Understanding the Legal Framework Behind Blood Center Licensing in India

The blood center is the core part of the blood supply chain. Blood banks function as establishments tasked with the collection, testing, storage, and distribution of blood and its components. Such centers are required to distribute safe and adequate blood, which is crucial to protect patients’ health. On the other hand, by comparing the current data with that from last year, the Blood Transfusion Service (BTS) has made significant improvements. 

These services are provided by the blood banks, which perform a vital role. But have you ever wondered what the process or the key requirement of the legal framework behind blood center licensing is? In this comprehensive guide, we will explore what legal requirements need to be followed to obtain a drug license registration. Let’s explore it in more detail.

What are the Drug Licensing Rules and Regulations?

In India, blood is tagged as “a drug.” During an emergency, the blood centers are the primary source to provide blood. The centers are involved in blood collection, processing, testing, and many other activities. However, there are also specified rules for blood bankers.

Drugs and Cosmetics Act, 1940

This is the most important and the primary constitution to operate the blood centers in India. According to this law, the blood and blood product operators are treated as manufacturers.

Drugs and Cosmetics Rules, 1945

This is another important rule. This rule determines the requirements to obtain a drug license. It outlines the specifics of personnel equipment and the operational procedures.

Licensing Authority

Blood is also tagged as a “drug.” Therefore, the Drug Controller General of India (DCGI), which is also known as the Central Licensing Authority, allocates drug certificates in India for blood centers.

Central Licence Approving Authority (CLAA)

With the CDSCO (Central Drugs Standard Control Organization), the DCGI works to approve the drug safety certification for blood banks. In India, CDSCO acts as a state licensing authority, whereas its head department, DCGI, serves as the Central Licensing Approving Authority.

National Blood Transfusion Council (NBTC)

For the blood transfusion service, the NBTC serves as the guide. It establishes the regulations and guidelines under standards. It also demonstrates the blood bank quality management. 

Requirements to Obtain a Drug License in India for Blood Banks 

The national authority has outlined specific requirements for those who are seeking to secure a drug certificate. For blood and blood component testing, storage, and distribution, the blood centers require a valid license. But, before licensing, they are required to meet the compliance and quality control management. The key requirements are 

Compliance with Schedule F

The standard for blood banks, such as equipment, infrastructure, and quality control, has been outlined in the Drugs and Cosmetics Rules, 1945, Part XII-B and XII-C of Schedule F. 

Infrastructure

Before applying for the license, the blood center operators are required to meet the specified space, equipment, and facilities requirements. 

Personnel

To operate the blood bank in India, only trained, experienced, and qualified applicants in the relevant subject are eligible. The medical professionals and the technical staff must have knowledge of the relevant field.

Quality Control

Aligning with the quality control system is mandatory for a blood center. It is important for blood and blood components’ safety and efficacy standards. 

Screening of blood

The guidelines of the WHO (World Health Organization) signify that before blood donations, it must be screened for transfusion-transmissible infections like HIV, and syphilis hepatitis B and C. 

What Kinds of Blood Centers are there in India?

Every blood center performs different roles. This can be understood as

Blood Banks: The blood centers are tasked with the collection, processing, and storage of blood and blood products.

Blood storage center: The hospital regulates most of the blood storage centers. These types of blood banks only store blood and blood products. 

BCSUs: It stands for blood component separation units. These units are experienced in dividing the blood into its components, such as platelets, plasma, or red blood cells. 

Final Words | Drug Safety Certification for Blood Centers

The legal structure for blood centers is basically designed to support voluntary, non-remunerated blood donations. The blood transfusion services have been enhanced a lot due to the public-private partnership. They hold a crucial position in the services related to blood transfusion. The primary objective of the legal framework is to guarantee the safety and sufficient standards of blood and its components. Ensuring the safety standards prevents transfusion-transmissible infections. In this situation, securing the drug license for blood centers has become crucial. To regulate the blood banks’, register with CDSCO now to obtain a license. To streamline the registration process, get in touch with LegalRaasta experts. 

Frequently Asked Questions

1. What is the Legal requirement for a blood banks?

Ans. Obtaining the license from the state licensing authority, which is approved by DCGI, is crucial. The drug certificate is a legal formality for all blood banks. 

2. How can I get a blood bank drug license in India?

Ans. Fill out the Form 27C and register with the relevant licensing authority to obtain a certificate. Further, pay mandatory registration fees and provide supporting documents. 

3. Which form is required to submit the documents?

Ans. For the document submission, you are required to fulfill Form 28C.

4. What CPD standards are for blood transfusion?

Ans. The CPD stands for “citrate-phosphate-dextrose. 

5. What is the total number of blood bank types available in India?

Ans. There are three types of blood centers. One is operated by the Indian government, and two are private and run by NGOs.