National Policy for Access to Plasma Derived Medicinal Products from Human Plasma for Clinical / Therapeutic Use

Aims of the policy

The Policy aims at making available, easily accessible and adequate supply of high quality of human plasma derived proteins for clinical/therapeutic use. The plasma is prepared as part of safe and quality blood and blood components collected/procured from a voluntary non-remunerated regular blood donor in well-equipped premises, which is free from transfusion transmitted infections, and is stored and transported under optimum conditions.

To enabling the mobilization of this excess plasma stocks at the blood banks for fractionation to make some more high value products, which hitherto are not often available in adequate quantities to meet the increasing clinical requirements.

The process of collecting standard plasma and transporting them under optimum conditions for fractionation, identifying critical parameters for safety, ensuring compliance with regulatory requirements, training for the appropriate usage of these products will be covered under this policy.

Objectives of the Policy

• To reiterate that Government will facilitate availability and utilization of safe and adequate quantity of plasma derived products for clinical/ herapeutic use.
• To make available adequate resources to develop and organize the plasma/PDMPs mobilization throughout the country.
• To take adequate Regulatory and Legislative steps for monitoring of activities related to plasma derived products.
• To encourage Research & Development in the field of blood components, plasma fractionation and plasma derived products.
• To strengthen Quality Systems in Blood Transfusion Services for plasma collection,transportation, processing, production and distribution of PDMPs.

For more information, visit National Policy for Access to Plasma Derived Medicinal Products from Human Plasma for Clinical / Therapeutic Use: Addendum to National Blood Policy 2003

Source: NACO