Government set to tighten stem cell therapy norms
By NEETU CHANDRA
PUBLISHED: 23:10 GMT, 21 March 2014 | UPDATED: 23:10 GMT, 21 March 2014
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India is moving to tighten regulations for stem cell therapy in the wake of domestic and international firms making tall claims about treating incurable diseases with the help of the advanced technology.
A high-powered committee set up by the Health ministry recently submitted a report to the Central Drugs Standard Control Organisation (CDSCO) with a road map for regulating the use of stem cells and other cell-based therapies.
The panel was formed in June last year after authorities noticed the increasing use of stem cells and related therapies by clinicians for treatment of diseases.
"While drafting the guidelines, we enquired about stem cell usage randomly across the country. We found that several national and international companies were minting money from patients by claiming to carry out treatment of various incurable diseases like multiple sclerosis and muscular dystrophy using stem cells," Dr Lalji Singh, chairman of the committee on stem cells, told Mail Today.
"Any patient who has lost hope of being cured would like to try a new therapy by taking a chance even though the doctor doesn't assure positive results. Such opportunities have opened a market in India for cashing in on patients' compulsions and illnesses," he said.
Singh said the companies are making "fraudulent claims" about using stem cells for curing diseases when the concept is still under research.
"With the new guidelines, even government hospitals will have to follow strict procedures for carrying out clinical trials," he said.
The panel has recommended that rules in the Drugs and Cosmetics Act of 1940 should be amended to include stem cells and other cell-based products as new drugs.
It said there should be a system based on specially appointed technical evaluation committees and trained examiners for examining and licensing facilities where work on this field is being carried out.
"All vaccines, recombinant DNAderived drugs and stem cell and cellbased products shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21 of the Drugs and Cosmetics Act.
A new drug shall continue to be considered as a new one for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever earlier," Singh said.
The committee also recommended that the government should invite, evaluate and approve specific applications from companies, hospitals, research institutes and universities that propose to use stem cells and cell-based products in clinical trials.
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