The Drug Controller General of India (DCGI) has asked the Pune-based Chaitanya Hospital to stop the treatments with stem cell products to the patients in the name of clinical trial with immediate effect. The DCGI's action comes in pursuance to the investigations carried out by the DCGI office for misuse and unethical stem cell clinical trial malpractices.
According to sources, the DCGI office had earlier received complaints against Chaitanya Hospital to investigate the misuse and unethical stem cell clinical trial malpractices. It was stated in the complaint that various stem cell treatments with high treatment costs such as cerebral palsy, stroke, Wilson's disease and spinal cord injury are being offered in the hospital. It was also mentioned in the complaint that the patients are being charged exorbitantly for unapproved and illegal transplants.
Taking cognizance of the complaint, an investigation was undertaken by CDSCO officials. The investigation team in its report had observed that the hospital had not obtained permission from CDSCO for the clinical trials. It was observed that the patients with bone marrow derived stem cells for various diseases like cerebral palsy, autism, vascular necrosis, spinal cord injury, diabetes mellitus, hemiplegia etc. were treated. The processing of bone marrow derived mono nuclear cells was claimed to be fall under minimum manipulation category as per ICMR guidelines but in the hospital there was no instrument or equipment provided which ensures aseptic processing and no documents were maintained as required under Good Clinical Practices and moreover patients were charged heavily for the treatment.
After examining the observations made by the investigation teams, the DCGI noted that the observations are serious in nature as there was no approval obtained for clinical trials already conducted. These observations prima facia imply that there are violations of the Drugs and Cosmetics Act, 1940 and the Drugs and the Cosmetics Rules, 1945 which has a bearing on the patient safety.
“In view of above, you are directed to stop the treatments with stem cell products to the patients in the name of clinical trial with immediate effect till further orders in public interest”, DCGI Dr GN Singh in his order said.