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- In India, by law, it received the approval of CDSCO, as per the Drugs & Cosmetics Act, 1940 and Rules, 1945 to run a blood bank.
- Ensures blood and the“ CDSCO License for Blood Banks ensures safe collection, testing, storage, and distribution of blood in compliance with Drugs & Cosmetics Act.” are collected, tested, stored, and distributed in a safe manner.
- Must follow GMP rules and hygiene and safety conditions.
- Blood samples need to be tested for HIV, Hepatitis B & C, Syphilis, and Malaria at designated laboratories.
- Inspections are made by officials at CDSCO in terms of infrastructure, equipment, and qualified staff.
Introduction
The License by CDSCO License for Blood Banks is a mandatory statutory regulatory requirement by the government that has to be complied with by an existing or proposed Blood Bank in India. The license from CDSCO, which works under the Drugs and Cosmetics Act, 1940 & Rules, 1945, helps ensure that blood and its components, which are processed, stored, tested, and utilized for transfusions, conform to established standards on safety, quality, and performance. Blood being such an important life-saving commodity that cannot be replaced with any other commodity owing to its rarity and value, it needs to be duly controlled to avoid any form of contamination and transmission of infections, and various mishandlings associated with blood transfusions.
What is CDSCO License?
CDSCO License: The CDSCO License is officially recognized as a statutory license that is provided by the Central Drugs Standard Control Organization (CDSCO), which acts as India’s national regulatory authority regarding drugs, devices, and cosmetics, as well as blood products. This document is provided on the basis of the Drugs and Cosmetics Act of 1940 and Rules of 1945 and must be required by entities dealing in various aspects of blood banks and devices in India.The license by the CDSCO ensures that there are standards in safety, quality, and efficacy of the product or the facility, including GMP standards and testing and trained staff and adequate infrastructure..
Key Points:
- This should contain the fact that this is regulatory clearance from the Central Drugs Standard Control Organization, or in short, CDSCO, which also should be mandatory.
- Being necessary for manufacturing, sale, stocking, or exhibition for sale or distribution of drug products, medical devices, cosmetics as well as blood components in Indian markets.
- Under the Drugs and Cosmetics Act, 1940, and the Rules, 1945
- This ensures it is safe, of quality, and effective.
- Acts as a guarantor of the maintenance of Good Manufacturing Practices.
Why is CDSCO Certification Mandatory
The CDSCO certification is of utmost importance because it ascertains that the drugs, medical devices, cosmetics, and blood products within India are of a high barrier in terms of safety, quality, and effectiveness. It prevents the manufacturing and selling of low-quality, unsafe, or counterfeited products that may pose a serious threat to human life. CDSCO helps prevent the sale of substandard, unsafe, or counterfeited products that may pose a serious threat to human life by compelling adherence to the Drugs and Cosmetics Act and GMP. CDSCO has gained the trust of patients in the quality of healthcare products and ensures the sale of only approved, tested products in the Indian market.
Key Reasons:
- Its role is to guarantee that drugs and devices for medical use meet the standards of safety, quality, and performance.
- Securing the health of the people against the sale of unsafe or substandard articles.
- Compliance with the Drugs & Cosmetics Act, 1940, and regulations thereunder.
- This ensures that Good Manufacturing Practices are followed by the manufacturing company.
- Enhances trust in healthcare products by patients as well as health providers.
