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