Introduction

In order to improve the standards of Blood and its components, the Central Govt. through Drugs Controller General of India, has formulated a comprehensive legislation to ensure better quality control system on collection, storage, testing and distribution of blood and its components. Central Govt. amended from time to time the existing requirements of Blood Banks in the Drugs Cosmetics Act, 1940 and Rules thereunder to meet the latest standards. Consequent to a public litigation case recently, Supreme Court of India directed Central Govt. to enact a comprehensive legislation on Blood Banks in collection, storage, testing and distribution of blood and its components. In this context, the office of Drugs Controller General of India made draft rules to further amend the existing law in the Drugs Cosmetics Act, 1940 and Rules thereunder to meet the direction of Hon’ble Supreme Court in order toimprove the blood banking system in the country.


National blood policy

Government of India published in the year 2002 the National Blood Policy. The objective of the policy is to provide safe, adequate quantity of blood, blood components and products. The main aim of the policy is to procure non remunerated regular blood donors by the blood banks. The policy also addresses various issues with regard to technical personnel, research , development and to eliminate profiteering by the blood banks by selling blood. The policy also envisages that fresh licences to stand alone blood banks in private sector shall not be granted and renewal of such blood banks shall be subjected to thorough scrutiny.


Scenario of legal framework

Human blood is covered under the definition of ‘Drug’ under Sec. 3(b) of Drugs Cosmetics Act. Hence, it is imperative that Blood Banks need to be regulated under the Drugs Cosmetics Act and rules thereunder.

In the year 1967, Central Govt. (Ministry of Health) enacted a separate provision in Schedule F Part XII B of Drugs Cosmetics Rules. Various requirements such as Accommodation, Technical staff, equipments etc. for operation of blood bank were included in this Part. State Drugs Controllers were authorized to issue the licences for blood banks. The standards for ‘Whole Human Blood’ was prescribed in Indian Pharmacopoeia.

Due to prevalence of AIDS virus, the Ministry of Health Family Welfare (Govt. of India) issued a notification in the year 1989 under the Drugs and Cosmetics Rules and made the test HIV 12 antibodies of Whole Human Blood as mandatory requirement before transfusion. It is imperative that each unit of blood and blood products were regulated in the year 1990 and 3 laboratories viz. NICD Delhi, NIV Pune and CMC, Vellore were notified to function as laboratory under 3A of Drugs and Cosmetics Rules to test HIV antibodies in respect of human blood and human blood products.

As trained technicians were not available in the Blood Banks to carry out the test for HIV 12 antibodies, the Ministry of Health Family Welfare notified 112 Surveillance Centres to act as a testing lab for the blood banks for carrying out the above test (ZBTC). The list of 112 Surveillance Centres is annexed.

Following M/s. Ferguson’s Report (which brought out various deficiencies with regard to quality control of blood and blood products etc. in the year 1990 and based on concern expressed in different fora and in Parliament, the DC Rules were again amended (Rules 68A, Part XB and Part XIIB of Schedule F) in the year 1992-93 and Drugs Controller General (India) was vested with the power of Central Licence Approving Authority (CLAA) to approve the licence of notified drugs viz. Blood and Blood Products, I.V. Fluids and Vaccines and Sera.

The requirement of a blood bank is inserted in Part X-B of the Drugs and Cosmetics Rules, 1945. The Rules from 122F to 122P explain the various procedure of making applications by a blood bank, fees to be paid for grant/renewal of licence by the applicant and conditions of licence to be followed by the applicant after grant/renewal and conditions of licence to be followed by the applicant after grant/renewal of licnece.

In accordance with the Supreme Court order, blood bank legislation has been extensively revised on 5.4.1999 to include Good Manufacturing Practices, Standard Operating Procedure and validation of equipments etc. The brief requirements for grant/renewal of blood bank licences are as follows: