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To prevent ‘counterfeit medicines’ from reaching the patients is the nation’s public health responsibility: Are we still in a denial mode to even accept the existence of this public health menace?

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In November 7, 2009, Financial Express reported with a headline,”Generic drug companies see a bitter pill in counterfeit“, because some believe that it has an in-built intellectual property right connotation.
The dictionary definition:

The word ‘counterfeit’ may be defined as follows:

1. To make a copy of, usually with the intent to defraud

2. To carry on a deception; dissemble

4. To make fraudulent copies of something valuable

5. A fraudulent imitation.

What does Indian Drugs and Cosmetics Act say?

May be for this reason the Drugs and cosmetics Act of India has specified that manufacturing or selling of the following types of drugs are punishable offence:

Section 17: Misbranded drugs

Section 17-A: Adulterated drugs

Section 17-B: Spurious drugs

No one has asked, so far, that as misbranding could involve trademark and design, why should it fall under Drugs and Cosmetics Act?

This was done in the past by the law makers because they believed that any attempt to deliberately and fraudulently pass off any drug as something, which it really is not, could create a serious public health issue, leading to even death.

Be that as it may, the pharmaceutical industry all over the world sincerely believes that counterfeit drugs involve heinous crime against humanity.

Definition of counterfeit drugs should cover the all types of medicines, which are not genuine:

Definition of counterfeit drugs should, therefore, cover the entire gamut of medicines, which are not genuine. Such medicines could be a fraudulent version of patented, generic or even traditional medicines and have nothing to do with patents or patent infringements.

At the same time it sounds very reasonable that a medicine that is authorized for marketing by the regulatory authority of one country but not by another country, should not be regarded as counterfeit on this particular ground in the other country, if it is not made available fraudulently.

The recent survey on ‘spurious’ and ‘sub-standard’ drugs by the Government of India:

To assess the magnitude of the menace of counterfeit drugs, Financial Express dated November 12, 2009 reported that much hyped “world’s largest study on counterfeit drugs” conducted by the Ministry of Health of the Government of India with the help of the Drug Controller General of India’s office, has come to the following two key conclusions:

1. Only 0.0046% of the drugs in the market were spurious

2. Quantum of sub-standard drugs in India is just 0.001%

From this report, it appears that India, at this stage, has nothing to worry about this public health hazard!!!
It is indeed quite baffling to understand, why did the government keep ‘misbranded drugs’, as specified in the Drugs and Cosmetics Act of India, outside the purview of this study.

Be that as it may, it appears that this survey has raised more questions than what it had attempted to answer. Such questions are expected to be raised not only by the pharmaceutical industry of India, its stakeholders and the civil society at large, but by the global experts, as well.

The problem of counterfeit is more prevalent in countries where regulatory enforcement is weak:

The menace of counterfeit medicines is not restricted to the developing countries like, India. It is seen in the developed countries, as well, but at a much smaller scale. Thus it is generally believed that the issue of counterfeit drugs is more common in those countries, where the regulatory enforcement mechanism is weak.

A study done by IMPACT in 2006 indicates that in countries like, the USA, EU, Japan, Australia, Canada and New Zealand, the problem is less than 1%. On the other hand, in the developing nations like parts of Asia, Latin America and Africa more than 30% of the medicines are counterfeits.

The role of ‘The World health Organization (WHO):

To effectively root out this global menace, the leadership role of the WHO is extremely important. Across the world, patients’ need protection from the growing menace of counterfeit medicines. As a premier organization to address the needs of the global public health issues and especially for the developing world, the WHO needs to play a key and much more proactive role in this matter.

Conclusion:

All stakeholders of the pharmaceutical industry must be made aware more effectively, without further delay, of the health threats posed by counterfeit medicines. Authorities and organizations like the Drug Controller General of India (DCGI) and its regulatory and enforcement agencies, healthcare professionals, patients, all pharmaceutical manufacturers, drug distributors, wholesalers and retailers should collaborate to play a very active and meaningful role in curbing the counterfeit drugs from reaching the innocent patients.

By Tapan 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

‘Swine Flu’ – why create so much of scare to disturb public life?