Importance and Benefits of CDSCO Certification
| Importance | Benefits |
| The above is made legal by the Drugs and Cosmetics Act of 1940. | It provides patient safety and product integrity. |
| Applicable to drugs, devices, cosmetics, blood banks, as well as blood products. | Improves trust and credibility of manufacturers and suppliers. |
| Published by Central Drugs Standard Control Organization, CDSCO. | Permits legal manufacturing, importation, and sale of the drug in India. |
| Calls for following safety, quality, and government standards. | Reduces the chances of facing legal action by the regulatory authority due to non-compliance |
| It involves inspection, test, and verify processes preceding the issuance of approval. | Enhances market acceptance and business development opportunities. |
Step-by-Step Process of CDSCO Certification
Step1:Documentation
- Define product category (drug, medical device, cosmetic, IVD)
- Technical dossier and product information preparation
- Obtain company registration documents and manufacturing/import licenses
- Compliance with CDSCO documentation requirements
Step2:Product Testing
- Send product samples to NABL-accredited/BIS-recognized
- Perform safety, performance, and quality tests
- Collect valid test reports
- Ensure adherence to CDSCO requirements
Step3:Application Submission
- Register yourself on the CDSCO SUGAM portal
- Submissions of Applications by CDSCO
- As mentioned in various
- All necessary documents and test reports have been uploaded
- Pay the mandated CDSCO government fees
Step4:Scrutiny and Inspection
- CDSCO evaluates submitted documentation
- Technical assessment: Product details
- Manufacturing site inspection can be performed
- Queries/ Clarifications raised, if any
Step5:Grant of License
- Application approved by Central Drugs Standard Control Organization
- CDSCO License / Registration Certificate issued
- Approved product for manufacturing/import and sale in India
- Validity of the license renewable as per regulatory terms
Documents Required for CDSCO Certification
| Category | Documents Required |
| Business Documents | Business license/registration, ISO certificate, organizational details |
| Manufacturer Details | Factory layout, process flow chart, machinery list, production details |
| Product Documents | Product specifications, component list, user manual, model details |
| Testing Documents | Test report from BIS-recognized lab, sample details, test request form |
| Legal & Compliance | Authorization letter, brand ownership proof, trademark certificate (if any) |
| Import/Foreign Manufacturer (If applicable) | AIR (Authorized Indian Representative) details, contract agreement, overseas manufacturer documents |
Timelines, Costs, Validity & Renewal
- Timelines: Processing of CDSCO certification typically consumes 20-30 working days, of which 7-15 days are required for product testing, subject to the nature of the product and resolution of inquiries.
- Expenses: Fees charged by the government differ according to product types, whether it be a drug, medical device, cosmetic, or import product. Other costs can also be incurred depending on inspection, retesting, or changing documentation.
- Validity:In most cases, a CDSCO license/registration certificate is issued with a validity period of 2 years, depending on several regulatory conditions.
- Renewal: The process of renewing a license has to be carried out before its expiry date to prevent a suspension or lapse in the license.
- Renewal Requirements:A set of updated documents, formatted test reports (if needed), and the payment of predetermined fees are the necessities for successful renewal under the Central Drugs Standard Control Organization.
Why Choose Diligence Certifications
Diligence Certifications is a reliable regulatory consultant company that has the expertise in assisting the healthcare, pharma, medical device, and blood bank companies in obtaining the necessary certifications like CDSCO in India. At Diligence Certifications, you will be associated with professionals that have in-depth knowledge of the regulatory process and will make the entire experience smooth for you. At Diligence Certifications, you can leverage the benefits of years of experience, personalized assistance, and success, which will make the process of documentation and compliance smooth for you and will prevent you from facing rejection. Their approach will also ensure that you or your business complies with all the requirements.
Conclusion
Professional consultancy services are available to offer expert guidance on obtaining licenses through the CDSCO and the regulations of the Indian government. Proper consultancy helps to prevent mistakes in the process and ensures fast clearance and compliance with the Drugs and Cosmetics Act and the guidelines of the CDSCO. Professional consultancy services enhance the efficiency and smooth running of the organization in the legal context, and the organization can function with high quality standards being met.
Frequently Asked Questions (FAQs)
What is a CDSCO License?
This is an authorized approval and has been provided by the CDSCO for regulating the control of drugs, devices, and even blood banks.
Is a license from the CDSCO mandatory for Blood Banks?
Yes, as it is mandatory, as per the Drugs & Cosmetics Act, 1940.
Which is the authority that issues the CDSCO License?
Central Drugs Standard Control Organization (CDSCO), Government of India.
Why is the CDSCO License important to Blood Banks?
It makes sure that it is tested for quality and safety before being infused into the body.
Which blood unit tests must be carried out?
HIV, Hepatitis B, Hepatitis C, Syphilis, and Malaria tests
How long does the approval from CDSCO take?
Typically around 20 to 30 working days, subject to the status of the documents and the inspection status.
Is the validity of a CDSCO license valid?
In general, it is valid for 2 years, with certain regulatory requirements.
Must inspection occur preceding approval?
“Yes, the CDSCO may inspect the infrastructure, equipment, and staff.”
Can the blood bank be run without CDSCO approval?
No, running the business without a CDSCO license is unlawful in India.
Is the CDSCO License renewable?
Yes, it has to be renewed before its expiry date in order to keep the business running.
