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Indian Express
24 October 2010

The Clinical Establishment Bill, which deals with clinical aspects of treatment and hospital functioning, is likely to be passed in the winter session. This Act specifically deals with practical aspects of stem cell management, defining what is permitted DR V M KATOCH, Director General, ICMR
SEVERAL stem cell treat ment practices are carried out in the country without government accreditation and a strong mechanism is needed to curb them, Director General, Indian Council of Medical Research (ICMR), Dr V M Katoch, said here on Sunday.

Speaking at a stem cell research conclave at Hyatt Regency in Andheri (East), he said, "The current guidelines, implemented in 2007 pertain only to research activities. But many leading private hospitals across the country are clinically implementing treatments that are still in the trial stage, particularly for neurological disorders."

He said the only stem cell therapy approved by the ICMR for clinical application was in the area of bone marrow. "Brain tissue regeneration and many umbilical cord blood cell treatments being practised have not been cleared by the Government of India," he cautioned.

The ICMR was in the process of bringing out a fresh set of guidelines under a new law that should be passed in the next six months, Dr Katoch said. "The Clinical Establishment Bill, which deals with clinical aspects of treatment and hospital functioning, is likely to be passed in the winter session. This Act specifically deals with practical aspects of stem cell management, defining what is permitted," said Dr Katoch.

A senior ICMR official present at the conclave said on the condition of anonymity, "We are trying to negotiate with Health Ministry officials to get the Medical Council of India and the Drugs Controller General of India to establish a regulatory framework for hospitals to provide stem cell therapy. At present, the ICMR does not have enough powers to stop such treatments, though we have knowledge of spurious activities."

The two-day national conclave saw participation of leading stem cell banking companies, like Cryo and Stem Cell Biologicals. Model and actress Lisa Ray, a cancer survivor, was the brand ambassador for the event.

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