Nutraceuticals with Therapeutic Claims: A Vulnerable Growing Bubble Protected by Faith and Hope of Patients

Posted on August 27, 2012 by Tapan Ray

Today a growing number of particularly the aging population wants to live a healthy life without consuming much of chemical drugs, which in turn is becoming a key growth driver for nutraceutical products across the world. Further, increasing interest towards preventive healthcare and self-medication with ‘Over The Counter (OTC)’ products are the additional factors boosting the growth of the nutraceutical products market in India.

It has been reported that by 2020, the number of senior citizens (60 plus age group) is expected to exceed 1.0 billion, with around 70% of them living in the developing world. This further highlights the growth potential of the nutraceutical industry in countries like India with rising per capita income.

Evolution of the terminology ‘Nutraceuticals’:

Dr. Stephen DeFelice of the ‘Foundation for Innovation in Medicine’ coined the term ‘Nutraceutical’ from “Nutrition” and “Pharmaceutical” in 1989. The term nutraceutical is now being commonly used in marketing for such products but has no regulatory definition, other than dietary or nutritional supplements.

It is interesting to note that the dietary supplement industry defines nutraceuticals as, “any nontoxic food component that has scientifically proven health benefits, including disease treatment and prevention.”

Perhaps because of this reason, it is very often claimed by the manufacturers of nutraceutical products that these are not just dietary supplements, but also help prevention and/or treatment of many disease conditions.

In India, nutraceuticals are being promoted to and even prescribed by the medical profession, not just as nutritional supplements but also with off-label claims for the treatment of disease conditions, like arthritis, osteoporosis, cardiology, diabetes, pain management etc.

Are nutraceuticals then ‘Nutritional Supplements’ or ‘Medicines’?

When for any nutraceutical, claims are made either for cure of a specific disease condition or for prevention of a particular ailment, the product assumes the status of a drug substance, which needs to be approved by the drug regulator with undisputed and demonstrable evidence of efficacy and safety on patients.

Thus, the questions that may be very appropriately raised, whether or not such product claims are backed by robust clinical data for efficacy and safety on long term use and whether or not such data have also been published in the peer review journals? The answer will probably be an unambiguous ‘No’.

Unfortunately, clinical trial data proving efficacy and safety are not required for nutraceutical products to get their marketing approval in India, as long as the manufacturers do not put any medicinal or therapeutic claims both on the product label and also in their promotional literature.

However, in practice, making off-label therapeutic claims for nutraceutical products in general, though illegal, are more a routine than exceptions in India.

Relaxed regulatory process for marketing approval of Nutraceutical Products:

As stated above, nutraceutical products do not go through the rigors of stringent regulatory process as followed for the marketing approval of any drug with similar claims. Due to this reason, nutraceutical products currently fall within a grey zone, which has not yet gone through intensive scientific scrutiny for their safety and efficacy on patients, in general.

Ethical issues:

As a result of such relaxed regulatory framework, the nutraceutical products industry also prompts to flag many ethical issues, which include concerns over inadequate disclosure of science based information particularly on the surrogate therapeutic claims based merely on anecdotal evidence, as a part of intensive off-label sales and marketing efforts on their part.

Off-label therapeutic claims for any product are even otherwise illegal in India, like in many other countries.

Appropriate measures by the Government need to be put in place sooner, not only to plug the regulatory loopholes for off-label therapeutic claims, but also to ensure that marketing malpractices are not followed by their manufacturers to boost the sales turnover. This is necessary keeping especially the health outcomes and safety of the patients in mind.

How effective and safe are the nutraceuticals?

As stated above, currently many nutraceuticals are being directly promoted just like any other modern medicines, in the garb of nutritional supplements, to the medical profession, but with illegal claims and intent without being supported by data that can pass through scientific or regulatory scrutiny.

Thus the questions that one can raise logically are as follows:

What happens when the nutraceutical products fail to live up to the tall claims made by the respective manufacturers on their efficacy and safety profile?
Are these substances safe, just because not enough data has been generated on their toxicity profile?

The New Zealand Medical Journal (Vol. 118 No 1219 ISSN 1175 8716) in an article titled, “Lead poisoning due to ingestion of Indian herbal remedies” reported about dangerous and life threatening lead poisoning as follows:

“We believe that our cases of lead poisoning was predominantly due to ingestion of lead contaminated Indian herbal medicines, and it is the first such case to be reported in New Zealand.”

Similarly, Times Health in its March 15, 2010 reported that dangerous “lead poisoning in Indian children in the Boston area were linked to consumption of Indian spices.”

Taking lessons from all these, incidence like ‘Tylenol tragedy’ must not be allowed to be repeated in India, the risk of which primarily lies within inadequate quality and safety standards arising out of overall gross deficiency in the product security measures for many of such substances.

Importance of robust clinical data for therapeutic claims:

Therapeutic efficacy of a drug in the treatment of a disease condition is established with pharmacokinetic, pharmacodynamics, other pre-clinical and clinical studies. Some experts believe that these studies are very important for nutraceutical products, as well, especially when therapeutic claims are made on them, directly or indirectly, as these substances are also involved in a series of reactions within the body.

Similarly, to establish any long term toxicity problem with such products, generation of credible clinical data including those with animal reaction to the products, both short and long term, using test doses several times higher than the recommended ones, is critical. These are not usually followed for nutraceutical products in India, even when therapeutic claims are being made.

The experts, therefore, quite often say, “A lack of reported toxicity problems with any nutraceutical should not be interpreted as evidence of safety.”

Should Nutraceuticals also follow ‘Evidence-Based Medicine (EBM)’ standards?

The term and concept of EBM originated at McMaster University of Canada in early 1990 and has been defined as “the integration of best research evidence with clinical expertise and patient values” (Sackett, 2000).

EBM is thus a multifaceted process of systematically reviewing, appraising and using clinical research findings to aid the delivery of optimum clinical care to patients. EBM also seeks to assess the strength of evidence of the risks and benefits of any particular treatment claim.

Thus many global pharmaceutical companies believe that EBM offers the most objective way to determine and maintain consistently high quality and safety standards of healthcare products in the healthcare practice.

EBM concept, I reckon, is important in the context of nutraceuticals too, because over a period of time more and more users of nutraceuticals will tend to look for authentic scientific evidence within a clinical set up for such products. It is about time that EBM standards are followed for nutraceutical products, as well, by the regulators.

Global pharma companies focus on EBM:

So far, the large global pharmaceutical players have been focusing mainly, if not only on EBM. Companies like, GlaxoSmithKline (GSK), were reported to have discontinued marketing those products, which do not fall under ‘Evidence Based Medicines (EBM)’, even in India.

Nutraceuticals market:

The global nutraceuticals market is currently estimated to be around US$ 117 billion and expected to reach US$ 177 billion by 2013 with a CAGR of 7%, driven mainly by ‘functional foods’ segment with a CAGR of 11%. The top countries in this category are Japan, USA and Europe with the former two together enjoying around 58% market share of the total nutraceuticals consumption of the world.

In 2009 Indian nutraceuticals market was around US$ 1.0 billion growing at 5% (IMS), around 55% of which being functional foods. As per IMS about 2800 brands were competing in the nutritional market in 2009.

The prices of most nutraceuticals products with off-label therapeutic claims, being outside government price regulations in India, are usually quite high.

Although India’s current market share of the global nutraceuticals market is around 1%, a report from PwC predicts that India will join the league of top 10 by 2020, primarily driven by the ‘functional foods’.

The status of nutraceuticals in the USA:

In the USA, Congress passed the ‘Dietary Supplement Health and Education Act’ in 1994. This act allows ‘functional claims’ to Dietary supplements without drug approval, like “Vitamin A promotes good vision” or “St. Johns Wort maintains emotional well-being”, as long as the product label contains a specific disclaimer that the said claim has not been evaluated by the FDA and that the product concerned is not intended to diagnose, treat, cure or prevent disease.

The above Act bestows some important responsibility on the doctors in particular, who are required to provide specific and accurate scientific information for nutraceutical products to their patients. This process assumes critical importance as the patients would expect the doctors to describe to them about the usefulness of nutraceutical products as alternatives to approved drugs. In such cases, if any doctor recommends a dietary supplement instead of pharmaceutical products, the doctor concerned must be aware of the risk that the patient’s health may suffer, for which the affected patient could sue the doctor for malpractice.

It is difficult to understand why is the Indian regulator not following, at least, the above practices in the country.

Only ‘Patented Traditional Medicines’ will soon require mandatory clinical trials:

Here comes possibly the beginning of a refreshing change in the drug regulatory mindset for nutraceuticals in the country.

It has recently been reported that all new traditional medicines will need to undergo clinical trials before their regulatory marketing approval in India.

However, it has also been clarified that “such products will include only the new patented drugs and not the classical formulations that find mention in India’s ancient texts, some of which are 5,000 years old.”

However, it defies scientific logic, when one argues that anecdotal evidence of last 5,000 years should be accepted as robust data for proven efficacy and safety of nutraceutical products on patients, especially during their longer term use, for the reasons as mentioned above.

Thus, this initiative of the government though commendable, will by no means ensure safety and efficacy of existing nutraceutical products making therapeutic claims – off-label or otherwise in their sales and marketing promotion to the medical profession.

An immediate action:

Nutraceutical products, wearing a tag of providing desirable therapeutic benefits with less or no side effects as compared to conventional medicines, is showing just a moderate growth in India, despite being within a favorable pricing and a relaxed regulatory environment.

As deliberated above, it may take some time for the drug regulator to grant marketing approval of nutraceutical products with therapeutic claims based only on robust clinical data for efficacy and safety. Till such time this happens, the Drugs Controller General of India (DCGI) without fail should make a statement, something like the following, mandatory on the packaging of all nutraceutical products, just as what has been done by the US-FDA:

“All claims made for this product have not been evaluated by the DCGI and the product is not intended to diagnose, treat, cure or prevent any disease.”

Conclusion:

I reckon, the nutraceutical products segment with surrogate or off-label therapeutic claims, is just a growing bubble, as it were, which continues to be well protected by faith and hope of the patients, in the absence of stringent drug regulatory measures for substantiation of specific medicinal claims with predictable efficacy and safety profile.

This bubble could easily burst… decisively, if generation of clinical data on safety and efficacy ever becomes mandatory regulatory requirements for getting marketing approval of nutraceutical products in India claiming therapeutic benefits, off-label or otherwise. In which case, to meet those stringent drug regulatory requirements, commensurate increase in price for such products could indeed make commercial survival of this industry extremely challenging.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Should India allow use of Compulsory License as a common tool to improve access to medicines?

Posted on August 20, 2012 by Tapan Ray

Compulsory License (CL) is generally considered a very important provision in the Patent Act of a country to protect public health interest not only by the governments, but also by a large number of experts across the globe and the intelligentsia within the civil society.

