Case Note & Summary
By way of public interest litigation under Article 32 of the Constitution of India, 1950, the petitioner, Common Cause, highlighted serious deficiencies in the collection, storage and supply of blood through blood centres across India and sought appropriate directions against the Union of India, States and Union Territories. Blood was treated as a drug under the Drugs and Cosmetics Act, 1940 and its regulations under the Drugs and Cosmetics Rules, 1945. The writ petition was filed in 1992. The Court observed that blood is essential to life but contaminated blood can cause death, and no greater service exists than donating blood to save lives. It noted that the 1990 Ferguson report commissioned by the Government assessed the status of government, private, commercial and voluntary blood banks, recommended policy and procedure changes, and prepared a scheme for modernization. The report found that out of 1018 blood banks, 616 were unlicensed; only 201 licensed commercial blood banks existed. Mandatory tests for AIDS, viral hepatitis, malaria and venereal diseases were rarely conducted, and up to 85 per cent of collected blood was not screened for AIDS. Storage facilities were unsatisfactory, with frequent electricity failures and lack of generators; many blood banks operated in unhygienic environments with middlemen exploiting professional donors. Professional donors, often unemployed, rickshaw pullers and drug addicts, sold blood 5-6 times a month and were high-risk for Hepatitis B and AIDS. The Union of India in its counter affidavit stated that after the Ferguson report, the Drugs Controller, India directed State Drug Controllers to inspect commercial and unlicensed government blood banks, cancel non-compliant licences, and submit status reports. 23 State Governments/Union Territories reported about 341 unlicensed blood banks, mostly run by Red Cross Societies and charitable institutions. During pendency, the Drugs and Cosmetics (First Amendment) Rules were notified on 22 January 1993, inserting Part X-B (Rules 122-F to 122-O) for collection, storage, processing and distribution of human blood and blood products, and substituting Part XII-B for space, equipment and supplies. Licensing was made subject to approval of the Drugs Controller of India. The Central Council of Health recommended building adequate blood banking services at State/District level, educating and motivating voluntary donation, encouraging voluntary donors, and enforcing quality control. The Union of India stated that WHO prescribed nearly 40 lakh units of blood required annually but collection was only 19.5 lakh units, making it impossible to ban professional donors until voluntary donations increased. It set long-term objectives including high-quality blood and blood components, expansion of voluntary and replacement donor base to phase out professional donors, and medium-term objectives for minimum facilities, trained manpower, awareness of blood components and geographical coverage. The Court considered the Ferguson report, the revised rules and the schemes submitted by the petitioner and Union of India. The available excerpt of the judgment does not include the final operative directions; the text ends during the Court's assessment of the draft schemes.
Headnote
A) Constitutional Law - Public Interest Litigation - Article 32 of the Constitution permits writ for enforcement of fundamental rights including right to health and safe blood - Constitution of India, 1950, Article 32 - The petitioner highlighted serious deficiencies in collection, storage and supply of blood through various blood centres and sought directions to Union and State Governments to obviate malpractices and inadequacies. The Court noted that blood is essential to life but contaminated blood can cause death and that regulatory measures are necessary. Held that there can be no greater service than offering blood to save life, and blood used by blood banks must be healthy and free from infection (Paras 1-2). B) Drugs and Cosmetics Law - Regulation of Blood Banks - Blood is a 'drug' under the Act and Rules prescribe requirements for blood banks - Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945, Part XII-B and Part X-B - Part XII-B was inserted in 1967 for equipment, supplies, accommodation, technical staff, labelling; after 1993 amendment Part X-B (Rules 122-F to 122-O) prescribed collection, storage, processing, distribution of human blood and manufacture of blood products; licence only with approval of Central Licence Approving Authority i.e. Drugs Controller of India. Held that state drug controllers are licensing and enforcing authorities and inspections should ensure compliance with prescribed standards (Paras 3, 7-8). C) Health Regulation - Deficiencies in Blood Banking - Licensing, Testing, Storage and Professional Donors - Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 - Ferguson report found 616 of 1018 blood banks unlicensed; mandatory tests for AIDS, hepatitis, malaria, veneral diseases rarely conducted; up to 85% blood not screened for AIDS; storage facilities unsatisfactory; professional donors bled frequently and many are alcoholics, drug abusers, high risk for Hepatitis B and AIDS; middlemen operate. Held that private/commercial blood banks should not be allowed to operate unless they fulfil all requirements and each unit of blood tested for transmissible diseases; unlicensed blood banks should be licensed only after conforming to standards (Paras 5-7). D) Health Policy - Voluntary Blood Donation and Modernization - Phasing Out Professional Donors - Drugs and Cosmetics Act, 1940; Constitution of India, Article 32 - Central Council of Health recommended building adequate blood banking services, educating and motivating voluntary donation, encouraging voluntary donors, enforcing quality control; long term objectives include expanding voluntary and replacement donor base to phase out professional donors. The Union of India stated that WHO prescribed nearly 40 lakhs units required but collection is only 19.5 lakhs units, so professional donors cannot be banned until voluntary donations increase. Held that modernisation of blood banks and augmentation of testing facilities through central funding is necessary (Para 9).
Issue of Consideration
Whether appropriate writ, order or direction should be issued to Union of India, States and Union Territories to ensure proper positive and concrete steps in a time-bound programme for obviating malpractices, malfunctioning and inadequacies of blood banks and to place before the Court a specific programme of action overcoming deficiencies in the operation of blood banks.
Final Decision
Not mentioned in provided text (the excerpt ends before the Court's final operative directions).
Law Points
- Blood is treated as a 'drug' under the Drugs and Cosmetics Act
- 1940
- regulation of blood banks under Drugs and Cosmetics Rules
- 1945
- Part X-B and Part XII-B
- mandatory testing for HIV
- hepatitis
- syphilis and malaria
- licensing by State Drug Controllers with approval of Drugs Controller of India
- professional blood donors to be phased out through voluntary blood donation
- public interest litigation under Article 32 of Constitution
