Blood Bank Licensing in India: Requirements Under the Drugs and Cosmetics Rules

Human blood is legally classified as a “drug” in India — a fact that surprises many hospital administrators evaluating whether to set up an in-house blood bank. That classification is the reason blood banking sits under some of the strictest licensing requirements in Indian healthcare, with a regulatory history shaped directly by a Supreme Court directive following documented quality failures in the system. This article explains what the law actually requires.

Why Blood Banking Is Regulated as Drug Manufacturing

Human blood falls within the definition of “drug” under Section 3(b) of the Drugs and Cosmetics Act, 1940, which means blood banks are legally treated as entities involved in the manufacture of a drug, and require a manufacturing licence accordingly — not a general clinical establishment registration. This framework traces back to 1967, when the government introduced a dedicated provision — Schedule F, Part XII-B of the Drugs and Cosmetics Rules — specifically covering accommodation, technical staff, and equipment requirements for blood bank operation. Following a Supreme Court directive prompted by a public interest litigation highlighting serious quality-control deficiencies in the blood banking system, the framework was further strengthened through amendments in 1992–93, and the Drugs Controller General of India (DCGI) was given Central Licence Approving Authority status over notified drugs including blood and blood products.

The Legal Framework in Brief

Blood bank licensing is governed by Rules 122-F through 122-O of the Drugs and Cosmetics Rules, 1945, with the detailed technical standards — space, equipment, and personnel requirements — set out in Schedule F, Parts XII-B and XII-C. The National Blood Policy, published by the Government of India, additionally shapes licensing practice: notably, it directs that fresh licences for standalone private-sector blood banks are not readily granted, and that renewal applications for existing standalone private blood banks are subject to thorough scrutiny — a policy stance that reflects the government’s preference for hospital-integrated blood banks over independent, freestanding ones.

Who Regulates Blood Banks

• State Drug Control Authority (SDCA): issues the primary manufacturing licence, on Form 28, and is the main day-to-day regulator.
• Central Drugs Standard Control Organization (CDSCO) / Drugs Controller General of India: exercises Central Licence Approving Authority functions over notified categories including blood and blood products.
• State Blood Transfusion Council (SBTC): issues a No Objection Certificate as part of the licensing process, generally assessed against geographic need for blood banking services in that area.
• National AIDS Control Organisation (NACO): sets testing and technical standards relevant to blood safety, particularly around transfusion-transmitted infection (TTI) screening.

Who Can Apply

Eligible applicants include government hospitals, private hospitals, charitable trusts, voluntary organisations, and the Indian Red Cross Society. Given the National Blood Policy’s stated caution around new standalone private blood banks, applicants are generally better positioned when the blood bank is integrated within a hospital’s existing services rather than proposed as a freestanding, independent facility.

Minimum Infrastructure Requirements

Schedule F specifies the space, plant, and equipment required for the specific operations a blood bank intends to perform. As a general reference point, a blood bank is commonly expected to have a minimum of around 100 square metres for core operations, with an additional area required if blood component preparation (such as separating plasma and platelets) is also offered. Distinct areas are typically required for blood collection, transfusion-transmitted infection testing (with appropriate biosafety provisions), component preparation (where offered), and dedicated cold-chain storage kept separate from any area used for medication storage.

Mandatory Testing

Every unit of collected blood must be tested for transfusion-transmitted infections before release, with HIV-1 and HIV-2 testing via ELISA (rather than rapid diagnostic kits, which NACO does not permit for licensed blood bank screening) among the mandatory requirements, alongside other notified infections. Any reactive unit must be discarded rather than released for transfusion. This testing requirement was itself introduced through a 1989 notification under the Drugs and Cosmetics Rules, reflecting the specific historical context of the HIV epidemic’s impact on blood safety regulation in India.

The General Application Process

1. Secure appropriate premises meeting Schedule F’s space and layout requirements, with distinct zones for collection, testing, storage, and (if applicable) component preparation.
2. Recruit the technical staff Schedule F requires, including a qualified medical officer responsible for the blood bank’s operations.
3. Obtain a No Objection Certificate from the State Blood Transfusion Council, generally based on an assessment of local need.
4. Apply for the manufacturing licence (Form 28) through the State Drug Control Authority, with supporting documentation on premises, equipment, and staff.
5. Undergo inspection by a Drugs Inspector appointed under the Drugs and Cosmetics Act to verify compliance before licence issuance.

The resulting licence is generally valid for five years from issuance, and any subsequent change in technical staff or in the constitution of the licensed entity must be reported to the Licensing Authority without delay.

Why NABL Accreditation, Though Not Mandatory, Is Worth Considering

NABL accreditation is not a mandatory precondition for a blood bank licence, but it is widely recommended because it independently demonstrates the facility’s competence and adherence to quality standards — a distinction that matters for hospital reputation, referral relationships, and, in some cases, empanelment discussions with insurers or larger networks. Facilities planning a full component-separation blood bank should factor NABL accreditation into their overall project planning and budget, even though it operates as a separate, voluntary layer on top of the core Form 28 licence.

Licence / Approval	Issued By
Form 28 manufacturing licence	State Drug Control Authority (SDCA)
No Objection Certificate	State Blood Transfusion Council (SBTC)
Technical/testing standards oversight	NACO, within the CDSCO framework
NABL accreditation (voluntary)	National Accreditation Board for Testing and Calibration Laboratories

Frequently Asked Questions

Is it easy to get a licence for a new standalone private blood bank?

It is generally harder than for a hospital-integrated blood bank. The National Blood Policy specifically directs caution around granting fresh licences to standalone private-sector blood banks and subjects their renewals to thorough scrutiny.

How long is a blood bank licence valid?

The licence is generally valid for five years from the date of issuance, after which renewal must be sought.

Can rapid diagnostic test kits be used for HIV screening of donated blood?

No. NACO mandates ELISA testing over rapid diagnostic kits for transfusion-transmitted infection screening in licensed blood banks.

Is NABL accreditation required to operate a blood bank?

No, it is not mandatory, but it is widely recommended as a demonstration of quality and competence, and can support broader accreditation, referral, and empanelment goals.

What happens if a blood bank operates without a valid Form 28 licence?

Operating a blood bank without a valid licence is an offence under the Drugs and Cosmetics Act, 1940, carrying legal and regulatory consequences for the operating entity.

Researched Sources

1. Central Drugs Standard Control Organization — Regulatory Requirements of Blood and/or Its Components (cdsco.gov.in)
2. GenZ CFO — Blood Bank and Diagnostic Lab Licensing Process in India
3. Adrine — How to Start a Blood Bank in India 2026: NACO License, Equipment and Compliance
4. Drugs Control Media Services — Regulatory History of Blood Bank Licensing in India

Disclaimer

This article is for general informational and educational purposes and reflects blood bank licensing requirements as understood at the time of writing. It is not legal advice; applicants should consult their State Drug Control Authority and State Blood Transfusion Council for current, location-specific requirements.