The key objectives:

The key objectives of the CL provisions in the statute are to:

Rectify any type of market failure

Discourage abuse of a patent in any form by the patent holder

WHO hails CL provisions:

‘The World Health Organization (WHO)’ says that ‘the provision for Compulsory Licenses (CL) is a critical element in a health-sensitive patent law’. It emphasized that CL constitutes an effective mechanism to:

- Promote competition

- Increase affordability of drugs, while ensuring that the patent owner obtains compensation

for the use of the invention

- Lack or insufficiency of working of patent

- Remedy of anti-competitive practices

- National emergency

- Government use for non-commercial purpose

- Other public interest grounds

WHO also recommends the use of CL for any “abuse of patent rights”. This is primarily to ensure that drug prices remain consistent with local purchasing power.

Even ‘UNAIDS’ have recommended the use of CL, as provided under the TRIPS Agreement, where countries have the right to issue such licenses.

Views of R&D based pharma companies:

It is well known that the provisions for the grant of CL other than national emergencies have been generally opposed by the research-based pharmaceutical industry on the grounds that they discourage investments on R&D.

Despite such opposition, most developed countries have CL provisions in their law, which the respective governments can use to promote competition and access to medicines.

Provisions for CL in TRIPS Agreement:

While TRIPS agreement does not limit the grounds or reasons for granting CL, countries can only use those grounds which are allowed by their own national legislation. The development of appropriate national legislation is therefore crucial.

TRIPs further states that the conditions under which a compulsory license is granted should be regulated in accordance with the TRIPs Agreement (Article 31), under a number of conditions aimed at protecting the legitimate interests of the right holder.

Examples of CL provisions in some important countries:

China: Quite close on the heel of grant of Compulsory License (CL) to Bayer AG’s expensive Kidney and Liver cancer drug Sorafenib Tosylate to the domestic Indian manufacturer Natco by the Indian Patent Office, as provided in the Indian Patent Law, China amended its own Patent Law allowing Chinese pharmaceutical manufacturers to make cheaper generic equivalent of patented medicines in the country not only during ‘state emergencies’, but also in ‘unusual circumstances’ or ‘in the interests of the public’.

U.S: Patent law does not provide for CL, which is allowed under the antitrust law. US has been granting CL to remedy anti-competitive practices and for governmental use, including national security.

Canada: The country introduced CL for drugs, way back in 1923. Canada has granted number of CLs and a robust generic pharmaceutical industry exists in that country.

France: French law authorizes CL when medicines are “only available to the public in insufficient quantity or quality or at abnormally high prices”.

Israel: In Israel a CL can be granted, “if it is necessary to assure the public of a reasonable quantity of a product capable of being used as a medicament, to manufacture a medicament or a patented process for manufacturing a medicament.”

Brazil: The country will grant CL in cases of “national emergency or public interest, declared by the Federal Executive Authorities. A temporary nonexclusive compulsory license can be granted if necessary. Brazil defines Public Health interest to include “public health protection, satisfying nutritional requirements, protection of the environment and other areas of fundamental importance to the technological or social and economic development of the country.”

Very few CLs granted between 1995-2012:

Despite having the provisions for the grant of CL in many countries, not many CLs have been granted across the world from 1995 to date. The details are as follows:

Country	Medicine	CL granted in
Israel	Hepatitis B Vaccine	October 1995
Italy	Imipenem (antibiotic)	June 2005
Italy	Sumatripan Succinate (migraine)	February 2006
Canada	Oseltamivir (influenza)	July 2006
Brazil	Efavirenz (HIV/AIDS)	May 2007
Thailand	Erlotinib, Docetaxel (cancer)	January 2008
India	Sorafenib Tosylate (cancer)	March 2012

Source: DNA, March 9, 2012

India joins the league in 2012:

Indian Patent Office granted a Compulsory License (CL) for Sorafenib Tosylate (Nexavar of Bayer Corporation) to Hyderabad based Natco Pharma Limited under the provisions of Section 84 of the Indian Patents Act. Nexavar is used for treatment for liver and kidney cancer.

The Compulsory License, first of its kind granted in India, enables Natco to sell the drug at a price not exceeding Rs. 8880 (US$ 178 approx.) for a pack of 120 tablets (one month’s therapy) against Rs. 284,428 (US$ 5,690 approx.) being the cost of Nexavar sold by Bayer before the CL was granted to Natco. The license is valid till the expiry of the patent on 2021.

The order on CL also makes it obligatory for Natco to supply the drug free of cost to at least 600 needy and deserving patients per year.

The grant of CL generated adverse impact from many developed nations of the world, as was expected by many.

However, welcoming the order Natco reportedly commented, “This opens up a new avenue of availability of life savings drugs at an affordable price to the suffering masses in India.”

Does grant of CL for non-NLEM products make sense in India?

Currently all government healthcare initiatives in India are focused on ‘The National List of Essential Medicines 2011 (NLEM 2011)’, be it drug price control, free distribution of medicines to all through government hospitals/health centers or even much hyped, ‘Universal Health Coverage’ proposal.

In this situation, another school of thought says that by granting CL to Natco for Sorafenib Tosylate (Nexavar of Bayer), which does not fall under NLEM 2011, hasn’t India diluted its focus on essential drugs? More so, when NLEM 2011 features quite a good number of anti-cancer drugs, as well.

The other side of the argument: Is CL a viable solution to improve access in the developing nations?

International Policy Network (IPN) in an article titled, “Compulsory licensing no solution to health problems in poor countries – say experts from India, Argentina, Canada and South Africa” stated that patents and other forms of Intellectual Property (IP) are an essential component in economic development of any emerging economy, which needs to be well protected by the governments.

The article further opines that any form of interference with IP by the grant of CL or even price controls will undermine investments and cause more harm than good. The paper, therefore, calls for stronger protection of IP across the world.

Yet another paper titled, “The WTO Decision on Compulsory Licensing – Does it enable import of medicines for developing countries with grave public health problems”, states that flexibility of innovator companies to adjust prices according to purchasing power of the people of different countries is constrained by the following two reasons:

A genuine risk that medicines sold at lower prices in the developing countries will be re-exported to high income markets.

Many high income developed countries also regulate the prices of medicines at the national level. There is a high risk that these countries will use prices in the developing markets as external reference pricing.

Thus, the author argues, in both the above situations, patented medicine prices will be undermined in the most important markets, making it difficult for the research-based companies to use prices only of high income countries to fund R&D costs for the discovery of new medicines.

Fostering innovation in India:

The healthcare industry in general and the pharmaceutical sector in particular have been experiencing a plethora of innovations across the world, not only to cure and effectively manage ailments to improve the quality of life, but also to help increasing overall disease-free life expectancy of the population with various types of treatment and disease management options.

Innovation being one of the key growth drivers for the knowledge economy, the creation of an innovation friendly ecosystem in India calls for a radical change in our mind-set.

From process innovation to product innovation, from replicating molecules to creating new molecules- a robust ecosystem for innovation is the wheel of progress of any nation, and India is no exception. It is encouraging to hear that the Government of India is working towards this direction in a more elaborate manner its 12^th 5 year plan.

However, the question that is being raised now: will frequent grant of CL vitiate the attempt of the government to create an innovative culture within the pharmaceutical industry in India.

CL will not arrest increasing ‘OoP’ for healthcare in India:

While India is making reasonable strides in its economic growth, the country is increasingly facing constraints in proving healthcare benefits to a vast majority of its population with ballooning ‘Out of Pocket (OoP)’ expenditure of around 78 per cent of its population.

This is mainly because of the following reasons:

Absence of ‘Universal Health Coverage’
Lack of proper healthcare financing and insurance system for all strata of society
Difficulty in managing the cost of healthcare even when the country is providing generic drugs for a sizable part of the world market

One finds some good initiatives though, for population Below the Poverty Line (BPL) and hears about the success of ‘Rashtriya Swasthya Bima Yojna (RSBY)’ and other health insurance schemes through micro health insurance units, especially in rural areas. It has been reported that currently around 40 such schemes are active in the country.

As the disease pattern is undergoing a shift from acute to chronic non-infectious diseases, OOP on healthcare will increase further.

Currently health insurance schemes only cover expenses towards hospitalization. Ideally, medical insurance schemes in India should also cover domiciliary or in-patient treatment costs and perhaps loss of income too, along with hospitalization costs, if India wants to bring down the OoP for its population or at least till such time the ambitious ‘Universal Health Coverage’ project gets translated into reality.

Greater focus of the Government in these areas, many believe, will help increasing access to essential medicines very significantly in India, rather than frequently granting CL, as is being envisaged by many, especially for drugs, which are outside NLEM 2011.

Access to patented medicines unlikely to be addressed effectively despite frequent grant of CL:

As we know, access to healthcare comprises not just medicines but more importantly healthcare infrastructure like, doctors, paramedics, diagnostics, healthcare centers and hospitals . In India the demand for these services has outstripped supply. There is a huge short fall in ‘Healthcare Manpower’ of the country as demonstrated in the following table:

	Target	Actual	Shortfall %
Doctors	1,09,484	26,329	76
Specialists	58,352	6,935	88
Nurses	1,38,623	65,344	53
Radiographers	14,588	2,221	85
Lab Technicians	80,308	16,208	80

Source: Rural Health Statistics 2011 in 12^th Plan draft chapter

Thus, there is an urgent need to have a holistic approach with the ‘Universal Healthcare’ in developing adequate healthcare infrastructure, efficient delivery system for medical supplies and creation of a talent pool of healthcare professionals and paramedics, to ensure access to healthcare for all the citizens of the country.

Without all these how will the diseases be diagnosed and the patients be treated for ailments, frequent grant of CL not withstanding?

Conclusion:

Be that as it may, the prices of medicines in general and the patented drugs in particular will continue to remain highly sensitive in most parts of the world, if not all, which some astute Global CEOs of the pharmaceutical majors have already contemplated.

One of these Global CEOs very aptly commented, “Pharmaceutical industry, too, on its part, needs to metamorphose to strike a balance in delivering affordable and innovative medicines. It is unacceptable to hear of the US$1billion cost to develop a drug, which includes the cost of failure. We need to fail less often and succeed more often.”

He reiterated, “Pharma companies need to understand that just because you have a patent, people don’t suddenly have money in their pockets, or can afford American prices.”

In the same context another Global CEO said, “Our strategy is really to have affordable medicines because in emerging markets you do not have government reimbursement. So you have to have medicines that people can afford to pay for.…I do not want us to be a colonial company with a colonial approach where we say we decide on the strategy and pricing. If you have to compete locally then the pricing strategy cannot be decided in Paris but will have to be in the marketplace. People here will decide on the pricing strategy and we have to develop a range of products for it.”

Keeping all these developments in view, as I said before, the contentious issue of the price of medicines cannot just be wished away across the world, which is perhaps more relevant now than ever before.

This is irrespective of the fact whether the country provides likes of ‘Universal Health Coverage’ or is driven by OoP expenditure by the majority of its population. Gone are those days, as articulated by the above Global CEOs, when a single global price for a product will be acceptable by all the nations across the world. India seems to be moving to this direction cautiously but steadily.

It appears, responsible pricing and effective working of patents are the only answers to respond to the CL issue in India.

