The Atomic Energy Regulatory Board inspected 28 of the 117 nuclear medicine units in India — and has noted safety violations in each of them. Chairperson Dr K S Parthasarthy said the violations caused concern.
Some transgressions observed: workers did not use personal dose meters; they worked without gloves, thus contaminating their hands; they smoked and ate within the facilities; waste was disposed of in a cardboard box instead of the recommended foot-operated waste bin; radiation-measuring equipment was faulty, as was the process of isolating patients after treatment. The clear lack of a safety culture and tendency to ignore precautions could lead to more serious violations.
The application of nuclear medicine in India is modest (160 nuclear medicine physicians and 220 technologists) compared to the US (over 2,700 physicians and 14,000 technologists). But safety is should still be a high priority, particularly with the doubling of units in the last two decades.
Twenty-nine-year-old Kaberi Roy died 24 hours after a ‘successful’ appendicitis operation. Her parents have filed a criminal case blaming Dr B L Chitlangia and his associates at Bombay Hospital for medical negligence. They hold that had their daughter would have survived if she had been operated upon promptly. She was operated upon 15 hours after her emergency admission.
Dr Chitlangia admits that the cause of death is not known but holds that the surgery was done properly. He denies a delay in surgery, saying the wait was for appropriate medical reasons.
A first-year MBBS student at Jawahar Lal Nehru Medical College in Raipur was stripped and made to run naked through the college complex for wearing coloured trousers, a violation of the dress code for junior students. Following a complaint by the student’s father, Raipur police arrested two of the accused students. A third is absconding. All three have been expelled from the college hostel (but not, apparently, the college). The director of medical education, Dr R C Bhola, says, “I have asked the dean of the medical college to submit a detailed report. We will take appropriate action.”
A special body is needed to regulate the use of medical devices such as those for laser surgery, said Dr RB Vajpayee, professor of ophthalmology at AIIMS. In the absence of such a system, such devices may be misused. Dr Vajpayee conducted a study which concluded that the use of the lasik laser for correcting eye defects, may be inappropriate for many Indians because they have smaller corneas on an average. This can result in complications if adequate screening precautions are not taken.
The Indian Council of Medical Research has unveiled draft guidelines to regulate infertility treatment in India, prompted by concerns about unethical practices in infertility clinics.
The guidelines specify infrastructure requirements and a code of practice for infertility clinics, as well as additional training for gynaecologists who specialise in the treatment of infertility through assisted reproductive technology. The council has also proposed the creation of a government agency to license infertility clinics and ensure that they adhere to standards. The agency would also have the power to fix the upper limit of charges for gamete donation and surrogacy.
The council’s draft guidelines will be debated over the next three months, after which a final version will be sent to the government for legislation.
An enquiry by the Mumbai Municipal Corporation has found that an estimated 1,200 civic medical practitioners in the city manage to retain their posting beyond the stipulated three years. A massive transfer drive is planned to rectify the situation.
The Supreme Court directed all states and union territories to take action against clinics advertising sex determination tests in violation of the law. Meanwhile, in Dharwar, Karnataka, the state health department seized two mobile diagnostic machines. These were being used to conduct sex determination tests for between Rs 100 and Rs 1,000, followed by an abortion if the foetus was female. PTI. SC calls for immediate action against sex-test ads.
Over 100 students from the B Block hostel of BJ Medical college in Ahmedabad representing the North Gujarat lobby and traditional fiefdom of former MCI president Ketan Desai broke into the rival A block armed with steel pipes, tubelights and other weapons. They were celebrating reports that Dr Desai was to be exonerated of corruption charges. They injured at least 10 students in the attack, two critically.
The injured doctors chose to be treated in a private hospital rather than the Civil hospital where they did not feel safe. Eye witnesses said the perpetrators included Deepak Limbachiya, now an assistant professor.
A British and German genetic study that analysed material from people in Kerala has renewed a debate on the need to regulate the flow of human biological material from India. The study analysed DNA from saliva of 988 healthy people from a coastal region in Kerala with the world’s highest levels of natural radiation. Indian scientists ask how the researchers took samples out of the country without approval, reiterating concerns that India’s diverse population might serve as a source of valuable genetic information with potential commercial value. Guidelines introduced in the late 1990s permit export of biological material for research only with approval from the health ministry.
The UK researcher, Dr Peter Forster, said informed consent was obtained from the volunteers and the university’s ethics committee had approved the study. He added that the study had no commercial application.
