- In order to regulated the unregularised stem cell industry in India. The government has decided to bring it under the ambit of the Drug and Cosmetic Act.
- The health ministry said that stem cells and their derivatives will have to follow protocols mandated for any new drug development.
- The government has taken this step to define stem cells as drugs.
As per the government notification, “Stem cell and cell-based products 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 an aim to curb the rampant use of stem cell therapy in India, the union health ministry has decided to amend the Drugs and Cosmetic Act. The government has prepared the draft rules. Till now, stem cells have not been governed by any act and have been widely used by the medical practitioners as a form of therapy for patients.
The Indian council of Medical research (ICMR) had strongly advocated, regulating the stem cell industry in India. And in 2017, it had submitted a set of guidelines. Over the years, stem cell use has been a widely debated topic among the doctors and health experts.
The Governments proposed draft states:
- Stem cell and cell-based products 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.
Explanation: For the purpose of this clause
- 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.
- 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.
- 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.
Doctors and the Stem Cell Society of India, has welcomed this move. While speaking to My Medical Mantra, Vice President of the Stem Cell Society of India, Dr Rohit Kulkarni said, “We are happy that a regulation is coming in on stem cells. This law will give us clarity and no longer will there be any grey area which will remain. This is indeed a welcome move by the government.”
Nowadays, stem cells have been widely used for cancer, neuro and muscular ailments treatment. Dr Nirmal Surya, President of the Epilepsy Foundation and a renowned Mumbai-based neurologist said, “The government should bring stem cells under strict regulation. Many times this therapy has been misused. And if someone is misusing this, the government should act against them.”