Thus, I reckon, it does make sense for India to have the relevant provisions of CL in its Patent Act, not just to rectify any type of market failure, but also to discourage any possible abuse of a patent in any form by the patent holder in the country, as mentioned above.

However, it is also important for India to examine the potential negative impact of CL to foster innovation in the country and the global ramification of the same, including attraction of more ‘Foreign Direct Investments (FDI)’, which has been universally proved to be so important for the economic progress of any country, like India and China.

That said, while none can deny that all citizens of India should have access to affordable life-saving essential medicines, it appears rather impractical to envisage that routine grant of CL by the Indian Patent Office, as enumerated above by Natco et al, will be able to resolve the critical issue of improving access to essential medicines on a longer term basis in India.The decision for grant of CL, I reckon, should be taken in India only after exhausting all other access improvement measures.

As enumerated above, the use of CL as a common tool to improve access to medicines could prove to be counterproductive in the long run for India.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

The ruckus over Clinical Trials in India compels Government tightening regulations before flooring gas pedal for regional leadership

Posted on August 13, 2012 by Tapan Ray

The subject of Clinical Trials in India has created a huge ruckus, mainly for wide spread alleged malpractices, abuse and misuse of the fragile regulations of the country by the players in this field. The issue is not just of GCP or other clinical trial related standards but more of ethical mind-set and reported rampant exploitation of uninformed patients even in case of trial related injuries or death.

The Bulletin of the World Health Organization (WHO) in an article titled, “Clinical trials in India: ethical concerns” reported as follows:

“Drug companies are drawn to India for several reasons, including a technically competent workforce, patient availability, low costs and a friendly drug-control system. While good news for India’s economy, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and the uneven application of requirements for informed consent and proper ethics review.”

Damning report of the Parliamentary Standing Committee:

Recently the Department Related ‘Parliamentary Standing Committee (PSC)’ on Health and Family Welfare presented its 59^th Report of 118 pages in total on the functioning of the Indian Drug Regulator – the Central Drugs Standard Control Organization (CDSCO) in both the houses of the Parliament on May 08, 2012.

The report begins with the following observations:

Medicines apart from their critical role in alleviating human suffering and saving lives have very sensitive and typical dimensions for a variety of reasons. They are the only commodity for which the consumers have neither a role to play nor are they able to make any informed choices except to buy and consume whatever is prescribed or dispensed to them because of the following reasons:

Drug regulators decide which medicines can be marketed
Pharmaceutical companies either produce or import drugs that they can profitably sell
Doctors decide which drugs and brands to prescribe
Consumers are totally dependent on and at the mercy of external entities to protect their interests.

In this prevailing condition, the committee felt that effective and transparent drug regulation, free from all commercial influences, is absolutely essential to ensure safety, efficacy and quality of drugs keeping just one objective in mind, i.e., welfare of patients.

Some critical findings on the Drug Approval Process:

The PSC in its report made, the following critical findings, besides others:

“A total of 31 new drugs were approved in the period January 2008 to October 2010 without conducting clinical trials on Indian patients.

Thirteen drugs scrutinized by the panel are not allowed to be sold in the United States, Canada, Britain, European Union and Australia.

Sufficient evidence is available on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.

Due to the sensitive nature of clinical trials in which foreign companies are involved in a big way and a wide spectrum of ethical issues and legal angles, different aspects of clinical trials need a thorough and in-depth review.”

Proper Auditing of Clinical Trials are lacking:

It is sad that that adequate focus on the ‘Clinical Trial Registry’ and even ‘Auditing of Clinical Trials’ is currently lacking in India, which are considered so important not only to maintain the credibility of the studies, but also to demonstrate their scientific integrity and ethical values.

Unfortunately, there seems to be many loose knots in the current clinical trial policy, practices and guidelines in the country, which require to be tightened by the Government to make the system efficient and transparent in the national endeavor of establishing India as one of the most favored destinations for global clinical trials.

Health Ministry recently responded:

Facing this stark reality and pressured by the Parliament, the government has recently demonstrated its intention of tightening the loose knots in the following two critical areas:

Permission to conduct Clinical Trial
Compensation of the Clinical Trial victims

A. “Permission to conduct Clinical Trial in India’ – the draft notification:

In response to the prevailing conundrum, ‘The Ministry of Health and Family Welfare’ of the Government of India issued a draft notification on 17th July, 2012 seeking stakeholders’ views on the ‘Permission to conduct Clinical Trial’.

The draft notification says that the licensing authority after being satisfied with the adequacy of the data submitted by the applicant in support of proposed clinical trial, shall issue permission to conduct clinical trial, subject to the following conditions:

Clinical trial shall be conducted in compliance to the approved GCP Guidelines.
Approval of the ‘Ethics Committee’ shall be obtained before initiation of the study.
Ethical aspects of the clinical trial as described in the “Ethical Guidelines for Biomedical Research on Human Participants” published by the Indian Council of Medical Research (ICMR), shall be fully complied with.
Clinical trial shall be registered at Clinical Trials Registry of India (CTRI) before enrolling the first patient in the study.
Annual status report on clinical trial viz. ongoing or completed to be communicated to the said Licensing Authority.
Any ‘Suspected Unexpected Serious Adverse Reaction (SUSAR)’ occurring during clinical trial shall be communicated within fourteen calendar days to the Licensing Authority and to the other investigator(s) participating in the study.
In case of study related injury or death, the applicant will provide complete medical care, as well as, compensation for the injury or death and statement to this effect shall be incorporated in the Informed Consent Document. The details of compensation provided shall also be intimated to the licensing authority.
The premises of sponsor/Clinical Research Organization (CRO) and clinical trial sites shall be open to inspection by the officer of Central Drugs Standard Control Organization (CDSCO), who may be accompanied by an officer of the concerned ‘State Drug Control Authority’ to verify compliance to the requirements of Schedule Y, GCP guidelines and other applicable regulation.
The sponsor/ CRO, investigators shall allow officers of CDSCO who may be accompanied by an officer of the concerned ‘State Drug Control Authority’, to enter with or without prior notice, any premises of sponsor/ CRO, clinical trial site to inspect, search and seize any record, data, document, books, investigational drugs etc. related to clinical trials and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of clinical trial.

This area of the clinical trial regulations will be finalized after taking into consideration of all the comments received from the stakeholders within the specified period.

B. ‘Compensation of the Clinical Trial victims’:

To address the pressing issues in this area Central Drugs Control Organization (CDSCO) in August 3, 2012, published an interim “GUIDELINES FOR DETERMINING QUANTUM OF FINANCIAL COMPENSATION TO BE PAID IN CASE OF CLINICAL TRIAL RELATED INJURY OR DEATH”

The document articulates as follows:

“Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice (GCP) Guidelines for Clinical Trials of India under para 2.4.7 provides that the research subject who suffers physical injury as a result of their participation in clinical trials are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from Ethics Committee. In case of death, their dependents are entitled to material compensation. Guidelines further provide that it is the obligation of the sponsor to pay the compensation.”

Such concerns were also raised in the Parliament and other forums regarding payment of compensation in the cases of injury or death, related to clinical trials.

CDSCO’s interim guidelines now prescribe an interesting formula, which will be used to arrive at the financial compensation for all clinical trial related injuries and deaths.

To assess right compensation for clinical trial related injuries or deaths following parameters have been mooted in the document:

Age of the deceased
Income of the deceased
Seriousness and severity of the disease, the subject was suffering at the time of his/her participation into the trial.
Percentage of permanent disability.

Prior to the above new interim guidelines of the CDSCO, there was no standardization for the financial compensation either for clinical trial injuries or for that matter even death. In the past, such compensation was expected to be decided by the ‘Ethics Committee’ on case to case basis.

As stated above, the above formula has been indicated to be an interim measure before the final notification comes into force after taking into consideration all stakeholders’ comments and suggestions on this very important subject.

Drawing a comparison with China:

Driven by the stellar economic growth together with its booming pharmaceutical industry have enabled China to position itself as an emerging hub for global clinical trials. Following are some examples of the key growth drivers in the clinical research space of China:

A large diverse treatment naive patient population
Significant cost arbitrage
Recent improvements in the regulatory standards
Reverse brain drain of Chinese-born scientists educated in the west
Changing disease profile
Incentives to conduct clinical research in the country

However, linguistic and cultural barriers that affect patient reporting, enrollment and other medical practices in China could work as major barriers to the growth of Chinese clinical trial sector.

Clinical Trials: A ‘China – India’ comparison

It has already been reported that India is ahead of China as most favored destination for global clinical trials, although the latter is quite close and breathing on the neck of India and could well even zoom past the former, if appropriate robust regulations and their effective implementation are still not ensured in India.

I. Majority of the Top 10 Pharma Companies conduct higher number of trials in India

Sr. No.	Company	Clinical Trials in India	Clinical Trials in China
1	Astra Zeneca	10	10
2	BMS	17	6
3	Eli Lilly	17	12
4	GSK	22	14
5	J&J	20	13
6	Merck	8	5
7	Novartis	9	6
8	Pfizer	16	5
9	Roche	5	14
10	Sanofi	15	13
	Total	139	98

(Source: clinicaltrials.gov, 26 Oct 2007)

II. India leads China and Russia in Cardiology and Diabetes trials

Therapy	India (%)	China (%)	Russia (%)
Cardiology	5.38	4.93	4.48
Diabetes	3.05	2.09	2.65
Neurology	0.90	0.90	3.62
Oncology	1.59	1.01	2.32

With the highest number of diabetic patients in the World and a very large population of patients with cardiovascular disorders, India has the potential to be the destination of choice for clinical trials in these two therapy areas, as we move on.

(Source: clinicaltrials.gov, 26 Oct 2007)

III. India has a greater % of phase II and III trials while China has more of Phase I and IV

Clinical Trials in India		Clinical Trials in China
Phase I	4%	Phase I	7%
Phase II	16%	Phase II	9%
Phase III	65%	Phase II	51%
Phase IV	15%	Phase IV	33%

(Source: clinicaltrials.gov, 26 Oct 2007)

IV. Of the total Industry sponsored trials only 3.5% are carried out in India and 2.63% in China

Company	Global Trials	India + China
Astra	231	20
BMS	148	23
Eli Lilly	238	29
GSK	347	36
J&J	461	33
Merck	213	13
Novartis	440	15
Pfizer	389	21
Roche	302	19
Sanofi	209	28
Total	2978	237

India	3.50%
China	2.63%
Global	93.87%

India and China’s share in the Industry sponsored Global clinical trial market is miniscule

Source: clinicaltrials.gov

Overall increasing trend of Clinical Trials Initiated in India:

The following table will substantiate the above point:

Year	No. Of Clinical Trials
1999	1
2000	0
2001	6
2002	6
2003	11
2004	26
2005	141
2006	206
2007	220
2008	295
2009	189

(Source: U.S. NIH, Pharmexcil Research)

India has the potential to accelerate its pace of growth significantly:

If robust regulatory measures are put in place, addressing serious concerns on the inadequacy of clinical trial regulations in India, together with uniform requirements for informed patients’ consent and appropriate ethics review, global pharmaceutical majors can be easily attracted to India for several reasons like:

Technically competent and English speaking workforce,
Patient availability and huge pool of naive patients
Low costs and an improving drug-control system.

