Scientists & doctors hail stem cell related amendments in new Indian gazette

New Delhi: The word ‘stem cell’ has been most often maligned and misused in India. Despite the immense potential, their use, unfortunately, has been often associated with the various controversies due to malpractices of few. While multi-level research into the area has been an ongoing process, the actual end products in form of drugs or therapies are still officially not allowed in the country.

In this backdrop, the Stem Cell Society of India organized its 4th international conference, SCSICON 2018 on 28th and 29th April in New Delhi. The conference had eminent keynote speakers who have contributed significantly in the field like Dr Rajneesh Verma, a program specific researcher in the department of human clinical application at CIRA, Kyoto University. He has worked very closely with Nobel laurite Dr Shinya Yamanaka. Dr Verma spoke on Induced Pluripotent Stem Cell technology and its application in human clinical trials.

Speaking at the event, Dr S Eswara Reddy, Drug Controller General (India) stated, “The Drugs and Cosmetics Rules, 1945 are proposed to be amended to provide regulation of stem cell-based drugs. At the same time, the stem cell-based drugs are demarcated from stem cell therapy not to overstep the role of the treating physician.”

The Union Health Minister, Mr Jagat Prakash Nadda in his message hinted towards allowing the stem cell therapy for patients with disabilities. “When the Prime Minister’s new and ambitious ‘Ayushman Bharat’, the National Health Protection Scheme, becomes operational, Stem cell therapy for providing relief to the disabilities in the ‘Rights of Persons with Disabilities Act,2016 may be considered for inclusion under this scheme,” he said.

The ‘SCSICON’ witnessed workshops and demonstrations on bone marrow extraction and processing. The third volume of the Indian Journal of Stem Cell Therapy, which is the official journal of SCS(I) was also released at the event. It is a platform for eminent researchers and doctors in the field to publish their clinical results, serving as an encouragement to young researchers to engage in stem cell research.

The conference was a conglomeration of stem cell application in various neurological, pediatric, orthopedic, cardiac, dermatological disorders as well as anti-aging potential of stem cell therapy. Dr Shivinder S. Deol who has robust experience in the field of anti-aging shared his knowledge about application of stem cells for anti-aging. Dr Ajay Singh a renowned pediatric orthopedician spoke about role of stem cell transplantation in pediatric orthopedics. Dr R N Srivastava spoke on role of stem cell therapy in spinal cord injuries. Dr Surya Kant spoke about role of stem cells in pulmonology.

Among the prominent speakers at the conference included Dr Alok Sharma who is a neurosurgeon and pioneer in the field of stem cell therapy in India. Dr Sharma spoke about the global developments in the ethics and regulations of stem cell therapy.

As per Dr Alok Sharma who is also the President of Stem Cell Society of India, mentioned, “The focus of the discussion in the conference was about the regulations for stem cell therapy in India. The scientists and doctors are hopeful about the future of stem cell therapy and welcome the new Indian Gazette. The progressive changes suggested in the Indian Drugs and Cosmetics Rule are highly appreciated.”

As per the Gazette of India published on 4th April 2018, it is proposed that, minimally manipulated stem cells will not be considered as ‘ a Drug’ and therefore will be excluded from the Drugs and Cosmetics Rule; while the more than minimally manipulated and substantially manipulated stem cells will be considered as ‘a drug’ and will, therefore, be under the purview of the Drugs and Cosmetics Rule.

While explaining and elaborating further on the new regulations Dr Sharma said, “Cells or tissues taken from the patients body, subjected to cleaning and separation for administering immediately without multiplying outside the body is termed as minimally manipulated cells. This is “stem cell therapy” which is under the surgeons or clinicians purview as opposed to “stem cell drugs” which would be a product or a drug. The cells or tissues which are taken from the body, multiplied in the laboratory or undergoes any genetic manipulation and stored in the laboratory to be used by the same patient or another patient are termed as more than minimally manipulated and these would be termed as “drugs” as per the amended Drugs and Cosmetics Act 1945 and will need to go through screening and trials as is expected from a new drug”.

Dr Sharma further said “These changes are very progressive following the recent developments in countries like Japan, Korea and USA. This amendment will facilitate growth of cell therapies in India and will also make these therapies available to lakhs of patients who are currently suffering with incurable diseases.

Stem cells and their far-reaching clinical & commercial impact 

Stem cells are the cells that have a potentially to grow into different cell types and therefore form the natural healing mechanism of the body. There are different types of stem cells like Embryonic stem cells, Umbilical cord blood cells, induced pluripotent stem cells whose safety is still unproven and are investigation for their effectiveness as well as adult stem cells which are safe and there is reasonable evidence of their presumed efficacy.

The potential of stem cells to provide cure for diseases is two folds. First, they have regenerative capabilities i.e. they can replace damaged tissue with healthy tissue. Second, they have paracrine effects which help to reduce inflammation in the body, facilitate the formation of new blood vessels, alter the immune responses of the body and stimulate local stem cells of the body. This potential of stem cells, as a tool for regeneration, is set to make breakthroughs in treating incurable and intractable diseases, such as incurable neurological conditions, cancer, orthopaedic diseases, cardiomyopathies, liercirrhosis, diabetes, retinal degeneration, etc.

The global stem cell market is expected to reach USD 15.63billion by 2025, growing at a CAGR of 9.2%, according to a new report by Grand View Research, Inc. Augmentation in research studies that aim at broadening the utility scope of associated products is anticipated to drive the market growth. These research projects have opened the possibility of implementation of several clinical applications of these cells, thereby impacting disease-modifying treatments.

Scientists are engaged in discovering novel methods to create human stem cells. This is to address the increasing demand for stem cell production for potential investigation in disease management. This factor is certainly expected to accelerate the development of regenerative medicine, thus driving industrial growth.

Moreover, cellular therapies are recognized as the next major advancements in transforming healthcare. Firms are expanding their cellular therapy portfolio, understanding the future potential of this arena in the treatment of Parkinson’s disease, type 1 diabetes, spinal cord injury, Alzheimer’s disease, and others.