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Journal of the Academy of Hospital Administration

India Plans Stringent Measures to Improve Health Care Quality

Author(s): Rajiv Kumar Jain*, Sidhartha Satpathy**

Vol. 12, No. 2 (2001-07 - 2001-12)

On October 4, India's Health Ministry announced that it intends to introduce legislation which will mean compulsory re-registration of doctors every 5 years, after they have done a prescribed module of continuing medical education. At present, doctors who are registered with the Medical Council of India (MCI) or any of the state medical councils, can continue to practice for life. Now the MCI will be asked to prescribe continuing medical education modules and lay down procedures for re-registration.

"It will ensure that medical personnel keep abreast with the latest advances in medical sciences", the Ministry said, The Delhi Medical Council (DMC) has already introduced CME modules for re-registration from this year onwards, Doctors will have to undergo compulsory continuing medical education for 100 hours spread over 5 years at institutions accredited with DMC, in order to qualify for re-registration after 5 years.

"We have to gain the confidence of the public that we are here to protect them. And we are getting good response from doctors", says DMC President Ranjit Roy Chaudhry. Also under discussion is legislation for fixing minimum standards for equipment, physical infrastructure, and manpower in all medical institutions. In addition, a presidential ordinance will soon be promulgated making it mandatory for a medical institution to make available medical records of a patient to the patient or family on demand. (THE LANCET, 2000, 356: 1336)

ICMR'S Ethical Guidelines for Biomedical Research on Human Subjects Released

Indian Council of Medical Research (ICMR) released 'Ethical Guidelines for Biomedical Research On Human Subjects'' in October 2000. These guidelines ha ve been formulated by the Central Ethics Committee on Human Research (CECHR) of the ICMR under the chairmanship of Hon''ble Justice M. N. Venkatachaliah, Former Chief Justice of India. This document updates the 'Policy Statement on Ethical considerations in research on Human Subjects'' of 1980 in view of the recent developments in modern biology and medical science so as to add to its contemporary relevance.

The CECHR Guidelines contain, apart from the statement of general principles on Ethical considerations, separate chapters on 'Ethical Review Procedures'', 'General Ethical Issues'', statements on 'Specific Principles for Clinical Evaluation of Drugs/Devices/ Diagnostics /Vaccines/ Herbal Remedies'', statement on 'Specific Principles for Epidemiological Studies'', on, ''Specific Principles on Human Genetic Research in Transplantation including total Tissue Transplantation and on "Assisted Reproductive Technologies''.

Prof N. K. Ganguly, Director General, ICMR has expressed hope and expectation that all institutions in the country which carry out any form of biomedical research involving human subjects follow these guidelines in letter and spirit to protect the safety and well being of all individuals who participate in such research for the progress of science through acquisition of new knowledge.

UNICEF''S Progress of Nations 2000

UNICEF''S Progress of Nations 2000'' report, the eighth in the annual series, records the world''s progress towards giving all children the chance to live a decent life. This year it focusses on the devastating speed with which HIV/AIDS has, in less than a generation, become the greatest catastrophe facing the continent of Africa and is now spreading in Asia and parts of central Europe and Latin America.

It estimates HIV/AIDS rates in youths at end-1999 in India at 0.6% in females and 0.4% in males, making it the fourth highest infected country, in South/East Asia and Pacific, after Cambodia, Thailand and Myanmar. Other relevant estimates for India are;

  1. Percentage of children under five who are stunted: 52;
  2. Percentage of children who have received 3 doses of DPT: 73;
  3. Percentage of population having access to clean water sources: 88;
  4. Percentage of population having sanitation facilities: 31;
  5. Percentage point difference between urban and rural school attendance: 20 ;
  6. Percentage point difference between male and female school attendance: 14 and
  7. Percentage of women (aged 15-49) attended by skilled health personnel at least once during pregnancy: 49.

On face value, the HIV infection rates of 0.6% and 0.4% for females and males in India seem to be low but they translate into 570,000 women and 340,000 men infected, the second highest number of infections after South Africa.

National Health Service and Private Hospitals to work together

National Health Services (NHS) of England will work more closely with private hospitals in three areas: waiting list operations, intensive care, and rehabilitation and preventive services for the elderly. The Labour government in a historic decision- signed a concordat with the Independent Health Care Association. The current Health Secretary, Alan Milburn, explained that the main problem in the NHS is no longer a shortage of cash but a shortage of capacity. "If there are operating theaters that are standing idle or hospital beds that are not being used, it seems sensible to take advantage of them for NHS patients", says Milburn.

The plan is to let an NHS team of doctors and nurses do the operations, where there are empty private theaters. Where the spare capacity is less clear cut, local health authorities and hospitals will negotiate block contracts, at a lower marginal rate, with private hospitals.

