New Delhi: Those seeking to store their children’s stem cells or start therapy using them will soon be able to use government-approved facilities for their storage and use.
Currently, there are no regulations governing stem cells, which are so-called master cells that have the ability to renew themselves and differentiating into a wide range of specialized cell types. The health ministry has approved and notified a committee to look at therapies related to stem cells and genes.
The 11-member committee will be headed by V.M. Katoch, secretary, department of health research, and director-general of the Indian Council of Medical Research (ICMR). The drug controller general of India is also one of the members.
Mint had reported in November that senior officials at the ministry were putting together a proposal to form an expert committee for stem cell banks and related therapies. In June, the ministry had also put up for public consultation draft rules for umbilical cord blood banking. The move towards some degree of regulation on the completely unregulated area of therapies that use stem cells, living cells and genes for treatment is seen as a step in the right direction by industry watchers.
“Any therapeutic product that is preserved for some time and then used for treatment is a manipulated product and can lead to death. Therapeutic products derived from stem cells, genes, xenotransplants... all fall under this category, and hence, need some regulation to their use. This is an attempt to bring that into effect,” said an official at the ministry of health on condition of anonymity.
The panel is being formed parallel to the existing investigational new drug committee, which gives mandatory approvals for clinical trials of new drug candidates in India. The stem cell committee’s approvals will not be mandatory for the time being but will become compulsory once the regulatory framework is in place.
“The committee will work in tandem with the draft rules that have been prepared for the same purpose and will look to enhance them later as well,” said another health ministry official. He did not want to be identified.
ICMR and the department of biotechnology 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.
“Cord blood banks do not have a licence scheme to go through. This is necessary in order to increase confidence in India about stem cell banking. A lot of clients need stem cell therapy, which is expensive and we don’t want these clients to be cheated by a sham set-up. So, we believe regulation is important for a developing field like this,” said Mayur Abhaya, executive director, LifeCell. The company has investments worth Rs 30 crore in India in the stem cell banking industry. A typical stem cell storage facility costs Rs 36,000 for collection, processing and testing and charges an annual storage fee of Rs 2,000 for per annum.
Over the past few years, India has seen a surge in the stem cell business. Apart from several foreign companies, the industry has witnessed the mushrooming of small domestic firms. According to industry estimates, the domestic market size is Rs 100 crore now and growing at an annual pace of 40%.