Regenerative medicines could be a potential gamechanger in healthcare, provided the market is streamlined with effective regulations and guidelines
One era’s fantasy is another era’s reality. The world keeps mentioning regeneration in multifarious ways, be it in comics or movies and what seems remarkably fictional is more likely a fact in reality. Many sci-fi movies portray fictional characters experimenting and acquiring the ability to regenerate organs. And many a times aftermath illustrates the catastrophic effects of ungoverned research.
Regeneration as an answer to cure a disease or personalised medicines are far from being a new idea. Ancient Greek legend of Prometheus, the god who was cursed to have an eagle peck out his liver each day, only to grow it back overnight, recognised the power of regeneration and claimed that the liver could heal itself. This made them address liver as ‘hepar’ meaning to heal itself. The modern science is intrigued by the applications of regenerative medicine which include genetical engineering, stem cell biology, cloning, biomaterials and biomedical devices to name a few. Dr Pradeep Mahajan, Regenerative Medicine Researcher and MD, StemRx Bioscience Solutions highlights, “Early works on regenerative medicine were in the form of cell based therapy for blood related conditions (leukaemia, bleeding disorders etc.) Medical science is now analysing the mechanics of utilising the power of these dynamic molecules in treatment of various chronic and previously untreatable conditions.”
Yash Sanghavi, CMD, Regenerative Medical Services informs, “India is a major biotech player in the Asia Pacific region, coming next to Japan and South Korea. The stem cell therapy market in India was valued at `1 billion in 2013. This is expected to reach `2 billion by the year 2018. India is projected to witness a rise in the number of stem cell banks and stem cell depositors in the near future and liberalisation of regenerative medicine research, along with government support, are the major factors aiding this growth gradient. Currently, over 40 institutions, hospitals and industry are engaged in research all over the country.” This rapidly growing interdisciplinary field involving the life, physical and engineering sciences also raises several ethical, legal and social issues.
Dr Geeta Jotwani, Senior Scientist, ICMR pointed out that the misleading and luring advertisements by private cord blood banks is increasing. Initially, started in metro urban class people who could afford the cost of banking are now, with intensive advertisement, are spreading across smaller cities and towns. But several international bodies such as American Academy of Pediatrician, American Society for Blood and Marrow Transplant, Royal College of Obstetricians and Gynecologists, American College of Obstetrics and Gynecology, American Medical Association, European Group on Ethics in Science and New Technologies etc., do not recommend routine private banking for future self use. The reasons include the likelihood of the stored blood being used for Hematopoietic stem cell transplantation (HSCT) is very small, probably as low as 0.005 to 0.04 per cent in the first 20 years of life and stem cell transplant using an individual’s own cord blood cannot be recommended for genetic disorders.
Dr Venkatesh Movva, MD Regenexx, deliberated that in the western world these advertisements are strictly prohibited whereas in India, they make way for commercial players to enter which raises the credibility issue.
Thus, to maintain standardisation, there arises the demand for companies to work within the regulatory framework of the governing bodies. The private sector and the government institutions are developing systems to establish processes to formulate clinical research protocol, review and monitor the human studies.
Evolution of regulatory framework
Inception
The Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT), in 2007, jointly released guidelines for stem cell research and therapy. These guidelines are directions for scientist, clinicians and industry involved in the field. Due to the growing scope along with new scientific and clinical findings these guidelines have been periodically updated.
Revision
The guidelines were revised in 2013 and a report on National Guidelines for Stem Cell Research 2013 by ICMR informed, “The present guidelines have retained the earlier classification of stem cell research into three categories, namely Permitted, Restricted and Prohibited categories. An additional layer of oversight, besides the Institutional Ethics Committee (IEC), in the form of Institutional Committee for Stem Cell Research (IC-SCR) and National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has been introduced. This mechanism of additional review has been accepted by the scientific community in the country and the required NAC-SCRT has become operational. The role and functioning of these committees is being streamlined.” Another integral recommendation of the Committee during the revision included omitting the word ‘therapy’ from the title of guidelines. This has been done to emphasise the fact that stem cells are still not a part of standard of care; hence there can be no guidelines for therapy until efficacy is proven.
