The high court of India will order the inspection by an expert committee of at least 35 state-run hospitals including GB Pant, Lok Nayak, Jai Prakash, Tegh Bahadur, and Deen Dayal Upadhyay hospitals. The 8 member expert committee will be led by DS Negri, principal secretary health and family welfare.
A school teacher lost her baby due to an “alleged lack of medical facilities” reported the Times of India. The bigger problem appears to be a dilapidated health system in public hospitals. During an investigation, the Delhi government acknowledged in a report that there was an acute crisis of manpower in the city’s state-run hospitals.
Medical Challenges Lead to Clinical Research Challenges
Apparently Justice Anup J. Bhambhani asked both the Delhi Government and counsel Prashant Manchunda, who has highlighted dilapidated healthcare infrastructure at various levels in government hospitals to suggest experts for the panel.
Not New Information
Even as far back as five years ago academics were reporting that India was facing troubling times with its hospitals. In one report the authors noted, “the public health system in the country continues to face formidable challenges.” Some key findings over the past several years include:
- Shortfall in health infrastructure especially for “Empowered Action Groups”
- Some fundamental shortfalls in certain facilities
- Distribution of Hospital bed (note in this case a comparison of availability of hospital beds per 1000 population between India and some much poorer countries offers a troubling glimpse into reality in some parts of India—some vastly poorer sub-Saharan countries actually perform better.)
- Deficient manpower (lack of adequately trained resources)
- Unmanageable patient load
- Absenteeism of health workers
The report authors noted, “Apart from general deficiencies in the development of public health infrastructure in the country (India), there has been particularly marked deterioration in services of public hospitals in more than two decades of pursuit of neoliberal policies in general and in health sectors as well which have been oriented toward the strengthening of private health care.”
Public vs. Private Healthcare in India
A large number of deaths occur there due to lack of medical treatment and facilities—a fundamental problem: India has a population of 1.5 billion and for every 10,189 people there is 1 doctor while 2,046 fight for a single bed. Generally death rates soar due to inadequate medical infrastructure.
In many respects India’s population is its strength but in the case of healthcare the opposite may be the case.
Other Healthcare Problems
Woefully short of doctors, some report that almost half of the rural area doctors are unregistered doctors who don’t hold a degree in allopathy. One reports notes urban areas have 58% qualified doctors while in the rural areas the rate could be as low as 18.8%—a dire situation. It is reported that India spends 1.2% of its GDP on health sector representing far less than some of the world’s poorest countries.
The availability of public health services is abysmal. Metrics from another report mirror above as they there is one doctor per 10,189 people and only one government hospital bed per 2,046 people and one state-run hospital per 90,345 people. Of the 1 million or so doctors operating in the country, 10% of them are committed to the public health sector. Even as recent as 2014, nearly 40% of India’s population lives in poverty (or below). These people depend on the public system and it is in poor shape.
Clinical Trials: They are Connected to the Health and Hospital System
Many of the hospitals being inspected in Delhi also have listed clinical trials. So these public hospitals also serve as clinical investigational sites. It is doubtful that the magnitude of problems faced (e.g. shortage of beds, doctors, nurses, etc.) are isolated and not impactful of the clinical research activity.
India has some clear appealing qualities for clinical research as well as some disadvantages as reported by Clinical Leader.
- Large number of specialists in different therapy segments
- Medical training in English
- 600,000 English-speaking physicians
- Often physicians trained in Europe or U.S.
- Large number of ICH/GCP sites
- Large, diverse, therapy naïve
- Advantage of having 6 out of 7 genetic varieties
- Large patient pool in acute/chronic disease segment
- Increase number of patients in lifestyle disorders segment, HIV & oncology
Clinical Research Infrastructure
- Over 200 medical college
- 22,000 graduates per annum
- 15,622 hospitals and 903,952 hospital beds (mostly urban areas)
- 14,000 diagnostic labs
- 700,000 scientists and engineering grads per year
- World class medical /lab facilities
Legal and Regulatory Challenges
India’s clinical trials industry faced trouble back in 2011 where most trials were disrupted across the country due to pervasive litigation challenging the regulatory framework and patient safety guidelines. A three tier clinical trial application process was instituted, causing major delays in Indian approval times. The country’s clinical trials industry become less competitive, while simultaneously China was on the rise in biotech.
By 2014 India reestablished new guidelines and protocols for informed consent, not to mention patient reimbursement, adverse event reporting and other categories. Generally there appears to be improvement, but it should be noted that probably most of the clinical research is occurring in the private sector. Since the regulatory overhaul, the number of clinical trials have improved dramatically.
Recently, the high court of Delhi has ordered a special committee to inspect at least 35 state-run hospitals. The Indian public health system is not in great shape. It would appear its private sector fares far better and this potentially reflects underlying political policies. Undoubtedly, clinical trials are occurring in both public and private sector hospitals that also maintain GcP clinical site infrastructure. Suffice it to say, sponsors should do their homework on hospitals that maintain clinical research capacity and the evidence appears that they should be particularly careful with at least some public sector hospitals.