The Drug Controller General of India (DCGI) has issued a safety alert against the use of Dendriatic cells for the treatment of cancer and has asked the Chennai-based Nichi-In Centre for Regenerative Medicine to stop sale of Dendriatic cell cancer vaccine in the name of Dendriatic cell immunotherapy.  

The DCGI's action comes in pursuance to the investigations carried out by the DCGI office at the facilities of Nichi-In Centre for Regenerative Medicine for administration of Dendriatic cells for the treatment of cancer.   

According to sources, the DCGI office had earlier received complaints against Nichi-In Centre for Regenerative Medicine for sale of Dendriatic cell cancer vaccine in the name of Dendriatic cell immunotherapy.  In the complaint against the firm, it was also mentioned that exorbitant fees were being charged from different cancer patients for administering the Dendriatic cell cancer vaccine.

Taking cognizance of the complaint, an investigation was undertaken by the CDSCO officials.   During the investigation, it was observed that the firm was involved in collection of blood from patients which is further subject to cell regeneration which includes cell isolation, cell culturing, centrifugation and dilution of Natural Killer Cell and T cells. These cell are being used in the treatment for cancer patients as autologous immunotherapy. There was no approval for this activity from competent authorities. It was also observed that the ethics committee of the firm was not registered with the CDSCO.  The investigation team also observed that firm's activities attracted the provision Section 3(b) of D&C Act, 1940.

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 cell regeneration which includes cell isolation, cell culturing, centrifugation and dilution of Natural Killer Cell and T cells and no valid market authorisation obtained from the CDSCO before the commercial use of the product and that the autologous immune enhancement therapy (AIET) given to the patients without any permission.  

The DCGI also noted that these observations prima facia imply that there were violations of D&C Act, 1940 and D&C 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 fro processing and administration of  Natural Killer Cell and T cells with immediate effect and providing the same to patients till further orders in public interest”, the DCGI in his order to Nichi-In Centre for Regenerative Medicine said.