The Union health ministry earlier in this month has proposed to amend Drugs and Cosmetics Act that may finally bring stem cells and cell-based products under the ambit of the law. In a notification issued on April 4, the ministry defined the category of stem cells and their derivatives that would be termed a drug, and would thereby have to follow the protocols mandated for any drug development.
Drug Controller General of India S Eswara Reddy said the Union Health Ministry has proposed amendments in the Drugs and Cosmetics Rules, 1945 to regulate the Stem Cell-based drugs. Reddy was speaking at the 4th international conference SCSICON 2018 organised by the Stem Cell Society of India on 28-29th April 2018.
Stem Cell Society of India President Dr Alok Sharma said the cells or tissues taken from the patient’s body and merely subjected to cleaning and separation for administering immediately without its manipulation outside the body is termed as ‘minimally manipulated stem cells.’ On the other hand, the cells or tissues taken out from the body and multiplied or subjected to genetic manipulation in the laboratory and subsequently stored for administering it to the same or another patient are termed ‘more than minimally manipulated stem cells.’ More than minimally manipulated and substantially manipulated stem cells’ would be considered as ‘drug’ under the amended Drugs and Cosmetics Rule, 1945, whereas ‘minimally manipulated stem cells’ would form part of the ‘stem cell therapy’ and fall under the purview of surgeons or clinicians as opposed to ‘stem cell drugs’ which would be a product or a drug.
by Kamal Pratap Singh