Thus, quite a number of criteria, as stated above, favor India to establish itself as a global hub for clinical research. Besides, availability of a number of government-funded medical and pharmaceutical institutions with state-of-the-art facilities could be very useful for mufti-centered clinical trials in the country.

Moreover, the cost to conduct a trial in India is lower by almost 50% – 75% than in the United States or in the EU. In addition, a good communication link favors quick recruitment of patients and faster regulatory approvals. Thus, clinical trials in India could be concluded faster, offering a sharp cutting edge for effective competition.

Due to all these reasons, India is gradually attracting more collaborative contract clinical research proposals in the country. Even many global Clinical Research Organizations (CRO) have already started establishing their set up in India. This pace can be accelerated significantly with the regulatory measures, as stated above.

Conclusion:

Clinical trials are the core of research-based pharmaceutical industry. No new drug can come into the market without clinical trials, which involve both potential benefits and risks to the participants. All clinical trials are conducted with the primary aim of bringing to patients new medicines with a favorable benefit–risk ratio.

Global clinical trials being relatively new to India, no wonder there are several misconceptions on the subject. The companies conducting research need to proactively publicize their commitment to protecting the rights, safety and well-being of trial participants.

All concerned must ensure that the proposals for clinical trials are approved by the government regulatory authorities before commencement and the trials must strictly follow the prescribed norms and procedures. For Phase I-IV human trials, the rights and privileges of the participants must be explained and the trials should commence only after their informed consent. The regulatory authorities, at the same time, should also ensure that any attempt of shortcuts or to bend the system by any means is met with severe consequences.

Although the Ministry of Health has already started initiating some action, as stated above, there is an urgent need for the players in this field to reassure the public, in general, about the high ethical standards that the pharmaceutical companies and Clinical Research Organizations require to comply with and continuously practice, while conducting clinical research.

It is therefore, high time for the Government to tighten the loose knots of the Clinical Trial regulations in the country before flooring the gas pedal to help India surging ahead as a major hub in the clinical trials space of the world, significantly distancing itself from China.

By: Tapan J Ray

e-Patients: Quality and Cost Empowered Patients Will Help Reducing Healthcare Costs in India Significantly

Posted on July 30, 2012 by Tapan Ray

Currently many important stakeholders of the healthcare industry, reportedly, are using or rather exploiting the individual patients not just to derive petty commercials gains, but also for quite significant strategic commercial advantages, mainly due to ignorance or helplessness of a large section of the ailing population of India.

The Lancet:

A relatively recent report on India dated January 11, 2011, published in ‘The Lancet’, states in a similar, though not exactly the same context, as follows: 1. “Reported problems (which patients face while getting treated at a private doctor’s clinic) include unnecessary tests and procedures, rewards for referrals, lack of quality standards and irrational use of injection and drugs. Since no national regulations exist for provider standards and treatment protocols for healthcare, over diagnosis, over treatment and maltreatment are common.” 2. “Most people accessed private providers for outpatient care – 78% in rural areas and 81% in urban areas.” 3. “India’s private expenditure of nearly 80% of total expenditure on health was much higher than that in China, Sri Lanka and Thailand.” Considering the above critical issues of India, as reported by ‘The Lancet’, it is rather apparent that these stakeholders could be doctors, hospitals, diagnostic centers, pharmaceutical industry, even activists and politicians. It is unfortunate that they all, sometime or the other use the patients as pawns to achieve their respective commercial or political goals or to achieve competitive gains of various types prompted by vested interests.

e-Patients:

e-Patients or empowered patients can play a very important role in India to take this raging bull by its horn to liberate themselves from such kind of a pathetic environmental condition.

The term e-Patients may be defined as those who seek or are encouraged to seek information regarding various therapeutic options, which will enable them to actively participate in the decision making process on whether or how to undergo a diagnostic or therapeutic procedure at the right cost or the pros and cons of pursuing other available alternatives.

In this sense, a large majority of patients in India are not empowered at all with health and disease related information. Despite unprecedented access to health related information in the cyberspace and elsewhere, not only a large section of the industry, but also majority within the medical profession, in general, does not seem to quite believe in the concept of e-Patients, as yet.

Though all concerned speak and even pontify about ‘Patient Centric’ approaches, at the ground level, most of them do not seem to walk the talk for tangible benefits of the patients.

In this context the news appeared earlier this month reporting that patients would soon be able to find the most affordable alternative to the medicine prescribed by the doctors through an SMS-based service, is a breath of fresh air.

The report stated, “The government plans to cover at least two-thirds of the prescription market through this scheme, which would include all widely used therapies like anti-infectives, painkillers, respiratory and gastro-intestinal drugs.”

This initiative, if becomes successful, can certainly be termed as one of the praiseworthy e-Patient related schemes of the Government.

Role of the Civil Society along with the Government:

Under the prevailing scenario, the government and the civil society, in tandem, should encourage creation of more and more e-Patients by making them understand how the healthcare system is currently working on the ground, what and which are the key obstacles in getting reasonably decent healthcare support in India and what should be done to uproot these barriers in civilized ways.

A movement yet to gather its full steam:

e-Patient movement first started in America in the 70’s, which asserts that for truly healthy living, one should get engaged in transforming the social situation and environment affecting their lives, demanding a greater say in their treatment process and observing the following tenets:

Patients’ choice and lifestyle cannot be dictated by others.

‘Patient empowerment’ is necessary even for preventive medicines to be effective.
Patients, just like any other consumers, have the right to make their own choices.

The ‘Empowered Patient’ should always play the role of a participating partner in the healthcare process.

e-Patients will help reducing the growing trust-deficit:

In today’s world, the distrust of patients on the healthcare system, pharmaceutical companies and the drug regulators, is growing all over the world, including in India. This situation makes an e- Patient resolve to actively participate in the decision making process of his/her required medical treatment.

Under the above circumstances, other stakeholders will have no other option but to take a ‘Patient-Centric’ posture in its real sense, the seeds of which are slowly and gradually being sown in India, as cited above.

In India, as ‘out-of-pocket’ healthcare expenses are skyrocketing, in the absence of a comprehensive and affordable universal health coverage, e- Patients’ will increasingly demand to know more of not only the available treatment choices, but also about the medicine prescriptions options.

e-patients will prompt a change in basic sales and marketing models of the pharmaceutical companies:

Not so long ago, to generate increasing prescription demand and influence the prescription decision of the doctors, the pharmaceutical companies used to provide product information to the medical profession through various persuasive means of the sales forces along with samples and a variety gifts, besides meeting their unmet needs with innovative medicines.

The above approach though still working well in India, will no longer fetch desired results to the pharmaceutical companies, as we move on, just as what is happening in the developed markets of the world.

e- Patients have already started demanding much more from the pharma players even through their doctors. As a result, many global companies are now cutting down on their sales force size to try to move away from just hard selling by gaining more time from the doctors. They have started taking new initiatives to open up a chain of direct communication with their primary and secondary customers with an objective to know more about them to satisfy them better.

In future, growing number of e-Patients is expected to prompt a radical change in the basic sales and marketing models of the pharmaceutical companies. At that time, so called ‘Patient-Centric’ companies of today will have no choice but to walk the talk.

Consequently, they will have to willy-nilly switch from the ‘hard-selling mode’ to a new process of achieving business excellence through constant endeavor to satisfy both the expressed and the un-expressed needs of the patients, not just with innovative products, but more with innovative and caring services.

Growing influence of e-patients in their healthcare decision making process:

In the years ahead, growing number of e- Patients is expected to play an important role in their healthcare decision making process, initially in urban India, ensuring further improvement not just in the public and private healthcare systems, but also in inviting the pharmaceutical industry to be a part of that changing process.

In the book titled, “The Empowered Patient: How to Get the Right Diagnosis, Buy the Cheapest Drugs, Beat Your Insurance Company, and Get the Best Medical Care Every Time”, Elizabeth Cohen articulated as follows:

“The facts are alarming. Medical errors kill more people each year than AIDS, breast cancer or car accidents. A doctor’s relationship with pharmaceutical companies may influence his choice of drugs for you. The wrong key word on an insurance claim can deny you coverage.”

‘USA Today’ dated August 31, 2010 in an article titled, “More empowered patients question doctors’ orders,” reported:

‘In the past, most patients placed their entire trust in the hands of their physician. Your doc said you needed a certain medical test, you got it. Not so much anymore.’

Unfortunately in India, the pace of this change is rather slow as on date. All stakeholders of the healthcare industry need to think now more of inclusive growth, not just the commercial growth of the respective organizations, which could further widen the socioeconomic divide in India, creating numbers of serious social issues. As we know, this divide has already started widening at a brisk pace, especially in the healthcare sector of the country, the impact of which we have started reading in the media much too often now.

Influence of e-patients in the R&D process:

Reinhard Angelmar, the Salmon and Rameau Fellow in Healthcare Management and Professor of Marketing at INSEAD, was quoted saying that ‘Empowered Patients’ can make an impact even before the drug is available to them.

He cited instances of how the empowered breast cancer patients in the US played a crucial role not only in diverting funds from the Department of Defense to breast cancer research, but also in expediting the market authorization and improving market access of various other drugs.

Angelmar stated that e- Patients of the UK were instrumental in getting NICE, their watchdog for cost-effectiveness of medicines, to change its position on the Age-related Macular Degeneration (AMD) drug Lucentis of Novartis and approve it for wider use than originally contemplated by them.

e-Patients have started influencing the global pharma companies:

To respond to the challenges of change posed by the e-Patients, pharmaceutical companies, especially in the US and Europe are in the process of developing a more direct relationship with the patients (consumers). Creation of ‘Patient Empowered’ social networks may help to address this issue effectively.

For example, Becton, Dickinson and Co. created a web-based patient-engagement initiative called “Diabetes Learning Center” for the patients, not just to describe the causes of diabetes, but also to explain its symptoms and complications. From the website a patient can also learn how to inject insulin, along with detailed information about blood-glucose monitoring. They can even participate in interactive quizzes, download educational literature and learn through animated demonstrations about diabetes-care skills.

To cite one more example, companies like, Novo Nordisk is developing a vibrant patient community named ‘Juvenation’, which is a peer-to-peer social group of individuals suffering from Type 1 diabetes. This program was launched by the company in November 2008 and now the community has over 16,000 members, as available in its ‘Facebook’ page.

Some other Pharmaceutical Companies, who are in the process of engaging with the customers through social media like Twitter, are Pfizer, Johnson & Johnson, Novartis, Boehringer Ingelheim, AstraZeneca, Bayer, GlaxoSmithKline, Sanofi, Roche and Merck.

Conclusion:

Since the last few years, especially in the developed countries of the world, pharmaceutical companies have been talking about being ‘Patient Interest-Centric’ to ride squarely the increasingly powerful tide of ‘Patient Empowerment’ in their endeavor to satisfy the assertive demands of the new generation of healthcare consumers – the e-Patients.

