Above: A synthetic version of a cardiac stem cell which offers benefits comparable to those from natural stem cells and reduces the risks associated with stem cell therapies/Photo: UNI

In a welcome development, the Union health ministry has proposed an amendment to Drugs and Cosmetics Act so that stem cells can be termed a drug and follow protocols mandated for drug development

~By Dr KK Aggarwal

The Union health ministry has proposed an amendment to the Drugs and Cosmetics Act that may finally bring stem cells and cell-based products within the ambit of the law. At present, stem cell research is being looked after by the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) under the Indian Council of Medical Research (ICMR).

According to the national guidelines for Stem Cell Research—2017 released by the ICMR and the Department of Bio­technology (DBT), Indian institutions working in the area of stem cell research need to constitute and register their Institutional Committee for Stem Cell Research (IC-SCR) with NAC-SCRT. This oversees stem cell research and therapy, formulates policy related to it and reviews ethically sensitive research and proposals for therapeutic use.

Interestingly, NAC-SCRT was apparently not consulted by the Drug Controller General of India for its draft notification. In the notification issued recently, the ministry defined those stem cells and their derivatives that would be termed a drug and would thereby have to follow the protocols mandated for any drug development. It said stem cells and products that are substantially altered, amounting to a change in biological characteristics or those subjected to gene editing or modification, will be treated as a drug and will have to seek the regulator’s approval before coming into the market.

Even today all drug trials are required to comply with the ICMR guidelines. As per Regulation 7.22 of the MCI Code of Ethics Regulations: “Clinical drug trials or other research involving patients or volunteers are to be undertaken as per ICMR guidelines keeping ethical considerations in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct.”

Similarly, for stem cells, the National Guidelines for Stem Cell Research—2017 should be followed. In their Foreword to the National Guidelines on Stem Cell Research, the director-general of ICMR and secretary, biotechnology, write: “The 2017 guidelines reiterate that any use of stem cells in patients, other than that for haematopoietic stem cell reconstitution for approved indications, is investigational at present. 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.”

The IMA and ICMR drew up some points for guidance:

• There are no approved indications for stem cell therapy other than the haematopoietic stem cell transplantation (HSCT) for haematological disorders. Stem cell therapies other than HSCT are investigational and can be conducted only in the form of a clinical trial following ICMR guidelines for clinical research after obtaining necessary regulatory approvals. Use of stem cells for any other purpose outside the domain of clinical trial is unethical.
• Any violation of ICMR Clinical Research Guidelines is actionable professional misconduct under “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations.”
• Also, while dealing with pharmaceuticals or allied industry, one needs to follow ethics regulation, which states that a medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries provided he obtains due permission from the competent concerned authorities; ensures that the research has the clearance of national/ state/institutional ethics committees/bodies and ensures ethicality of the project.
• Stem cell clinical trials for conditions other than HSCT will require approval from Institutional Ethics Committee (IEC) and Institutional Committee for Stem Cell Research (IC-SCR) and CDSCO.
• Clinical trials using human stem cells should be in compliance with Schedule Y of Drugs and Cosmetics Act and GCP Guidelines of CDSCO as well as ICMR-Ethical Guidelines for Biomedical Research involving Humans. Any violation will be professional misconduct as per MCI ethics regulation. The physician/scientist engaged in stem cell research shall avoid any activity that leads to unnecessary hype, or unrealistic expectations in the minds of study participants or public at large regarding stem cell therapy.
• Promotional advertisements by private banks offering storage of cord blood for possible future use are misleading. As there is no scientific basis for preservation of cord blood for future self-use at present, this practice is not recommended. The only exception is when there is a child with a haematological disease curable by haematopoietic progenitor-stem cells (HPSC) and the mother is pregnant. In such a situation, storage and release of stem cells from cord blood of the newborn sibling, subject to matching patients or donors for blood or marrow transplant, shall be recommended. On the other hand, parents should be encouraged to voluntarily donate to public cord blood banks for allogeneic transplantation (when stem cells are collected from a matching donor and transplanted into the patient to suppress the disease and restore the patient’s immune system) and research purposes.
• IC-SCR and IEC shall ensure that the patients/participants recruited under clinical trial shall not be charged, including for hospital stay and laboratory-based investigations.
• Prior to enrolment of subjects in clinical trials or procurement of stem cells for research, it is mandatory to obtain informed consent from the donor. Independent informed consent in advance should be obtained for termination of pregnancy and for donation of the foetal material for research. There should be no inducement for donation of gametes/embryos/somatic cells by way of payment or in lieu of medical services, except for reimbursement of reasonable expenses for travel and loss of wages incurred by the person (amount to be decided by IC-SCR/IEC)
• Use of umbilical cord blood stem cells (except when the HPSCs are used for conditions approved for bone marrow HPSC transplantation), HSC or MSC (haematopoietic stem cells or mesenchymal stem cells) is experimental at present and shall be permitted only under conditions of controlled clinical trial by the IC-SCR and IEC. In most of the hematological/genetic disorders, the child’s own stored cord blood stem cells cannot be used for the same child as they will carry the same defect.
• An institution or laboratory developing or processing stem cells for human use should obtain accreditation from the National Accreditation Board for Testing and Calibration for all laboratory procedures required for product development.

The Drug Controller had a member in the ICMR apex committee. But with ICMR and DCGI both being under one ministry, both should work together in the interest of society to stop unethical mushrooming in stem cells.

—The writer is national president, Indian Medical Association