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Are common patients in India just as the pawns of the game of chess or the victims of circumstances or both, in the socio-economic milieu of the country?

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“Public healthcare in India has the power to deliver improved health outcomes, as demonstrated by a growing number of national and international examples. However, supportive policies need to be put in place in order to change traditional determinants of health,”said Professor Sir Andrew Haines, Director, London School of Hygiene and Tropical Medicine at the third foundation day function of the Public Health Foundation of India (PHFI), not so long ago.The healthcare industry of India has indeed this power, which can catapult the industry to a growth orbit to generate an impressive revenue of around US$.150 billion by 2017 as estimated by India Brand Equity Foundation (IBEF) in November 2009. This growth will be driven primarily by the private investments in country.Be that as it may, the current healthcare standard and infrastructure in India, as we all know, is far from satisfactory. Though we have some healthcare centers of excellence spread sporadically across various cities and towns of India, public healthcare facilities are grossly inadequate to satisfy the current healthcare demand of the common man of India.

Healthcare spends in India:

Although total health spending of the nation is around 6 percent of its GDP being one of the highest within the developing countries of the world, public expenditure towards healthcare is mere 0.9 percent of the GDP and constitutes just a quarter of the total healthcare cost of the nation. According to a World Bank study, around 75 percent of the per capita spending are out of pocket expenditure of individual households, state and the union governments contribute around 15.2 percent and 5.2 percent respectively, health insurance and employers contribute just 3.3 percent and foreign donors and state municipalities contributing the balance of 1.3 percent.

Out of this meager allocated expenditure only 58.7% goes for the primary care.

Four essentials in Primary Healthcare:

When it comes to Primary Healthcare, following are the well accepted essentials that the government should effectively address:

1. Healthcare coverage to all, through adequate supply of affordable medicines and medical services

2. Patient centric primary healthcare infrastructure and networks

3. Participative management of healthcare delivery models including all stakeholders with a change from ‘supply driven’ to ‘demand driven’ healthcare program and policies

4. Health of the citizens should come in the forefront while formulating all policies for all sectors including industry, environment, education, deployment of labor, just to cite a few examples.

It is unfortunate that most of these essentials have not seen the light of the day, as yet.

The key reason for failure:

Inability on the part of the central government to effectively integrate healthcare with socio-economic, social hygiene, education, nutrition and sanitation related issues is one of the key factors for failure in this critical area.

Moreover in the healthcare planning process, health being a state subject, not much of coordinated planning has so far taken place between the central and the state governments to address the pressing healthcare related issues.

In addition, budgetary allocation and other fiscal measures, as stated earlier, towards healthcare both by the central and the state governments are grossly in adequate.

National Rural Health Mission (NRHM) – a good beginning:

To address this critical issue, the National Rural Health Mission (NRHM) was conceived and announced by the government of India. NRHM aims at providing valuable healthcare services to rural households of the 18 States of the country namely, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Himachal Pradesh, Jharkhand, Jammu and Kashmir, Manipur, Mizoram, Meghalaya, Madhya Pradesh, Nagaland, Orissa, Rajasthan, Sikkim, Tripura, Uttarkhand and Uttar Pradesh, to start with.

The key objectives of this novel scheme are as follows:

• Decrease the infant and maternal mortality rate
• Provide access to public health services for every citizen
• Prevent and control communicable and non-communicable diseases
• Control population as well as ensure gender and demographic balance
• Encourage a healthy lifestyle and alternative systems of medicine through AYUSH

As announced by the government NRHM envisages achieving its objective by strengthening “Panchayati Raj Institutions” and promoting access to improved healthcare through the “Accredited Female Health Activist” (ASHA). It also plans on strengthening existing Primary Health Centers, Community Health Centers and District Health Missions, in addition to making maximum use of Non-Governmental Organizations.

NRHM is expected to improve access to healthcare by 20 to 25 percent in the next three years:

To many the National Rural Health Mission (NRHM) has made a significant difference to the rural health care system in India. It now appears that many more state governments are envisaging to come out with innovative ideas to attract and retain public healthcare professionals in rural areas.

On January 11, 2010, the Health Minister of India Mr. Ghulam Nabi Azad, while inaugurating the FDA headquarters of the Western Zone located in Mumbai, clearly articulated that the NRHM initiative will help improving access to affordable healthcare and modern medicines by around 20 to 25 percent during the next three years. This means that during this period access to modern medicines will increase from the current 35 percent to 60 percent of the population.

If this good intention of the minister gets translated into reality, India will make tremendous progress in the space of healthcare, confirming the remarks made by Professor Sir Andrew Haines, Director, London School of Hygiene and Tropical Medicine, as quoted above.

Is NRHM scheme good enough to address all the healthcare needs of the country?

NRHM is indeed a very good and noble initiative taken by the government to address the basic healthcare needs of the rural population, especially the marginalized section of the society. However, this is obviously not expected to work as a magic wand to resolve all the healthcare related issues of the country.

Are patients the pawns of the game of chess or the victims of circumstances or both of the socio-economic systems?

Currently, some important stakeholders of the healthcare industry seem to be using the patients or taking their names, mainly for petty commercials gains or strategic commercial advantages. They could be doctors, hospitals, diagnostic centers, pharmaceutical industry, activists, politicians or any other stakeholders. It is unfortunate that they all, sometime or the other, want to use the patients to achieve their respective commercial or political goals or to achieve competitive gains of various types or just for vested interests..

‘The Patient centric approach’ has now become the buzz word for all – do we ‘walk the talk’?

