Health Cell

The human right to health means that everyone has the right to the highest attainable standard of physical and mental health, which includes access to all medical services, sanitation, adequate food, decent housing, healthy working conditions, and a clean environment.

• The human right to health guarantees a system of health protection for all.
• Everyone has the right to the health care they need, and to living conditions that enable us to be healthy, such as adequate food, housing, and a healthy environment.
• Health care must be provided as a public good for all, financed publicly and equitably.

The human right to health care means that hospitals, clinics, medicines, and doctors’ services must be accessible, available, acceptable, and of good quality for everyone, on an equitable basis, where and when needed. The design of a health care system must be guided by the following key human rights standards:

Universal Access: Access to health care must be universal, guaranteed for all on an equitable basis. Health care must be affordable and comprehensive for everyone, and physically accessible where and when needed.

Availability: Adequate health care infrastructure (e.g. hospitals, community health facilities, trained health care professionals), goods (e.g. drugs, equipment), and services (e.g. primary care, mental health) must be available in all geographical areas and to all communities.

Acceptability and Dignity: Health care institutions and providers must respect dignity, provide culturally appropriate care, be responsive to needs based on gender, age, culture, language, and different ways of life and abilities. They must respect medical ethics and protect confidentiality.

Quality: All health care must be medically appropriate and of good quality, guided by quality standards and control mechanisms, and provided in a timely, safe, and patient-centered manner.

The human right to health also entails the following procedural principles, which apply to all human rights:

Non-Discrimination: Health care must be accessible and provided without discrimination (in intent or effect) based on health status, race, ethnicity, age, sex, sexuality, disability, language, religion, national origin, income, or social status.

Transparency: Health information must be easily accessible for everyone, enabling people to protect their health and claim quality health services. Institutions that organize, finance or deliver health care must operate in a transparent way.

Participation: Individuals and communities must be able to take an active role in decisions that affect their health, including in the organization and implementation of health care services.

Accountability: Private companies and public agencies must be held accountable for protecting the right to health care through enforceable standards, regulations, and independent compliance monitoring. ISSUES OF CONCERN IN THIS CHAPTER ARE: 

1. Right to life
2. Right to health
3. Universal access to treatment
4. Free access to treatment
5. Universal access to essential drugs
6. Right to informed consent
7. Medical negligence
8. Reasonable care 

RIGHT TO LIFE

Public authorities must take steps to protect an individual’s life, in almost all circumstances, and must not take away a person’s life except in very limited circumstances. For example,  when lawfully defending someone from violence.

This protection requires that there should be an official investigation into deaths resulting from the state’s failure to protect life or use of force.

RIGHT TO HEALTH

The human right to health is recognized in Article 25 of the Universal Declaration of Human Rights (UDHR) and in numerous other international instruments. Prime among them being the 1966 International Covenant on Economic, Social and Cultural Rights (ICESCR), the 1965 International Convention on the Elimination of All Forms of Racial Discrimination (ICERD), the 1979 Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) and the 1989 Convention on the Rights of the Child (CRC). No government hospital shall deny the treatment of patient at any cost whatsoever. According to a report by the IMS Institute for Healthcare Informatics titled “Understanding Healthcare Access in India”, rural areas remain significantly underdeveloped in terms of health infrastructure, with about half the people in India and over three-fifths of those who live in rural areas forced to travel beyond 5 kms to reach the nearest healthcare center. It clearly shows that physical accessibility of public and private healthcare facilities is a major challenge in rural areas. The report also shows that availability of healthcare services is skewed towards urban centers with these residents, who make up only 28 per cent of the country’s population, enjoying access to 66 per cent of India’s available hospital beds, while the remaining 72 per cent, who live in rural areas, have access to just one-third of the beds. Similarly, the distribution of healthcare workers, including doctors, nurses and pharmacists, is highly concentrated in urban areas and the private sector. The National Human Rights Commission’s core group on health has observed rights perspective is missing from the draft National Health Policy, 2015.

The aim is to support better understanding of human rights law for health and social care professionals and explain how it can be used to ensure that patients and care recipients receive a service based on fairness, dignity and respect.

FREE ACCESS TO TREATMENT

Over one million HIV/AIDS patients in India are without access to the much-needed anti-retroviral (ARV) treatment, a new international report said today, suggesting that India should consider issuing compulsory licensing for increasing availability of drugs.

The joint report issued by the World Health Organization, UNAIDS, and UNICEF said India had made progress in scaling up access over the years, but said given its robust generic drug industry it could have done better.

“India has done well in scaling up access to the ARV therapy over the last seven years,” says a senior WHO official, suggesting there is still a huge gap to address.

The universal gap between those needing urgent ARV treatment for HIV/AIDS the world over and those unable to have any access climbed to over 15 million people and there is an urgent need for funds to the tune of USD 10 billion, says Rifat Atun, a senior official of the Global Fund which is the main provider of assistance to countries afflicted with HIV/AIDS, Tuberculosis, and Malaria.

India now ranks third in scaling up access, after South Africa and Kenya during the last five years.

However, it needs to cross some distance for ensuring universal access for all its HIV/AIDS patients.

Around 3,20,074 have received ARV therapy in India at the end of last year as compared to 2,34,581 patients to the previous year. Between 1.1 and 1.4 million HIV/AIDS patients have no access for ARV therapy in India.

Given the number of health professionals and the state of the art generic drug industry in India, the performance on the HIV/AIDS front could be far better in comparison with other low-income countries in Southern Africa.

India must consider issuing compulsory licenses for ensuring free access to second and third-line treatment for all patients.

Compulsory licensing enables a national government to revoke a license issued to a patent holder and thereby, allow other parties to produce and sell a patented product for non-commercial purposes.

Several industrialized nations resorted to compulsory licensing to enable their national health departments to procure medicines at low prices so as to provide free of cost in government hospitals.

India is yet issue a compulsory license despite its rising HIV/AIDS patients who now need second and third-line treatment.

In 2006, Thailand issued compulsory license for the production of patented drugs for for its HIV-infected population. Later, Brazil also issued compulsory license for the production of patent-drugs produced by an American pharmaceutical company despite enormous pressure from the US.

Heart disease is particularly endemic in India, where a genetic trait renders Indians three times more vulnerable than Americans or Europeans. While the average age for a heart attack in London is 65, in India it is 45 years. One in four Indians gets a heart attack before retirement and about 25 percent of all heart-disease deaths happen to those under the age of 40. As a result of this higher prevalence, the Indian subcontinent alone accounts for 45 percent of coronary artery disease worldwide.

In the face of such high demand, India’s healthcare system faces great difficulties in serving people’s needs. On average, there is one doctor per 2000 people, 70 percent of which live in urban areas. Thus, access to care is determined by the convenience and affordability of travel. Even when people can get to a hospital, 50 percent of patients seeking cardiac care at a district hospital before 2001 would die before they could get specialist help.