However, in many cases the prevailing healthcare provisions, its structure and culture, together with stiff resistance of the regulators to let the industry engage directly with the patients, have inhibited the ‘Patient Interest-Centric’ intent of the stakeholders to take off the ground in a meaningful way.

At the same time, the aggressive marketing focus of the pharmaceutical industry and blatant commercialization of the system by the healthcare professionals, have more often than not failed to translate the good intent of ‘Patient Interest-Centric’ healthcare process into reality.

Increasing general awareness and rapid access to information on diseases, products and the cost-effective treatment processes through internet, in addition to fast communication within the patients/groups through social media like, ‘Twitter’ and ‘Facebook’ by more and more patients, I reckon, are expected to show the results of creation of more number of e-Patients in India.

As reported by the World Health Organization (WHO), at the First European Conference on ‘Patient Empowerment’ held in Copenhagen, Denmark on 11–12 April 2012, Robert Johnstone of the International Alliance of Patient Organizations said:

“What needs to happen is for doctors to come down off their pedestal and for patients to get up off their knees.”

To reduce healthcare costs significantly in India, let the government together with the civil society accelerate the process of creating more and more e-Patients – Quality and Cost-Empowered Patients in the country, avoiding any further delay. In that endeavor likes of SMS based services, as stated above, are expected to be just the small steps before a giant leap is taken towards this direction.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

“Pharmaceutical Marketing Malpractices are Barriers to Healthcare Access” – The Relevance of Government Code of Ethical Marketing Practices in India

Posted on July 23, 2012 by Tapan Ray

Last week (July 19, 2012), most of the leading English business dailies of India reported that much-awaited “Uniform Code of Pharmaceutical Marketing Practices (UCPMP)” authored by the Department of Pharmaceuticals, quite in line with the amended guidelines for the Medical Profession by the Medical Council of India (MCI), is expected to be notified by the government next month for implementation by the entire pharmaceutical industry on a voluntary basis, to start with.

This is only because the draft UCPMP has already specified the following:

“This is a voluntary code of Marketing Practices for Indian Pharmaceutical Industry, for the present and its implementation will be reviewed after a period of six months from the date of its coming into force and if it is found that it has not been implemented effectively by the Pharma Associations/Companies, the Government would consider making it a statutory code.”

This decision of the government is the culmination of a series of events, covered widely by the various sections of the media, at least, since 2004.

The series of events:

Way back, in its January – March, 2004 issue, ‘Indian Journal of Medical Ethics (IJME)’ in the context of marketing practices for ethical pharmaceutical products in India commented: “If the one who decides, does not pay and the one who pays, does not decide and if the one who decides is ‘paid’, will truth stand any chance?” Three years later in 2007, the situation remained unchanged when IJME (April – June 2007 edition) once again reported: “Misleading information, incentives, unethical trade practices were identified as methods to increase the prescription and sales of drugs. Medical Representatives provide incomplete medical information to influence prescribing practices; they also offer incentives including conference sponsorship. Doctors may also demand incentives, as when doctors’ associations threaten to boycott companies that do not comply with their demands for sponsorship.”

‘The Times of India’ also reported the following in its December 15, 2008 edition:

“1. More drugs a doctor prescribes of a specific company, greater are the chances of his/ her winning a car, a high-end fridge or a TV set. 2. Drug companies dole out free trips with family to exotic destinations like Turkey or Kenya. 3. In the West, unethical marketing practices attract stiff penalties. 4. In India, there are only vague assurances of self-regulation by the drug industry and reliance on doctors’ ethics”.

Thus, it has been quite a while from now, serious concerns are being expressed by the media, government and the civil society at large about the means adopted by the pharmaceutical industry in general to get their respective brands prescribed by the doctors.

The discontentment still growing:

Many within the civil society feel, as a result of fast degradation of ethical standards, moral and the noble values, just in many other areas of public life, in the healthcare space as well, the patients in general have started losing their absolute faith and trust both on the medical profession and the pharmaceutical companies, by and large. However, health related multifaceted compulsions do not allow them, either to avoid such a situation or even raise a strong voice of protest against the vested interests.

Growing discontentment of the patients both in the private and public healthcare space in the country, is being regularly and very rightly highlighted by the media all over the world, including reputed medical journals like, ‘The Lancet’ to help arrest this moral and ethical decay with demonstrable and tangible proactive measures.

The issue:

The entire issue arises out of the key factor that the patients do not have any say on the use/purchase of a medicine brand/brands that a doctor will prescribe.

It is generally believed by the civil society that doctors predominantly prescribe mostly those brands, which are promoted to them by the pharmaceutical companies in various ways. Thus, in today’s world and particularly in India, the degree of commercialization of the noble healthcare services, as reported quite often by the media, has reached a new high, sacrificing the ethics and etiquette both in medical and pharmaceutical marketing practices at the altar of unlimited greed, want and conspicuous consumption.

A credible international report: Let me now combine this scenario with a relatively recent report on India dated January 11, 2011, published in ‘The Lancet’, which states in a similar (though not the same) context, as follows:

1. “Reported problems (which patients face while getting treated at a private doctor’s clinic) include unnecessary tests and procedures, rewards for referrals, lack of quality standards and irrational use of injection and drugs. Since no national regulations exist for provider standards and treatment protocols for healthcare, over diagnosis, over treatment and maltreatment are common.” 2. “Most people accessed private providers for outpatient care – 78% in rural areas and 81% in urban areas.” 3. “India’s private expenditure of nearly 80% of total expenditure on health was much higher than that in China, Sri Lanka and Thailand.” Considering the above three critical issues of India, as reported in ‘The Lancet’, the need to follow a transparent code of pharmaceutical marketing practices by the entire pharmaceutical industry is of utmost importance.

A global phenomenon:

Since quite some time, this issue has indeed become a global phenomenon. Many countries, including India, are taking note of such examples of socioeconomic decay, that too in the healthcare sector.

Just the other day, the July 4, 2012 edition of ‘The Guardian’, while reporting that GlaxoSmithKline has agreed to pay $3bn (£1.9bn) to settle a series of old criminal and civil investigations by the US authorities into the sales and marketing of some of its best-known products, commented, “GlaxoSmithKline’s bribes are evidence that Big Pharma isn’t working – the inadequacies of relying solely on market forces for our drugs are clearer than ever. This scandal should prompt a rethink.”

The Guardian further commented:

“After all, this has happened before. All the giants – AstraZeneca, Bristol-Myers Squibb, Merck, Eli Lilly, Pfizer – have been investigated for bribery. One of the most notorious episodes of misconduct involved Merck’s anti-inflammatory drug Vioxx, withdrawn in 2004 after the company persistently played down its risk of causing cardiovascular problems.”

The New York Times (NYT) in its April 12, 2010 edition in an article titled, “Data on Fees to Doctors is Called Hard to Parse”, reported that though some big pharmaceutical companies have started disclosing payments to doctors who act as consultants or speakers, many still find it far too difficult to follow the money trail.

NYT reported in the same article, “Senate researchers have found that some prominent doctors at academic medical centers have failed to disclose millions of dollars in drug company payments, despite university requirements that they do so. Federal prosecutors say some payments are really kickbacks for illegal or excessive prescribing”.

General scenario was not much different even in the US until recently:

‘The New England Journal of Medicine’, April 26, 2007 reported that virtually, all doctors in the US take freebies from drug companies, and a third take money for lecturing, and signing patients up for trials. The study conducted on 3167 physicians in six specialties (anesthesiology, cardiology, family practice, general surgery, internal medicine and pediatrics) reported that 94% of the physicians had ‘some type of relationship with the pharmaceutical industry’, and 83% of these relationships involved receiving food at the workplace and 78% receiving free drug samples. 35% of the physicians received re-reimbursement for cost associated with professional meetings or Continuing Medical Education (CME). And the more influential a doctor was, the greater the likelihood that he or she would be benefiting from a drug company’s largess. As a result of some strict regulatory measures, the situation in the US has presumably started changing now.

However, such issues are not related only to physicians. ‘Scrip’ dated February 6, 2009 published an article titled: “marketing malpractices: an unnecessary burden to bear”. The article commented:

“Marketing practices that seem to be a throwback to a different age continues to haunt the industry. Over the past few months, some truly large sums have been used to resolve allegations in the US of marketing and promotional malpractices by various companies. These were usually involving the promotion of off-label uses for medicines. One can only hope that lessons have been learnt and the industry moves on.”

“As the sums involved in settling these cases of marketing malpractices have become progressively larger, and if companies do not become careful even now, such incidents will not only affect their reputation but financial performance too.”

‘The Physician Payment Sunshine Act’:

As the financial relationship between the pharmaceutical companies and the physicians are getting increasingly dragged into the public debate, disclosure of all such payments made to the physicians by the pharmaceutical companies has been made mandatory by the Obama administration, as a part of the new US healthcare reform process.

As a result, ‘The Physician Payment Sunshine Act’, originally proposed in 2009 by Iowa Republican Charles Grassley and Wisconsin Democrat Herb Kohl, became a part of the US healthcare law in 2010. This Act came as an integral part of the healthcare reform initiatives of President Obama to reduce healthcare costs and introduce greater transparency in the system.

The Act requires all pharmaceutical and medical device companies of the country to report all payments to doctors above US $10. As stated earlier, the industry’s gifts to physicians in the US, reportedly, can range from expensive hospitality/dinner in exotic locations, pricey golfing vacations in various places of interest to consulting and speaking fees. As the Act came into force with all its rules in place, failure to provide such details will attract commensurate penal provisions.

Australia sets another example: The Australian Competition and Consumer Commission (ACCC) has decided to grant authorization for five years to Medicines Australia’s 16th edition of its Code of Conduct. The Code sets standards for the marketing and promotion of prescription pharmaceutical products in Australia. The Code provides, among other measures, a standard to address potential conflicts of interest from unrestricted relationships between pharmaceutical companies and the doctors, which may harm the consumers through inappropriate prescriptions. The Code also prohibits the pharmaceutical companies from providing entertainment and extravagant hospitality to doctors with the requirement that all benefits provided by companies should be able to successfully withstand public and professional scrutiny. “The requirement for public disclosure was imposed by the ACCC as a condition of authorization of the previous version of Medicines Australia’s Code and was confirmed on appeal by the Australian Competition Tribunal.” Edition 16 of the Code fully incorporates the public reporting requirements.

“Market malpractices are barriers to healthcare access”: The WHO report of 2006:

A 2006 report of the ‘World Health Organization (WHO) and ‘The Ministry of Health and Family Welfare, Government of India’ titled ‘Options for Using Competition Law/Policy Tools in Dealing with Anti-Competitive Practices in Pharmaceutical Industry and Health Delivery System, states:

“The right to health is recognized in a number of international legal instruments. In India too, there are constitutional commitments to provide access to healthcare. However despite the existence of any number of paper pledges assuring the right to health, access to health remains a problem across the world”.

“There are several factors that are responsible for such deprivation. Market malpractices in general, and in particular, anti-competitive conduct in the pharmaceutical industry and the health delivery system are also among them.”

