New Delhi: Stem cell banking in India is finally set to come under a regulatory framework. As a first step, senior officials at the ministry of health and family welfare are in the process of putting together a proposal for the formation of an expert committee for stem cell banks and therapy.
There are no rules or laws governing stem cell banking once a laboratory is approved by the state. There are no checks on the condition and temperature in which the cells are stored or transported. If a consumer has a complaint against a stem cell bank, the government has no power to act on it.
The ministry’s department of health research is drafting a Bill for a biomedical authority that will cover stem cells as well, said V.M. Katoch, secretary, department of health research, and director general, Indian Council of Medical Research (ICMR). The Bill is likely to be put forth for cabinet approval next year.
Also, the Drug Controller General of India (DCGI), along with ICMR, will soon form a committee to study the proposals submitted by firms looking to set up stem cell banks before getting approval from DCGI. This will become mandatory once the regulatory framework is in place.
The expert committee would study applications for stem cell banking as also their characterization and indication and submit a recommendation to DCGI, based on which the regulator would give approval or a no-objection certificate. At the moment, only stem cell research that aims to create a drug requires prior approval from DCGI for conducting human clinical trials.
Stem cell treatments are a type of therapy that introduce new cells into damaged tissue to treat a disease or injury. Stem cell banks store blood and frozen tissue samples for both research and surgery.
“We require special approvals for stem cell banking because it is like a bio-insurance thing since it is used in the future. Is there anyone to check that during transportation of the cells they are not damaged? Opening a bank is not a problem but maintaining is the problem. So, there must be someone to keep checks and conduct audits,” says Karan Goel, chairman and founder, Stem Cell Global Foundation.
Listen to V.M. Katoch, director general of the Indian Council of Medical Research, talk about stem cell research and regulation
He adds that there is need for regulations for stem cells that are injected into the patient’s body as well in therapy.
“We will meet DCGI in the next few weeks and by the end of this month, we will have a core group to look at this area. With no regulations in place right now, violators of the guidelines can easily escape. So, I am very keen that by next year, registration of stem cell banks and research is in place,” said Katoch.
ICMR and the department of biotechnology (DBT) had laid down guidelines for stem cell research and therapy in 2007, but in the absence of laws specific to the issue, they do not carry much weight.
Over the last few years, India has witnessed a tremendous growth in the stem cell business. Apart from many foreign companies, the industry has witnessed the mushrooming of small domestic players. According to industry estimates, the domestic market size is Rs100 crore now and growing at an annual pace of 30-40%.
“The area of stem cells storage is not very regulated. Many untrained people are fleecing the general public by giving some ‘stem cells’. ICMR does not have (the) power to impose regulations. There is a dire need for such regulation; otherwise, quacks will be giving ‘stem cells’ by the roadside,” says Anoop Misra, director and head of the department of diabetes and metabolic diseases, Fortis Hospitals, who recently undertook a clinical trial using stem cells to cure diabetic foot.
According to drug controller general Surinder Singh, since stem cells is a new area, he has been unable to give approvals or no-objection certificates to companies seeking his approval to bank stem cells.
“But this is an area where we don’t have any domain expertise and are getting into for the first time. So, we have called experts from institutes like ICMR, All India Institute of Medical Sciences and Maulana Azad Medical College to help us make a proposal for a stem cell committee to the ministry,” says Singh.
Stem cell banking company LifeCell International Pvt. Ltd was one of the two companies that sought a no-objection certificate from DCGI to start umbilical cord tissue banking, a step that is mandatory in the US and Europe. “We have made our presentations to DCGI (drug controller general Singh) and now await his response. Once he forms the core group, we will know the status,” said Mayur Abhaya, executive director, LifeCell.
Ramesh Bhonde, technical director, Stempeutics Research Pvt. Ltd, a Bangalore-based stem cell research company, says the proposed regulatory framework is a welcome step.
“It is the need of the day because the cells which are stored are ultimately going back to the patient and should not elicit any secondary effects,” he said.
Both Singh and Katoch admit that the regulatory process for stem cells will be slow and will take a year to fall in place, starting with voluntary approval and registration of stem cell banks. Singh intends to put names of approved banks on the Internet to spread greater awareness. “People will prefer going to approved banks and slowly, as systems fall in place, we will make this registration mandatory,” he said.