Like many other countries, cost is the biggest barrier to medical treatment in India. Of the 22.5 million Indians in need of heart surgery annually, less than 3.5 percent can afford it. The ripple effects are enormous: when a poor family loses its primary breadwinner, the whole family is made destitute. In other words, affordability of healthcare is a pre-requisite for emerging out of poverty. But less than 15 percent of Indians have access to health insurance, including the 2 percent that can afford private insurance.

Furthermore, led by developed economies, the trend in healthcare has been moving away from large hospitals to smaller clinics that provide a more tailored and unique experience, in addition to a stronger focus on new technologies, vaccines, and “wonder drugs”. While it is an exciting time in global healthcare since most diseases are curable, treatment remains prohibitively expensive, excluding most poor people from the healthcare system. In fact, 100 years after the first heart surgery, only 8 percent of the world’s population can afford one.

UNIVERSAL ACCESS TO ESSENTIAL DRUGS

Access to essential medicines as part of the right to the highest attainable standard of health (“the right to health”) is well-founded in international law. The right to health first emerged as a social right in the World Health Organization (WHO) Constitution (1946) and in the Universal Declaration of Human Rights (1948). The binding International Covenant on Economic, Social, and Cultural Rights (ICESCR) of 1966 details the progressive realization of the right to health through four concrete steps, including access to health facilities, goods and services.

The authoritative General Comment 14 (2000) further applies the principles of accessibility, availability, appropriateness and assured quality to goods and services, which include essential medicines “as defined by the WHO Action Programmed on Essential Drugs”.

In India, a silent crisis in access to essential medicines confronts most patients who seek treatment of acute and chronic diseases. Close to 40% of Indians live on less than US $1 per day and most of them pay out of pocket for using healthcare. Out-of-pocket spending in India is over four times higher than public spending on healthcare. Unexpected illness can have a catastrophic effect on the family of the ill person: direct out-of pocket payments could push 2.2%% of all healthcare users and one-fourth of all hospitalized patients, into poverty in a year.

In addition, most Indians pay for medicines – a key factor that can contribute to the impoverishing effect of out-of-pocket payments for healthcare. According to the World Health Organization (WHO), an estimated 649 million people in India do not have regular access to essential medicines. Public provision of these medicines is poor; the median availability of 30 essential medicines in six states in India varied between 0% and 30 %. Patients are forced to buy medicines from the private market, a compulsion that often spells calamity for those who can ill afford the twin burdens of sickness and healthcare costs.

For example, India has the largest number of patients with diabetes in the world. A study has shown that patients belonging to the low income group in urban India were spending 27% of their annual income and those in rural India 34% of their annual income on diabetes care; most of this was spent on purchase of medicines. A recent study calculated the expenditure incurred on outpatient treatment of community-acquired pneumonia as a proportion of the mean per capita expenditure on food. Urban patients spent 17.6 % of their mean per capita expenditure on food (rural patients spent 23.4%) on the medicines prescribed for communityacquired pneumonia . Studies have also shown that of the rising out-of-pocket expenditures on healthcare, which push an estimated 32-39 million people below the poverty line annually  more than 70% of expenditure was incurred on purchase of medicines .

The reality of healthcare in India is that the private sector now caters to 80% of outpatient and 60% of inpatient care. Patients are therefore forced to purchase medicines from the market, which functions (and is being allowed to function) in a manner antithetical to India’s public health needs. Not only do public health systems fail to provide essential drugs to patients, but the Indian pharmaceutical market is flooded with overpriced medicines that are inappropriate and irrelevant to the public health needs of the country.

The lack of access to essential medicines — 348 drugs are listed in the national list of essential medicines of India is the result of the inadequate budgetary provision for healthcare, the lack of a comprehensive policy on medicines in India, and a weak regulatory framework which allows medicines to be produced, promoted and prescribed without assurance of their rationality, quality or reasonableness of price. To reduce healthcare costs, it is important that people are able to access medicines of assured quality that are efficacious, safe and affordable. These essential medicines must satisfy the priority healthcare needs of a majority of the population and must be available as part of a basic healthcare system .

Government announcement on free generic and essential medicines

Some activities in 2012 suggest that this scenario might change. In February 2012, partly as a response to the persistent demands of civil society and the recommendations of the High Level Expert Group of the Planning Commission, the government announced plans to increase the outlay for health to 2.1% of the gross domestic product by the end of the 12th Five Year Plan (2012-17). The President’s speech in the budget session of 2012 referred to plans by the government to ensure universal access to free generic essential medicines in public health institutions in a time-bound and phased manner. This plan was also referred to by the Prime Minister in his 2012 Independence Day address. This was a welcome announcement (even if long overdue) articulated at the highest level of the government, although a year later the scheme has still not received adequate budgetary allocation to allow for its launch. If translated into reality by exercise of political will, good governance and allocation of adequate resources, it can revitalize the public health system in India.

1. Mistaken notions of ‘branded’ and ‘generic’ medicines in India

In India, confusion and misinformation about generic medicines abound. The confusion is spread across stakeholders including the public, prescribers, policymakers and pharmaceutical trading agencies.

In their 2012 addresses to the nation, the President and the Prime Minister emphasised the importance of access to generic medicines, and rightly so, because worldwide, generic medicines are being seen as an answer to soaring healthcare costs. For example, in the US, not only are six of every 10 prescriptions filled with generic medicines , but pharmacists are also allowed to replace branded medicines with generic ones. By contrast, in India, home of one-fifth of the world’s production of generic medicines, a consumer finds it difficult to access low-cost generics. We explain this paradox by clearing the misinformation about branded and generic medicines in India.

A generic drug is defined as a drug product that is comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. In countries where product patent laws are in effect, the originator firm holding the patent markets the medicines under a trademarked name with no competition for a period of up to 20 years. In these countries, generic medicines are low-cost versions of the innovator product, produced by a number of manufacturers after the patent on the medicine expires. Thus generic medicines are off-patent medicines made by companies other than the originator company, and may be marketed under a trade name (branded generic) or under the international nonproprietary name, or INN (unbranded generic). For example, Paracetamol is marketed as Crocin, Calpol, or Metacin (branded generic), or simply as Paracetamol (unbranded generic). Generic versions of the original patented drug, chemically identical to the originator product, are required by law to satisfy the same standards of quality, and are similar in safety, efficacy, risks, benefits, and intended use. Sceptics often raise the issue of bioequivalence and therapeutic equivalence of generic and brand/reference products. Actually, drug products are considered bioequivalent if there is no clinically significant difference in their bioavailability (as measured by extent and rate of absorption, and maximum blood concentration) . Generic drugs are identical and bioequivalent to an innovator brand . In the case of oral drugs, if the blood concentrations of two drugs are the same, then their concentration at the site of action and their effectiveness are also considered to be the same . There are few cases in which two drug products with the same active ingredient in the same dose may have different bioavailability. In all other circumstances, generic and brand name drugs can be considered interchangeable. A systematic review of 38 randomized controlled trials of generic and brand named cardiovascular drugs concluded that they were clinically equivalent.

