3 hospitals to start stem cell therapy without MCI approval

Health dept is already facing a PIL for operating a similar unit at School of Tropical Medicine since 2013. Though the state health department has given clearnace, it is yet to procure permission from MCI, ICMR and drug controller of India.

The health department has given the go-ahead to set up stem cell therapy units at three government hospitals. They will conduct clinical trials on diabetic ulcer patients. However, sources said, the government is still to procure the mandatory clearance to set up the units from the Medical Council of India (MCI), the Indian Council of Medical Research (ICMR) and the Drug Controller-General of India.

The health department, which is under the direct supervision of the chief minister, is already facing one public interest litigation (PIL) for operating a similar stem cell therapy unit at the School of Tropical Medicine since 2013 without the necessary clearance from MCI and the other central bodies. The hospitals shortlisted now are MR Bangur Hospital, Vidyasagar State General Hospital and Sambhunath Pandit Hospital, all in Kolkata.

“We started the unit at our hospital on July 9. All the doctors conducting the human trials have undergone stem cell therapy training at STM. The director of medical education (DME), Dr Susanta Banerjee, and the director of health services (DHS), Dr BR Satpathi, cleared the trials. We don’t know if MCI or any other central agency has given their nod,” Dr Anuradha Deb, the superintendent of MR Bangur Hospital, told HT.

Dr Uttam Majumder, the superintendent of Vidyasagar State General Hospital in Behala, said, “Our unit will start soon. Dr Niranjan Bhattacharya, who is in charge of stem cell therapy treatment at the STM’s regenerative medicine unit, is looking after the project in our hospital.” The unit at Sambhunath Pandit Hospital is
also to start functioning soon.

DHS Dr Satpathi refused to comment on the matter when HT got in touch with him, while repeated attempts to contact DME Dr Banerjee were futile.

A section of the doctors as well as administrators at Swasthya Bhaban, the health department headquarters, are also upset with the government for going ahead with the stem cell therapy units without the mandatory clearances from the central agencies. A senior health department official said, “The unit at STM is using human beings as guinea pigs by subjecting them to such therapy without valid permissions. The unit should be closed immediately. It can function only after getting the approvals.”

HT had published a report on October 3, 2013, on how the regenerative medicine unit at STM was administering stem cell therapy under the supervision of Dr Bhattacharya, who is a retired gynaecologist. The authorities had then claimed that they had sought the approval of the central agencies and it would come soon. The approval, although, is still to arrive.

A three-member central team led by Dr Mammen Chandy, a haematologist and the director of Tata Medical Centre in Kolkata, had surveyed the unit at STM in June 2013. Dr Chandy had stated in his report that the unit led by Dr Bhattacharya was conducting human trials and most patients undergoing such treatment were poor and illiterate, having no idea about what they were being subjected to. The team had recommended the immediate closure of the unit.