CDSCO says Indian hospital charged for stem cell treatments given during unapproved trial

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Good clinical practice

Chaitanya Hospital, Pune India
Chaitanya Hospital, Pune India
Indian regulators have accused a hospital of conducting unauthorised clinical trials of stem cell therapies and of charging patients who took part for the treatments.

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’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​).

Related products

show more

What are the building blocks of DCTs?

What are the building blocks of DCTs?

Medable | 26-Apr-2021 | Technical / White Paper

How to create a seamless experience across eConsent, eCOA and more.

Over the past year, tremendous progress was made toward digitizing and...

How a clinical metadata repository helps with data

How a clinical metadata repository helps with data

Formedix | 22-Mar-2021 | Technical / White Paper

This article covers the various ways a clinical metadata repository helps with data quality, and in turn, with data quality in the clinical trials process....

Introduction to eLAS®

Introduction to eLAS®

Clinical Ink | 08-Mar-2021 | Product Brochure

Clinical Ink has developed a unique offering — the electronic Lupus Assessment Suite (eLAS®) to address fundamental challenges impacting systemic lupus...

Related suppliers

Follow us


View more