Regulation of Blood and Blood products in India, USA and EU

Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 2

Abstract

Blood and blood products are precious commodity which gives life to another person. Though we have immense discoveries and invention in science and technology, yet we cannot make blood hence, human blood has no substitute. The availability of safe blood and blood products is essential for diverse modern healthcare services including some surgeries, treatments for cancer, chronic medical conditions, trauma care, organ transplantation, and childbirths that ultimately improve life for millions of patients who are need of transfusion annually. We do not have yet well-defined and stringent regulatory framework for blood products regulation. Frailty may arise from the inability of governments to enforce laws, regulations, and policies and personnel who may not aware or cannot follow quality assurance and/ or good manufacturing practices. While the health sector in developed nation has made outstanding accomplishments in the past few decades. The study sheds on the overview of blood transfusion system in India and other developed nations. There were a mix of methodologies, including literature review (government documents), interviews with key officials in Indian Red Cross Society and analysis of data was used. Results of analysis showed that there are several areas that need to be addressed as it potentially affect the timely availability of safe blood products, which calls for strengthening the planning and monitoring of blood transfusion services.

Authors and Affiliations

Swati Gupta, Harvinder Popli

Keywords

Related Articles

A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines

USFDA is one the most regulated agencies wherein the submission process is most critical. The study depends on how to submit ANDA application as per FDA, CDER guidelines in paragraph IV submission in Federal Food, Drug,...

Requirements for introducing Medical devices in India and US market - A comparative study of regulations

Medical devices are widely used in the healthcare sector and are manufactured by the pharmaceutical industry. The Government of India has periodically come out with certain guidelines, to be followed by the companies tha...

Drug approval process in India and Europe

Every time a new drug is developed it requires a great amount of research work in manufacturing, Pre- clinical Science, Controls, Chemistry & Clinical trials. Regulatory agencies have Drug Reviewers who has the responsib...

GENERIC MEDICINES REGULATION IN BRAZIL

The regulation of medicines in Brazil has proven to be one of the major concerns of government policies in recent decades. In order to improve access to quality medicines for the population, the National Drug Policy was...

CURRENT REGULATION OF MEDICAL GASES IN INDIA AND FUTURE ASPECTS

Generally medical gases are administered or supplied directly to the patients. They should be manufactured and transferred with the highest quality possible as per standards and limits decided by the different regulatory...

Download PDF file
  • EP ID EP329342
  • DOI 10.22270/ijdra.v6i2.246
  • Views 138
  • Downloads 0

How To Cite

Swati Gupta, Harvinder Popli (2018). Regulation of Blood and Blood products in India, USA and EU. International Journal of Drug Regulatory Affairs, 6(2), 72-84. https://europub.co.uk/articles/-A-329342