India Today:

The current scenario in India though not very much different, in terms of seriousness of the issue, from what is being reported in the US, the evolving regulatory standards in the US in this matter are definitely more robust and far superior to what we see in our country.

In India, over 20, 000 pharmaceutical companies of varying size and scale are currently operating. It has been widely reported in the media that the lack of regulatory scrutiny is prompting many of these companies to adapt to ‘free-for-all’ types of aggressive sales promotion and cut-throat marketing warfare involving significant ‘wasteful’ expenditures. Such practices reportedly involve almost all types of their customer groups, excepting perhaps the ultimate consumer – the patients.

It has been well reported that industry’s gifts to physicians in India can range from expensive cars, dinners in exotic locations, pricey vacations at various places of interest of the world and sometimes with the doctors’ families, to hefty consulting and speaking fees.

Unfortunately in India there is no single government agency, which is accountable to take care of the entire healthcare needs of the patients and their well-being, in a holistic way.

The pharmaceutical industry in India, in general, has already expressed its desire for self-regulation of marketing practices, instead of any regulatory compulsion by the Government.

However, many activists groups and NGOs still feel that the bottom-line in this scenario is the demonstrable transparency by the pharmaceutical companies in their dealings with various customer groups, especially the physicians/doctors.

Ministry of Health blinked first by amending the MCI Guidelines:

Being concerned with the media outcry, MCI, in 2009, amended their guidelines of ‘Professional Conduct, Etiquette and Ethics’ for the doctors, clearly articulating what they can and cannot do during their interaction and transaction with the pharmaceutical and related industries.

MCI, through amendment of the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation 2002” introduced a new code of conduct for doctors and their professional associations in their relationship with the pharmaceutical and allied industry in India. The amended regulations are known as the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009 – Part-I”, which prohibit the doctors from accepting, among many others, any travel facility or hospitality, including gifts of any value, from any pharmaceutical companies.

The Ministry of Health believes that these guidelines, if strictly enforced, would severely limit what the doctors can receive from the pharmaceutical companies in terms of free gifts of wide ranging financial value, entertainments, free visits to exotic locations under various commercial reasons, lavish lunch and dinner etc. in exchange of prescribing specific pharmaceutical brands of the concerned companies.

‘Draft Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ from the DoP:

In May 2011, the Department of Pharmaceuticals (DoP) released a draft ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ for the Pharmaceutical Industry of India for comments by the stakeholders.

Some Key features of the DoP Code are as follows:

All promotional material must be consistent with the requirements of this Code.
Brand names of products of other companies must not be used for comparison without prior consent of the concerned companies.
Paid or arranged publication of promotional material in journals must not resemble editorial matter.
The names or photographs of healthcare professionals must not be used in promotional material.
Audio-visual material must be accompanied by all appropriate printed material to ensure compliance of the Code.
Samples should be provided directly to prescribing authority and be limited to prescribed dosages for three patients and in response to a signed and dated request from the recipient. Each sample pack shall not be larger than the smallest pack presented in the market.
Medical and Educational events for doctors should be organized in the appropriate venue in India and all expenses must be incurred only for the events held in India.
Outline of a detailed Complaint Lodging and Redressal mechanism (Committee for Code of Pharma Marketing) to ensure compliance of the marketing code.

The quality of UCPMP:

The UCPMP draft document is well written, balanced and by and large fair. The DoP should indeed be commended on the great work that they have done in putting all details of pharmaceutical marketing practices together in this document in a very comprehensive manner.

Draft UCPMP does not seem to pose any major extra restrictions to the pharmaceutical companies as compared to the MCI guidelines. All concerned should welcome this decision of the DoP, as the same ethical standards will now be applicable to all small, mid-sized and large pharma players, equally. The main focus of the DoP should be in ensuring that all companies across the pharmaceutical industry follow these well-defined standards in their marketing practices and interactions with the doctors.

The draft UCPMP also states that companies must maintain a detailed record of expenditures incurred on these events. It is not quite clear though, as to what extent the pharmaceutical companies are expected to keep these detail records and how long? It is also not clear whether such records have to be maintained on file by the individual companies and supplied to the DoP only on specific requests for the same or all these details are expected to be disclosed on a regular basis to the regulator.

The draft UCPMP indicates that industry associations must upload full details of received complaints on their respective websites. Although this provision could help making the system transparent, the DoP should clearly articulate the details about the specific information that will require to be disclosed in cases of any proven breach of the marketing code.

It is interesting to note that the draft UCPMP states that media reports and published letters alleging that a company has breached the UCPMP will be treated as complaints.

Skepticism with the UCPMP:

Some are quite skeptical about the effectiveness of UCPMP in containing unethical marketing practices within the Indian Pharmaceutical Industry.

This section of people believes, with thousands of pharmaceutical companies operating in India, just self-control with UCPMP without any properly enforceable stringent Government regulation, will simply not work.

Conclusion:

In all countries and India is no exception, pharmaceutical companies, by and large, have been articulating that they try to follow the legal ways and means to maximize turnover of their respective brands. Many of them do follow transparent and admirable stringent self-regulations, stipulated either by themselves or by their industry associations.

‘Self-regulation with pharmaceutical marketing practices’ and ‘voluntary disclosure of payment to the physicians’ by some leading global pharmaceutical companies are laudable steps to address this vexing issue. However, the moot question still remains, are all these good enough for the entire industry in India?

It appears, immediately after the Department Related Parliamentary Standing Committee on Health and Family Welfare presented its 58th Report on the action taken by the DoP on the recommendations / observations contained in the 45th report to both the Lower and the Upper houses of the Parliament on May 08, 2012, the DoP has reportedly taken an extra step forward towards this direction last week. The amended MCI regulations for the doctors coupled with the notified UCPMP for the entire pharmaceutical industry should make the financial transactional relationship between the physicians and the pharmaceutical industry in India clean and transparent.

It was also reported last week that Government will soon decide whether there will be an independent industry appointed ‘Ombudsman’ for the enforcement of UCPMP across the country or the implementation of the code will strictly be monitored under the Government control.

It is worth reiterating that the draft UCPMP very categorically warns, in case the self-control with UCPMP by the industry appointed independent ‘Ombudsman’ does not work effectively, the Government would seriously consider making it statutory for the entire pharmaceutical industry of India. This is indeed quite a strong signal from the government to the industry for ‘Shaping Up’… sooner the better.

The popular dictum, especially used by the healthcare industry, “patients’ interest come first”, should not be allowed to be misused or abused, any further, by some unscrupulous elements and greedy profiteers, to squeeze out even the last drop of financial resource from the long exploited population of ailing patients of India, as “Pharmaceutical Marketing Malpractices are Proven Barriers to Healthcare Access”.

By: Tapan J Ray

‘Free Essential Medicines for All’ – A Laudable Public Healthcare Initiative of India, Tough Challenges Notwithstanding

Posted on July 16, 2012 by Tapan Ray

Recently the Government of India has taken a landmark ‘Public Healthcare’ related initiative to provide unbranded generic formulations of all essential drugs, featuring in the ‘National List of Essential Medicines 2011’, free of cost to all patients from the public hospitals and dispensaries, across the country.

This social sector project is expected to roll out, as reported in the media, from October/November this year with a cost of around US$ 5 billion during the 12^th Five Year Plan period of the country.

Considering medicines account for around 70% of the total ‘Out of Pocket’ expenses, this particular initiative is expected to benefit, especially the poorer patients, significantly.

Recommendations of the Parliamentary Standing Committee:

Noting the keen interest of the Government for speedier implementation of this scheme, it appears that the Ministry of Health has accepted the recommendations made by the ‘Parliamentary Standing Committee (PSC) for Health and Family Welfare’ to the Indian Parliament on August 4, 2010, regarding prescription of medicines by their generic names in the Public hospitals and dispensaries, to start with.

In this context, it is worth noting that the ‘Drugs Technical Advisory Board (DTAB)’ has also reportedly considered the proposal to amend the rules of the ‘Drugs and Cosmetics Act of India’ for regulatory approval of all drug formulations containing single active ingredient in the generic names by all State Licensing Authorities.

This recommendation of the PSC is based on the premises that the ‘Brand Building’ exercise of the generic drugs includes a very high sales and marketing expenditure.

The Committee felt that by putting in place a well structured policy such ‘avoidable’ expenditures can easily be eliminated making generic medicines available to the common man at much cheaper prices. ‘Jan Aushadhi’ scheme of the Government is often cited as an example to drive home this point.

The scheme is new for India, but other countries have already taken similar steps:

Just to cite an example, as reported by ‘The Guardian” on August 23, 2011, the Spanish government recently enacted a law compelling the doctors in Spain to prescribe generic drugs instead of more expensive patented and branded pharmaceuticals, wherever available. This move is expected to help the Spanish government to save €2.4 billion (£2.1billion) a year, as in Spain the drug costs are partly reimbursed by the government.

As a result, the doctors in Spain require prescribing only in the generic or chemical names of such drugs. Consequently the pharmacies will be obliged to dispense ‘the cheapest available versions of drugs, which will frequently mean not the better-known brand names sold by the big drugs firms’.

Product quality of generic/ generics and branded generics:

Drugs and Cosmetics Act of India requires all generic/generic and branded generic drugs to have the same quality and performance standards. Thus when a generic/generic medicine is approved by the drug regulator, one should logically expect that it has met with the required standards set for the identity, strength, quality, purity and potency of the chemical substance.

It is not uncommon that there could be some variability taking place during their manufacturing process and all formulations of both the categories produced by different manufacturers may not also contain exactly the same inactive ingredients.

In any case, both generic/generic and branded generic drugs must be shown to be bio-equivalent to the reference drugs with similar blood levels to the respective reference products. Regulators even in the USA believe that if blood levels are the same, the therapeutic effect will also be the same.

A recent study:

As reported by the US FDA, “A recent study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand-name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. [Kesselheim et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21)2514-2526]”.

Generic drugs are prescribed more, even in America:

As per published reports, generic medicines account for around 78% of the total prescriptions dispensed by retail chemists and long-term care facilities in the US. For example, in 2010 generic prescriptions were four percentage points more than what these were in 2009 and came up from 63% as recorded in 2006.

Capacity constraints could hold back full implementation of the Indian initiative:

Huge shortages in the number doctors, nurses, paramedics and hospital beds per 10,000 population in India will pose a tough challenge for speedier implementation of ‘Free medicines for all’ project in the country. India should respond to its healthcare infrastructure developmental needs much faster now than ever before to achieve its objective of providing ‘healthcare to all’, sooner.

Overall impact of the scheme:

I reckon, this new scheme will hasten the overall growth of the pharmaceutical industry, as poor patients who could not afford will now have access to essential medicines. On the other hand, rapidly growing middle class population will continue to favor branded generic drugs prescribed by the doctors at the private hospitals and clinics.

Some people are apprehending that generic drug makers will have brighter days as the project starts rolling on. This apprehension is based on the assumption that large branded generic players will be unable to take part in this big ticket drug procurement process of the Government.

However, in my view, it could well be a win-win situation for all types of players in the industry, where both the generic/generic and branded generic businesses will continue to grow simultaneously, because of the reasons as mentioned above.

