The Central Drugs Standard Control Organization (CDSCO) launched its investigation of Chaitanya Hospital in Pune in November after reports that unapproved cell therapies were being offered to patients with cerebral palsy, stroke, Wilson’s disease and spinal cord injury in unauthorised clinical trials.
According to a letter sent to the hospital on November 21, the CDSCO investigation confirmed the reports and said that – in addition to failing to gain approval – the institution had also broken good clinical practices (GCP) regulations.
Specific infractions included that the hospital lacks the equipment needed to process the bone marrow derived cells in an aseptic manner despite its claim they were handled under "minimum manipulation category as per ICMR [Indian Council of Medical Research] guidelines."
The CDSCO added that: “No documents were maintained as required under Good Clinical Practices and moreover patients were charged heavily for the treatment for period 2013 to Sep 2014.”
The regulator ordered Chaitanya Hospital to halt the trials with immediate effect in a follow up letter sent earlier this month.
Representatives for Chaitanya Hospital did not respond to Outsourcing-pharma.com’s request for comment ahead of publication.
The hospital is listed as the site of several stem cell studies on the Indian Clinical Trial Registry (here).