Straight from the Heart: IMA ICMR Initiatives – Annual Round Up
IMA endorses National Guidelines for Stem Cell Research (NGSCR): The NGSCR-2013 covers only stem cell research, both basic and translational, and not therapy as the same is experimental as on date. Any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational and must only be done within the purview of an approved and monitored clinical trial. Every use of stem cells in patients outside an approved clinical trial is malpractice.
Points about stem cell therapy every IMA member must know
· There are no approved indications for stem cell therapy other than the hematopoietic 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 (Clause 10.3.1)
· Any violation of ICMR Clinical Research Guideline are actionable professional misconduct under “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 7.22 “Research: Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct.”
· One dealing with pharmaceuticals and or allied industry one also need to follow 6.8.1 e regulation of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations:” Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfilment of the following items (i) to (vii) will be an imperative for undertaking any research assignment / project funded by industry – for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:- (i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities. (ii) Ensure that such a research project(s) has the clearance of national/ state / institutional ethics committees / bodies. (iii) Ensure that it fulfils all the legal requirements prescribed for medical research. (iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself. (v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s). (vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way. (vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document / agreement for any such assignment”
The MCI ethics violation will attract “First time censure, and thereafter removal of name from Indian Medical Register or State Medical Register for a period depending upon the violation of the clause.”
· Stem cells clinical trials for conditions other HSCT will require approval from Institutional Ethics Committee (IEC) and Institutional Committee for Stem Cell Research (IC-SCR) and CDSCO. The IEC should be registered with Central Drug Standards Control Organization DSSCO and IC-SCR with National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). Only registered entities are permitted to conduct these trails. Stem cells used for intervention should be processed/developed under CDSCO certified GMP facility.
· Clinical trials using human stem cells should be in compliance with Schedule Y of Drugs and Cosmetics Act and GCP Guidelines of CDSCO (www.cdsco.nic.in) as well as ICMR-Ethical Guidelines for Biomedical Research involving Human Participants (http://www.icmr.nic.in/ethical_guidelines.pdf). All clinical trials on stem cells shall be registered with Clinical Trial Registry India (CTRI). (Clause 10.2)
o Any violation will be a professional misconduct as per MCI ethics regulation 1.9 to be read with regulation 7.1
o 1.9: “Evasion of Legal Restrictions: The physician shall observe the laws of the country in regulating the practice of medicine and shall also not assist others to evade such laws. He should be cooperative in observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic substances Act, 1985; Medical Termination of Pregnancy Act, 1971; Transplantation of Human Organ Act, 1994; Mental Health Act, 1987; Environmental Protection Act, 1986; Pre–natal Sex Determination Test Act, 1994; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with Disabilities (Equal Opportunities and Full Participation) Act, 1995 and Bio-Medical Waste (Management and Handling) Rules, 1998 and such other Acts, Rules, Regulations made by the Central/State Governments or local Administrative Bodies or any other relevant Act relating to the protection and promotion of public health”.
o MISCONDUCT: The following acts of commission or omission on the part of a physician shall constitute professional misconduct rendering him/her liable for disciplinary action
o 7.1 Violation of the Regulations: If he/she commits any violation of these Regulations.
· The physician/scientist engaged in stem cell research shall avoid any activity that leads to unnecessary hype, or unrealistic expectations in theminds of study participants or public at large regarding stem cell therapy. The study participant and other responsible family members must be given adequate and unbiased information about the trial protocol, its limitations and potential adverse effects. (Clause 7.5). The same is also actionable under The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
o 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 HPSC and the mother is pregnant. In such situation storage and release of stem cells from cord blood of the new-born sibling, subject to HLA match shall be recommended. On the other hand, parents should be encouraged for voluntary donation to public cord blood banks for allogeneic transplantation and research purposes. (Clause 12.2)
o “Disclaimers / Qualifiers” the advertisements should carry so that there is a standard declaration which is unambiguous to a lay consumer?
· The IC-SCR and IEC shall ensure that the patients/participants recruited under clinical trial shall not be charged including hospital stay and laboratory based investigations. (Clause 10.2.5.5)
· Prior to enrolment of subjects in clinical trials or procurement of stem cells for research, it is mandatory to obtain informed consent from thedonor. (Clause 4.1)
· Independent informed consent in advance should be obtained for termination 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 of 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). (Clause 13.1.2)
· Use of Umbilical cord blood stem cells (except when the HPSCs are used for conditions approved for bone marrow HPSC transplantation) , HSC or MSC is experimental at present and shall be permitted only under conditions of controlled clinical trial by the IC-SCR/IEC (Clause 12.2)
o In most of the haematological/genetic disorders, child’s own stored cord blood stem cells cannot be used for the same child as those will carry the same defect.
· An institution or laboratory developing or processing stem cells for human use should obtain NABL accreditation for all laboratory procedures required for product development.
Presidential address on 28th December I spoke “IMA also wants the government to declare a special fund for rare diseases and orphan drugs.”
ICMR set up a registry of rare diseases. Apart from maintaining a database, the registry, set up on April 28 2017, will also help formulate policies on funding, treatment and more. A disease is defined as rare when it affects less than one in 2,500 individuals. Over 70mn Indians suffer from such disorders and live with them throughout their lives. There are only 500 FDA-approved drugs for over 7,000 rare diseases globally. There is often no cure, only supportive care. Treatment is extremely costly too, ranging from lakhs to crores a year. The health ministry is currently discussing a draft policy for treatment of rare diseases.
In Gorakhpur issue IMA raised the absence of autopsies in such cases
The under-five mortality rate in India stands at 50 per 1000 live births. The pilot project that will begin in January, 2018, at New Delhi’s Safdarjung hospital, is a part of the global CHAMPS— Child Health and Mortality Prevention Surveillance, project, wherein tissue biopsies of the brain, liver, spleen and other tissues are taken in a minimally invasive way. This will benefit in districts like Gorakhpur where child deaths are high. For six months— January to June, all child deaths that take place at Safdarjung hospital will be examined. Informed consent will be taken from the parents.
IMA Women Life Time Achievement Award to ICMR DG
Other issues: C. auris ICMR advisory, AMR, NCD
May Measurement Month