Government asked to revamp I.V. drug supply system by the Commission
The National Human Rights Commission was seized of this important matter regarding contamination of life saving I.V. fluid, which related to the health care of the citizenry of the country, on receipt of a reference from the Himachal Pradesh State Human Rights Commission, Shimla. The State Commission had informed NHRC that the Administrator of Indus Hospital, Shimla had brought to the notice of the Commission a very serious matter, having wide implication, on the public health of the people of India and, indeed to their right to life.
The State Commission had forwarded a copy of the complaint to NHRC. The NHRC had also taken suo motu cognizance of a press report that had appeared in a national daily to the effect that life saving fluids threatened lives of patients at the Ram Manohar Lohia Hospital (RML), New Delhi. It had issued notice to the manufacturer and the Secretary, Union Ministry of Health. Notices were also issued to the Chief Secretary and Drug Controller of NCT of Delhi and Medical Superintendent of RML.
The Commission felt that the State has the duty to take all possible measures to ensure the maintenance of the highest standard of quality and purity of drugs at all stages, from manufacture to the point of administration to the patients.
To examine the causes for the contamination of dextrose bottle, ascertain the stages at which the contamination occurred, fix responsibilities for the lapses and find measures to prevent the recurrence of such lapses, the Commission chose two eminent experts : Dr. Nityanand, Chairman, India Pharmacopoeia Committee and former Director, Central Drug Research Institute, Lucknow and Mr. Prafful D. Sheth, President India Pharmaceutical Congress Association, Chairman, Industrial Pharmaceutical Division, Indian Pharmaceutical Association.
After making an indepth study, the Expert Committee submitted its final report to the Commission on 12 January 1999. In its report, the Committee observed that there was no reliable mechanism for obtaining a feedback on the nature of contamination of dextrose bottle or ascertaining the stage at which contamination occurred.
The Commission accepting all the aspects and findings of the Expert Committee, has recommended to the Central Drugs Standard Control Organisation to provide infrastructure and manpower to administer the system of licensing, WHO certification and market complaint handling of Large Volume Parentals (LVPs) and other medicines in hospitals.
It has also recommended that a post of Joint Drug Controller of India (Pharmaceutical Services) be created at the Centre under the Drugs Controller General of India. Government laboratories and testing laboratories also need upgradation in terms of infrastructure and trained staff. Modern hospital pharmacy should be set up in government hospitals under an officer with a minimum qualification of post-graduation in pharmacy.
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 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.
In further directions to the hospital, the Commission recommended that a flow chart complaint handling procedure be developed and there should be partnership for networking within manufacturers and regulatory agencies for speedy disposal of defective and recycled goods. It called upon the hospital to prepare guidelines on sampling of stocks including complaint samples, by approved testing laboratories detailing exact quantity to be drawn, fixing responsibility for drawn samples.
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 routing the supply to hospitals through the depots and eliminating wasteful activities of re-routing the goods to hospitals.
The Commission called also upon the parties concerned to implement the respective recommendations within one year and report back to it.
With a view to monitoring timely compliance, the Commission has asked for quarterly progress reports, the first one falling due on 15 July 1999. It has also directed the Governments and authorities concerned to provide the necessary staff and finance for this purpose, to facilitate expeditious compliance.
The State Commission had forwarded a copy of the complaint to NHRC. The NHRC had also taken suo motu cognizance of a press report that had appeared in a national daily to the effect that life saving fluids threatened lives of patients at the Ram Manohar Lohia Hospital (RML), New Delhi. It had issued notice to the manufacturer and the Secretary, Union Ministry of Health. Notices were also issued to the Chief Secretary and Drug Controller of NCT of Delhi and Medical Superintendent of RML.
The Commission felt that the State has the duty to take all possible measures to ensure the maintenance of the highest standard of quality and purity of drugs at all stages, from manufacture to the point of administration to the patients.
To examine the causes for the contamination of dextrose bottle, ascertain the stages at which the contamination occurred, fix responsibilities for the lapses and find measures to prevent the recurrence of such lapses, the Commission chose two eminent experts : Dr. Nityanand, Chairman, India Pharmacopoeia Committee and former Director, Central Drug Research Institute, Lucknow and Mr. Prafful D. Sheth, President India Pharmaceutical Congress Association, Chairman, Industrial Pharmaceutical Division, Indian Pharmaceutical Association.
After making an indepth study, the Expert Committee submitted its final report to the Commission on 12 January 1999. In its report, the Committee observed that there was no reliable mechanism for obtaining a feedback on the nature of contamination of dextrose bottle or ascertaining the stage at which contamination occurred.
The Commission accepting all the aspects and findings of the Expert Committee, has recommended to the Central Drugs Standard Control Organisation to provide infrastructure and manpower to administer the system of licensing, WHO certification and market complaint handling of Large Volume Parentals (LVPs) and other medicines in hospitals.
It has also recommended that a post of Joint Drug Controller of India (Pharmaceutical Services) be created at the Centre under the Drugs Controller General of India. Government laboratories and testing laboratories also need upgradation in terms of infrastructure and trained staff. Modern hospital pharmacy should be set up in government hospitals under an officer with a minimum qualification of post-graduation in pharmacy.
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 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.
In further directions to the hospital, the Commission recommended that a flow chart complaint handling procedure be developed and there should be partnership for networking within manufacturers and regulatory agencies for speedy disposal of defective and recycled goods. It called upon the hospital to prepare guidelines on sampling of stocks including complaint samples, by approved testing laboratories detailing exact quantity to be drawn, fixing responsibility for drawn samples.
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 routing the supply to hospitals through the depots and eliminating wasteful activities of re-routing the goods to hospitals.
The Commission called also upon the parties concerned to implement the respective recommendations within one year and report back to it.
With a view to monitoring timely compliance, the Commission has asked for quarterly progress reports, the first one falling due on 15 July 1999. It has also directed the Governments and authorities concerned to provide the necessary staff and finance for this purpose, to facilitate expeditious compliance.