The term generics are understood differently in India. In India, there was no patent protection for medicinal products before 2005 (only processes for manufacture of medicinal products could be patented); and the term generic medicines was used for those medicines which were marketed under the generic name (INN). A recent term for generic medicines used by the WHO is multi-source pharmaceutical products , which avoids the prevailing confusion between generic medicines (which can be marketed under a brand name), and the generic (non-proprietary) name of a medicine . In countries like the USA, prescriptions for unbranded generics predominate, while branded generics are a small part of the market — 58% of the dispensed prescriptions were for unbranded generics compared to only nine per cent for branded generics .

We use the term generic in line with its global usage to denote medicines which are off patent. The term used in this sense would represent virtually all the drugs in the Indian pharmaceutical market, since few enjoy patent protection. In India, the basic division is therefore not between medicines under patent and off-patent medicines, but between unbranded medicines (generic in the Indian sense) and branded medicines. Branded drugs in India are actually branded generics which are often misunderstood by patients, or even the media, as patented medicines , which they are not.

The brand scam

Drug makers and pharmaceutical trading agencies create an impression that branded generics are vastly superior to unbranded generics (which are often procured in the public health system and are available to patients free of cost). Even medical professionals consider unbranded generics to be substandard medicines. To add to the confusion, branded generics in India have been artificially divided by academicians and policymakers into two categories: branded products, which apparently refer to drugs made by reputed companies and promoted through doctors, and so-called branded generics , drugs apparently made by less reputed companies and promoted through retailers . Patients value quality, safety and cost-effectiveness of a medicine; it matters little to them whether the medicine is branded or unbranded and whether it is promoted through the retailer or the doctor. All drugs in India also have to meet the same requirements with regard to quality, irrespective of whether they are marketed under the INN or trade name, and regardless of the route of promotion.

Drug makers and pharmaceutical trading agencies aggressively promote their brand name drugs, often using dubious means. Each brand claims superiority over competing brands or unbranded medicines. The top 50 companies spent Rs 5,840 crore on drug promotion in a single year. This practice and cleverly created myths have made it difficult for patients to access low cost medicines in India. The argument that brand A is better than brand B does not hold for a number of reasons.

First, drug makers often market the same molecule under a variety of brand names and at widely differing prices. For example, Ranbaxy uses two brand names to market ciprofloxacin: Cifran (the best-selling brand) and Ciproace (the lesser-known brand). A tablet of Cifran (500 mg)  costs Rs 9.90; that of Ciproace Rs 6.20. Does it mean that Cifran kills bacteria faster than Ciproace does? How would Ranbaxy justify the difference in the prices of its two brand names?

Second, drug makers also market both so-called brands and branded generics. A recent study did not find any difference in quality between brands and so-called branded generics made by the same company, yet the difference in price is substantial.

Third, medical professionals often indicate that they trust drugs made by highly reputed companies. Their trust is misplaced because reputed companies in India often do not manufacture but only market medicines (which may range from vitamins to very expensive antibiotics). The medicines marketed by reputed companies are actually manufactured by so-called less reputed companies. For example, Glaxo Smith Kline (GSK) is well known for its brands such as Zevit (multivitamin with zinc), Augmentin (amoxicillin-clavulanate: an oral and parenteral antibiotic), and Esblanem (Meropenem: an antibiotic costing Rs 1,200 per gram). Little do the doctors and public know that GSK gets them manufactured by less well-known companies such as Remidex, Medreich and Hospira and merely markets these brands (information from product packages). This is true for hundreds of other companies as well.

Fourth, the companies argue that drugs promoted through chemists are cheaper than those promoted through doctors, because they do not have to offer the incentives and freebies that they routinely offer to doctors. This argument also does not hold because companies promote medicines to doctors as well as chemists. While doctors are offered gifts and even incentives, chemists are also offered bonuses on brands and hugely discounted prices on commonly used drugs. Recent studies have shown that trade margins in India for branded drugs can vary from 200% to over 1,000%. Self-medication practices are widespread across the different socio-economic groups in India, as is the practice of over-the-counter drug dispensing. For minor ailments, consumers often do not see a doctor and prefer to medicate themselves. Blissfully unaware of the profit margins on simple antibiotics, cough syrups, painkillers or anti-histaminics, they end up paying exorbitant prices for the over-the-counter drugs they buy from local chemists. Abroad, generics are much cheaper than the originator product . Not so in India. The so-called branded generics have a printed maximum retail price which is sometimes even higher than that of so-called branded product.

Prescription malpractice

We wish to emphasise that the Indian pharmaceutical market is entirely a generics market, one in which a few branded generics, masquerading as innovator products, monopolise the market. There are thousands of brand name drugs in this market and patients have little access to low-cost branded or unbranded medicines. For patients to access low-cost generic drugs, it is important that drug companies reduce their profit margin, pharmacies stock and promote them and prescribers start writing them. Although the Medical Council of India’s code of ethics for doctors explicitly mentions that Every physician should, as far as possible, prescribe drugs with generic names, this practice is seldom followed.

We believe that doctors must write drugs by generic names in both public and private sectors. To begin with, public health facilities must enforce this practice because unbranded medicines are procured and dispensed in these institutions. The usual practice of patients seeking healthcare in the public health facilities being forced to buy brand name medicines from private chemists must be checked . The generic-name prescriptions in the private sector haven’t succeeded because private pharmacies either do not stock them or the pharmacists replace low-cost drugs with expensive branded ones. Therefore the government’s advice to all doctors to prescribe by generic name cannot be translated into practice. Also, when doctors prescribe fixed dose combinations (FDCs), they always choose brand name drugs. They argue that because FDCs have multiple ingredients, they find it difficult to prescribe them by their non-proprietary names. Prescribing by generic name in India will take root only when doctors prescribe unbranded single ingredient medicines, and take irrational FDCs off their prescriptions.

Regulatory negligence

The drug regulatory agencies in developed countries like the US, Canada, the UK and Australia promote the use of generics and highlight their therapeutic equivalence to brand name originator products. In India, most prescribers do not know there is no difference, in pharmaceutical terms, between unbranded and branded medicines, or between brands, and the drug regulatory authorities make no effort to educate them. Both doctors and patients prefer brand name drugs over generic drugs because the latter, in their eyes, are low quality and substandard — if not counterfeit — drugs. Patients prefer to spend on brands they can trust, and consider a company’s visibility and corporate image as a proxy for authenticity and quality control.

If the government were to provide quality assurance of all medicines available in the market, then a truly competitive market for generics competing on the basis of price could emerge in India which would immensely benefit the consumer. There would be increased prescriber support for unbranded generics in India and a better performance of schemes like the Jan Aushadhi stores which aim at providing good quality low-priced, unbranded medicines from five public sector  companies. Our own experience of running pharmacies at secondary and tertiary care institutions, based on low cost, unbranded as well as branded, generics sourced from carefully chosen drug companies, has been very positive in terms of savings in cost to patient and patient outcomes.