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Why has so much of scare been created on ‘Swine Flu’ in India? Who are responsible for creating and spreading such panic?Any attempted answers to these question perhaps will remain baffling to many of us when we read that out of the total population of India, 1159 cases of ‘Swine Flu’ have been reported with 17 cases of death, as on August 12, 2009.Deaths due to other communicable diseases, including seasonal Flu, are far more than ‘Swine Flu’:

While looking at the above simple statistics, I wonder why we all fail to create a fraction of such awareness campaign for other almost equally infectious diseases in India, like malaria, tuberculosis, measles, and diarrhoea.

It is important to note, WHO reports that the seasonal influenza causes about 250,000 deaths per year. Deaths due to some other communicable diseases are also very significant and are as follows:

1. Tuberculosis: 365,000

2. Measles, Diphtheria: 287,000

A mad rush for H1N1 screening and test:

Due to such scare and panic, only in Mumbai 3,768 persons showed up for H1N1 screening in various Government hospitals just in one day on August 11, 2009 between 9 am and 5 pm. After screening all these people, only 448 individuals were identified for H1N1 test and only 14 of them were quarantined.

Awareness and preventive guidelines are necessary – without creating a mass hysteria:

Adequate awareness and preventive guidelines are absolutely necessary for any such disease without creating panic. Has H1N1 infection been used as a competitive tool, just as politicians very often do, to achieve relative competitive prowess by some? Highlighting each death due to H1N1 infection as administrative inefficiency and by creating a public scare in that process, no meaningful public health purpose can possibly be served, excepting perhaps attracting the eyeballs.

‘Swine Flu’ – reported to be a very low fatality disease:

2009 ‘Swine Flu’ pandemic is indeed a global outbreak of a new type of virus identified in April 2009 as H1N1. This strain of Flu virus is believed to be a mutation of four types of Flu viruses, one is usually endemic in human, the second one is endemic in birds and the other two are endemic in pigs or swine. This virus like many other infectious diseases, is usually transmitted from human to human.

The incidence worldwide:

Worldwide, out of over 1,62,380 H1N1 positive cases in 168 countries, 1,154 deaths have taken place as of August 4, 2009. Against this number 250,000 deaths per year take place due to seasonal influenza, as stated above . This vindicates that the fatality rate of this disease is indeed quite low, as of now. This percentage may even be lower, if those deaths are excluded, which were due to other conditions and complications not directly related to H1N1 infection.

All countries by and large, are affected by the ‘Swine Flu’ pandemic. WHO’s America’s region, where the outbreak was first detected, reports highest number of deaths with 1,008, followed by 65 deaths by its South-East Asia region, 41 deaths in Europe and 39 in Western Pacific region.

‘Swine Flu’ – reported to be a self limiting disease:

It has been reported that ‘Swine Flu’ is mostly a self-limiting disease. Clinical studies have confirmed that drugs like ‘Tamiflu’ reduce the duration of illness by a couple of days. The symptoms of the disease are moderate. Complete recovery from the disease has also been reported to be common with no future complications.

Panic related to H1N1 is unnecessary and avoidable:

Unfortunately ‘over-awareness’ and over communication of ‘possible fatality’ of the disease have lead to an unnecessary panic in India, especially, around the disease affected regions. Due to such panic people are running around with any slight ‘flu-like’ symptoms, crowding the H1N1 test centres and hospitals where the chances of getting infection by a non-infected person from others infected with H1N1 virus will be many times more.

Strain on scarce medical resources:

This mad rush, on the other hand, is putting unnecessary strain on the scarce medical resources of those towns and cities where the incidence of H1N1 infection is relatively more . Schools, shopping malls are being closed down and many important programs are being postponed. Migration of people from infected to non-infected places is further jeopardising the situation.

Conclusion:

Both tangible and intangible losses created out of ‘Swine Flu’ scare are bound to be quite significant. Who will take the responsibility of creating this nightmare?

We have our usual ‘punching bag’, the Government of course, to keep on bashing for any such issues totally forgetting our own responsibilities, individually or collectively. There is a silver lining though. A sense of responsibility, at last, appears to be slowly dawning on to those who really matter. Those who had ignited this fire of fear are now trying to douse it by themselves and in the best way as they possibly can. Obviously after much damage has been done. I take it as ‘better late than never’. But the moot question will still haunt many. Have we learnt anything out of this artificial crisis created through a real panic of H1N1 infection? Was it necessary? Has it served any meaningful purpose to the common man in general?

By Tapan 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.

Dire need of quality ‘Cold Chain’ infrastructure for pharmaceuticals in India and its efficient management through Public Private Partnership initiatives.

