Govt to define stem cells as DRUG, regulate use in therapy

New Delhi: Ministry Of Health and Family Welfare has proposed the further amendment to the Drugs and Cosmetics Act bringing down the stem cells under the category of drug in order to bring stem cells and cell-based products under the territory of the law.

The health ministry in its notification issued on April 4, has informed that the stem cells and their derivatives that would be termed a drug, and would thereby have to follow the protocols mandated for any drug development.

It further has amended that stem cells and products which are substantially altered, amounting to a change in biological characteristics or those subjected to gene editing or modification will be treated as a drug and will have to seek the regulator’s approval before coming to the market.

According to the notification, where the individual’s own stem cells are collected and minimally treated before infusing it back into the patient without checking, such therapies meant to repair or regenerate damaged cells, tissues and organs are more widely used in centres across the country these would be considered “minimal manipulation”. Hence, doctors could continue to offer them without requiring a nod from the drug regulatory body.

The amendment was proposed after the consultation with the Drugs Technical Advisory Board. The ministry has said that the objections and suggestions which may be received from any person within the period specified forty five days 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 druqsdiv-mohfwgov.in.

What DRAFT RULES SAY

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. ”

Below is the attached notification for the same.