But the concordat fails to clarify what should happen when there are problems with private patients in private hospitals. Currently, when something goes wrong patients are transferred at an NHS intensive care bed. It seems that one big private insurer, PPP, pays for this NHS treatment, but the other big provider, BUPA, does not. Health managers would like to see this clarified. (The Lancet 2000, 356 : 1663)

Doctors Revise Declaration of Helsinki

The World Medical Association (WMA) has sent out its strongest ever signal to pharmaceutical companies and research organisations around the world that rich populations should not exploit poor populations by testing on them new treatments from which they will never benefit.

The WMA General Assembly, meeting in Edinburgh, approved a revised Declaration of Helsinki, which was first drawn up in 1964 and has since become the most widely accepted guidance world - wide on medical research involving human participants.

This is the fifth revision of the Declaration of Helsinki, which was first drawn up in response to the atrocities of the second world war, when prisoners of the Nazis were for experimentation.

The new declaration says that freely given informed consent, preferably in writing, should be obtained from all participants, and that people who cannot give informed consent would be included in research only under exceptional conditions.

It also specified that research is justified only if the populations to be studied stand to benefit and that doctors participating in research have an obligation to declare any financial or other potential conflict of interest.

The WMA was particularly concerned about protecting people in poorer countries from being used as research subjects for the benefit of others. It has done that by specifying in the revised declaration that every patient entered into a study should have access to the best treatment identified by the study after the study is completed.

The WMA also agreed to support the Indian Medical Association in condemning the practice of female feticide and circulate national medical associations with a statement on the issue. It will also issue a public statement making it clear it is improper for pharmacists to be involved in diagnosing and treating illness.(BMJ (321) 14th Oct., 2000)

Pulse Polio Programme - Last Lap?

Although the overall prevalence of Polio cases in India has declined rapidly ; it still leads the race in number of Polio cases. Out of 7086 cases reported world-wide in 1999, 2814 were in India. Till June 2000, out of 394 global cases, 70 have been reported from India. The Government of India has planned four rounds of Pulse Polio campaign in autumn and winter and has launched an advertising blitz, with an objective of interupting transmission in 28 states.

Reports have indicated that several states viz. Uttar Pradesh, Bihar, West Bengal and even the capital Delhi, have unacceptably "low" rates of immunisation. In few pockets, upto 88% of children have been missed last year and are vulnerable to Polio. The UNICEF has stated that the greatest challenge is to maintain an effective "cold chain" for storage of the oral Polio vaccine, especially in the light of repeated power failure, load shedding etc. Some cases of children contracting polio even after receiving upto a dozen doses have also come to light, thus raising questions regarding whether this is actually the "last lap". (BMJ (321) 14th Oct., 2000)

Indian Doctors not Accountable; Consumer Report

A consumer advocacy group VOICE has said that patients claiming damages for medical negligence are often unable to prove their allegations because doctors are unwilling to testify against other doctors. A survey conducted in the three cities of Delhi. Hyderabad and Lucknow examined the grievance redressal mechanisms in 81 large hospitals and small clinics ; alongwith 86 cases of negligence filed in Consumer Courts. The cases included allegations of medical negligence that led to death, permanent physical injury or multiple operations. The study was supported by the World Bank and Health Ministry ; and it showed that more than half of the hospitals did not have mechanisms to manage complaints from patients or their relatives. The study also vindicated the stand that patients turn to consumer courts after trying to resolve grievances through in-house mechanisms. (BMJ (321) 9th Sept., 2000)

India's Animal Experimentation Rules Tightened

The ongoing war of attrition between India''s biomedical researchers and the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), headed by animal activist and minister for social justice Maneka Gandhi, has escalated since it was found that Gandhi has secretly amended the rules governing animal experimentation.

After an uproar over stringent rules last year it was agreed that approvals for experiments involving smaller animals will be granted by institutional animal ethics committees, instead of all applications being referred to the central committee. This was done to cut down delays in granting approvals. However, it was made mandatory that one representative of the CPCSEA would have to be a member of all institutional committees.

Recently, however, these rules have been changed by Maneka Gandhi, giving CPCSEA representatives the powers to veto any project put before the institutional committee. If this representative disagrees with any proposal for experimentation, the proposal will rejected regardless of the views of other committee members. In addition, decisions taken by institutional committees in the absence of the CPCSEA nominee are invalid and the power of institutional committees to approve the import of animals has been taken away.

"What was agreed to in public has been retracted in private", comments Sandip Basu, director of the National Institute of Immunology, which has closed down several research projects owing to delays by the CPCSEA. With regards to future action, Basu said, "short of going to the court, there is no other solution. In any case, experiments involving anything bigger than mice have to be referred to the CPCSEA. Now the procedure will be even more time consuming". (The Lancet (356), 14th Oct., 2000)

Rajiv Kumar Jain*
Sidhartha Satpathy**

* Registrar-Cum-Secretary, Delhi Medical Council,
Res: 480,Sector 37, Faridabad 121003, Haryana, India
E-mail : [email protected]
** Assistant Professor, Department of Hospital Administration,
AIIMS, New Delhi-110029, India,
E-mail: [email protected]

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