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The biopharmaceutical manufacturers of products such as vaccines, recombinant DNA, and others, can approach the central drug regulator with the approval of Institutional Biosafety Committee (IBSC) for manufacturing of test items for examination, test and analysis if the test item is generated using lower risk genetic engineering (GE) experiments, rather than taking one more approval from the Review Committee on Genetic Manipulation (RCGM).
The Central Drugs Standard Control Organisation (CDSCO) has shared the clarification from the Department of Biotechnology (DBT) with the biopharmaceutical manufacturers in a circular.
The DBT has recently requested the Drug Controller General of India (DCGI) to accept IBSC approval from biopharma industries for submission of form CT 10 in cases where the test item is generated using Category I and Category II GE Experiments as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017.
According to the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017 Category I experiments may be commenced after intimating the IBSC, while category II experiments may be initiated subsequent to the IBSC approval and an intimation to the RCGM.
However, all category III and above GE experiments shall require prior authorization from IBSC and subsequent approval from the RCGM before the commencement of the experiments through submission of information in the prescribed proforma.
The Category I and Category II GE experiments in laboratory do not require RCGM approval and regulatory pathways as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017 to be followed.
"However, the biopharma industries are still submitting form C1 for RCGM consideration to carry out R&D and submitting the corresponding RCGM approval letter to CDSCO in the process of seeking approval for examination, test & analysis and attaching the same with Form CT 10," said Dr Nitin K Jain, member secretary, RCGM, in a letter to the DCGI.
"Therefore, it is requested to accept IBSC approval from biopharma industries for submission of form CT 10 seeking permission for manufacturing of test items for examination, test and analysis in cases where the test item is generated using Category I and Category II GE Experiments as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017," said Jain.
Following this, the DCGI, shared the information to the biopharmaceutical manufacturers for their attention and necessary action.
According to the 2017 guidelines, the Category I includes experiments which generally do not pose significant risks to the laboratory workers, community or the environment and the modifications have no effect on safety concerns. Category II genetic engineering experiments may pose low-level risks to laboratory workers, community or the environment. However, Category III and above genetic experiments pose moderate to high risks to laboratory workers, community or the environment.
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