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Why Cold Chain for pharmaceuticals?Drugs are complex entities and many of these are temperature sensitive in nature. This entails them requiring precise and continuous temperature conditions in transit in order to retain their potency and resultant efficacy.Many life saving drugs including biotech products and vaccines fall under such category. Any break in the cold chain process for such drugs can lead to immediate denaturing or deterioration in their quality parameters. It is imperative that a careful consideration is given by all concerned including government agencies mainly at the seaports and airports while providing storage space at their warehouses for such drugs.

Current bottlenecks and lack of proper cold chain infrastructure:

Currently in India there are bottlenecks at the Airports and Seaports that include authorities not being able to assure cold room space despite getting advance notices from the pharmaceutical companies about the possible unloading of large consignments of temperature sensitive products.

Some of the other gaps include improper training and refresher courses for the handling staff who handle such products at the ports. Storage of Pharmaceutical products along with meat and food products is against the GMP norms.

Cold Chain medicines require different and special temperature control:

Cold Chain Medicines require special temperature controlled Cold storage. There are two commonly recommended temperatures specified on labels of cold chain products:

1. Products requiring temperature between 2 to 8 degree centigrade

2. Products requiring temperature around -10 to -20 degree centigrade

Cold Chain should be an uninterrupted series of storage and distribution activities which will maintain required temperature range of 2 to 8 degree centigrade or -10 to -20 degree centigrade as per products requirements.

Proper Cold Chain Management system is essential to ensure right product quality:

Proper Cold Chain Management of pharmaceuticals will ensure that the right quality of such products is maintained not only during storage but during transportation also to meet regulatory specifications. There is a greater focus and stringent regulatory guidelines/standards are in place today in the developed markets around the world for strict adherence to right storage and transportation process for cold chain sensitive pharmaceuticals.

It should be kept in mind always that Cold Chain products are mostly sensitive biological substances that can become less effective or lose potency if not properly stored.

Some examples:

Products requiring 2 to 8 degree storage will not be effective if:

i. They are frozen or stored below 2 degree centigrade
ii. Exposed to temperatures above 8 degree centigrade
iii. Exposed to direct sunlight or fluorescent light

The loss of potency is cumulative and irreversible. If products are exposed to conditions outside the established range, the quality may be adversely affected, reducing their assigned shelf life, diminishing their effectiveness or making them ineffective. The exposed product may look just as the same – the loss of potency may not be visible.

World class SOPs for Cold Chain storage and handling facilities are essential :

Quality of storage and handling of Cold Chain Pharmaceutical products at Airports and Seaports in the course of export from or import into India requires special care and attention. Since multiple products are stored and handled at Seaports/ Airports, personnel may not be able to appreciate the special need for Cold Chain pharmaceuticals’ storage & handling. Thus, there should be Standard Operating Procedures (SOPs) for storage and handling of pharmaceuticals laid down by the Port Management authorities, so that the personnel handling pharmaceuticals strictly adhere to the pre-set norms.

Pharmaceutical products requiring cold chain facilities are rapidly growing in numbers:

Pharmaceutical Products for which efficient Cold Chain facilities are required are rapidly growing in numbers. In their movement across the supply chain from the manufacturers to the patients, the medicines are handled and stored by various stakeholders like transporters, Airports, Seaports, Distributors, Stockists, Retailers etc. Since the storage and handling of Cold Chain Pharmaceuticals Products are unique, an uninterrupted Cold Chain is to be maintained in the entire supply chain network without any discontinuity, even for a short while. This will ensure that medicinal products of high quality reach the patients, always. it is, therefore, very important for all concerned stakeholders to ensure maintenance of proper Cold Chain facilities.

Government plan of “Pharma Zones” in India:

The Drugs Controller General of India (DCGI) has planned a separate dedicated controlled environment – ‘Pharma Zone’, within the cargo premises at Airports and Seaports for proper storage of Pharmaceutical products in line with Good Manufacturing Practices and Good Distribution Practices so as to assure right quality, safety and efficacy of Pharmaceutical products, which are to be either imported or exported.

Currently no ‘Pharma Zones’ in India:

At present there are no ‘Pharma Zones’ in India. However, Mumbai International Airport Private Limited (MIAL) has created 4 new cold rooms for pharmaceuticals. It has been reported that the new Cargo Terminal of Delhi International Airports Limited (DIAL), which is expected to be commissioned later in the year, will have around 4000 square metres of additional cold room capacity compared to the current cold room capacity of 400 square metres. Similarly, MIAL is also planning for a dedicated Cold Room facility for Pharmaceutical Products in their new set–up.

