Blood Products

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.


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Blood Products

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.

CliniExperts offers a broad range of specialised services to assist companies to bring new biological/biosimilars to market faster. With over a decade of experience in the clinical trial space, Cliniexperts specialises in the planning, management and efficient conduction of Phase II-III local and global clinical trials. We can also assist you in Phase IV Trial or Post Marketing Studies (PMS) (exclusively in India).

Summary

  • 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.

References

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Frequently Asked Questions

In which cases the extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible?

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.

Any biological product manufactured under Form CT-14 & Form CT-15 shall be kept in containers bearing labels, indicating the name of the biological product or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organization or the center where the CT is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been manufactured.

The permission granted in Form CT-11/CT-14/CT-15 to manufacture a biological product or substance to conduct CT shall remain valid for a period of 3 years from the date of its issue, unless suspended or cancelled by CLA. In exceptional circumstances the CLA may extend the period of the permission granted for a further period of 1year.

The application submitted to CLA for grant of permission to conduct clinical trial of a biological product discovered in India or research and development of the biological product are being done in India and also the drug is proposed to be manufactured and marketed in India, such application shall be disposed by way of grant of permission or rejection or processed by way of communication to rectify any deficiency of the application, as the case may be, as specified in rule 22, by the CLA within a period of 30 working days from the date of the receipt of the application. If no communication has been received from the CLA to the applicant within the said period, the permission to conduct clinical trial shall be deemed to have been granted.


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