Govt constitutes Evaluation Committee to screen & approve applications for stem cell therapy
Union government has constituted a Cellular-based Biological Therapeutic Drug Evaluation Committee to screen and approve applications submitted for the stem cell therapy. The committee is headed by Dr VM Katoch, secretary, department of health research, ministry of health and family welfare and director-general, Indian Council of Medical Research (ICMR).
The formation of the Committee will now help to handle the issues on stem cell applications for a host of therapies. It will also oversee the assessment of standardization of methods for isolation, culture, storage of stem cells, development of standard operating procedures, process validation, inspection of controlled Good Manufacturing Practice (GMP) infrastructure, monitoring the delivery of stem cells and safe use of and data entry among others.
The Cellular-based Biological Therapeutic Drug Evaluation Committee will now formally approve all the stem cell projects for clinical applications. Final stem cell guidelines are not yet through. The ICMR and DCGI have asked for comments on the draft guidelines from the industry and research centres which have been provided. Now the two regulatory authorities are expected to finalize the same and place it for clearance from Parliament.
“The formation of the new committee is a step in the right direction and it will also look into the legal aspects. The committee will meet in the first week of February to look at our submissions to seek the clearance for phase II b and phase III studies for critical limbs ischemia,” stated BN Manohar, president, Stempeutics.
Stempeutics has now carried out animal studies in association with the National Institute of Nutrition Hyderabad to carry out the safety and toxicology studies for its product Stempeucel. The product has completed the pre-clinical studies. Now the company has applied to the Drugs Control General of India (DCGI) for the permission to carry out phase II b and phase III trial.
ICMR is the technical and clinical committee but all formal clearances for the human studies will come in from the Drugs Control General of India. While the Department of Bio-Technology (DBT) promotes the science of stem cells and encourages research, the DCGI has been looking at ways for the commercialization of stem cell autologous and allogenic therapies, he added.
Overall stem cells is a promising field but it is quite clear now that there are evidently no shortcuts. Therefore a marathon effort is needed to arrive at the final product. The researchers are looking to upscale the product to the clinical phase need to define the product, indicate the formulation process in detail and systematically maintain all data right from processing to product development. Stem cells can be produced only in controlled Good Manufacturing Practice (GMP) facility to ensure the production of a high quality efficacious product, stated Manohar.
The formation of the Committee will now help to handle the issues on stem cell applications for a host of therapies. It will also oversee the assessment of standardization of methods for isolation, culture, storage of stem cells, development of standard operating procedures, process validation, inspection of controlled Good Manufacturing Practice (GMP) infrastructure, monitoring the delivery of stem cells and safe use of and data entry among others.
The Cellular-based Biological Therapeutic Drug Evaluation Committee will now formally approve all the stem cell projects for clinical applications. Final stem cell guidelines are not yet through. The ICMR and DCGI have asked for comments on the draft guidelines from the industry and research centres which have been provided. Now the two regulatory authorities are expected to finalize the same and place it for clearance from Parliament.
“The formation of the new committee is a step in the right direction and it will also look into the legal aspects. The committee will meet in the first week of February to look at our submissions to seek the clearance for phase II b and phase III studies for critical limbs ischemia,” stated BN Manohar, president, Stempeutics.
Stempeutics has now carried out animal studies in association with the National Institute of Nutrition Hyderabad to carry out the safety and toxicology studies for its product Stempeucel. The product has completed the pre-clinical studies. Now the company has applied to the Drugs Control General of India (DCGI) for the permission to carry out phase II b and phase III trial.
ICMR is the technical and clinical committee but all formal clearances for the human studies will come in from the Drugs Control General of India. While the Department of Bio-Technology (DBT) promotes the science of stem cells and encourages research, the DCGI has been looking at ways for the commercialization of stem cell autologous and allogenic therapies, he added.
Overall stem cells is a promising field but it is quite clear now that there are evidently no shortcuts. Therefore a marathon effort is needed to arrive at the final product. The researchers are looking to upscale the product to the clinical phase need to define the product, indicate the formulation process in detail and systematically maintain all data right from processing to product development. Stem cells can be produced only in controlled Good Manufacturing Practice (GMP) facility to ensure the production of a high quality efficacious product, stated Manohar.
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