On April 04, 2018 Ministry of Health and Family Welfare proposes a draft to amend Drug and Cosmetics Rule, 19451 that defines stem cell and stem cell based products (SCBP) to streamline the regulatory framework for advanced research.

Central government in exercise the power conferred by section 12 and section 33 of the drug and cosmetics Act, 1940  and after consultation with the Drugs Technical Advisory Board, has published the draft proposal via gazette notification for information of all persons likely to be affected thereby; further, this 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 Official Gazette containing these draft rules are made available to the public;

The proposed draft rule amend 122E of the Drugs and Cosmetics Rules, 1945 where after the clause (c) and before explanation the following clause and explanation shall be inserted -

"(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. "

Key Takeaway- The proposed draft defines Stem Cell and Cell based Product as a drug, which has been derived from processed cells by means of substantial and more than minimal manipulation with the objective of differentiation of the cell or tissue. Moreover, the draft further explained substantial or more than minimal manipulation processing methods involves during stem cell preparation.


1 http://www.cdsco.nic.in/writereaddata/April%204th%20%202018%20GSR%20334(E).pdf

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