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Specific law to regulate stem cell banks in India: Experts
Seeking a specific law to regulate stem cell banks in the country, experts in the field have warned that the absence of a strict regulation may lead to compromising the safety of millions.
Seeking a specific law to regulate stem cell banks in the country, experts in the field have warned that the absence of a strict regulation may lead to compromising the safety of millions.
India currently does not have any particular law to regulate stem cell banks -- the high-tech labs that store umbilical cord blood and frozen tissue samples for both research and treatment for a host of diseases.
"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," Karan Goel, chairman and founder, Stem Cell Global Foundation (SCGF) said.
"There is no monitoring 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," Goel said.
Echoing similar views, Anoop Misra, director and head of the department of diabetes and metabolic diseases, Fortis Hospitals, said there is a dire need for a regulation.
"Otherwise, you will find quacks giving 'stem cells' by the roadside in the future," he warned.
At present, only stem cell research that aims to create a drug requires prior approval from Drug Controller General of India (DCGI) for conducting human clinical trials.
In 2007, the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) have come out with guidelines for stem cell research and therapy, but those do not carry much weight in the absence of specific laws on stem cell banking.
Under the guidelines, stem cell banking is "permissible" but the "commercial exploitation of stored blood" is restricted.
It has also called for "special care in collection, processing and storage of umbilical cord stem cells to avoid transmission of infections".
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