WP 91 of 1992
Operation of blood banks

Summary :

Background of the PIL

In 1992, Common Cause filed a Public Interest Litigation (PIL) before the Hon’ble Supreme Court of India under Article 32 of the Constitution, highlighting grave deficiencies in the country’s blood banking system. The petition drew attention to the unregulated collection, testing, storage, and distribution of human blood, and the alarming use of professional donors — a practice fraught with ethical, medical, and public health concerns.

The PIL underscored systemic violations of the Drugs and Cosmetics Act, 1940 and its corresponding Rules, 1945, particularly with respect to licensing, hygiene, quality control, and the mandatory testing of blood for communicable diseases such as HIV/AIDS, Hepatitis B, and Syphilis.

Core Issues Raised

  • A large number of unlicensed and substandard blood banks were in operation.
  • Professional blood donors, often from high-risk groups, were regularly used, jeopardizing patient safety.
  • Inadequate infrastructure, lack of trained personnel, and non-compliance with safety and testing protocols.
  • Absence of a coherent regulatory framework to monitor and standardize blood transfusion services nationwide.

Common Cause sought comprehensive judicial directions to overhaul the existing framework and ensure access to safe and voluntarily donated blood.

Judgment and Directions

After extensive hearings, expert submissions, and reports from both governmental and independent agencies, the Supreme Court delivered a path-breaking judgment, laying down a national roadmap for reform.

The Court directed as follows:

Constitution of a National Council of Blood Transfusion as a registered society under the Societies Registration Act, comprising representatives from the Ministry of Health, Drug Controller General of India, Indian Red Cross Society, major health institutions, and civil society organisations.

  • Establishment of corresponding State Blood Transfusion Councils to implement policy at the regional level.
  • Mandatory licensing of all blood banks within one year; unlicensed or non-compliant facilities to be shut down.
  • Phased elimination of professional blood donors within two years, with a national shift toward voluntary blood donation through awareness campaigns and institutional engagement.
  • Development of training infrastructure for technical staff and drugs inspectors, and establishment of postgraduate courses in transfusion medicine.
  • Creation of regional blood centres in major metropolitan cities to ensure standardized, quality-controlled blood collection, storage, and distribution.
  • Recommendations for granting 100% income tax exemption to donations made toward blood banking and transfusion services.
  • Strengthening of regulatory oversight through the Drug Control Organisation, and consideration of a dedicated legislation for blood transfusion services in India.

Impact of the Judgment

This judgment marked a watershed moment in India’s public health jurisprudence. Initiated by Common Cause, the case catalysed the institutionalisation of a safe, ethical, and voluntary blood donation system in India. It brought the issue of blood safety into the national spotlight and compelled the State to address long-standing regulatory failures.

The Court’s intervention led to the formation of the National Blood Policy, tighter enforcement mechanisms, and a substantial decline in the use of unsafe, commercially sourced blood. It also paved the way for greater public trust in the health system and enhanced patient safety across the country.