How to Obtain a Drug License for a Blood Center: A Complete Guide?

Under the Drugs and Cosmetics Act, “blood” is described as a drug. The blood centers are tasked with the responsibility of managing blood and blood products. The Central Drugs Standard Control Organization mandates that any individual who is involved in manufacturing, selling, and distributing drugs, including blood, must obtain a drug certificate. In short, drug licensing is important for blood entering to meet the safety, quality, and efficacy standards. 

As CDSCO oversees the operations of drugs from manufacturing to distribution, DCGI also operates the blood operations. In this blog, we will explore how a blood center can obtain a drug certificate in India, the process, its importance, and its requirements. Let’s explore it in more detail.

Why is the blood center important in the Pharmaceutical Industry?

As mentioned in the previous sections, the blood center is the core part of the pharmaceutical industry. Such centers are responsible for providing the blood and its components, which are required for producing life-saving treatments. Additionally, the blood centers guarantee the standardization of blood and its components.

This can be understood as the blood centers act as the source of blood and blood products (red blood cells, plasma, and platelets). Plasma is a blood component that is widely used for pharmaceutical product manufacturing. The plasma is used to manufacture clotting factors and various other therapeutic proteins. 

As a blood center established after complying with strict regulatory rules and regulations, it reduces the risks of transfusion-transmissible infections. 

How is the Drug Safety Certification Crucial for Blood Centers?

Human blood and its components are legally defined as a drug. Under the Drugs and Cosmetics Act, blood and its products are legal drugs. Here is why drug license registration is vital for blood centers:

1. Legal Formality: Drug licensing for blood centers is a legal requirement under the Drugs and Cosmetics Act of 1940. This signifies that whoever is involved in the storage, manufacture, or sale of drugs, as well as blood and its components, needs to register with the CDSCO. 
2. Quality Control: Drug safety certification in India ensures that whoever registers as a blood center must comply with strict quality control parameters. They need to follow the quality control measures from donor screening and blood collection to the storage process. 
3. Consumer Safety: Drug registration decreases the potential risks of infection and serious transfusion-related disease. Through the licensing, the authority gets access to blood center operations, which is crucial for patient safety. 
4. Traceability and Accountability: The blood and blood components are traced through the drug certification. The licensing process enables tracking and investigating any adverse events or quality issues. 
5. Compliance with Standards: Drug license signals that blood centers comply with the compliance with standards. It boosts the trust of the national and international healthcare professionals.
6. Monitoring and Oversight: A drug certificate offers a robust structure for ongoing monitoring and oversight by the national regulatory body. It is required to ensure that the blood centers manage the specified practices and standards. 

Step-by-step—Drug License Registration for Blood Center

To obtain a drug license in India, one needs to follow several steps, including applying to the relevant state’s drug control authority, to Central inspection, and personnel. Here is a detailed breakdown:

  1. Understand the Requirements

• State-Specific Regulations: Both central and state drug control authorities work together to issue the drug license in India. Before applying, you must gain knowledge of your state’s specific authority and its guidelines. You can also take the help of a drug license consultant to streamline the process.
• Type of License: Define your license type. For which blood service do you want to obtain the license, e.g., blood collection, storage, processing, or distribution?
• Infrastructure Requirements: Your blood center infrastructure must comply with the relevant authority requirements. This encompasses the storage facilities, suitable space, and testing facilities.

2. Necessary Documentation

• Application form: Navigate to the state’s drug licensing portal to complete the application form. 
• ID and address proof: The personal details of the applicant and other key personnel, including their address proofs. 
• Premises Documents: Provide the ownership proof, including the layout of the site plan and NOC (No Objection Certificate) from the landlord. 
• Legal firm documents: MoA (Memorandum of Association) to define the blood center’s objectives, goals, and perspectives. The Articles of Association are created to define internal rules and regulations.
• Competent Person Certificates: The pharmacist and the operator of the blood center must have a pharmacy qualification, including a registration certificate. 

3. Online Application Submission

• Registration: Fill out the application form and submit it to your state drug licensing authority.
• Document Submission: Please attach the required documents along with the application form. Before application and document submission, you must ensure accuracy to avoid mistakes. 
• Fee Payment: Pay the mandatory drug license registration fee and keep the payment receipt as proof. 

4. Inspection by Drug Inspector

• Verification: The Blood Center will be inspected by the drug inspector to ensure compliance with standards. They will also ensure that the details you provide comply with regulations.
• Compliance Check: During inspection, the storage facilities, premises, and personnel qualifications will be verified by the inspector. 

4. License Issuance:

• Review: The inspection reports and the application will be reviewed by the drug control authority.
• Approval: If the application is approved, a drug certificate for the blood center will be issued to you. 

Final Discussion | CDSCO drug license for Blood Center

The guidelines of the Central Drugs Standard Control Organization determine that whoever engages in blood and blood product manufacturing, selling, and storage must obtain a drug certificate. Acquiring the drug safety certification for your blood center is a legal requirement. As mentioned, the drug license in India is a legal requirement, but it also acts as a quality assurance measure, protecting patient health, boosting the trust of healthcare professionals, and much more. Overall, drug license registration is a pivotal tool that is used to manage the integrity and safety of the blood supply and safeguard the consumer’s health. To facilitate the drug license registration process, consult with the experts of LegalRaasta, who specialize in drug licenses online.

Frequently Asked Questions

1. What is the form for a blood license?

Ans. Form 27-C is primarily used to obtain a license to operate the blood bank. Its form is used for blood bank licensing in India. 

2. How to get the CDSCO certificate for a blood center in Delhi?

Ans. To obtain a CDSCO license for a blood center in Delhi, you need to register on the CDSCO official online portal. Use the form MD-12 for CDSCO registration. 

3. How much area is required to obtain a drug license for a medical shop?

Ans. As per the Central Drugs Standard Control Organization guidelines, to obtain a drug certificate for a medical shop, the area should be 10 square meters. 

4. In India, who approves a new drug?

Ans. Under the Directorate General of Health Services and the Ministry of Health and Family Welfare, the Central  Drugs Standard Control Organization (CDSCO) approves new drugs. 

5. What is the full form of CDSCO’s SUGAM?

Ans. SUGAM stands for “System for Unmanned Gateway Approval of Manufecturers”.