A notification earlier this month for stricter clinical trial norms for stem cells has raised concerns
Drug controller general of India S Eshwara Reddy on Sunday said that the law has been amended to ensure unhindered access to stem cell therapy. A distinction has been made between the therapy and stem cell drugs and only the latter would be subject to the clinical trial requirements of new drugs.
The statement would cool nerves as an April 4 notification bringing stem cells under the ambit of new drugs has caused apprehensions in the sector.
Speaking at the 4th international conference SCSICON 2018 organised by the Stem Cell Society of India, Reddy said that the proposed amendments would demarcate ‘stem cell- based drugs’ from the ‘stem cell therapy’. This would ensure that the physicians using the latest medical technique in treatment is not legally inconvenienced.
Cells or tissues taken from the patients body and administered immediately without its manipulation outside the body is termed as ‘minimally manipulated stem cells’
The April 4 notification concerns amendments to Rule 122E of the Drugs and Cosmetics Rules, 1945. The amended rule would include “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.”
The rule concerns a new drug or a “A drug, as defined in the Act including bulk drugs substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognised as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims: Provided that the limited use, if any, has been with the permission of the licensing authority.”
Explaining the proposed demarcation between the two key terms, Stem Cell Society of India president Dr Alok Sharma said the cells or tissues taken from the patients body and merely subjected to cleaning and separation for administering immediately without its manipulation outside the body is termed as ‘minimally manipulated stem cells.’
He said such ‘minimally manipulated stem cells’ would not be considered a ‘drug’ and, so, it would not fall under the purview of the Drugs and Cosmetics Rule, making it liable to statutory screening and trial runs, which the new drugs have to undergo.
