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Year : 2022  |  Volume : 7  |  Issue : 1  |  Page : 103

Blood is a drug and drugs controller is the right regulatory authority for licensing and monitoring blood transfusion services - Our view


Regional Blood Center, Teaching Hospital, Anuradhapura, Sri Lanka

Date of Submission10-Mar-2022
Date of Decision21-Mar-2022
Date of Acceptance26-Mar-2022
Date of Web Publication29-Apr-2022

Correspondence Address:
Dr. Namal Bandara
Regional Blood Center, Teaching Hospital, Anuradhapura
Sri Lanka
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/gjtm.gjtm_21_22

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How to cite this article:
Bandara N. Blood is a drug and drugs controller is the right regulatory authority for licensing and monitoring blood transfusion services - Our view. Glob J Transfus Med 2022;7:103

How to cite this URL:
Bandara N. Blood is a drug and drugs controller is the right regulatory authority for licensing and monitoring blood transfusion services - Our view. Glob J Transfus Med [serial online] 2022 [cited 2022 Jun 26];7:103. Available from: https://www.gjtmonline.com/text.asp?2022/7/1/103/344332



The Food and Drug Administration (FDA) defines a drug as that “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”[1] Blood products are a critical treatment modality in modern medical practice. Blood today is used as red cell, platelet, and plasma products and plasma derivatives such as human albumin and intravenous immunoglobulin. These products are widely used not only for life-saving emergencies but also routinely for transfusion-dependent patients.

Further, blood like any other drug is prescribed by qualified and authorized medical practitioner, and outcome of the treatment is monitored clinically and by means of laboratory tests.[2] Viewed in this context, blood qualifies to be a drug.

Next issue is who should regulate Blood and Blood Products? In many countries, blood and blood products are under the regulation of drug controller. If blood is a drug, it is appropriate to consider that “Drugs Controller is the Right Regulatory Authority for Licensing and Monitoring Blood Transfusion Services.”

Transfusion of blood products follows a complex chain of activities including collection as whole blood or aphaeresis donations; processing, testing storage, and transportation. These require knowledge of good manufacturing practices which the drugs controller by virtue of being pharmacists are aware of.

Testing of blood components involves testing for purity (freedom from infections), sterility, dose, and adverse effects, all of which are similar to drugs. Blood is manufactured from donors who constitute the raw material, and hence, the raw material (donor) undergoes tests to qualify for donation or use as raw material. Blood components are prepared in batches just like drugs, and each batch is tested for quality. Like any other drug, blood components also come with stipulated date expiry, storage, and dispensing instructions. Like drugs, they have therapeutic effects and adverse effects on the user. Therefore, it is essential to have a regulatory authority to make sure that every step involved is done according to the accepted standards. Most countries have given this authority to an organization that is responsible to ensure the safety of drugs and medicinal products of the country. For example, FDA is responsible for regulatory oversight of the blood supply of the United States,[3] and the Medicines and Healthcare Products Regulatory Authority is responsible for monitoring compliance with these regulations in the UK. In India, human blood is covered under the definition of “Drug” under Sec. 3(b) of Drugs and Cosmetics Act and State Drugs Controllers are authorized to issue the licenses for blood banks.[4]

In conclusion, it is evident that blood and blood products are used in the capacity of a drug in modern-day medicine, and hence, it has to be under the regulatory authority of the country that is responsible for drugs and medicinal products of the country.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
FDA Definition of Drug. Available from: https://www.fda.gov/industry/regulated-products/human-drugs#drug. [Last accessed on 2022 Mar 18].  Back to cited text no. 1
    
2.
Robinson S, Harris A, Atkinson S, Atterbury C, Bolton-Maggs P, Elliott C, et al. The administration of blood components: A British Society for Haematology Guideline. Transfus Med 2018;28:3-21.  Back to cited text no. 2
    
3.
Regulation of the Blood Supply. Available from: https://www.fda.gov/vaccines-blood-biologics/blood-blood-products/regulation-blood-supply. [Last accessed on 2022 Mar 21].  Back to cited text no. 3
    
4.
Regulatory Requirements of Blood and/or its Components Including Blood Products. Available from: https://drugscontrol.org/blood-banks.php. [Last accessed on 2022 Mar 21].  Back to cited text no. 4
    




 

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