The new set of rules has been drafted under the 'Drugs and Cosmetics Act, 1940'.
Though ICMR and the Department of Biotechnology (DBT) had laid down the fundamental guidelines for stem cell research and therapy way back in 2007, the health department has woken up to the matter now.
The most important source of stem cells is the umbilical cord blood, having large number of undifferentiated cells with ability to regenerate themselves and develop into a range of specialized cell types.
Stem cell therapy has the potential capability to cure diseases that are currently incurable.
Stem cell market in India
Stem cell banks store umbilical cord blood and frozen tissue samples for research and surgery..
Statistically, with more than 80,000 births per day or 26 million births per year, India is poised to be the largest source for umbilical cord blood in the world.
Analysts estimate that the market of Indian stem cell banks, which is currently Rs100 crore and still growing at a rate of 30-40 percent annually, would generate Rs 2,700 crore in revenues by 2012, accounting for 17 percent of the world market.
Loop-holes in Stem cell banking
Today, Indian government has no rules to regulate stem cell banking once a laboratory is approved. Due to lack of rules there are no checks on the condition and temperature at which the cells are stored or transported.
If a consumer comes with a complaint against a stem cell bank, the government has no laws to act upon it.
Karan Goel, chairman and founder, Stem Cell Global Foundation (SCGF) said, "When there is no one to check what you do, it would be easy for you to cheat. Similarly, as there is no government regulation, there is always the fear of commercial exploitation of stem cells."
Presently, if a drug has to be created using stem cell research, prior approval from Drug Controller General of India (DCGI) for conducting human clinical trials is required.
An official from Health Ministry said, “Cord blood stem cell banking was allowed a few years ago. They currently fall under the rules of blood banks, but we needed guidelines separately for them.”
Now, the ministry has also started preparing a biomedical authority bill to check issues like stem cell research, genetic engineering, and clinical trials.