Need for outsourcing Cold Chain services:

In the developed markets of the world there are private cold chain storage and third party logistics providers to offer contract logistics and storage services especially to cater to the growing demands of the Biopharmaceutical segment, which is now the fastest growing manufacturing sector within global pharmaceutical industry.

It is expected that spend of the Biopharmaceutical companies towards outsourcing of cold chain facilities will grow by over 10% to 15% for the next three to five years in the developed markets. India being the second largest producers of Biopharmaceuticals after China, similar opportunities exist in the country.

In India some renowned international courier companies like DHL and World Courier have been reported to have developed an efficient cold-chain management process, especially for the pharmaceutical companies to properly maintain the cold chain in their logistics network.

Conclusion:

A world class cold chain infrastructure and its efficient management within the country will help immensely to Indian domestic pharmaceutical companies, as well, as they are exploring more and more opportunities to export Biopharmaceuticals in the global market. To achieve this objective modern cold chain warehouses and their efficient management as per regulatory guidelines will play a key role in ensuring right product quality standard that India will export.

Over a period of time cold-chain management practices of global standards will be required to achieve this goal. Currently for both import and export of cold-chain sensitive pharmaceuticals, as indicated above, the available infrastructural facilities pose to be one of the key challenges encountered by the industry to maintain high product quality during shipment and warehousing at the ports. Individual pharmaceutical companies like Eli Lilly, India have their own vehicles equipped with cold-chain management systems for transportation of their cold chain sensitive products.

Greater initiative by the DCGI in particular in this area, in collaboration with the Indian pharmaceutical industry, sooner, is absolutely essential. For the patients’ sake.

By Tapan 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.

Tackling the menace of counterfeit medicines – vested interests or petty sentiments should not make the pressing public healthcare issue irrelevant.

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There are following three clearly emerging views on the global issue of counterfeit drugs:1. The innovator companies feel that the generic pharmaceutical industry and the drug regulators are
not really very keen to effectively address and resolve this global public health issue.2. The generic companies and the drug regulators feel that the problem is not as acute as it is
projected to be and the innovator global pharmaceutical companies through their intense advocacy
campaign are trying to exploit the situation to fight against generic medicines and parallel imports.

3. Some other group, including a section of NGOs claim that an important public health sentiment is
being used by the R&D based global pharmaceutical companies to extend intellectual property rights
(IPR) to patients’ safety issue, allegedly for vested interest. These organizations have taken their arguments
to various international platforms like Anti-Counterfeiting Trade Agreement (ACTA) and
International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the World
Health Organization (WHO), for effective resolution of their grievances.

Addressing some of these concerns:

• IPR being extended to the definition of counterfeit medicines:

Even in India, ‘misbranding’ though an integral part of IPR, is considered as a public health issue and is an offence under Section 17 of the Drugs and Cosmetics Acts, 1940. Albany Law Journal of Science and Technology, 2006 has estimated a loss to the industry towards such counterfeit medicines of US$ 30 billion, which is about 6% of the turnover of the global pharmaceutical industry.

• Magnitude of problem with counterfeit medicines has been inflated:

In the industrialized and developed nations of the world with effective regulatory control, the problem perhaps, may not be as acute. A study done by IMPACT in 2006 indicates that in countries like, the USA, EU, Japan, Australia, Canada and New Zealand the problem is less than 1%.

Similar study, on the other hand, indicated that in the developing nations like parts of Asia, Latin America and Africa more than 30% of the medicines are counterfeits. It has also been reported that in South East Asia, estimated prevalence of counterfeit artesunate for malaria is 33-53%.

• Apprehension from some section of the generic pharmaceutical industry:

Apprehensions from some section of the generic pharmaceutical industry that attempts are being made by the interested groups within the industry to bring generic drugs under the purview of counterfeit medicines, is indeed unfounded. As from no developed countries around the world, there has been any threat to non-patent infringing legal generic medicines. And why there should be any such threat at all, when the world is witnessing the global pharmaceutical companies scaling up their generic business operations?