Brand name medicines in India cause the cost of treatment to spiral and are also a frequent but under-reported cause of medication errors. More than 60,000 brands exist in the Indian market but there is no registry of these drugs. As a result, brand names of medicines with dissimilar therapeutic effects (lookalike or sound-alike drugs; Table 1), result in serious medication errors. In our clinical practice, almost every day we see dozens of patients who are unable to find the drugs their doctors have prescribed, because the brand name drugs in the prescription they carry are available at only a few select shops close to their doctor’s clinic.

1. Overpricing of medicines in India: the imperative for price regulation

Price regulation has been a key element of India’s pharmaceutical policy since 1970. Prices of medicines have however been rising over the past few decades due to progressive dismantling of the system of price regulation. The Drug Prices Control Order (DPCO) initially placed price limits on 348 medicines deemed essential in India, a number that shrank to just 74 drugs by 1995. Most drugs required to treat diseases of public health importance were either underrepresented in this list or were not represented at all. The list did not include vaccines, oral rehydration salts, drugs for cancer or coronary artery disease, and included very few drugs for respiratory diseases, hypertension, and diabetes.

Market failure

The government tried to justify its lax control over regulation of drug prices by arguing that competition alone was enough to control their prices, an expectation belied by subsequent developments. Drugs not listed in the DPCO started getting costlier, and the rise in drug prices consistently outstripped the prices of all other commodities (37). For 17 years — 1995 to 2012 — the number of drugs under price control did not change.

A public interest litigation filed in the Supreme Court of India is seeking to re-introduce price regulation of all the medicines in the National List of Essential Medicines (NLEM). At the behest of the court, the NLEM was recently revised (10) and a revised National Pharmaceuticals Pricing Policy is on the anvil (39)

The government, however, intends to switch to a market based pricing formula which, if implemented, will either only marginally reduce drug prices, or may actually increase them (40, 41) Several publications have pointed out that the new policy may adversely impact public health in India (42, 43, 44) An analysis of the top-selling 300 brands suggested that 62% of them contained medicines outside the NLEM, and of the 115 FDCs only 20% could be considered rational. These medicines and such combinations would be outside the purview of price control, and this would reduce the efficacy of price control as an intervention to reduce healthcare-related costs.

Are price differentials ethical?

Medicines are overpriced in India. In India, the pharmaceutical sector shows three types of price differentials which reflect this overpricing. The first differential is the greater than 10-fold difference in the maximum retail price of different brands of the same medicine which is seen in the market (Table 2). Differences between retail prices of perhaps a lesser magnitude are seen across therapeutic categories of medicines in India. The disconcerting fact is that in India the market leader in a particular therapeutic segment is also the price leader, or amongst the highest priced medicines in that segment. For example, Atorva, an anti-lipid brand name drug, outsells hundreds of brands, some of which are 10 times cheaper (Table 2). This is clearly an indication that market forces fail to regulate drug prices, as was naively assumed by the government over the years. This state of affairs exists because patients pay but do not decide, while doctors – the key players who are often heavily influenced by the pharmaceutical companies – decide but do not pay. In such a situation, patients with diseases like diabetes, hypertension or cancer pay substantially more if their doctor prescribes the more expensive brand for each of these conditions.

The second inexplicable difference in prices is between the price to retailer and the price to consumer for branded generics. A study found trader margins for the branded generics promoted through retailers of the order of 201-1,016% . These enormous trade margins have been known to the government since 1998 as pointed out by the Drug Price Indian Journal of Medical Ethics Vol X No 2 April-June 2013 Control Review Committee. This vast differential points to the enormous mark-ups which exist in drugs and which are being pocketed either by the pharmaceutical trader or the company (hospitals and doctors who dispense the drugs also share the profits). If drug makers agree to reduce the exorbitant profit margins, and drug prices are tightly regulated, all drugs might become available at affordable prices. while there are 131 brands of thiazides in combination with other medicine

The final revealing differential is between the price paid for purchase of medicines in pooled public procurement programmes in Tamil Nadu and other states which buy quality assured medicines, and of the brands which sell in the market. For example, Tamil Nadu procured 10 tablets of Omeprazole (a commonly used drug for acid peptic disease) for Rs 2.4 while the market leader sells at Rs 39.7 for 10 tablets. Similarly, Tamil Nadu procured human insulin at nearly a third of the prevailing market price. The variation in retail prices, the margins offered to the traders, hospitals and doctors who dispense the drugs and the difference between retail prices and prices in pooled procurement are unique to the pharmaceutical sector.

These differentials raise an ethical question for public policy. These price variations may not be illegal, but are they morally right? Are these wide variations in drug prices – which have no parallel amongst all other commodities – ethically acceptable when access to medicines can constitute the difference between life and death? Should the government not intervene to ensure that patients are not at the mercy of the prescribers’ whims and the vagaries of the market? Should the ambit of price regulation not cover all medicines as suggested by the National Commission of Macroeconomics and Health, rather than just the 348 medicines mentioned in the NLEM? Won’t this control of prices, limited to those of essential medicines, induce the industry to migrate from production of price-controlled medicines to those outside control? This selective approach to price control could ultimately promote the production and marketing of medicines which are not in the NLEM.

1. The need for evidence-based drug approval and improved access to essential medicines

India and its pharmaceutical industry have acquitted themselves very creditably on the global platform. Indian generics account for about 40% of the anti-retroviral medicines provided globally. Worldwide, these low-cost high-quality medicines are a lifeline to millions of people. There are an estimated 10,563 manufacturers in India, and more than 65,000 formulation .

These numbers look impressive but the paradox is that, at home, large portions of the population lack access to even the most essential drugs. The limited funds available are frequently spent on ineffective, unnecessary, or dangerous medications. The money spent on overpriced medicines is very often also a waste of precious resources. This is because the Indian pharmaceutical market is full of ineffective, unnecessary medicines. Since these medicines outnumber those which are cost-effective, they directly impact the availability of and access to essential medicines .

Lack of essential medicines in the market

Iron deficiency anaemia is an important public health problem in India, associated with low birth weight in infants, pregnancyrelated deaths, and decreased work capacity. Ferrous sulphate and ferrous fumarate – low cost medicines recommended for treatment of iron deficiency which are distributed free of cost in public health facilities – are not available in most drug stores in India. The July 2012 edition of Current Index of Medical Specialities (CIMS), a prescriber handbook, does not mention a single preparation which contains ferrous sulphate in the dose mentioned in the NLEM 2011. Hundreds of iron preparations are available in the market they contain salts with poor efficacy or co-existing with other nutrients (vitamins, minerals including zinc, amino acids) which do not increase their efficacy. Yet they cost much more than simple iron preparations and push up the cost of treatment of iron deficiency anaemia as much as 70-fold, according to an estimate. We are unable to understand why such ineffective and irrational preparations continue to be in the market and why iron pills are not under price control.

