Drug controller says stem cell therapy is “new drug”; safety, efficacy not recognised

The new notification is in line with last year’s ICMR Guidelines that said stem cell except for some limited use is for investigational purposes

The Drug Controller General of India has decided to notify stem cell therapy as a “new drug”. This means that every time stem cells are manufactured, a special licence would be required from the Central Drugs and Standards Control Organisation (CDSCO), and also that the therapy is yet to be recognised by the drug controller as “effective and safe”.

In a notification issued earlier this month, the ministry of health which is the controlling ministry for CDSCO made amendments to Rule 122E of the Drugs and Cosmetics Rules, 1945 to include in it “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.”

Drug…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.”

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.”

While this is in line with the present position of the ICMR that most stem cell use in Indian patients is basically research and not therapy, the change in rule means that the drug controller can act against stem cell clinics for flouting the “new drug” norms. For new drugs, for a period of four years, surveillance data has to be submitted to the government. The inclusion under Rule 122E means that data for stem cells will have to be constantly submitted to the government till that rule is amended to exclude stem cells.

ICMR, the premier medical research body in the country when it came out with revised stem cell research guidelines last year had held: “The 2017 guidelines, reiterate that any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational at present. Accordingly, any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.”