On the contrary generic pharmaceutical business, in almost all developed markets across the world, is growing at a much faster pace than the patented products of the innovator companies and this trend is expected to continue at least in short to medium term.

An unexplained similarity:

From the above details one will be tempted to draw a conclusion that in all those countries where access to modern medicines is poor, incidences of counterfeit medicines are higher. IMPACT has reported counterfeit versions of all types of medicines ranging from anti-malarial, anti-hypertensives, anti-tubercular, anti-retroviral to cardiovascular and other life saving and life style drugs, from these countries.

Various types of counterfeit medicines:

WHO has indicated following types of counterfeit medicines:

• Without active ingredients: 32%

• Wrong ingredients: 21.4%

• Incorrect quantities of active ingredients: 20.2%

• Right quantities of active ingredients but in fake packaging: 15.6%

• High levels of impurities and contaminants: 8.5%

• “Substituted ingredients of anything from paracetamol to boric acid, talcum powder, rat poison or
road paint”

• Medicines purchased online from illegal internet sites: 50%

Factors influencing flourishing trade of counterfeit medicines:

WHO IMPACT has reported following key factors:

• Low manufacturing costs, thus higher profit margin

• Albany Law Journal reports that high pricing ratio of counterfeit medicines compared to a branded
product attracts counterfeiters

• In countries like India the risk of detection of fake medicines is quite low where the penalties for such
heinous crime even today is very lenient, as the amended anti-counterfeit law, for some strange
reasons, has not been made operational, as yet.

Global sales forecast for counterfeit medicines:

The sales of counterfeit medicines across the world as estimated by the ‘Centre for Medicine in Public Interest’ will be around US$75 billion by the end of 2010. This is an increase of over 90% as compared to 2005.

Incidence of detection of counterfeit medicines:

A report from the WHO’s Executive Board in its 124th session indicated that the detection of counterfeit medicines in 2007 had increased to more than 1,500. This reflects an increase of around 20% over 2006 and ten times more compared to year 2000.

Volume of counterfeit seizures, the world over:

WHO indicated that in 2005-06 the volume of counterfeit drug seizures included 2.7 million articles and the main countries where these articles originated from, were reported as follows:

• India: 31%
• UAE: 31%
• China: 20%

Conclusion:

We have, therefore, enough data to establish that counterfeit drugs are posing a growing menace to the humanity. All stakeholders should join hands to address this public health issue, leaving aside petty commercial interests, be it generic pharmaceutical companies or research based pharmaceutical companies, across the world and India is no exception. Otherwise, thugs and criminals who are running to their banks, more often than ever before, with sacks full of money from this illicit trade, at the cost of the innocent patients, will keep going almost scot free, forever.

By Tapan 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.

Improving ‘Access to Modern Medicines’ in India –Public Private Partnership (PPP) is the way forward.

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Despite various measures being taken by the Government of India (GoI) from time to time, around 65% of Indian population are not having access to modern medicines. It appears, GoI is of the view that the reason for poor ‘access to modern medicines’ to a vast majority of our population is intimately linked to the issue of ‘affordability of medicines’.To make medicines affordable to the common man, the Government took a radical step in 1972 by passing a law to abolish products patent in India. The change in paradigm at that time, encouraged domestic pharmaceutical players to manufacture and market even those latest and innovative drugs, which were protected by patents, n many countries of the world. The new ball game enabled the domestic players to highly specialize in ‘reverse engineering’ and launch generic versions of most of the New Chemical Entities (NCEs)at a fraction of the innovators price, in India.This shift in Paradigm in 1972, catapulted the Indian domestic pharmaceutical industry to a newer orbit of success. India in that process, over a period of time, established itself as a major force to reckon with, in the generic pharmaceutical markets of the world. Currently, the domestic pharmaceutical industry in India caters to around one third of the global requirement of generic pharmaceuticals.

From 1972 to 2005 domestic Indian pharmaceutical companies focused on replicating all most all blockbuster drugs, like for example, major Cox2 inhibitors (Merck and Pfizer), Viagra and Lipitor (Pfizer) etc, to low price generic substitutes and that too just within a year or two from the date of first launch of these products in the developed markets of the world.

In 1972, the Market share of the Indian domestic companies, as a percentage to turnovers of the total pharmaceutical industry of India, was around 20%. During the era of ‘reverse engineering’, coupled with many top class manufacturing and marketing strategies, domestic Indian pharmaceutical players wheezed past their multinational (MNCs) counterparts in the race of market share, exactly reversing the situation in 2009.