Dexorange was a market leader for the treatment of iron deficiency anaemia. Although this drug contained a poorly absorbed salt of iron and haemoglobin that came from slaughterhouse blood, it enjoyed a lot of support from medical professionals between 1970 and 2000 (when the use of haemoglobin in anaemia preparations was finally banned). This combination had no parallel anywhere in the world. Similarly, the market is flooded with irrational fixed dose combinations to treat infectious diseases, as well as “me-too” drugs — members of the same group as essential medicines which do not confer any therapeutic advantage but are more expensive. It is a moot point whether the 11 calcium channel blockers available in the Indian market fulfil any therapeutic need. On the other hand, essential medicines are scarce. Thiazide diuretics are amongst the cornerstones of treatment of hypertension. However, there were only five brands of thiazides listed in CIMS , while there are 131 brands of thiazides in combination with other medicines .

Unnecessary and irrational fixed dose combinations

Fixed dose combinations (FDCs) are combinations of drugs, used in situations where such a combination is pharmacologically justified. More than 40% of the formulations in India are composed of FDCs, a proportion which is unprecedented. For example the NLEM which lists 348 medicines has only 15 combinations of medicines. In contrast, in the market there are more than 15 combinations of paracetamol alone.

FDCs are justified when the combination of the active drugs increases efficacy, decreases adverse effects, reduces the risk of drug resistance, lowers prescription cost, simplifies therapy or promotes adherence to therapy. Such combinations with a Indian Journal of Medical Ethics Vol X No 2 April-June 2013 therapeutic advantage are therefore justified (some examples are oral contraceptives, anti-malaria therapy, anti-TB drugs, HIV therapy, and drugs for asthma, hypertension and diabetes). A basic requirement is that the drugs comprising the FDC should have compatible pharmacokinetics and pharmacodynamics. The major disadvantage of FDCs is an inability to vary the dose of the individual components of the combination, and increased incidence of adverse effects.

In India, the FDCs often lack pharmacological justification. India’s most widely available antibiotic combination of ampicillin/amoxicillin and cloxacillin is pharmacologically irrational , compromises the treatment of staphylococcal infections because the dose of cloxacillin in the FDC is half of what it ought to be, and promotes the development of drug resistance. The use of other FDCs of antibiotics like ciprofloxacin + metronidazole has contributed to increasing resistance in enteric infections like typhoid fever.

FDCs often also contain chemicals which lack efficacy but increase the cost of therapy. For example, an FDC of painkillers with serratiopeptidase, a drug isolated from silkworm intestine, is commonly prescribed in India. This drug was voluntarily withdrawn from the market in Japan by its manufacturer Takeda in 2011, when clinical trials failed to show evidence of its efficacy compared to placebo, but continues to be popular in India.

A number of FDCs are downright hazardous. The European Medicines Evaluation Agency approved Nimesulide only for restricted and short term use in adults. The agency warned that combination of this drug with other painkillers like paracetamol could adversely affect the liver. Yet, several leading Indian companies (Lupin, IPCA, and Dr Reddy’s Laboratories) market such FDCs in India.

Table 3 lists the irrational FDCs made in India. Indian pharmaceutical manufacturers have WHO good manufacturing practices certification and a number of them have US FDA approval. Is it not axiomatic that the content of medicines manufactured be also such that would stand the scrutiny of an agency outside India? The presence of unnecessary and ineffective drugs makes the process of drug regulation even more daunting as the authorities waste their time and resources fixing the prices or monitoring the quality of preparations which should not have been manufactured in the first place. For example, the National Pharmaceutical Pricing Authority has determined prices for 78 formulations of cloxacillin, a medicine which is under price control. All these 78 formulations are irrational as they contain combinations of cloxacillin with various other antibiotics (ampicillin, amoxicillin, cefixime, cefpodoxime), and varying concentration of lactobacillus spores (20-60 million) .

The drug approval process in India and its lacunae

Drug regulatory agencies all over the world approve medicines for use in their countries on the basis of an evidence-based process which evaluates the data on their efficacy (obtained through randomised controlled trials) and safety. In India in light of the public health problems that we face, the widespread poverty and high out-of-pocket expenditure incurred by patients, the drug regulatory authorities have an additional responsibility: to ensure that the medicines being approved for manufacture serve the public health needs of the country and are cost-effective.

The Drugs Controller General of India (DCGI) heads the Central Drug Standards Control Organization (CDSCO) which oversees the process of approval of medicines for India. This process needs to be rigourous, transparent and evidence-based, as is the case with drug regulatory agencies in the developed countries. The website of the CDSCO should list the approval letters, approved indications, and information for patients who are to use the product.

However, the drug regulatory agencies in India have paid inadequate attention to rigourous, impartial review of the scientific evidence, public health relevance, transparency and public disclosure before approving a drug. A parliamentary committee report on the functioning of the CDSCO in 2012 observed: A review of the opinions submitted by the experts on various drugs shows that an overwhelming majority are recommendations based on personal perception without giving any hard scientific evidence or data. Such opinions are of extremely limited value and merely a formality. Still worse, there is adequate documentary evidence to come to the conclusion that many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures.

The issue of irrational FDCs in India is a pointer to the lacunae in the drug approval process. The genesis of many irrational FDCs has been at the state level where the state licensing officers in contravention of the amended Drugs and Cosmetics Act were found to be issuing licenses to companies for the manufacture of FDCs. The DCGI issued a directive in 2002 to all the state drug controllers to refrain from issuing any new drug licensing for the manufacture of FDCs. But as was noted by the parliamentary committee, no action has been taken in the past 11 years on this issue .

In response to a public interest litigation the DCGI’s office had identified 294 FDCs which had been sanctioned by the state licensing authorities without its approval. Such FDCs are illegal and could have been banned immediately, but even these have yet to be withdrawn. One example from this list of FDCs that was approved by a state licensing agency, though classified as ‘absurd’ by the DCGI, is a combination of non-steroidal anti-inflammatory drugs and other drugs, chlorzoxazone + Ibuprofen+Paracetamol+diclofenac+Oxyphe nbutazone+Magnesium hydroxide.

While state drug controllers can be blamed for many irrational FDCs, irrational FDCs have been approved in recent years by the CDSCO. FDCs of antibiotics are clearly dangerous to public health – as pointed out in the recent parliamentary committee report. For example, the DCGI has approved an Indian Journal of Medical Ethics Vol X No 2 April-June 2013 FDC of Moxifloxacin with cefixime for the treatment of lower respiratory tract infections (Table 3). Moxifloxacin is a newer generation fluoroquinolone and one of the few orally effective drugs for multi-drug resistant tuberculosis. Such a combination, if used frequently to treat pneumonia, could further complicate the problem of multi-drug resistant TB.

