Annual Report 1999-2000 experts to assist it in its work. They were Dr. Nityanand, Chairman, Indian Pharmacopoeia Committee and former Director, Central Drug Research Institute, Lucknow; and Mr. Praflul D. Sheth, President, Indian Pharmaceutical Congress Association, and Chairman, Industrial Pharmaceutical Division, Indian Pharmaceutical Association. 3.95 After making an in-depth study, the Expert Committee submitted its final report titled 'Large Volume Parenterals: Towards Zero Defect' to the Commission on 12 January 1999. Shri L.K. Advani, Union Minister for Home Affairs, formally released the report on II June 1999 in the presence of the then Union Minister of State for Health, Shri Dalit Ezhilmalai. 3.96 The Commission, in accepting the comprehensive findings of the Expert Committee, has recommended a series ofsteps to be taken by the Central Drugs Standard Control Organization to improve the infrastructure and manpower required to administer the entire system of licensing, new product approvals, certification and market complaint handlihg of Large Volume Parenterals (LVPS) and other medicines in hospitals. 3.97 It has also recommended that a post of Joint Drugs Controller of India (Pharmaceutical Services) be created at the Centre under the Drugs Controller General of India. The Government analyst laboratories and testing laboratories also need upgradation in terms of infrastructure and trained staff. Modem hospital pharmacies should be set up in Government hospitals, under an officer having a minimum qualification of post-graduation in Pharmacy. 3.98 In its recommendations, the Commission called upon RML Hospital to develop policies and procedures for the procurement of medicines and inventory control, receipt handling, storage, quality control distribution and dispensing. It directed the hospital to develop policies and procedures for handling of complaints relating to quality, medication errors and adverse drug reactions. It also asked the premier Central Government hospital to develop good hospital warehousing practices, including rodent control, and also to frame good warehouse practice guidelines. "It shall impart training to hospital staff in good warehousing practices and ensure maintenance of records of defective stocks at one place", the Commission recommended. 3.99 In further directions to the hospital, the Commission recommended that a flowchart complaint handling procedure be developed, and that there should be partnership for networking within manufacmrers and regulatory agencies for speedy disposal of defective and recalled goods. It called upon the hospital to prepare guidelines on sampling of stocks, including complaint samples, by approved testing laboratories, detailing the exact quantity to be drawn, and fixing responsibility for drawng samples. 3.100 With regard to the Medical Stores Depot, the Commission called for reviewing the present procedures of procurement of LVPs and other medicines, and the system of 44

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