‘Reverse engineering’ was one of the key growth drivers of domestic pharmaceutical industry during this period. In its absence, during post IPR regime, the growth rate of branded generic industry is not expected to be as spectacular. However, the low cost ‘essential medicines’ will continue to be produced and marketed in India in future, as well.

Be that as it may, from 1972 to 2005, India could produce and offer even the latest NCEs, at a fraction of their international price, to the Indian population. There were as many as 40 to over 60 generic versions of each successful blockbuster drug of the world, in India. Cut-throat competition was intense and still it is, which keeps the average price of such medicines well under control. To further tighten its grip over pharmaceutical products pricing, GoI imposed stringent price control and price monitoring mechanism simultaneously, which are in place even today. Despite competitive pricing pressure coupled with Government price control, over nearly four decades, with a key policy focus on ‘affordability of medicines’, why then ‘access to modern medicine’ remained abysmal for a vast majority of the population of India?

To address this vexing problem, Industry Associations reported to have suggested a policy shift towards public-private-partnership (PPP) model to the Ministry of Chemicals and fertilizers in 2006-07. At that time, the Associations seem to have offered that the Pharmaceutical Industry will supply to the GoI the essential medicines at 50% of their Maximum Retail Price (MRP), to cater to the need of the common man, especially those who are below the poverty line (BPL).

However, to make this proposal effective there is a fundamental need for the Government to quickly initiate significant ‘capacity building’ exercise, initially in our primary and then in the secondary healthcare value chain. Towards this direction, the Federation of Indian Chambers of Commerce and Industry (FICCI) reported to have suggested to the Government for an investment of around US$ 80 billion to create over 2 million hospital beds.

Frugal budget allocation (1.12%) of the GoI towards healthcare as % of GDP of the country, suggests that Government is gradually shifting its role in this very important area, primarily from healthcare provider to healthcare facilitator for the private sectors to develop it further. In such a scenario, it is imperative for the government to realize that the lack of even basic primary healthcare infrastructure, leave aside other incentives, impede effective penetration of private sectors into semi-urban and rural areas. PPP model should be worked out to address such issues, effectively.

I have highlighted the remedial measures to be taken to address this situation in my article, which can be read by clicking on the following link:

http://www.tapanray.in/profiles/blogs/65-of-indians-do-not-have

Over 70 percent of our population are located in rural India. A relatively recent study indicates that despite some major projects undertaken by the Governments, like National Rural Health Mission (NRHM), about 80 percent of doctors, 75 percent dispensaries and 60 percent of hospitals are located in urban India. Another recent initiative taken by the Department of Pharmaceuticals (DoP) called ‘Jan Aushadhi’ is also orientated towards urban and semi-urban India.

I had deliberated upon the ways to increase penetration of ‘Jan Aushadhi’ in rural India, in another article, which can be read by clicking on the following link:

http://www.tapanray.in/profiles/blogs/jan-aushadhi-medicines-for

The net result of such policy initiatives, denies over 65 percent of Indian rural population from having access to quality healthcare services. Such lack of focus on rural areas, perhaps will explain the reason why only 35 percent of Indian population is having access to modern medicines.

Instead of trying to find a solution for this alarming ‘access to medicines’ problem, by limiting focus mainly on the issue of ‘affordability’ of medicines, for several decades, the Government is doing a great disservice to the common man, mainly located in the rural and semi-urban India. It is now high time that the GoI analyzes the available data to address the root cause of poor healthcare delivery, infrastructure and almost total lack of healthcare financing for all strata of Indian society.

Let me hasten to add that in no way I am trying to say that ‘affordability of medicines’ is no issue in India. All I am saying is that an integrated approach towards the root causes will quite effectively take care of ‘affordability’ issue and NOT the vice versa.

Even a problem of such magnitude can be converted into an opportunity. India can certainly be made a global hub for quality and affordable healthcare services, flashes of which we see in medical tourism initiatives.

Therefore, to address the acute problem of ‘access to modern medicines’ to a vast majority of the Indian population, GOI should reach all out to attract significant private and even foreign direct investments (FDI) through innovative Private Public Partnership initiatives. A strong will to have an ‘out of box’ solution to this critical problem is the crying need of the hour.

By Tapan 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.

National Rural Health Mission (NRHM), a much hyped public healthcare initiative – has it delivered since its inception in 2005?

