The Drug Controller General of India (DCGI) has issued safety alerts against the use of Dendriatic cells for the treatment of cancer and has asked the two companies engaged in selling the medicine to stop collection and sale of Dendriatic cells. The DCGI's action comes in pursuance to the investigations carried out by the DCGI office at the facilities of the two companies for administration of Dendriatic cells for the treatment of cancer.
According to sources, the DCGI office had earlier received complaints against two companies--Gurgaon-based APAC Biotech Pvt Ltd and Noida-based Denvax Clinic—for the sale of Dendriatic cell cancer vaccine in the name of Dendriatic cell immunotherapy. In the complaints against these firms, 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 along with experts from AIIMS against APAC Biotech. During the investigation, it was observed that the firm had not obtained the clinical trial permission from the CDSCO for the trial which was carried out in 2011. It was also observed that as per the product label claim made on the package insert, the product falls under the purview of the D&C Act. It was also observed that after the completion of clinical trial in 2011, the firm had provided Autologous preparation containing mature Dendriatic cell (APCEDEN) to some patients.
Taking cognizance of the complaint, an investigation was also undertaken by the CDSCO officials against Denvax Clinic. The investigation team observed that the company did not take the clinical trial permission from CDSCO for the trial that was carried out in 2005-2006 and 2005-2008. It was also observed that as per the product label claim made on the package insert, the product falls under the purview of the D&C Act.
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 the clinical trial already conducted and no valid market authorisation obtained from the CDSCO before the commercial use of the product and that the Denvax and the APCEDEN were administered to the patients after the trial 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 the above, you are directed to stop collection of blood from any new patients for precessing and packaging of the product Dendriatic cell preparation with immediate effect and providing the same to patients till further orders in public interest”, the DCGI in his order to Denvax Clinic said.
“In view of the above, you are hereby directed to stop collection and sale of Autologous preparation containing mature Dendriatic cell with immediate effect and till further orders in public interest”, the DCGI in his order to APAC Biotech said.
Source:Pharmabiz
According to sources, the DCGI office had earlier received complaints against two companies--Gurgaon-based APAC Biotech Pvt Ltd and Noida-based Denvax Clinic—for the sale of Dendriatic cell cancer vaccine in the name of Dendriatic cell immunotherapy. In the complaints against these firms, 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 along with experts from AIIMS against APAC Biotech. During the investigation, it was observed that the firm had not obtained the clinical trial permission from the CDSCO for the trial which was carried out in 2011. It was also observed that as per the product label claim made on the package insert, the product falls under the purview of the D&C Act. It was also observed that after the completion of clinical trial in 2011, the firm had provided Autologous preparation containing mature Dendriatic cell (APCEDEN) to some patients.
Taking cognizance of the complaint, an investigation was also undertaken by the CDSCO officials against Denvax Clinic. The investigation team observed that the company did not take the clinical trial permission from CDSCO for the trial that was carried out in 2005-2006 and 2005-2008. It was also observed that as per the product label claim made on the package insert, the product falls under the purview of the D&C Act.
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 the clinical trial already conducted and no valid market authorisation obtained from the CDSCO before the commercial use of the product and that the Denvax and the APCEDEN were administered to the patients after the trial 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 the above, you are directed to stop collection of blood from any new patients for precessing and packaging of the product Dendriatic cell preparation with immediate effect and providing the same to patients till further orders in public interest”, the DCGI in his order to Denvax Clinic said.
“In view of the above, you are hereby directed to stop collection and sale of Autologous preparation containing mature Dendriatic cell with immediate effect and till further orders in public interest”, the DCGI in his order to APAC Biotech said.
Source:Pharmabiz
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