As foreign pharmaceutical companies target India for ‘cheaper and faster’ clinical trials, how are research subjects protected from harm during such trials? There are many mechanisms – but most of them don’t do what they are supposed to do.
The Indian Council of Medical Research guidelines are not necessarily enforced. Once a research project gets ethical approval, there is no authority to monitor the research to ensure that it is carried out ethically.
EC members are often handpicked by those who have an interest in the trial, says Dr Sanjay Nagral, member of the Forum for Medical Ethics Society in Mumbai.
Companies pay volunteers; a drug company recently paid Rs 2,000 to volunteers for an anti-rabies vaccine trial at the Haffkine institute, notes Dr SM Sapatnekar, director of the Haffkine Insitute. Such amounts will surely influence the ‘informed consent’ of poor and amount to inducement.
Drug companies also ‘donate’ research equipment to institutions conducting trials – which is bound to colour the result of research.
Even as the Maharashtra government ruled out mandatory HIV tests before marriage, village elders of Hivare Bazar near Ahmednagar, Maharashtra, have decreed that any outsider planning to marry someone from their village will have to be tested for HIV beforehand. If the gram sabha approves this proposal, it will be enforced from next April.
State health minister Digvijay Khanwilkar recently stated that mandatory tests would add to the social and ethical problems associated with the disease, and a law to this effect would be in violation of NACO guidelines.
The Maharashtra Medical Council has never been more efficient than over the last three years after it was taken over by a court administrator following allegations of bogus voting. The backlog of csses is being tackled, hearings are held and judgements handed out. But the number of complaints has dropped sharply, says Dr S M Sapatnekar, the court-appointed administrator. The widespread perception that the medical profession is unethical should have led to an increase in complaints, but the MMC’s reputation is such that the public no longer considers it the appropriate forum for redressing grievances against doctors.
An eleven member Constitutional bench of the Supreme Court ruled that there will be no more ‘free’ or ‘payment’ seats in medical, engineering and other professional colleges in the country. Fees will be uniform for all students in any particular college, though they may differ from area to area depending on the costs incurred by the college.
The bench held as unconstitutional the scheme framed by a two-judge bench in 1992 fixing ‘free’, ‘payment’ and ‘management quota’ seats while admitting students in professional educational institutions. That scheme was framed to check capitation fees. The bench held to “the principle that there should not be capitation fees”.
With an estimated shortfall of 20,000 nurses in the UK and US, Indian health care majors have jumped into the fray with services to train and place Indian nurses in hospitals abroad. Already, reputed hospitals lose 20-25 per cent of their nurses to hospitals abroad, usually in the Gulf. This will soon include the UK and US, said Dr Arti Verma of Max Health Care.
At the same time, medical tourism is predicted to double in the next few years as health services in India are a fraction of what they cost in the West. Apollo hospital gets 10-11 foreign patients every month. Five to seven per cent of Escorts’ patients are from abroad. Though most of the traffic is from West Asia, south-east Asia and Africa, “We are talking to international health insurance companies so our hospitals are recognised and Non Resident Indians can combine their treatment here with family visits,” says Dr Yogi Mehrotra of Indraprastha Apollo hospital.
The Organisation of Pharmaceutical Producers of India has unveiled the code of ethics for advertisement of drugs. The object of the code is to ensure responsible advertising in promoting medicines which may be purchased by the public without any prescription and for which therapeutic claims are made.
In his address on understanding the Indian consumer the managing director of Morepen Ltd emphasised the role of the housewife in household drug purchases. He described the company’s concept of a housewife’s ‘pitara’ which consists of a number of OTC drugs and also some ethical drugs stored for self-mediation. The latter have generally been bought after the first prescription has been made by the family physician. The executive director (consumer pharmaceuticals) of Johnson & Johnson, USA, said the Asia-Pacific OTC market was valued at $ 15.1 billion in 2001. The varying sizes of OTC markets in different countries were determined by purchasing power, awareness, definition of OTC, competition, government regulation and cultural differences. “Self medication is accepted as part of treatment options in health care in this part of the world.”
A watchdog committee set up by the Supreme Court will probe the process by which the Medical Council of India grants recognition to medical colleges. The members of this committee are Padmabhusan Dr N Rangabhasham, neurologist PN Tandon, orthopaedist Bhabsali and former vice-chancellor of the Rajiv Gandhi Health University, S Kantha.