This year a proposal for revision in the form of guidelines has been drafted. Dr Jotwani, highlighted, “The draft National Guidelines for Stem Cell Research 2017 addresses to rampant unethical use of stem cells for treatment of unproven indications without scientific backing. The stakeholders were of the opinion that there is no regulation for stem cell research and therapy and therefore it was initially proposed to frame separate regulation for stem cell research but it would have taken long to formalise the same as ART Bill and Biomedical Ethics Bill which is still pending. Therefore, we have chosen path of harmonising existing acts, rules and regulations. The following existing acts and rules were revisited and an attempt made to harmonise them in the draft guidelines:
- Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
- Indian Medical Council (Professional Conduct, Etiquettes and Ethics) Regulation 2002 and amendments.
- Drugs and Magical Remedies (The Objectionable Advertisements) Act- 1954.
- The Code for Self-Regulation of Advertising Content in India by ASCI
- ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.”
Industry opines
Industry stakeholders throw light on the many challenges that are faced in the market. Satyen Sanghavi, Chief Scientific Officer, Regenerative Medical Services observes, “The field of regenerative medicine has to contend with several challenges associated with the evolution of its science and technology of which the major are regulatory framework, education to the clinicians and funding. From an ethical perspective, concerns ranging from proper guidelines/ instruction for conducting research to investigator-initiated clinical practice without regulatory approvals is something that India is facing currently. In the early part of this century, India was among the few active countries in the field of regenerative medicine and had a head start. However, regrettably, with obscurity in the regulations and funding, proposals for clinical trials have been languishing for years. Consequently, India is lagging in the world order in the domain of regenerative medicine. With the establishment of standards in regulatory approvals, evidence-based research and clinical practice, cell therapies will find a major niche in medical advancement in the future.” He further added India has sharp conflicts developed between local funders of stem cell product applications and the national government over the conditions under which they may be used and marketed. Countires like Thailand, Japan, South Korea and Taiwan, regularly find stem cell products on offer as cosmetic cell therapy or as holistic medicine. Disagreement about the interpretation of key terms can undermine effective regulation.
The way forward
Dr Jotwani strongly refutes it and informs,”R & D industry initially faced challenges like delay in getting regulatory approvals. But later from 2011 the process is streamlined by establishing separate committee under CDSCO to review clinical trial applications i.e. CBBTDEC. For approval of clinical trials, Drug Controller General India DCG(I) has established a committee namely ‘Cellular Biology Based Therapeutic Drug Evaluation Committee (CBBTDEC)’ for the ‘Therapeutic products derived from Stem Cells, human Gene manipulation and Xenotransplantation technology’. This committee is chaired by Secretary DHR and DG, ICMR and till date, approved around 30 clinical trials. Few stem cell and cell therapy products have been given conditional approval by the committee to address the unmet need in the field of medicine after evaluating safety and efficacy.So far 30 trials have been approved. One stem cell based product has been given conditional approval (StempuCell). Another cell-based products approved are Ossron and Chondron. Industry stakeholders share solutions in regards to providing education at medical school level along with introduction of fellowship/post-graduate programmes.”
Dr Jotwani adds, “Contrary to the popular belief that there is no regulatory framework to curb the unethical practices, above acts and rules do exist that can very well regulate the misuse of innovative technologies in medical field including stem cells. Proposed guidelines are therefore critical to incorporate these advances and to harmonise them with the internationally revised guidelines.”
To continue to grow at a fast pace , both the government as well as the private players need to come to a common consesus to carry on the evolution and transformation of regenerative medicines in a smooth way in India. A conceited effort is the need of the hour.