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National Rural Health Mission (NRHM), a very ambitious and noble initiative for the rural population of India was launched by the Government of India on April 12, 2005. The interim budget allocation of NRHM for the year 2009–10 has been increased to Rs. 12,070 crore. The primary purpose of NRHM, as announced by the Government, was to improve access to quality healthcare for the poor population of 18 states, to start with, of rural India.

Along with such a commendable initiative, the Government declared an increase in its spending towards public health from mere 0.9% to 2–3% of the GDP over a five year period. This decision was in line with the well articulated prime focus of the Government on public health and education.

During the launch of NRHM, the Health Minister of India announced that the nation would see the results of these efforts in three years time.

Three years are over now. Let us, therefore, have a look at the key achievement areas of this ambitious scheme for the budget year 2008-09, as announced by the Finance Minister recently in his interim budget speech for 2009–10.

The performance areas were highlighted as follows:

• 462,000 Associated Social Health Activists were trained
• 177,924 villages have sanitation committees functional
• 323 district hospitals have been taken for up gradation

Against such a soft performance parameters of the Government, let us see some hard facts, which are real indicators of performance of NRHM. A report on the recent study done by Chronic Care Foundation indicates that in India about 86% of highly populated rural districts still do not have provisions for basic diagnostic tests for chronic ailments.

The study also highlights that in rural areas, as a percentage of total expenses, out of pocket healthcare costs are more than the urban areas, with hospitalization expenses contributing the most to the total costs. In many rural areas the healthcare costs have been reported to be as high as around 80% of the total expenses. Such a high out of pocket expenses have mainly been attributed to the lack of facilities in these rural areas, requiring patients to travel to distant areas for medical treatment. It was also reported that even in rural areas due to inefficient and inadequate services at the Government healthcare units, there has been a very high dependence on more expensive private healthcare facilities.

After almost four years from the inception of NRHM, if this is the state of affairs for rural public healthcare, the obvious questions which come to my mind are as follows:

• Where is the huge money allocated for NRHM going?
• Who is or are accountable for such a poor performance of this great scheme?

In my opinion, to make NRHM work satisfactorily the Government should outline, decide and announce the key success parameters for performance evaluation of the scheme. This is to be done disclosing the names and designations of the responsible senior Government officials who will be held accountable for the success or failure to deliver the deliverables. All these details should be uploaded on to the website of the Ministry of Health for public scrutiny, at least half yearly. With tax-payers money being utilised for this important and critical public health arena, no non-performance should escape attention and go unpunished.

Moreover, with the help of experts, the Government should decide, which elements of each identified success parameters the Government will be able to deliver better with its own internal resources and which are those areas where the Government should outsource.

Such an approach when worked out in great details will be able to ensure whether through NHRM the country is making progress to improve access to quality healthcare for a vast majority of its rural population. Otherwise this scheme may well be treated just as one of those which failed to deliver and vanished in the oblivion.

By Tapan 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.

An integrated approach towards Public Private Partnership (PPP) initiatives to improve access to healthcare in India is the way forward.

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Despite so much of stringent government control, debate and activism on the affordability of modern medicines in India, on the one hand, and the success of the government to make medicines available in the country at a price, which is cheaper than even Pakistan, Bangladesh and Sri Lanka, on the other, the fact still remains, about 65% of Indian population do not have access to affordable modern medicines, compared to 15% in China and 22% in Africa.The moot question therefore is, despite all these stringent price regulation measures by the government and prolonged public debates over nearly four decades or so to ensure better ‘affordability of medicines’, why then the situation on ‘access to modern medicines’has remained so abysmal to a vast majority of the population, in India?This, in my view, is mainly because; no single minister or ministry can now be held accountable by the civil society for such a dismal performance in the access to healthcare, in India.

Poor healthcare infrastructure:

As per the Government’s own estimate, India records:

1. A shortage of 4803 Primary Health Centres (PHC)

2. A shortage of 2653 Community Health Centres (CHC)

3. No large Public Hospitals in rural areas where over 70% of the populations live

4. Density of doctors in India is just 0.6 per 1000 population against 1.4 and 0.8 per 1000 population in China and Pakistan respectively, as reported by WHO.

The Government spending in India towards healthcare is just 1.1% of GDP, against 2% by China and 1.6% by Sri Lanka, as reported by the WHO.

