The Ministry of Health and Family Welfare of India, after consultations with the Drugs Technical Advisory Board (DTAB), has proposed a draft amendment to the Drugs and Cosmetics Rules, 1945, that defines stem cell-based products (SCBP) to streamline the regulatory framework for advanced research and regenerative therapies in this rapidly growing field.
The amendment proposes to add a comprehensive definition of stem cell-based drug. The draft also provided guidelines for gene editing techniques.
Stem cells are found in the body’s organs, tissues, blood and immune system and have the ability to regenerate into additional stem cells or differentiate into specialised cells, such as nerve or blood cells. However, their use in the treatment of such diseases involves a complex multi-step process which entails the challenge of balancing the expected therapeutic benefits with the potential risks while complying with the existing regulations and guidelines. While effective and stringent regulatory guidelines are in place in the US and the European Union, India still doesn’t have specific and standard norms for SCBP.
As per the newly proposed clause, a stem 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 and gene modification”.
A ‘substantial or more than minimal manipulation’ is further elaborated as “ex-vivo alteration in the cell population including T-Cell depletion and cancer cell depletion and expansion which is expected to result in alteration of function”. As per the proposed clause, 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, sterilisation by washing or gamma irradiation, freezing, thawing and such similar procedures are regarded as minimal manipulations. They are not considered as processing by means of substantial or more than minimal manipulation. Moreover, human cells or tissues removed from an individual for implantation 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.
The draft amendment is open to public comments and concerns till May 18.