to rule 122E concerning Stem Cell and Cell-based Products. The public has 45 days from the date the Gazette is available to submit objections or suggestions.
Key Points / Main Content:
* **Amendment Context:**
* The Central Government proposes further amendments to the Drugs and Cosmetics Rules, 1945.
* These amendments are made in exercise of powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
* The amendments follow consultation with the Drugs Technical Advisory Board.
* **Effective Date:**
* The rules will come into force on the date of their final publication in the Official Gazette.
* **Amendment to Rule 122E:**
* A new clause "d" is inserted into rule 122E of the Drugs and Cosmetics Rules, 1945, defining "Stem Cell and Cell-based Product".
* Stem Cell and Cell based Product means a drug which has been derived from processed cells including cell or tissue which has been processed by means of substantial or more than minimal manipulation with the objective of propagation and or differentiation of a cell or tissue,' cell activation, and production of a cellline, which includes pharmaceutical or chemical or enzymatic treatment, altering a biological characteristic, combining with a noncellular component, manipulation by genetic engineering including gene editing gene modification
* **Explanation of Manipulation:**
* *Substantial or more than minimal manipulation* means ex-vivo alteration in the cell population (T-Cell depletion, cancer cell depletion, expansion) expected to result in alteration of function.
* *Minimal manipulations* include isolation of tissue, washing, centrifugation, suspension in acceptable medium, cutting, grinding, shaping, overnight culturing without biological and chemical treatment, disintegration of tissue, separation of cells, isolation of a specific cell, treatment with antibiotics, sterilization by washing or gamma irradiation, freezing, thawing and such similar procedures.
* Human cells/tissues removed from an individual for implantation into the same individual during the same surgical procedure, undergoing only rinsing, cleaning, or sizing, are not considered as processing.
Impact Analysis:
* **Drug Manufacturers and Researchers:**
* *Impact:* Must adhere to the new definitions and regulations for Stem Cell and Cell-based Products.
* *Action Required:* Review manufacturing and research processes to ensure compliance with the amended rules and definitions, particularly regarding cell manipulation.
* **Public and Stakeholders:**
* *Impact:* Affected by the regulations concerning stem cell and cell-based products.
* *Action Required:* Submit objections and suggestions regarding the draft rules to the Under Secretary Drugs within 45 days of the Gazette being made available to the public.
* **Central Government (Ministry of Health and Family Welfare):**
* *Impact:* Responsible for considering public feedback and finalizing the rule amendments.
* *Action Required:* Review and consider all objections and suggestions received from the public before finalizing the amendments to the Drugs and Cosmetics Rules, 1945.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules governing the regulation of drugs and cosmetics in India, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: The principal legislation governing drugs and cosmetics in India, under which the Drugs and Cosmetics Rules were framed and are being amended.
Drugs Technical Advisory Board: A board consulted by the Central Government in making amendments to the Drugs and Cosmetics Rules, 1945.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare policies and regulations. It is the department under which the notification is issued.
New Delhi: The location of Ministry of Health and Family Welfare
Drugs and Cosmetics Amendment Rules, 2018: The name given to the set of amendments to the Drugs and Cosmetics Rules, 1945, as proposed in this notification.
Stem Cell and Cell based Product: A definition of 'Stem Cell and Cell based Product' introduced in the amendment to Drugs and Cosmetics Rules.
Nirman Bhavan, New Delhi 110011: Location where Objections and suggestions may be addressed.
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2006 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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[एफ.स.ं एB स.11014/21/2017-डीआरएस]
सुधीर कुमार, संयुB त सिचव
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(cid:4)कया गया।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 4th April, 2018.
G.S.R. 334(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 sections 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 as required by sub-section (1) of the section 33 of the said Act 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 forty five days from the date on which the copies of the Official Gazette 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;¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
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
druqsdiv-mohfwgov.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 of their final publication in the Official Gazette.
2. In rule 122E of the Drugs and Cosmetics Rules, 1945 after the clause (c) and before explanation the following
clause and explanation shall be inserted, namely,-
"(d) Stem Cell and Cell based Product means a drug which has been derived from processed cells
including cell or tissue which has been processed by means of substantial or more than minimal
manipulation with the objective of propagation and / or differentiation of a cell or tissue,' cell activation,
and production of a cell-line, which includes pharmaceutical or chemical or enzymatic treatment, altering
a biological characteristic, combining with a non-cellular component, manipulation by genetic
engineering including gene editing & gene modification.
Explanation - For the purpose of this clause–
(i) Substantial or more than minimal manipulation means ex-vivo alteration in the cell population
(T-Cell depletion, cancer cell depletion), expansion, which is expected to result in alteration of
function.
(ii) The isolation of tissue, washing, centrifugation, suspension in acceptable medium, cutting,
grinding, shaping, overnight culturing without biological and chemical treatment,
disintegration of tissue, separation of cells, isolation of a specific cell, treatment with
antibiotics, sterilization by washing or gamma irradiation, freezing, thawing and such similar
procedures, regarded as minimal manipulations and are not considered as processing by means
of substantial or more than minimal manipulation.
(iii) Human cells or tissues removed from an individual for implantation of such cells or tissues
only into the same individual for use during the same surgical procedure should not undergo
processing steps beyond rinsing, cleaning or sizing and these steps shall not be considered as
processing. ”
[F. No. X.11014/21/2017-DRS]
SUDHIR KUMAR, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No.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.