Blood products are used in the treatment of many life threatening diseases and complex surgical procedures. Blood products refer to blood components prepared in the blood transfusion centre (red cells, platelets, fresh frozen plasma and cryoprecipitate) or plasma derivatives such as albumin, coagulation factors, immunoglobulins and microcontent protein.
Blood and blood components perform numerous vital functions in the body - severe blood loss could result in serious conditions which require immediate blood transfusion in order to prevent organ failure and death. Blood transfusion is also used as a supportive therapy for surgery, chemotherapy, and stem cell and organ transplantation, as well as the treatment of serious acute and chronic diseases caused by deficiencies or defects in plasma proteins or cellular blood components. A number of diseases are due to deficiencies or defects in a single blood component or plasma protein (for example clotting factor deficiency for haemophilia); this has led to the evolution of targeted therapy with specific blood components.
The processing of blood into various therapeutics or products is a highly specialized field as blood products are inherently variable due to the nature of the source materials as well as the methods used to produce them.
The increasing global demand for blood products have led to enormous increase in the manufacturing of blood products; this has resulted in a significant increase in the complexity of preparations, which, in turn, has paved the way to the development of stringent regulations to conduct clinical trials in order to enhance the safety and quality of blood and blood components.
Blood products come under the category of biological drugs. In India, CDSCO regulates the manufacture and import of blood products. CDSCO is responsible for:
● Approving clinical trials
● Granting permission to import biologicals for local trials
● Authorizing firms to export biologicals for biochemical and immunological analysis
Clinical trial of blood products should be conducted in accordance with the New Drugs & Clinical Trial Rules, 2019.
Clinical trial application for blood products – Key points to consider
Just like a new drug application, clinical trial application for blood products is submitted using Form CT-04 along with the pre-specified fees.
Once the application submitted, the central licensing authority has 90 calendar days to evaluate the application if the blood product is developed outside India. However, if the biological product is discovered in India or research and development of the biological product are being done in India and also the biological product is proposed to be manufactured and marketed in India, then the timeline for disposal of an application for conduct of such clinical study is 30 working days from the date of receipt of application. In such case, if no response is issued by the central licensing authority within 30 working days, the clinical trial will be considered to be deemed approved. Even if the sponsor doesn’t get any response from central licensing authority, it is mandatory to inform central licensing authority before initiating a clinical trial via Form CT-4A so central licensing authority can record the information.
The central licensing authority can waive the requirement for a local trial if the blood product has already been approved outside India in certain countries as per periodic order released.
The central licensing authority gives permission through Form CT-06. The permission remains valid for two years from the date of its issue. Before enrolment of first participant in the trial, registration in Clinical Trials Registry- India (CTRI) is mandatory.
Import of a biological product or substance for clinical trial
Any sponsor who intends to import a biological product or substance for clinical trial needs to make an application in Form CT-16 to the central licensing authority. After evaluating the Form CT-16 and the necessary documents, if satisfied, that the requirements of the rules have been complied with, the central licensing authority may grant the licence to import the biological product for CT in Form CT-17 within a period of 90 working days from the date of receipt of the application. The license is valid for a period of 3 years from the date of its issue, unless suspended or cancelled by central licensing authority. In exceptional circumstances the central licensing authority may extend the period of the license granted under rule 68 for a further period of 1 year.
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Clinical trial application for blood products is submitted using Form CT-04 .
The central licensing authority gives permission for clinical trial conduction through Form CT-06. The permission remains valid for two years from the date of its issue.
Before enrolment of first participant in the trial, registration in Clinical Trials Registry- India (CTRI) is mandatory.
New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).
Guidelines on management of blood and blood components as essential medicines. WHO. Available at:https://www.who.int/bloodproducts/brn/ManBloodEM_GL_WHO_TRS_1004_web_Annex_3.pdf. Accessed on: 30 April 2020.