Some good but sporadic public healthcare initiatives:

The government allocation of around US$ 2.3 billion for the National Rural Health Mission (NRHM), is a good initiative to bring about uniformity in quality of preventive and curative healthcare in rural areas across the country.
While hoping for the success of NRHM, inadequacy of the current rural healthcare infrastructure with about 80 percent of doctors, 75 percent dispensaries and 60 percent of hospitals located only in the urban India, may encourage skepticism.

Addressing the issue of improving access to healthcare:

While addressing the issue of improving access of healthcare, following three important ‘Public Private Partnership (PPP)’ initiatives would be most appropriate.

1. PPP to improve affordability:

To address this vexing problem, industry associations had jointly suggested a policy shift towards public-private-partnership (PPP) model to the government in 2006-07, instead of a stringent price control mechanism, which has not worked thus far to improve access of modern medicines, in India. Instead, the associations seemed to have suggested that the pharmaceutical industry will supply to the government the essential medicines at 50% of their Maximum Retail Price (MRP), to cater to the need of below the poverty line (BPL) families.

It is worth mentioning, many OPPI member companies like, Novartis, GSK, Pfizer, Sanofi-Aventis etc. have their own access to medicines programs in India.

Although the government did not respond to this proposal, to make it effective the ministry of health will require to quickly initiate significant ‘capacity building’ exercises, both in the primary and also in the secondary public healthcare facilities in the country. FICCI is reported to have suggested to the Government for an investment of around US$ 80 billion to create over 2 million hospital beds, for such capacity building exercises .

Frugal budget allocation by the government towards healthcare of the country, suggests that Government is gradually shifting its role in this very important area, primarily from healthcare provider to healthcare facilitator for the private sectors to develop it further. If it is so, it is imperative for the government to realize that the lack of even basic primary healthcare infrastructure, leave aside other incentives, impede effective penetration of private sectors into semi-urban and rural areas. Effective PPP model should be worked out to address such issues, without further delay.

2. PPP to leverage the strength of Information Technology (IT) to considerably neutralize the system weaknesses:

Excellence in ‘Information Technology’ (IT) is one of the well recognized strengths that India currently possesses. This strengths needs to be adequately leveraged through PPP to neutralize the above weaknesses. Harnessing IT strengths, especially in the areas of drug procurement and delivery processes, especially in remote places, could hone the healthcare delivery mechanism, immensely.

Another IT enabled technology that India can widely use across the nation to address rural healthcare issues is ‘‘Telemedicine’ for distant diagnosis and treatment of ailments. Required medicines for treatment could be made available to the patients through ‘Jan Aushadhi’ initiative of the Department of Pharmaceuticals (DoP), by utilising the Government controlled distribution outlets like, public distribution system (ration shops) and post offices, which are located even in far flung and remote villages of India.

3. PPP in healthcare financing for all:

Unlike many other countries, even as compared to China, over 72 percent of Indian population pay out of pocket to meet their healthcare expenses.

Out of a population of 1.3 billion in China, 250 million are covered by insurance; another 250 million are partially covered by insurance and balance 800 million are not covered by any insurance. Converse to this scenario, in India total number of population who may have some sort of healthcare financing coverage will be around 200 million with penetration of health insurance at just around 3.5% of the population. India is fast losing grounds to China mainly due to better response to healthcare infrastructure.

Even after leveraging IT for ‘Telemedicine’ and improving healthcare delivery processes, together with availability of low priced quality medicines from ‘Jan Aushadhi’ outlets, a robust healthcare financing model for all strata of society to make healthcare products/services affordable to a vast majority of the population, will remain an essential requirement for the country to address the issue of improving access to healthcare to all.

According to a survey done by National Sample Survey Organisation (NSSO), 40% of the people hospitalised in India borrow money or sell assets to cover their medical expenses. A large number of populations cannot afford to pay for the required treatment, at all.

Conclusion:

In my view an integrated approach for creating effective healthcare infrastructure throughout the country, leveraging IT in the entire healthcare space, appropriately structured ‘Health Insurance’ schemes for all strata of society ably supported by well spread out ‘Jan Aushadhi’ outlets even in far flung rural areas, deserve careful consideration by the Government.

A PPP model in all these three areas needs to be worked out in detail to address the pressing issue of improving ‘Access to Affordable Integrated Healthcare to ALL’.

By Tapan 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.