Health Ministry distinguishes stem cell-therapy from drugs
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 stated that 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. 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.