Need for transparency in the approval process

In its report, the parliamentary committee drew attention to a collusive nexus between drug manufacturers, some CDSCO functionaries and some medical experts  which resulted in irregular drug approvals. On the issue of irrational FDCs, it stated in very clear terms, The Committee is of the view that Section 26A is adequate to deal with the problem of irrational and/or FDCs not cleared by CDSCO. There is a need to make the process of approving and banning FDCs more transparent and fair. In general, if an FDC is not approved anywhere in the world, it may not be cleared for use in India unless there is a specific disease or disorder prevalent in India, or a very specific reason backed by scientific evidence and irrefutable data applicable specifically to India that justifies the approval of a particular FDC. The Committee strongly recommends that a clear, transparent policy may be framed for approving FDCs based on scientific principles.

Irrational FDCs continue to thrive because drug companies take advantage of the lengthy litigation in Indian courts. In such cases the onus of proof – that the FDCs are harmful – lies on the complainant. With virtually no system of post-marketing surveillance, it is nearly impossible to gather evidences of harm against FDCs in India.

Lessons from successful initiatives in improving access to essential medicines

As the government endeavours to improve the availability of medicines in public health facilities, it would be beneficial for it to incorporate lessons from some successful initiatives in improving availability of essential medicines. Beginning October 2, 2011, Rajasthan state has started supplying free medicines at public health facilities. Since 1994, Tamil Nadu Medical Services Corporation has ensured ready availability of all essential drugs and medicines in the government medical institutions throughout Tamil Nadu by adopting a streamlined and transparent procedure for their procurement, storage and distribution. This quality-assured process of pooled public procurement has several features worthy of replication at the national level. A similar initiative has been implemented in Delhi state.

These initiatives have succeeded in procurement of unbranded essential medicines at very low prices, eliminating irrational medicines and unscientific fixed dose combinations. They have shown that given political and administrative will, it is not difficult to gather support from healthcare professionals for improving access to healthcare and decreasing the burden of expenses for patients, while achieving substantial savings in cost for the public exchequer.

The common people who purchase medicines at nearly half a million chemist shops in India, every day, await a similar exercise of political and administrative will of the government to improve access to low-cost drugs in the public health facilities. As this article goes to press, the quantum of funds for the free generic medicines scheme is not known as it did not appear in any line item in the budget for 2013-2014.The Working Group on Food and Drugs Regulations for the 12th Plan has estimated that an allocation of just Rs 5,000 crore per year would suffice to fulfil the central government’s share (85%) of the cost of the ‘free medicines for all’ scheme.

Direct out-of-pocket payments push one out of 45 healthcare users into poverty in a year; this number would fall to just one of 200 if healthcare users do not have to pay out-of-pocket for purchase of medicines. Reduction of this out-of-pocket spending on medicines which is impoverishing people by the millions is an ethical imperative for public health in India.

In conclusion, the plan to improve access to essential medicines through improved provisioning in public health facilities is a welcome initiative. However, given the current realities of the healthcare system in India and the catastrophic effects of out of- pocket payment on purchase of medicines being borne by the poor, making essential and rational medicines affordable in India is also an urgent imperative.

The government must correct the present distortions around the concept of generic medicines in India by providing quality assurance of medicines, emphasizing the equivalence of different branded or unbranded medicines, and allowing the emergence of a true generics market, where different products can compete on price rather than on brand image. Prescription by generic name in all public health facilities should be mandated. The market should be made to move towards single ingredient, unbranded medicines.

To address the anarchy of drug prices which is impoverishing people, we need a comprehensive cost-based system, and not the market-based system of price regulation. The drug approval system in India needs to be overhauled on the lines suggested by the recent parliamentary committee which looked into the functioning of the CDSCO. The process of drug approval needs to be rigourous, evidence-based, transparent, and in line with the interests of public health in India. The government should address the lack of single-ingredient essential medicines in India for priority health conditions. All FDCs which lack a pharmacological rationale, contain ineffective or hazardous combinations, or are illegally approved by state drug controllers need to be removed from the market. The present predicament, of poverty of access to medicines amidst a plenty of overpriced, non-essential medicines which worsen poverty, should not be allowed to continue to imperil the lives and health of Indians.

Source: CIMS July 2012, company websites

Source: CIMS India, April-July 2012, www.medlineindia.com. Mahatma Gandhi Institute of Medical Sciences pharmacy rate list (December 2012)

Source: http://cdsco.nic.in/ for list of approved drugs for 2006-2011. [cited 2013 Feb 3]

RIGHT TO INFORMED CONSENT

Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary.

For a drug to get approved and enter into the market it has to prove its safety and efficacy in clinical trials. Clinical trial is a term used to describe all research related activities, which use human being as subjects. As no individual has right to infract fundamental rights of another person for the sake of fulfilling his own purpose, so an important tool called “informed consent” came into existence.

The informed consent is described in ethical codes and regulations for human subject’s research. The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding “to” or “not to” participate in the research study.

Conventionally informed consent is thought to be in terms of the documents signed and dated by participants, setting forth the purpose, benefits, risks and other study information necessary to allow the participants to make an informed and voluntary decision to participate in the clinical study. In reality, informed consent is the process that applies to each communication to participants, commencing with the subject recruitment material and the initial telephone screening of potential subjects through the conclusion of the study. It also describes the obligation of the investigator to inform the subject about personal benefits and risk, individual faces in study.

Informed consent is not only required for clinical trials but is an essential prerequisite before enrolling each and every participant in any type of research involving human subjects including; diagnostic, therapeutic, interventional, bioequivalence, social and behavioral studies and for all research conducted domestically or abroad. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, the procedures to be undergone, the potential risks and/or benefits of participation and alternative treatments available if any. Subjects in the study must participate willingly only after consenting based on the information given 

BASIC ELEMENTS FOR WRITTEN INFORMED CONSENT DOCUMENTS

1. A statement that the study involves research;
2. An explanation of the purpose of research and the expected duration of the subject’s participation;
3. A description of the procedures to be followed and identification of any procedures that are experimental;
4. A description of any foreseeable risks or discomforts to the subject, an estimate of their likelihood and a description of what steps will be taken to prevent or minimize them;
5. A description of any benefits to the subject or to others that may reasonably be expected from the research. Monetary compensation is not a benefit;
6. A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the subject;
7. A statement describing to what extent records will be kept confidential, including a description of who may have access to research records;
8. For research involving more than minimal risk, an explanation and description of any compensation and any medical treatments that are available if research subjects are injured; where further information may be obtained and whom to contact in the event of a research-related injury;
9. Information on the amount of remuneration/compensation, if any, that will be provided to subjects;
10. An explanation of whom to contact for answers to pertinent questions about the research and the research subject’s rights (include the clinical center’s patient representative and telephone number);
11. A statement that participation is voluntary and that refusal to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled.

INFORMED CONSENT PROCESS FLOW

Notes to Flowchart

    Source documents must reflect that consent was obtained before the start of study treatment and procedures

    A copy of the signed consent form must be kept at the site

    All versions of approved consent forms must be kept in the site study file; only the current Institutional Review Board (IRB) approved version may be used to consent new patients.

