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Stem Cells Come Under Drug Rules, Man’s Treatment Stops Suddenly

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Friday, April 12, 2019

NEW DELHI, India - "A treatment that was benefiting me, preventing further disability and also made me regain a large amount of my strength, has now been stopped overnight," rues 29-year-old Aditya Bhatia, who suffers from a rare condition FSHD Muscular Dystrophy.

Bhatia, a para athlete, was receiving stem cell therapy as part of a clinical trial since 2013 in New Delhi at a clinic called Nutech Mediworld, after being diagnosed with the condition in 2012.

The treatment, however, wasn't stopped on a whim. It was discontinued after the government enacted new rules for the mostly unregulated industry. On 19 March, the Union Health Ministry had notified New Drugs and Clinical Trial Rules, 2019, which for the first time include "stem cell derived products" as "new drugs". And treatments will have to go through approvals, with clinics having to procure licences for the same.

But what about patients whose lives depend on these existing treatment, asks Bhatia as he filed a petition with the Delhi High Court.

His writ petition states that under Article 21 of the Constitution, Bhatia's fundamental right to life and personal liberty has been violated with discontinuation of the stem cell treatment that he was undergoing according to The Indian Express. And an interim status quo must be permitted until clinics manage get licences.

A genetic muscle disorder, Facioscapulohumeral Muscular Dystrophy, better known as FSHD, is characterised as a wasting and weakening of shoulder, arms, face, abdomen and leg muscles.

"With the help of this treatment, I have been able to reverse the disease to an extent to reach a level of becoming a para athlete. But it requires continuous efforts to remain stable until a definite cure can be established." He says the progress he has made is now threatened by the therapy being discontinued.

The new rules will now require a clinic to attain licence for clinical trials, marketing, usage or treatment of stem cell for any condition.

In his petition, Bhatia argues that the approvals for stem cell will take months, meanwhile causing "debilitating effects" on him.

The clinic, at which Bhatia was being treated, reportedly said that they've stopped all ongoing stem cell procedures and a decision on whether they'll apply for the licence or not is yet to be taken.

Experts have been divided over the developments. While many welcome the much-needed regulations and said patients can't be given false hopes, others said suddenly stopping treatment of patients is inhumane.

Source: Fit
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