January 10, 2002

    Peripheral centres and hospitals will henceforth be allowed to store Whole Human Blood and Blood Components without having to obtain regular licence for running blood bank. The Ministry of Health and Family Welfare has amended Schedule K to the Drugs and Cosmetic Rules to insert these provisions.

    The amendment will exempt the First Referral Units, Community Health Centres, Primary Health Centres and hospitals having captive consumption of Whole Human Blood or its components of not more than 2000 units annually, from taking a licence to operate a blood bank, for storing Whole Human Blood or its components obtained from licensed blood banks or regional transfusion centres or Indian Red Cross Society Blood Banks. Such storage centres, however, need to have a qualified medical officer to ensure proper procurement, storage and cross matching. These centres are required to have a minimum area of 10 sq. mtrs with equipment like blood bank refrigerator, etc. The approval for these will be given by the State Licensing Authorities for a period of two years, which can be renewed further.

    The amendment was necessitated as several District and Taluk hospitals represented that they could not fulfil the stringent conditions stipulated under the Rules to operate a blood bank. This was causing shortages of blood and blood components in peripheral hospitals. Moreover, carrying blood by individuals to remote areas could result in deterioration of the blood due to improper storage during transition. The matter was considered by the National Blood Transfusion Council, which recommended that to facilitate the availability of safe human blood or its components in the hospitals situated in the peripheral or remote areas, blood storage centres should be licensed under certain conditions.