At least 20 youths from UP and Bihar are reported to have died in Amritsar and Jalandhar after donating their organs because they were not given proper post-operative care. This is reported to have taken place over the last two and half years. A member of the gang arrested for this racket is reported to have confessed that he cremated 15 bodies under fake names and addresses. The authorisation committee for kidney donation was found to have authorised transplants on the basis of false affidavits. Arrest warrants have been issued for an advocate who was allegedly instrumental in preparing fake affidavits for Rs 10,000 each.
The president elect of the Indian Medical Association, Maharashtra, Dr Dilip Guha, has ordered an inquiry into allegations of bogus voting during its annual conference in Sangli. Two voters, who were registered as doctors from Mumbai, stated under interrogation that they were not doctors but had come to vote for Dr Vasant Shenoy, general secretary of the Mumbai suburban west branch. Dr Shenoy said he had nothing to do with the two men. After this incident came to light Dr Guha received other similar complaints. Sources said many doctors aspired to become office-bearers of the IMA because of the money associated with pharmaceutical firms that sponsor events. The IMA has a membership of 1.5 lakh doctors in India.
A survey of patient satisfaction at the King Edward Memorial Hospital in Mumbai, the city’s largest public hospital, found that not only were the majority of patients satisfied with its services, they also rated the hospital better than private clinics they had attended before admission to KEM.
Seventy per cent felt doctors gave good treatment though they did not communicate enough and other staff were unhelpful. Many felt post-operative care was poor. The food was okay but bed linen was inadequate and the toilets dirty. People had to wait for tests and treatment, and were not informed of delays. Even subsidised services were too expensive. Over 90 per cent were unaware that a grievance cell existed in the hospital.
Dr Arun Bal of ACASH says the survey demonstrates the need for public hospitals. Dr N Kshirsagar, dean of KEM hospital, said the survey has led to some changes but much of the problem lies in money shortages. The hospital needs Rs 9 crore annually but gets only Rs 3 crore.
On October 1, 2002, doctors all over Kerala responded to a call by the Indian Medical Asociation, Kerala State Branch, to strike in protest against the increasing attacks on doctors and hospitals.
At the Emergency State Working Committee meeting in Guruvayur, IMA Kerala State president Dr PT Cheriyan announced that the strike call was binding to all IMA members and that anyone defying the IMA’s directives would be seriously dealt with.
The US government has issued a Compliance Program Guidance for Pharmaceutical Manufacturers to control drug company handouts to the medical profession. The recommendations, however, are voluntary.
The Guidance warns drug manufacturers against paying or otherwise encouraging doctors and pharmacists to switch patients from the products of one company to those of another, offering entertainment, travel, or other benefits for attending drug information programmes, and providing financial incentives to large scale purchasers of drugs.
Compliance Program Guidance for Pharmaceutical Manufacturers can be read at www.oig.hhs.gov
A close look by The Hindu at an inquiry report by the Indian Medical Association, Kerala branch, seems to have dug up a can of worms. The reports appeared between October 25, 2002, and December 2, 2002.
The IMA inquiry into the kidney transplant racket in the state concluded that money did change hands between kidney donor and recipient – but that doctors and hospitals knew nothing about it. Apparently the doctors were earnest but innocent.
The report documented irregularities in various hospitals but pardoned them. It referred to a person who complained that he was coerced into handing over his kidney but did not investigate it further.
Investigations revealed that the IMA’s report findings were diluted before being made public. This was done to let guilty doctors and hospitals go scot free.
The original report included a complaint that a kidney was extracted from a pregnant woman with a six-month-old child. She underwent an abortion and five days later she was certified fit for surgery by a gynaecologist, AM Indira. Her kidney was removed one month later. The original report also noted that at some hospitals, money for the kidney sale would be kept at the hospital cash counter for safe custody.
Senior doctors in Kerala issued a statement condemning the IMA for its refusal to hold the medical profession accountable for its involvement in the kidney trade. The People’s Health Movement, a people-oriented global initiative, expressed concern over the illegal trading of kidneys in Kerala and the effort of the professional body of doctors to protect the culprits. www.hinduonnet.com
India’s health ministry announced that blood donors found to be HIV positive would be told of their infection and asked to seek confirmatory tests and counselling. This will end the existing policy in which blood infected with HIV is discarded without repeating the test and without informing the donor. India’s blood banks have been screening blood for HIV since the early 1990s, but health officials say donors could not be informed because of a lack of infrastructure for counselling.
The health ministry has announced a plan that seeks to introduce an accreditation scheme for blood banks to achieve required quality standards by March 2003.