This document, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization, addresses Ms. Weilness Solution of Co Legacy Health Solution regarding their Dendritic cell immunotherapy treatment. Following a complaint and subsequent investigation, it was found that the company is collecting patient blood, sending it to Institute of Cellular Therapies (ICT) for Dendritic cell vaccine preparation, and administering it to cancer patients without the necessary approvals under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. Citing concerns for patient safety, the organization directs Ms. Weilness Solution to immediately cease the collection of blood from new patients for the processing, packaging, and administration of Dendritic cell vaccine until further notice. Copies of this directive have been sent to the Indian Council of Medical Research (ICMR), the Drugs Controller in Chennai, and the Deputy Drugs Controller in Bangalore for necessary action.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Dendritic cell immunotherapy: A type of immunotherapy that uses dendritic cells to stimulate the immune system to fight cancer.
Institute of Cellular Therapies ICT, Noida: An organization involved in the preparation of Dendritic cell vaccine.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs and Cosmetics Rules, 1945: Rules formulated under the Drugs and Cosmetics Act, 1940 to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
Indian Council of Medical Research ICMR, New Delhi: The apex body in India for the formulation, coordination and promotion of biomedical research.
Bangalore, Karnataka: Location of the Sub Zonal office of Central Drug Standard Control Organisation
Chennai, Tamil Nadu: Location of the South Zone office of Central Drug Standard Control Organisation
F.No. X-11026/98/14-BD
Directorate General of Health Services
Central Drugs Standard Control Organization
Biological Division
FDA Bhawan, Kotla Road,
New Delhi-110002
Date:
To,
M/s Weilness Solution,
C/o Legacy Health Solution,
No, 72, 2 Main Road Nanjappa Layout,
Behind Kethams Hospital Vidyaranyapura,
Bangalore-560097.
Subject: Action in pursuance to the investigation carried out at facility for administration of
Dendritic cells or treatment of eaucer,
‘This is with reference to the above subject matter and to state that a complaint was received
against your firm to investigate on the issue of sale of Dendritic cell cancer vaccine in the name of
Dendritic cell immunotherapy. It was also mentioned in the complaint that exorbitant fees is being
charged from different cancer patients for administering the Dendritic cell cancer vaccine.
Taking cognizance of the complaint, an investigation was undertaken by CDSCO officials. The
investigation team in its report has observed that you are involved in collection of blood from patients and
which is transported to Institute of Cellular Therapies (ICT), Noida for the preparation of Dendritic cell
vaccine and which is being used in the treatment for Cancer patients. It was observed that as per the
product label claim made on the package insert, the product falls under the purview of the Drugs and
Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
That the observations as made by the investigating team were examined in the CDSCO, HQ. The
observations are serious in nature as there was no approval obtained for the collection of blood for the
processing of Dendritic cell vaccine for commercial use to be administered in patient without any
permission of Competent Authority. 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 collection of blood from any new patients for
processing, packaging and administration of Dendritic cell vaccine with immediate effect and providing
the same to patients till further orders in public interest.
“Yours faithfully,
. (Dr. G. N. Singh)
‘Drugs Controller‘ General (1)
Copy for necessary action to:
1) The Director General, Indian Council of Medical Research (ICMR), Ansarl Nagar, Post Box No. 4911,
2) N The ew D D ee pl uh ti y - 1 D1 r0 u0 g2 s9 . C ontroller (1), Central Drug Standard Control Organis; ation, South Zone, Second Floor,
Shastri Bhavan Annexe, 26, Haddows road, Chennai- 600 006.
3) The Deputy Drugs Controller (1), Central Drag Standard Control Organisation, Sub-Zonal office,2" Floor,
Palace Road (Drug Controller Office), Bangalore (Karnataka).