WAIVERS TO INFORMED CONSENT

1. A waiver of informed consent under 45 Code of Federal Regulations (CFR) 46.116 (d)
2. An alteration of consent under 45 CFR 46.116 (d)

An IRB may waive the requirements to obtain informed consent provided the IRB finds and documents that:

1. • The research involves no more than minimal risk to the subjects;
   • The waiver or alteration will not adversely affect the rights and welfare of the subjects;
   • The research could not practicably be carried out without the waiver or alteration and
   • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
2. A waiver of parent/guardian permission under 45CFR 46.408 (c)
3. A waiver of assent under 45 CFR 46.408 because the minors are not capable of assent
4. A waiver of assent under 45 CFR 46.408 because the research holds out a prospect of direct benefit that is available only in the context of the research

CHALLENGES IN INFORMED CONSENT PROCESS

Language Barriers

It is assumed that the individual who signs the consent form does so with full understanding of what is stated on the consent form. However, it is very difficult to evaluate their viewpoint about trial since there is no established method to measure the level of understanding that a participant has about the information given. Thus, it can be assumed that there is a degree of misunderstanding that occurs. Misunderstandings can occur because of incorrect or inadequate language translations. Many individuals sign the consent form without being fully aware of what they are signing, which results in withdrawal of subject at later stages of ongoing clinical studies. Hence, the responsibility of researcher enlarges when a study is performed in multilingual subjects.

Religious Influence

The informed consent process is designed to give every participant the liberty to decide whether to accept or refuse the recommended medical treatment. Sometimes their decision for participating in researcher projects is influenced by the religious beliefs. It is commonly observed that how the methodology of the experiment come into conflict with the rules of behavior set by a participant’s religion.

False Expectations

Even when there are no language barriers or religious impediments to hinder the communication relationship between researcher and participant, misunderstanding can still occur due to participants false expectations of the experiment outcome. Some patient fear of being treated as mere “experimental model” for the studies while others refuse to take part because of historical evidences of clinical trial fraud and misconducts known to them.

Patient Perceptions

Most patients believe that, trials will put extra burden on them. They assume that the conventional treatment is best and they are afraid of the unknown side-effects of new treatment. Convincing and receiving an informed consent from such patient is most difficult. In some case disclosing too much information of the potential side-effects may unnecessarily scare the patient away from a potentially life-saving or life-enhancing surgery or procedure.

Children

Where research involves children (under the age of 18) consent/permission has to be obtained from parents. If the child is above 7 years of age then “child assent” is also mandatory. It is arguable that children are capable of being partners in research and that they have rights to receive information, to be listened to, have their wishes and feelings taken into account and to give or withhold consent if judged competent to do so. Difficulty arises when parents give their consent while child refuses to assent.

Vulnerable People and Groups

Vulnerable groups include the person who is absolutely or relatively incapable of protecting their interests. Obtaining informed consent is critical when working with them, specifically with some groups like people with learning disabilities. There may be potential problems of understanding what the research is about, what their role in the research will be and how the research will be used. Hence, obtaining informed consent can be difficult and special care needs to be taken to develop the appropriate strategies for communicating the implications of involvement in research.

Indian Scenario

In countries like India, the clinical investigations are based on regional values and practices, the concept of disease as perceived through social values and power hierarchies in family of villages based on cultural systems. To get a meaningful and ethical informed consent in these settings become challenging due to differences in cultural values in western countries and local customs in developing countries including India. In a study by DeCosta  that was carried out in a village of Haryana state of India, the majority of respondents interviewed by them could decide on clinical trial participation after discussing with community members. Another important factor emerged from this study, which showed an implicit trust by respondents in the medical system and ignorance about the information that should be known before consenting to be a part of the research study. These factors put a huge responsibility on the part of the investigator to get informed consent. The investigator must explain in most comprehensive and complete manner the risks involved in participating in the research study. Thus, investigator should have the patience to get informed consent from these subjects allowing them to discuss with other family and community members. The ethical principles of western countries require all adults to be the primary decision makers of their participation, which may not be applicable in Indian system, which is culturally and socially different from the western world. Another important aspect of informed consent arises in psychiatric clinical studies. As large numbers of psychiatry studies are conducted in India, these studies present complex and unique challenges in Indian context. These issues include risk of worsening of illness, use of placebo and validity of informed consent. The informed consent procedure requires patient to be of sound mind and in understanding the information presented and make a sound judgment regarding participation. Assessment of consent capacity may be difficult due to fluctuation in illness, which requires continued assessment of consent capacity. Thus, conducting clinical trials and obtaining informed consent for psychiatry studies is difficult and raises a doubt on the conduct of clinical trials due to lack of trained researchers. The guidelines are prepared keeping in mind the western culture and may not replicate the same results due to cultural variability in non-western countries like India. The dilemma in obtaining informed consent from subjects with cognitive impairment includes validity of informed consent by subject, implications and validity of third party consent, protection of human subjects. Regulations don’t provide information and guidance on ethical issues of psychiatry research.

CONCLUSION

Though enveloped by challenges, informed consent is an important tool in clinical trials, which facilitates the entry of new therapeutic interventions into the market. No research activity involving human subjects can be conducted and proceed unless informed consent is completely sought. The responsibility of conducting trial ethically and genuinely lies in the hands of those involved in it. Everyone must understand their obligations and should not misuse their power for own benefit. Rights, safety and well-being of trial subjects should always prevail over the interest of science and society, so that a layman never feels being deceived off in name of a social cause. The issue of informed consent in India is a challenge on the part of investigator as a lot of complexities arise. Further, regulations are based on the western guidelines, which do not necessarily reflect the requirements of India. The guidelines on informed consent in India should be based on complex factors such as culture, level of education, demographics and risks involved during the study.

MEDICAL NEGLIGENCE

Recently, Indian Society is experiencing a growing awareness regarding patient’s rights. This trend is clearly discernible from recent spurt in litigation concerning medical professional or establishment liability, claiming redressal for the suffering caused due to medical negligence, vitiated consent, and breach of confidentiality arising out of the doctor patient relationship.

What Is Medical Negligence?

Negligence is simply failure to exercise due care. The three ingredients of negligence are as follows:

1. The defendant owes a duty of care to the plaintiff
2. The defendant has breached this duty of care.
3. The plaintiff has suffered an injury due to his breach.

And in case of medical negligence mostly the doctor is the defendant. Negligence is predominantly a theory of liability concerning allegations of medical malpractice, making this type of litigation part of the Tort Law.

Civil Liability and Medical Negligence

Negligence is the breach of a legal duty to care. It means carelessness in a matter in which the law mandates carefulness. A breach of this duty gives a patient the right to initiate action against negligence.

Persons who offer medical advice and treatment implicitly state and undertake to have the skill and knowledge to do as under:

• To undertake particular job.
• To decide whether to take a case or not ,
• To decide the treatment suitable for particular case
• To administer that treatment.

This is known as an “implied undertaking” on the part of a medical professional.

