New panel to clear clinical trials

Market potential for stem cell-based therapies estimated at $540 mn in India.

In a bid to tighten the regulatory control over cell-based therapies taking place in the country, the office of the Drugs Controller General of India has set up a new committee of experts to clear the clinical trial programmes related to cell research.

The committee, chaired by V M Katoch, secretary, Department of Health Research, will be in charge of clearing all experimental therapies involving tissue transplants and stem cell interventions.

The committee is expected to have its first meeting next week, on March 9.

According to health ministry officials, the DCGI's clearance for clinical trials such as stem cell therapies will now be given on the basis of the reports given by the Cellular Biology-Based Therapeutic Drug Committee.

A Frost & Sullivan study estimates the market potential for stem cell-based therapies alone at $540 million in India, for 10 indications.

“There is a need for a structural mechanism to regulate cell therapies. Since it has been a grey area in terms of conventional clinical trial approvals, we have formed a specialized committee to look into such applications,” Katoch said.

The move comes in the backdrop of increased interest among clinical practitioners to try out cell-based therapies for cardiac aliments, spinal injuries, neuro disorders among others.

All major private hospitals such as Apollo, Fortis, Medanta, LV Prasad Hospital have initiated cell based therapy programmes.

The move will also be the first step before the government can crack down on illegal trials and unsubstantiated therapeutic claims using cell therapies, officials said.

Meanwhile, drug industry officials hoped that the move will ease the procedural delays associated with cell based medication development.

"It took 18 months for the first approval to come for our stem-cell based product for AMI and second approval took 15 months. Now, it could be down to 12 months for us to secure an approval," said B N Manohar, CEO, Stempeutics Research Pvt Ltd, the Manipal Group-owned Bangalore-headquartered firm.

Stempeutics had tied up with domestic pharmaceutical major Cipla last year to market stem cell-based therapies.

Reliance Lifesciences is another domestic firm that is into stem cell therapies.