The Telegraph
Since 1st March, 1999
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Stem cell march, minus checks
- Lack of research rules allows doctors to do as they like

New Delhi, Nov. 16: Flaws in rules for medical research and a failure of government agencies to exercise their watchdog rights have facilitated controversial human embryonic stem cell studies in India, scientists have said.

As reported in The Telegraph today, government officials and senior scientists have questioned claims by a Delhi-based doctor that she has used embryonic stem cell to treat nearly 100 patients with different diseases or injuries.

The claims by fertility specialist Geeta Shroff, made at a news conference here today, have attracted widespread criticism from scientists who have warned that embryonic stem cell technology is not mature enough for applications in humans.

Health secretary Prasanna Hota, chief guest at the conference, said his presence should not be construed as an endorsement of the work. “But sometimes, scientific knowledge cannot wait for bureaucratic apparatus,” Hota said.

However, reacting to claims by Shroff, scientists have said the absence of regulatory oversight allows virtually unfettered research by the private sector in India.

“It looks like anyone can do anything in medical research,” said Satish Totey, director of stem cell research at Manipal Hospital in Bangalore. “Is this the message India wants to give to the world'”

One concern among scientists is that embryonic stem cell may carry the risk of tumours. Shroff has asserted that she has not broken any law. “We’re not doing anything unethical. If the ICMR tells us to stop, we will stop,” she said.

Top ICMR officials said they had written to Shroff that her work did not have their approval. Existing guidelines on medical ethics make it mandatory for doctors to seek approval from the Indian Council of Medical Research for such research, but there is nothing it can do when private doctors flout guidelines.

“Guidelines are only guidelines. Any violations cannot be punished,” said Dorairajan Balasubramanian, research director at the LV Prasad Eye Institute in Hyderabad, himself involved in the use of stem cell to treat eye diseases.

The ICMR and the Department of Biotechnology are working to tighten stem cell research rules, but researchers believe progress has been slow. “They should have acted five years ago,” said Totey.

Shroff, who got MP Ajit Jogi and other patients to talk about their experiences with her therapy at the conference, said she has informed the ICMR.

But ICMR officials said Shroff had only sent details of her patients. “We don’t need patient information for approval process. We have asked for protocols ' things like patient selection criteria, the source of the embryonic stem cell, the method of injecting them and the dosage,” they said.

Some stem cell researchers fear a regulatory backlash. “The rules may now become so tight that we’ll find it hard to work,” Totey said.

While the ICMR has drafted legislation to make medical ethics mandatory for all, a senior official said it was hard to predict when it would come into effect. It has been cleared by the law ministry and is awaiting cabinet approval,” said Vasantha Muthuswamy, the head of basic medical sciences at the ICMR.

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