That said procedural delays and drug quality issues while procuring cheaper generics may pose to be a great challenge for the Government to ensure speedier implementation of this project. Drug regulatory and law enforcing authorities will require to be extremely vigilant to ensure that while sourcing cheaper generic drugs, “Public health and safety” due to quality issues do not get compromised in any way.

How long will it take?

Full implementation of ‘Universal healthcare’ projects takes considerable time in any country. China has taken a long time for its roll-out covering even a larger population than India. Even Mexico has reportedly taken more than seven years for implementation of similar public healthcare initiative.

Thus, I guess, though it is quite possible for India to offer ‘Free Essential Medicines’ to its 1.13 billion people, it may take a decade long efforts for the country to reach out to the entire population.

Are generic/generic drugs really cheaper than their branded generic equivalents?

The recommendation of the ‘Parliamentary Standing Committee for Health and Family Welfare’ on this issue, as stated above, makes sense for India. However, the moot question, which is the basis of choosing generic/generic drugs over their branded generic equivalents, still remains as follows:

“Are the generic/generic drugs really cheaper than their branded generic equivalents in India?”

From the MRPs, as printed on the packs of both branded generic and the generic/generic formulations, it appears that this basic assumption may not hold good universally across the country.

Following examples will vindicate this point:

Molecule		Product	Company	Batch No.	Price Per Tab.
Telmisartan 40 mg	Branded Generic	Telmiline 40 mg	John SmithKline	M111622	14/-
Telmisartan 40 mg	Generic/Generic	Generic	Unichem	BTL(11/11001)	30/-

Molecule		Brand/ Generic	Company	Batch No.	Price Per Tab.
Rosuvastatin 10 mg	Branded Generic	Rosufine	Morpen	P20472	13.20
Rosuvastatin 10 mg	Generic/Generic	Generic	Sharon Bio-Medicines	AC-2159	16/-

Molecule		Brand/ Generic	Company	Batch No.	Price Per Tab.
Cetirizine HCL 10 mg	Branded Generic	Cetfast	Elder	CO81810	2.50
Cetirizine HCL 10 mg	Generic/Generic	Generic	Ra Biotech	CT 016B	3/-

Molecule		Brand/ Generic	Company	Batch No.	Price Per Tab.
Nimesulide 100 mg	Branded Generic	NICIP	Cipla	-	2.53
Nimesulide 100 mg	Generic/Generic	Generic	Themis	-	3/-

Molecule		Brand/ Generic	Company	Batch No.	Price Per Tab.
Amlodipine 5 mg	Branded Generic	Aginal 5	Alkem	-	2.48
Amlodipine 5 mg	Generic/Generic	Generic	Sandoz	-	2.70

Molecule		Brand/ Generic	Company	Batch No.	Price Per Tab.
Ampicillin 500	Branded Generic	Ampisyn	Cipla	-	6.40
Ampicillin 500	Generic/Generic	Generic	SGS	-	7.50

As on July 6, 2012

Let me hasten to add, it is quite possible to present another set of examples, which may show that the MRPs of generic/generic drugs are lesser than the comparable branded generics.

However, the bottom-line is, it will not be fair to comment that MRPs of generic/generic drugs, which do not include any expenditure towards ‘brand-building’, are always significantly lesser than their branded generic counterparts as shown above.

Why are MRPs of generic/generics and branded generics not much different?

It is a general perception, as stated above, that ‘Brand Building’ exercise for generic drugs in India includes a very high component of ‘sales and marketing expenditures’ which are built into the price, making MRPs of the branded generic formulations significantly higher than their generic/generic equivalents.

However, it will not be realistic to accept that generic/generic drugs are not promoted at all, in any form, by the concerned manufacturers. The fact is, in case of generic/generic medicines almost the same amount that is spent on ‘sales and marketing’ for branded generic drugs, is passed on to the retail chemists by their manufacturers as huge incentives for promotion and substitution of such drugs by the respective pharmacies.

Thus, in a large number of cases the patients do not get any significant pricing benefit for buying generic/generic drugs against doctors’ prescriptions instead of branded generics from the retail outlets.

Conclusion:

In the prevailing scenario, the decision of the Government to procure and distribute only the generic/generic essential medicines through public hospitals/dispensaries simply on pricing ground, keeping the branded generics at bay, is indeed intriguing.

From the data presented above, it will be quite reasonable to believe that MRPs being similar, the ‘sales and marketing’ costs for branded generics are quite comparable to hefty discounts being passed on to the wholesalers and retail chemists by the manufacturers of generic/generic drugs.

Hence, in the balance of probability, a branded generic product can well compete with its genuine generic/generic equivalent, even on pricing ground, in the government procurement process.

Thus, to be fair to the pharmaceutical companies, across the board, the government should invite all generic manufacturers selling their products with or without brand names to participate in the public procurement process and thereafter make the final purchase decisions based on well laid out and transparent criteria, which can stand scrutiny of the strictest audit.

That said, I fully recognize that the participation in the public procurement process of essential medicines, will indeed be the business decision of individual companies. If it makes commercial sense, there is no reason why large companies, including the multinationals, will not participate in this laudable project of the Government.

The record of the Government in the implementation of various social sector projects, thus far, may not be brilliant by any measure. Despite that, it does make enough sense for all of us to be rather optimistic about this well hyped ‘Free Essential Medicines for all’ project of India, considering the immense benefits that the common man will derive out of it.

For the effective implementation of the project, the government should now get adequately prepared with required wherewithal, put in place world class skill-sets by partnering with private domain experts wherever required and chart the pathway of success with clearly assigned accountability to each individual responsible for translating this grand ‘Public Healthcare’ initiative of India into reality .

By: Tapan J Ray

Healthcare Malpractice in India: Even Medical Association distastes the ‘Bitter Pill’

Posted on June 11, 2012 by Tapan Ray

At a peak of repeated overdose of media sensationalism covering various facets of happenings around us, at times almost mimicking ‘self-flagellation’ though, the program ‘Satyamev Jayate (Truth Alone Triumphs) ’ of Bollywood icon Aamir Khan has the potential to be a ‘game changer’ in terms of transformation of mindset of ‘We the People of India’ towards ‘What we can do for the country’ and JUST NOT ‘What the country can do for us’.

My perspective:

As I see it, the show endeavors to instill a sense of introspection in the viewers’ mind providing relevant information and knowledge, especially when for misdeeds of all shades, hues and colors around our lives, we tend to instinctively blame others, positioning ourselves on the illusive high pedestal of probity and considering ourselves ‘Lilly-white’ …and just the victims of circumstances.

What made me aware of it?

Personally, I became aware of the show, when one of my good friends strongly recommended watching its ‘Episode 4′ titled, “Every Life Is Precious: Does Healthcare Need Healing?’ He in fact mailed me even the video link of the same. Thereafter, I collected similar video links for previous other episodes from the internet and was highly impressed with the sense of purpose of the program.

What did it want to achieve?

As far as I am concerned, I am quite convinced that this particular episode highlights that:

“People trust medical practitioners, believing that they are equipped with the knowledge and skills to safeguard their health. But when this knowledge is misused to exploit this trust, medical care becomes a nightmare. The profession is riddled with unscrupulous doctors and hospitals out to make big bucks at the cost of patients, but there are still medical practitioners who stand up for the Hippocratic Oath, and those who want to clean up the profession.”

Dishonest acts in healthcare need to be opposed with courage:

In the program, Aamir Khan started by saying that that the episode was not about mistakes and negligence that a doctor may commit but about dishonest acts of some doctors, which were committed undoubtedly with equally dishonest intentions, amounting to fraud and a breach of trust between doctors and the patients.

The ‘Episode 4′ not only highlighted the deficiencies in the existing system related to medical ethics, but also issues pertaining to pricing of drugs, medical education and the functioning of the Medical Council of India (MCI).

Strong protests do not prove innocence:

Unfortunately, instead of appreciating the social transformation efforts of the program, many doctors reportedly protested against this particular episode.

I shall not be surprised, if some more protests from other quarters reach Aamir Khan in a different guise, even in the guise of seemingly support, especially from those who are perpetually in a denial mode stating: ‘what all were shown in the program are misguiding/misleading’, ‘you don’t know the facts/reality’, ‘what was shown is just half truth’, ‘our way is the right way’ and ‘we were not given a chance to express our views’.

However, as we all know that strong and venomous protests, even protests well concealed in the guise of support, do not prove innocence of the perpetrators, at all, though we all have a right to protest in our country.

In a protest credibility also matters:

A leading magazine of the country, ‘India Today’ in its August 25, 2011 edition titled ‘Address sick state of the health system’, reported in a different context:

“Among the multitude of people who flocked to the Ramlila grounds this week in support of the anti-corruption crusader Anna Hazare were some surprises. A delegation of the Indian Medical Association (IMA) met Hazare and extended support to his fight against corruption”.

“Subsequently branches of the association all over the country were told to organize candle light vigil and sit-ins against corruption. IMA is the largest professional body of Indian doctors and their support to the anti-graft movement should be taken seriously. After all, doctors are considered strong opinion makers in the society”.

“However, a careful look at the association’s past and its stand on the issue of corruption in medical community makes one wonder if IMA’s views on corruption have any value at all”, the report added.

Reports of protest on “Every Life Is Precious: Does Healthcare Need Healing?’ :

The daily newspaper ‘DNA’ in its June 2, 2012 issue reported, “Indian Medical Association asks Aamir Khan to apologize.”

The report elaborated that the Indian Medical Association demanded an immediate apology from Aamir Khan for having ‘defamed’ the medical profession in his TV show and warned him of legal action if he fails to comply with their demand.

Voices of sanity:

Being in unison with many other voices of sanity, against the demand of apology by the medical association, the lyricist and social activist Javed Akhtar reportedly had commented, “The Indian Medical association wants Aamir to apologize for exposing corruption in their profession. That is really sick.”

The Crusader remains unfazed against threats:

However, as reported by NDTV, Aamir Khan has refused to apologize and said, “I will not apologize to the doctors, I have not insulted the medical profession. Those doctors who indulge in unethical practices have defamed the profession, not me.”

Some other examples of ‘Medical Negligence’:

As reported by ‘Livemint (WSJ)’ in its May 15, 2012 edition, “Dozens of hospitals all over the country are ransacked each year by irate relatives and other ‘socially conscious’ citizens in an attempt to get back at alleged cases of medical malpractice. In many cases patients are crippled for life or even killed, and many of these cases may indeed involve instances of incompetence or malpractice. This does not in any way condone the violence, but then the victims have little recourse to justice or investigation”.

Highlighting similar medical negligence, ‘Times of India’ ‘ on October 22, 2011 reported that ‘The National Consumer Disputes Redressal Commission (NCDRC)’ on October 21, 2012 ordered a compensation amount of Rs 1.73 Crore to be paid to the US-based husband of a child psychologist who died in Mumbai due to medical negligence.

