To ensure unhindered access of 'stem cell therapy' for treatment by physicians, the Union Health Ministry has proposed to statutory distinguish it from 'stem cell drugs,' making the latter alone liable to the usual screening and trial runs stipulated for new drugs.



Apprising an international conference on stem cells of the government's move, Drug Controller General of India S Eswara Reddy today said the Union Health Ministry has proposed amendments in the Drugs and Cosmetics Rules, 1945 to regulate the Stem Cell-based drugs. The proposed amendments would demarcate 'stem cell- based drugs' from the 'stem cell therapy' and ensure that the physicians using the latest medical technique in treatment is not legally inconvenienced. Reddy was speaking at the 4th international conference SCSICON 2018 organised by the Stem Cell Society of India.

The proposed amendments to the Drugs and Cosmetics Rule, 1945, demarcating 'stem cell drugs' from the 'stem cell therapy' have been incorporated in the Gazette of India published on April 4. 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. Such '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, he said. On the other hand, 'more than minimally manipulated and substantially manipulated stem cells' would be considered as drug' under the amended Drugs and Cosmetics Rule, 1945, he said.

Elaborating further, Dr Sharma said 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.' Such cells would be termed as drugs as per the amended Drugs and Cosmetics Act 1945 and, accordingly, will have to undergo the requisite screening and trials, stipulated for a new drug.

The focus of the discussion in the conference was about the regulations for stem cell therapy in India. The scientists and doctors are hopeful about the future of stem cell therapy and welcome the new Indian Gazette," said Dr Sharma. These changes are very progressive following the recent developments in countries like Japan, Korea and USA. This amendment will facilitate growth of cell therapies in India and will also make these therapies available to lakhs of patients who are currently suffering with incurable diseases.