However, no human being is perfect and even the most renowned specialist could make a mistake in detecting or diagnosing the true nature of a disease.

A doctor can be held liable for negligence only if one can prove that she/ he is guilty of a failure that no doctor with ordinary skills would be guilty of if acting with reasonable care. An error of judgment constitutes negligence only if a reasonably competent professional with the standard skills that the defendant professes to have, and acting with ordinary care, would not have made the same error.

Doctors must exercise an ordinary degree of skill. However, they cannot give a warranty of the perfection of their skill or a guarantee of cure. If the doctor has adopted the right course of treatment, if she/ he is skilled and has worked with a method and manner best suited to the patient, she/ he cannot be blamed for negligence if the patient is not totally cured.

Certain conditions must be satisfied before liability can be considered. The person who is accused must have committed an act of omission or commission; this act must have been in breach of the person’s duty; and this must have caused harm to the injured person. The complainant must prove the allegation against the doctor by citing the best evidence available in medical science and by presenting expert opinion.

Criminal Liability and Negligence

Indian Penal Code 1860 sections 52, 80, 81, 83, 88, 90, 91, 92 304-A, 337 and 338 contain the law of medical malpractice in India.

A physician can be charged with criminal negligence when a patient dies from the effects of anesthesia during, an operation or other kind of treatment, if it can be proved that the death was the result of malicious intention, or gross negligence. Before the administration of anesthesia or performance of an operation, the medical man is expected to follow the accepted precautions.

In such cases, the physician should be able to prove that he used reasonable and ordinary care in the treatment of his patient to the best of his judgment. He is, however, not liable for an error judgment. The law expects a duly qualified physician to use that degree of skill and care which an average man of his qualifications ought to have, and does not expect him to bring the highest possible degree of skill in the treatment of his patients, or to be able to guarantee cures.

“Gross Lack of competency or gross inattention, or wanton indifference to the patient’s safety, which may arise from gross ignorance of the science of medicine and surgery or through gross negligence, either in the application and selection of remedies, lack of proper skill in the use of instruments and failure to give proper attention to the patient.” (Hampton v State; State v Lester)

When Does The Liability Arise In Case Of Medical Negligence?

The liability of a doctor arises not when the patient suffers injury but when the injury results due to the conduct of the doctor, which was below reasonable care. Hence once there exist a duty which has to be established by the patient, then the next step is to prove breach of such duty and the causation.

Normally the liability arises only when the plaintiff is able to discharge the burden on him of proving negligence. However, in some cases the principle of “res ipsa loquitor” which means the thing speaks for it might come into action. Mostly the doctor is liable only for his own acts. However in some cases a doctor can also be made vicariously liable for the acts of another. The example of such a situation is when a junior doctor assisting the senior doctor commits a mistake it becomes the duty of the senior to have supervised him hence vicariously liable.

Proof of Medical Negligence 

It has been held in different judgments by the National Commission and the Hon’ble Supreme Court that a charge of professional negligence against a doctor stood on a different footing from a charge of negligence against a driver of a vehicle. The burden of proof correspondingly greater on the person who alleges negligence against a doctor. It is known fact that things can go wrong even wit the best doctor. And the guilt or the negligence should be established beyond all reasonable doubts that his skill fell below reasonable care that he ought to take during the treatment/ surgery.

Steps/ Procedure to File Complaint Pertaining To Medical Negligence

Medicine is a noble profession and practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise reasonable degree of care. Neither the very highest nor a very low degree of care and competence, judged in the light of the particular circumstances of each case, is that the law requires.

1. Damage to organ due to negligence.
2. Wrong treatment due to wrong diagnosis.
3. Money receipt or prescription or discharge summary or test reports when not provided.
4. When treatment not chosen as accepted and established in medical norms /as per medical research/available medical literature.
5. Theory of res ipsa loquitur [a thing speaks of itself] – in case any instrument left in the body, a wrong part removed, allopathic treatment given by a homeopathic doctor etc.
6. Govt Hospital liable if contribution from the employee’s salary deducted OR Payment made by insurance company.
7. Negligent if three steps necessary are not observed by the medical practitioners.
   First – To decide whether he has to take up the case or not:Third- Whether the treatment given as per the diagnosis made.
   8) Hospital can also be negligent if ‘it is a case of non- availability of oxygen cylinder either because of the hospital having failed to keep available a gas cylinder or because of the gas cylinder being found empty.

REASONABLE CARE

The Indian health system includes public and private hospitals as well as specialised Ayurvedic hospitals offering this traditional Indian system of alternative medicine. English-speaking doctors are easy to find, as most Indian doctors speak fluent English. All major cities and medium-sized urban centres have private hospitals that provide an excellent standard of care.

Health insurance only covers hospitalisation and emergency costs. Other care must be paid for upfront, but even privately it is extremely reasonable compared to other countries, so medical costs should not be a significant expense.

Most western expats working in India take out private health cover, either independently or as an employee benefit. As such, foreigners should head to or call a private hospital in an emergency, as the quality of treatment and care is likely to be better than a state hospital.

Government-funded Healthcare

Publicly funded government hospitals provide basic care only and often lack adequate infrastructure. They can also be crowded and waiting times can be long. Government hospitals are often understaffed, which is why a family member usually attends to the patient during a hospital stay.

Though the cost of care is less at these government hospitals, the standard is inferior compared to private hospitals, and in general western expats opt for private healthcare.

The Private Sector

Most locals and expats prefer to use the services of private hospitals and clinics. These offer a high standard of care that is at the same level as North American and European countries. Private hospitals are modern and well equipped, and the doctors are highly qualified and often trained abroad. The following private hospital groups have good reputations and are located in all major cities:

• Apollo
• Fortis
• Manipal
• Max

The cost of medical care is very reasonable compared to other countries. Some hospitals practice double-pricing, with higher fees for foreigners. These fees can be negotiable.

Doctors and Clinics

General practitioners are available in hospitals, clinics and in private practices. The best way to find a doctor is to ask for recommendations from friends, co-workers or neighbours. Embassies and consulates can also provide a list of recommended doctors.

There are hundreds of medical facilities across the country. Your health insurance provider will normally provide details of the options in your locality. In addition, the following links provide contact information for a range of hospitals and clinics.

• The Health section on the India government website provides details and directories of a number of health care options.
• For lists of contact details for selected hospitals and clinics.

Pharmacies

All types of prescription medicines and health care products are available in India at a very low cost. Doctors provide prescriptions for certain medications but some pharmacies do not always ask for them.

Pharmacies are easily found in almost every street in all Indian cities. These can be simple roadside stalls or bigger shop-like businesses. Some may display green or red crosses.

Dental Procedures

There are many qualified dentists in India operating in private practices offering high-quality dental care and procedures at very reasonable rates. Health insurance does not cover dental care but if a dental procedure requires hospitalisation, this may be covered.

Again, ask for recommendations for a dentist from friends, co-workers or neighbours. Always check that the dentist has the correct qualifications.