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The landmark judgement in 1996 by the Supreme Court of India in the “Common cause versus Union of India”, brought to the fore, the then predominant practice of blood donation by professional donors, the risks associated with transfusion transmitted infections (TTE), and the basic consideration of high haemoglobin level1. It was this verdict that directed the government to improve the blood transfusion service and resulted in the Government through National AIDS Control Organization (NACO) establishing the National and State Blood Transfusion Councils (NBTC/SBTC) to develop policies and programmes for bringing about improvements in blood banks. In 1997, HIV counselling and testing services were started in India. In 2001, testing of blood for hepatitis C virus (HCV) antibodies was made mandatory2. In 2002, the WHO Guidelines on the Clinical Use of Blood was adopted by NACO. In 2003, the Government of India framed and adopted the National Blood Policy (NBP)3. This also brought about a sea change in the activities related to regulation, licensing and operations of blood banks, with the NACO and the office of the Drugs Controller General of India (DCGI) working in tandem to review and amend the Drugs and Cosmetics Act of 1940 to incorporate various provisions that brought blood banking practice under more stringent oversight. The greatest impact of the judgement besides introducing mandatory licensing of all blood banks was the banning of professional donors and the directions to the Government to promote voluntary blood donors in the country4.
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