Policy News

Regenerative medicine experts’ meet seeks to strengthen regulations

Subhra Priyadarshini

doi:10.1038/nindia.2014.115 Published online 25 August 2014

India's policy regulating stem cell based therapies will come under the scanner at the conference.

© MedicImage / Alamy

India’s first comprehensive regenerative medicine centre, state-of-the-art 3D printing of human body parts and the debate surrounding the ethics and regulation of stem cell therapies will be some hot topics of discussion when nearly 600 regenerative medicine experts meet in the country early next year.

The experts will meet in Delhi and Mumbai as part of the OSU-India Health Sciences Innovation Conference being jointly organised by US-based Ohio State University (OSU) and New Delhi’s All India Institute of Medical Sciences (AIIMS) from January 15 to 18, 2015. Nobel laureate Luc Montagnier, the discovered of HIV, will be one of the star speakers at the conference.

“Talks are already on with AIIMS for a collaborative regenerative medicine centre – the first such comprehensive centre in India – with engineers, biomaterial and material scientists and medical practitioners,” says Chandan Sen, director of the Centre for Regenerative Medicine and cell-based therapies at OSU and associate dean of research at OSU’s Wexner Medical Center. The OSU centre is credited with creating the first human trachea. “As a result of the discussions at the conference, you will see more and more ‘first-in-human’ efforts coming out of India too,” Sen told Nature India.

Director of the department of surgical disciplines at AIIMS Mahesh Misra says the OSU pioneers in regenerative medicine will provide strong inputs for the proposed centre, to be funded by the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT). The conference, he says, will give the AIIMS team a global exposure to issues at hand. “We will have a workshop to prioritise and build protocols for proposals and grant writing."

3D bioprinting, which is taking the world by a storm, could also make its foray into India following the conference. Experts at the meet will discuss the risks and benefits of 3D printing of human body parts and the ethical and regulatory challenges surrounding it. Global experts will also deliberate on how India can siege the opportunity by framing a regulatory mechanism early on in the debate when regulatory agencies across the world are bracing up to deal with this emergent technology in the regenerative medicine landscape. “For instance, experts will be discussing how to reconstruct a traumatised face. And the barriers, ethical considerations and risks that India could face as the technique is developing in the broader landscape,” Sen says.

Besides, wound care will also figure prominently. India has no organised wound care system in place. “There’s just no training, and healthcare professionals are doing the best they can. But for cases such as foot ulcers in diabetics, options are limited leading to the risk of amputation. The rate of amputation is pretty high all over the world in the diabetic population. This can very well be prevented with specialised wound care not just helping the diabetics but also by reducing the cost burden to society of having a crippled person,” Sen says.

The surgical sessions at the conference will feature vascular biology, neuroscience, material science and cord blood banking. Scientific updates on organ engineering and tissue engineering will also form a significant part of the discussions. The experts will deliberate at length on the mushrooming of stem cell clinics in India. “The Medical Council of India faces the challenge of regulating mushrooming stem cell practitioners. It is important that we bring them into the loop and educate them to safeguard patient interests” Sen feels. The conference will look at the risk benefit ratio and provide direction for cell-based therapies. “This dialogue will lead to regulatory pathways and will inform India’s new government about international regulations.”

Misra says India has been opposed to stem cell shops that take patients for a ride and bypass all regulatory norms to make money. “The trend is dangerous and this international get-together of cell-based therapy experts should provide policy level guidance to curb the menace.

"Prior to the conference, OSU has signed agreements with AIIMS, the Indian Institute of Technology (IIT) Bombay and Indian Institute of Management (IIM), Ahmedabad for academic collaborations. Besides, OSU is hoping to clinch more research collaborations with Indian biotech and pharmaceutical companies, hospitals and academic institutions.

As part of a trade fair that will run parallel to the conference, experts will take a look at the huge Indian business of providing raw materials for the world need of herbal supplements. “We will evaluate which components of this market are sustainable and which are hype-based and will fizzle out. This will help the Indian government make policy decisions on investment, for example on a specific type of cash crop to make sure our rural folks are doing better," Sen says.

Another interesting session at the conference will put to scrutiny the tall advertising claims made by some healthcare products.  “Well known brands to small ones, everyone is making unfounded claims such as making a child 6-inch taller or growing hair with stem cell therapy. This is completely unacceptable. It is time to implement stringent regulations to see how India can turn a corner as a developing country,” Sen says.