Concerned about the booming stem cell banking industry, which is completely deregulated,the Food and Drug Administration has asked the Drug Controller General of India (DCGI) bring storing of cord blood under its purview.
Though unproven, abusiness has grown up in recent years allowing parents to privately bank umblical cord blood, source of potentially life saving stem cells, for a period of 20 to 25 year sataco stranging from Rs 80,000 to Rs 1.25 lakh.
Officials say no one knows what will happen if a stem cell bank is destroyed due to natural calamities or the cells just disappear at the end of 25 years. While the cells are supposed to be storied under sub zero temperatures, there is no quality check by any government agency. In a meeting of drugs consultative committee held earlier this week in Delhi, state’s FDA Commissioner Mahesh Zagade said that the stem cell banking industry needs regulations as lakhs of people are opting to bank cord blood and stem cells extracted from dental pulp.
Currently ,mere draft notifications forcord blood banking are available. "I am not evengoing into the debate of the proven and unprovenstemcell the rapies as that is some thing the government should take a call on," said Zagade.
The Indian government has approvedonly Bone Marrow Transplantation (BMT) therapy as a proven form of stem cell therapy. Any other stem cell therapy can be only conducted as a clinical trial after an approval from the DCGI.
However, several centers have flourished across the country and are charging for various forms of stem cell therapies even as they should be carried out for free after the patients consent as a part of a clinical trial.
Zagade said that the FDA has received several applications for grant of license for processing the stemcell sand the irbanking. "Inviewof changing scenario in the field of medicine, there is an urgent need to regulate this areaand lay down provision for licensing, operating of cord blood banks and even stem cell processing laboratories."Source
Times of India
16 November 2013,
By - Jyoti Shelar