There does not seem to be much inclusiveness in the entire scheme of things in the private healthcare system, excepting some odd but fascinating examples like Dr. Devi Shetty, Sankara Nethralaya etc. As a result, excepting the creamy layers, patients from all other strata of society are finding it difficult to bear the treatment cost of expensive private healthcare facilities.

I personally know a working lady with a name Kajol (name changed) whose husband is suffering from blood cancer. One will feel very sad to watch how is she fast losing all her life’s savings for the treatment of her husband, pushing herself, having no alternative means, towards an extremely difficult situation day by day. There are millions of such Kajols in our society, who are denied of effective public healthcare alternatives to save lives of their loved ones.

If all stakeholders are so “patient centric” in attaining their respective objectives, why will over 650 million people of India not have access to modern medicines, even today? Is it ALL for poor healthcare infrastructure and healthcare delivery system in the country? If so, why do we have millions of Kajol’s in our country?

Consumer awareness and pressure on healthcare services and medicines in India will increase – a change for the better:

With the winds of economic change, rising general income levels especially of the middle income population, faster awareness and penetration of health insurance among the common citizens, over a period of time Indian consumers in general and the patients, in particular, like in the developed countries of the world, will start taking more and more informed decisions by themselves about their healthcare needs and related expenditure through their healthcare providers.

As the private healthcare providers will emerge in India, much more in number, like the developed world, they will concentrate not only on their financial and operational efficiencies exerting immense pressure on other stakeholders to squeeze out the best deal at the minimal cost, but also to remain competitive will start charting many uncharted frontiers and explore ways of enhancing the ‘feel good factors’ of the patients through various innovative ways… God willing.

Conclusion:

All stakeholders of the healthcare industry need to think of inclusive growth, not just the commercial growth, which could further widen the socio-economic divide in the country, 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

It is hightime for the civil society, as well, to ponder and actively participate to make sure that the inclusive growth of the healthcare sector in India takes place, where like primary education, primary healthcare should be the ‘fundamental right’ for ALL citizens of the country.

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.

Collaborative commercialization of inexpensive smaller incremental innovation in Chemistry will play an important role in bringing affordable new drugs or new drug delivery systems

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It started in the 17th century:

Alchemy, a medieval chemical science and speculative philosophy aiming to achieve the transmutation of the base metals into gold, searching for a universal cure for disease and indefinitely prolonging life, not considered a science by many, gradually became the basis for the development of chemistry into the 17th century. However, perceivable impact of chemistry on humanity, through its smaller incremental innovation, started being felt only in the second half of the 19th century.

Chemistry – an interface between the physical world and humanity:

Experts in this field often opine that the current form of human civilization has been made possible, to a great extent, through significant advancement of such innovation in chemistry and its role in modern technology. Chemistry is indeed an interface between the physical world on the one hand and the humanity on the other.

Getting a perspective of resource and time requirements for such initiatives:

Is there any similarity between development of pharmaceutical chemistry and IT software?

Now a days, one finds a striking similarity between small incremental innovation in IT software and the same in pharmaceutical chemistry. Both are creative and belong to the knowledge economy. Scientists in both the communities try to generate innovative ideas, which can lead to their effective commercialization.

Resource requirements for these two are strikingly different:

However, the nature of the commercialization process of these two sciences, though seemingly similar in terms of innovativeness, is indeed quite different. In the software community, two people can implement an idea with minimal resource requirement and could end up with a profitable commercialized product, without much difficulty. In contrast, two chemists may come up with a brilliant idea, which in many cases, may require significant investment of resources much before to even think to get the initial product commercialized. Subsequent steps of scaling up will be a separate issue altogether, with more resource commitment.

The process of commercialization of smaller incremental innovation in pharmaceutical chemistry is much longer:

As we all know, the process of commercialization of incremental innovation in chemistry takes a much longer time scale, as these are not usually spare time projects, unlike computer softwares. The cost involved in testing out and implementing a new idea in chemistry is very high and may not even be possible without any robust institutional backing.

Target inexpensive smaller incremental innovation in pharmaceutical chemistry:

Some illustrative examples of such smaller incremental innovation in chemistry are as follows:

1. Development of pharmaceutical co-crystals

2. Merger of chemistry of traditional and modern medicines for synergy in both efficacy and safety

3. Chemical technology switch: taking technology of one field and transferring it to a different field to get a new drug substance

4. Application of polymorphic chemistry in drug discovery.

The process has begun:

International experience:

The chemistry department of Oxford University, U.K, which is incidentally the biggest chemistry department of the western world, has made significant advances in commercializing incremental innovation in chemistry. Among many, they created and commercialized the following three entities through such incremental innovation:

• Medisense

• Oxford Molecular

• Oxford Assymetry

The Indian experience:

Despite all challenges, in India, as well, the commercialization process of smaller incremental innovation in chemistry has already begun. The Chemistry Department of the University of Delhi has developed 11 patentable technologies for improved drug delivery system using nano-particles. One of such technologies was development of ‘smart’ hydrogel nano-particles for encapsulating water-soluble drugs. This technology was sold to Dabur Research Foundation in 1999.

Another nano-particle drug delivery technology in opthalmogy area was also commercialized by transferring it to Chandigarh based Panacea Biotech Ltd.

Conclusion:

This process is expected to gain momentum in our country too, contributing significantly to the progress of the healthcare sector of the nation. “Commercializing smaller incremental innovation in Pharmaceutical Chemistry”, I reckon, will play a key role in providing affordable modern medicines to a vast majority of the population, as India transforms itself into a knowledge superpower.

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.