India : quality control of health technologies

The project will help to construct, equip, train staff for and set into operation a National Institute for Biologicals (NIB). For the purposes of this project, biological products includes vaccines, blood products, and diagnostic kits that involve an immunological reaction (e.g., ELISA test kits for AIDS or Hepatitis B. With help from a Government of Japan loan to defray local currency expenditures, the project will establish the NIB on a 30-acre campus as a mechanism for improving and monitoring the quality of vaccines and related biological products. The NIB will, inter alia: (1) perform tests on samples referred by the Drugs Controller of India (DCI) and its state and regional counterparts and serve as a the final arbiter on the release of all biologicals; (2) evaluate and report on manufacturers" test results; (3) furnish the rationale and supporting data for procedures and regulations pertinent to biologicals; (4) assist the DCI in inspecting manufacturing plants and laboratories every 2 years. The NIB will also: validate testing in other laboratories, develop biological reference standards, promote the use of optimal testing and manufacturing procedures, and establish linkages with at least four international agencies. The NIB will also engage in an outreach program to provide TA and training to public and private manufacturers. Over the life of the project, a staff of 363 persons will hired for the NIB and trained. Training will begin with U.S study tours for the director and deputy director, with short-term U.S. and third-country training of 10 senior scientists and 20 junior scientists. Other specialists, such as safety officers, quality assurance officers, and veterinarians, will also receive short- term U.S. or third country training. Approximately 40 people per year will receive in-country training of 2 weeks in a variety of specialized areas. Ongoing training will be encouraged and personnel returning from abroad will be expected to organize seminars and workshops. Finally, the project will install at the NIB a computerized system to serve as a central repository and information source on quality control of biologicals. The system will allow over 50 users to simultaneously enter data, make database queries, and print reports. The system will also be used for program monitoring and evaluation and the production of training manuals, bulletins, etc.