Very few doctors punished for Medical Malpractice:

Effective January 1, 2011, just 17 doctors from all over India were found guilty on account of Medical Negligence/Misconduct and received varying degree of punishment from the MCI.

It is worth noting, unlike other countries and despite all these maladies being faced by a common man reportedly on a daily basis, not a single erring doctor’s name has been removed permanently from the Indian Medical Register/State Medical Register by the MCI or any State Medical Council, since 2008?

Some very recently reported actions by MMC and MCI:

Meanwhile the news daily ‘DNA’ in its June 6, 2012 edition reported that for different errant behavior, so far, the Maharashtra Medical Council (MMC) has sent show-cause notices to 31 doctors in the state and suspended registrations of five doctors.

Not so long ago to maintain desirable ethical standards within the Medical Profession, the notification of the Medical Council of India (MCI) dated December 10, 2009 amending the “Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations 2002″ was also welcomed by concerned right thinking individuals including a large section of the medical profession.

Conclusion:

Medical malpractice, of course, is not just an Indian issue. ‘The Wall Street Journal’ in an article titled, ‘How Other Countries Judge Malpractice’, published on June 30, 2009 reported that in his speech to the ‘American Medical Association’, President Barack Obama held out the tantalizing possibility of reforming medical malpractice law as part of a comprehensive overhaul of the U.S. health-care system.

With TV shows like ‘Satyamev Jayate (Truth Alone Triumphs)’, let us collectively move towards the day, transforming ourselves as the change agents, when all of us rich, middle-class or poor will live in a country where things will be quite different from what we are experiencing today.

Many erudite medical practitioners of our country who still stand up for the ‘Hippocratic Oath’, will expectedly take initiative to clean up their profession, being harsh on the ‘Black Sheep’, probably through stringent self-regulations, even if the MCI continues to keep its eyes closed.

Let us all conscientiously try to pave the way for that day, when despite socioeconomic disparity people from all strata of our society will be able to get quality healthcare, driven by competent regulators, socially conscious industry and above all the dedicated medical profession, who under ‘Hippocrates Oath’ will consider each life equally precious, taking their noble profession almost back to the earlier high pedestal of a ‘Human God’!.

Against the mighty power of rejuvenated human will, all concerned in the healthcare space, willy-nilly, hopefully will have to swallow the ‘Bitter Pill’, not just in India, but across the world, for the sake of humanity.

Let ‘Truth Alone Triumph’….‘Satyamev Jayate’.

By: Tapan J Ray

Increasing Healthcare Consumption in India with equity

Posted on May 14, 2012 by Tapan Ray

Along with the economic progress of India, healthcare consumption of the population of the country is also increasing at a reasonably faster pace. According to McKinsey India Report, 2007, the share of average household healthcare consumption has increased from 4 per cent in 1995 to 7 per cent in 2005 and is expected to increase to 13 per cent in 2025 with a CAGR of 9 per cent, as follows:

Share of Average Household Consumption (AHC) (%)


	Household Consumption	1995	2005 E	2015 F	2025 F	CAGR %
1.	Healthcare	4	7	9	13	9
2.	Education & Recreation	3	5	6	9	9
3.	Communication	1	2	3	6	12
4.	Transportation	11	17	19	20	7
5.	Personal Products and Services	4	8	9	11	8
6.	Household Products	2	3	3	3	5
7.	Housing & Utilities	14	12	12	10	5
8.	Apparel	5	6	5	5	5
9.	Food, Beverages & Tobacco	56	42	34	25	3

(Source; McKinsey India Report 2007)

From this study, it appears that among all common household consumption, the CAGR of ‘healthcare’ at 9 percent will be the second highest along with ‘education’ and ‘communication’ topping the growth chart at 12 percent.

As per this McKinsey study, in 2025, in terms of AHC for ‘healthcare’ (13 percent) is expected to rank third after ‘Food & Beverages’ (25 percent) and ‘transportation’ (20 percent).

Thus, over a period of time AHC for ‘healthcare’ shows a very significant growth potential in India. Hence, this important area needs much greater attention of the policymakers to help translate the potential into actual performance with requisite policy and fiscal support/incentives.

Sectoral break-up of the Healthcare Industry:

According to IDFC Securities 2010, the sectoral break-up of the US$ 40 billion healthcare industry is as follows:

Industry	%
Hospitals	50
Pharma	25
Diagnostics	10
Insurance & Medical Equipment	15

(Source: IDFC Securities Hospital Sector, November 2010)

Therefore, as per this above report, the top two sectors of the healthcare industry are hospitals with 50 percent share and pharmaceuticals at 25 percent.

Public sector drives the healthcare expenditure in the developed countries:

Almost all OECD countries now provide universal or near-universal health coverage for a core set of health services, which are primarily funded by the public sector.

The report titled, ‘Health at a Glance 2011’ indicates that adjusted for purchasing power parity United States of America (USA) at US$ 7290 per capita expenditure on health in 2007, which is almost two and a half times more than the OECD average of US$ 2984, towers above other OECD countries. However, the same for Turkey and Mexico was less than one-third of the OECD average.

India and South East Asia are different:

Unlike OECD countries, according to the World Health Organization (WHO), in South East Asia, except Thailand and Indonesia, healthcare is primarily driven by private expenditure, as seen in the following table:

Public and Private Expenditure on Health as % of Total

Country	Public %	Private %
Laos	17.60	82.40
Cambodia	23.80	76.20
India	32.40	67.60
Philippines	34.70	65.30
Vietnam	38.50	61.50
Malaysia	44.10	55.90
Indonesia	54.40	45.60
Thailand	74.30	25.70

Source: World Health Statistics 2011, World Health Organization (WHO)

In India, the critical healthcare industry is heavily dependent on private sector investments, where the total public expenditure on health is just around one third of the country’s total expenditure for the same, though in the 12th Five Year Plan period the the government is likely to increase its health expenditure as a percentage to GDP to 2.5 percent.

Healthcare – a more sensitive sector in India:

According to an article titled, ‘Financing health care for all: challenges and opportunities’, published in ‘The Lancet’ dated February 19, 2011 ‘Out of Pocket’ expenditure on health in India (78 per cent) is one of the highest as compared to its neighboring, except Pakistan (82.5 percent). The details are as follows:

	Country	‘Out of Pocket’ expenses (%)
1.	Pakistan	82.5
2.	India	78
3.	China	61
4.	Sri Lanka	53
5.	Thailand	31
6.	Bhutan	29
7.	Maldives	14

Such a high out of pocket expenditure for health in India, makes ‘affordability’ of healthcare products and services so sensitive to all concerned.

Just Hospital oriented health insurance plans are not adequate enough:

The above article from ‘The Lancet ‘also indicates that 74 per cent of the total healthcare expenditure goes for only outpatient or in-clinic treatment of the patients. Only 26 per cent of healthcare expenditure goes for inpatient treatment in the hospitals.

Thus coverage of only expenditure towards hospitalization by the health insurance companies will not be able to provide significant benefits to most of the citizens of India.

Further, the article says that from 1986 to 2004, there has been three times increase in the average real expenditure per hospital admission, both in the government and private hospitals.

Threefold increase in the drug prices from 1993-94 to 2006-07 was mentioned as the key factor for cost escalation in the medical care in India.

Private healthcare sector needs more fiscal incentives and lesser cost of capital:

As indicated above, private healthcare players will increasingly play a very significant role to increase healthcare consumption with equitable span across the population of India. To encourage them to spread their wings in the semi-urban and rural areas of the country effectively, lucrative fiscal/ financial incentives along with the availability of low cost capital, are absolutely necessary.

It is worth mentioning that the growth of rural middle class population is now faster than ever before and much more than their urban counterpart.

Exploitation of the patients must stop:

Unfortunate and deplorable incidences of exploitation of patients, mainly by the private players, are critical impediments to foster growth in quality healthcare consumption within the country.

In this context, ‘The Lancet’, January 11, 2011 highlighted as follows:

“Reported problems (which patients face while getting treated at a private doctor’s clinic) include unnecessary tests and procedures, rewards for referrals, lack of quality standards and irrational use of injection and drugs. Since no national regulations exist for provider standards and treatment protocols for healthcare, over diagnosis, over treatment and maltreatment are common.” Prevailing situation like this calls for urgent national regulations for provider-standards and treatment-protocols, at least for the common diseases in India and more importantly their stricter implementation across the country.

UHC will significantly improve healthcare consumption:

In October 2010, the Planning Commission of India constituted a ‘High Level Expert Group (HLEG)’ on Universal Health Coverage (UHC) under the chairmanship of the well-known medical professional Prof. K. Srinath Reddy. The HLEG was mandated to develop a framework for providing easily accessible and affordable health care to all Indians.

UHC will guarantee access to essential free health services to all. However, because of the uniqueness of India, HLEG proposed a hybrid system that draws on the lessons learnt not only from within India, but also from other developed and developing countries of the world.

UHC is expected to ensure guaranteed access to essential health services to every Indian, including cashless in-patient and out-patient treatment for primary, secondary and tertiary care. All these services will be available to the patients absolutely free of any cost.

Under UHC all citizens of India will be free to choose between Public sector facilities and ‘contracted-in’ private providers for healthcare services.

It is envisaged that the people would be free to supplement the free of cost healthcare services offered under UHC by opting to pay ‘out of pocket’ or going for private health insurance schemes, as per their individual requirements.

Conclusion:

India has already been globally recognized as one of the fastest growing healthcare markets of the world. All components in the healthcare space of the country including hospital and allied services are registering sustainable decent growth, riding mainly on private investments and now fueled by various government projects, such as:

National Rural Health Mission (NRHM)
National Urban Health Mission
Rashtriya Swasthya Bima Yojana (RSBY)
Universal Health Coverage (UHC)
Free Medicine from the Government hospitals
Centralized procurement by both the Central and the State Governments

Supported by newer, both public and private initiatives, like:

Increase in public spending on healthcare from 1.0 per cent to 2.5 per cent of GDP in the 12th Five Year Plan period
Increasing participation of the private players in smaller towns and hinterland of the country
Wider coverage of health insurance
Micro-financing
Greater spread of telemedicine
More number of mobile diagnosis and surgical centers

All these interesting developments adequately fueled by rising income levels and improving access to healthcare though albeit slowly at present, equitable consumption of healthcare in India, I reckon, is expected to improve by manifold in the years ahead, despite shrill voices of naysayers of vested interests, orchestrated many a times from beyond the shores of India.

By: Tapan J Ray

PILMAN

A Tapan Ray Website

Tag Archives: Healthcare

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The ruckus over Clinical Trials in India compels Government tightening regulations before flooring gas pedal for regional leadership

e-Patients: Quality and Cost Empowered Patients Will Help Reducing Healthcare Costs in India Significantly

“Pharmaceutical Marketing Malpractices are Barriers to Healthcare Access” – The Relevance of Government Code of Ethical Marketing Practices in India

‘Free Essential Medicines for All’ – A Laudable Public Healthcare Initiative of India, Tough Challenges Notwithstanding

Healthcare Malpractice in India: Even Medical Association distastes the ‘Bitter Pill’

Increasing Healthcare Consumption in India with equity