The company has violated the D&C Act, 1940 and D&C Rules, 1945
Chennai-based Nichi-In Center for Regenerative Medicine has been by the DCGI, to stop selling the Dendriatic cell cancer vaccine for Dendriatic immunization therapy. The controller has also issued a safety alert against the use of dendriatic cells for the treatment of cancer.
The company's facility was investigated by the DCGI, and it noted that the company collected blood from the patients, which after subsequent treatments like centrifugation and dilution was given to cancer patients as autologous immunotherapy. There was no approval for this process from competent authorities. It also observed that the ethics committee of the firm was not registered with CDSCO.
The company has violated the D&C Act, 1940 and D&C Rules, 1945 which have a bearing on patient safety.
"In view of violating rules, you are directed to stop the collection of blood from new patients for 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," said the DCGI in its statement to the company.