Plasma Therapeutics in India: Opportunities & Challenges

1. Plasma Therapeutics in India:
Opportunities & Challenges
Sunil Kumar Doda

2. Introduction

3. Plasma Derived Product
• Definition
– “Blood Product” means a drug manufactured or obtained from pooled
plasma of blood by fractionation, drawn from donors
– “Donor” means a person who voluntarily donates blood after he has been
declared fit after a medical examination

4. Blood Vs Plasma
Average 450 ml/unit
Average 200 ml/unit

5. Plasma for Fractionation
• Source plasma is not permitted for fractionation
• Plasma derived product only manufactured from recovered plasma
• Recovered plasma need to be collected from the Govt. approved Blood Banks
• Blood Bank sell only surplus plasma to fractionators
• Total Licensed Blood Bank: ≈ 3321
• Total Blood Collection: 12.7 mi blood units (2019-20)
e-Rakt Kosh is an initiative to connect, digitize and streamline the workflow
of blood banks across the nation

6. Utilization of Recovered Plasma
44% plasma fractionators
31% plasma used as a
single unit
25% clinical utilization of
plasma

7. Plasma Fractionators in India
• Reliance Lifesciences
• Intas Pharmaceuticals
• Virchow Biotech
• Hemarus Therapeutics
• Bharat Serums & Vaccines
• Other new players

8. Indian Regulatory Scenario

9. Regulatory Structure
Central Drugs Control Organisation (CDSCO)
Drugs Controller General of India- The Central License Approving Authority CLAA)
State Licensing Authority
Licenses issuing authority based on joint inspection with CLAA
National AIDS Control Organisation
Policy planning of Blood Safety program
Indian Pharmacopoeia Commission
Monographs and reference standards
National Institute of Biologicals
QC testing of blood products/ NRL

10. • Screening for Hepatitis B Surface antigen,
Hepatitis C virus antibody, HIV I and II
antibodies, Syphilis and Malaria @ each
blood unit
• Testing @ fractionation unit: Mini-pool
Pool  Finished product
• Virus Inactivation process: enveloped and
non-enveloped viruses
• Schedule F, Part XII B
• Schedule M
Regulatory Acts

11. Towards Safer Transfusion Services
Improvement in value chain due to economics
Rapid ELISA  Chemi/Automated NAT
Blood banks can charge more based on advanced test methods
Ref: NACO SIMS report for 2016-17 & internal estimate

12. Opportunities & Challenges in India

13. Opportunities
• Dedicated talent pool of Indian scientists and technicians
• Lower manufacturing/labour cost
• Structured regulatory framework- Shorter regulatory approval time – no clinical trials
requirement
• Quality products comparable to available market standards
• Support from Government of India with favourable policy making - NACO surplus
plasma,
• Certified blood banks being enabled to process recovered plasma appropriately while
maintaining quality standards

14. Challenges
• Limited plasma pool due to voluntary blood donations and dependency on blood banks
• Non availability of source plasma for fractionation and donor compensation
• Limited plasma processing setups
• Shortage of products
• Lack of focus for creating a robust and sustained model for plasma fractionation
program
• Lack of awareness for plasma product manufacturing and usage
• Govt. price control

15. Common Products
• Human Albumin: 5%, 20% 25% solution & 20% Low salt
• Human Normal Immunoglobulin Intravenous (IVIG): 5% & 10%
• Human Normal Immunoglobulin Subcutaneous/Intramuscular: 16.5%
• Factor IX concentrate: 600 IU
• Factor VIII concentrate: 250 & 500 IU

16. Thank You