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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;

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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.

2018-04-05T16:23:29+0530ALOK KUMAR