Tobacco: The Slow Poison Engulfing India

Nearly 4000 chemical constituents are present in tobacco smoke

Tobacco use is a major preventable cause of premature death and disease worldwide.
Nearly one million people die in India every year due to tobacco use. Tobacco smoking is a major risk factor for many diseases, including cardiovascular disease (CVD), respiratory disease, and cancers at multiple sites. Tobacco use, including reverse smoking (smoking with the lit end inside the mouth), chewing of betel quid (a mixture of areca nut, slaked lime, and tobacco wrapped in betel leaf), and use of smokeless tobacco increases the risk of cancers of the upper aerodigestive tract. In the past few decades inadequate public awareness of smoking risks, combined with aggressive marketing by tobacco companies, has resulted in a sharp increase in tobacco addiction in India.
Indian perspective of tobacco use
In terms of tobacco habit, India is unique. In 17 states of India, tobacco use is more than 69 %. The North Eastern region exhibits highest rates of tobacco use in Mizoram more than 80 per cent of men use some form of tobacco, followed by Tripura (76 %) and Assam (72%). Arunachal Pradesh is the second largest state after Mizoram whose people chew tobacco products (Gupta 2006). Only 22% of total tobacco is consumed in India in the form of cigarettes, 54% is in the form of bidis and 24% is consumed in the form of chewing tobacco, pan masala, snuf, khaini, gutkha, masheri and tobacco tooth paste. These chewable tobacco products contain purified tobacco, paraffin, areca nut, lime, catechu and 230 permitted additives and flavours including known carcinogens.
Global adult tobacco survey (GATS) of India
According to GATS 2009-2010 the key features have been enlisted below
1. The prevalence of tobacco use in India is very high and more than one third (35%) of adults in India use tobacco in some form or the other.
2. The prevalence of overall tobacco use is 48 % among men and 20 % among women.
3. Among them 21 % adults use only smokeless tobacco, 9 % only smoke and 5 % smoke as well as
smokeless tobacco.
4. The estimated number of tobacco users in India is 274.9 million.
5. There is significant variation in prevalence of both smoking and smokeless tobacco use in different
regions and states. The prevalence of tobacco use among all the states and Union Territories ranges
from the highest of 67 % in Mizoram to the lowest of 9 % in Goa.
6. Prevalence of tobacco use is higher among rural population as compared to urban and prevalence is
found to decrease with increase in education level.
Tobacco use prevalence among youth
According to the Global Youth Tobacco Survey (GYTS, 2006), a total of 36.9% children in India initiate smoking before the age of 10. Among students 4.2% smoke cigarettes with rate for boys significantly higher than girls and 11.9% students use other tobacco products. Cigarette smoking
among youth is higher in central, southern and northeastern regions (12%). Exposure to secondhand
smoke (SHS) in public places is as high as 40%.
Toxic chemistry of tobacco
Nearly 3000 chemical constituents have been identified in smokeless tobacco, while 4000
are present in tobacco smoke. These include alkaloids such as nicotine, nornicotine, cotinine, anatabin, anabasin; aliphatic hydrocarbons present in the waxy leaf coating and hundreds of isoprenoids that give the aroma to tobacco. Phytosterols such as cholesterol, campesterol, etc. and alcohols, phenolic compounds, chlorogenic acid, rutin, carboxylic acids and several free amino acids are present in tobacco. A wide range of toxic metals including mercury, lead, cadmium, chromium and other trace elements have been found in Indian tobacco. The alkaloids nicotine and nornicotine give rise to carcinogenic Nnitrosonornicotine (NNN), while another potent carcinogen 4methylnitrosamino1( 3pyridyl)1butanone (NNK) is derived from nicotine. Nnitrosoanatabin
(NAT) and Nnitrosoanabasin are other Nnitrosamines derived from the alkaloids anabasin and anatabin, respectively. Both NNN and NNK are present in high concentrations in smokeless tobacco and tobacco smoke. The tobacco related carcinogens can be metabolically activated to intermediates that react with DNA, forming covalently bound products known as DNA adducts. With persistence of DNA adducts during DNA replication permanent DNA mutation may occur. Mutations in particular regions of crucial genes, like RAS or MYC oncogenes or TP53 or CDKN2A tumorsuppressor
genes, may result in loss of normal cellular growthcontrol regulation and tumor development. Nicotine and carcinogens can also bind directly to some cellular receptors, leading to activation of the serine threonine kinase AKT (protein kinase B), protein kinase A and other factors. These lead to decreased apoptosis, increased angiogenesis and increased cell transformation. Tobacco products may also activate protein kinase C (PKC), activator protein 1 (AP1) or other factors, thereby enhancing carcinogenesis.
Tobacco and cancer in India
Tobacco addiction is an established risk factor for cancers of the lung, head and neck (oral
cavity, pharynx, larynx), nasopharynx, esophagus, stomach, pancreas, liver, kidney, bladder, and
cervix, and leukemia (IARC, 2012). Globally approximately 6.7 million smokingrelated
cancer cases are diagnosed every year of which 4.3 million cases are from developing countries .Even the frequency of newly diagnosed lung, stomach, liver, head and neck, esophagus, cervical, and
nasopharyngeal cancers and leukemia cases are more in developing countries than developed
countries. Cigarette smoking confers a 15 to 30 fold increase of lung cancer, a 10 fold increase of
laryngeal cancer, a 4to 5fold increase of both oral cavity and oropharyngeal cancers, a 1.5to 5 fold
increase of esophageal cancer, a 2to 4 fold increase of pancreatic cancer, and a 1.5 to 2.5 fold
increase of nasopharyngeal, stomach, liver, kidney, cervix cancers, and leukemia. In terms of global
cancer mortality, tobacco smoking accounts for 42% of oral and oropharyngeal cancer, 42% of
esophageal cancer, 13% of stomach cancer, 14% of liver cancer, 22% of pancreatic cancer, 70% of
trachea, bronchus, and lung cancers, 2% of cervical cancer, 28% of bladder cancer, 9% of leukemia,
21% of all cancers.

The tobacco related cancers constitute 56.4% and 44.9% of cancers in males and females, respectively. The top five or six cancers in men are all tobaccorelated cancers which include lung,
oral cavity, larynx, oesophagus and pharynx whereas in women, these are cancers of cervix, oral
cavity, oesophagus and lung. Case control studies conducted in India on cancer at various sites have
shown that both smoking and smokeless tobacco use (including tobacco with lime and paan with tobacco) cause elevated risks for intraoral, oropharyngeal, oesophageal and cervical cancers, and
cancer of the penis. They have shown that smoking in India causes elevated risks for cancer of the
lungs, hypopharynx, larynx and stomach. Associations with smokeless tobacco are suggested for
cancers of the oral cavity, esophagus, and the pancreas .The attributable fraction of tobaccorelated
cancer incidence for smokeless tobacco varies considerably by region and sex. In India oral cavity
cancer cases that are attributed to smokeless tobacco are estimated to be 52.5% in men and 51.6% in
women. The tobacco habit varies regionally within India that dictates difference in gestation period
and molecular phathophysiological characteristics of oral precancerous and cancerous lesion (website
reference on tobacco habits in India). Areca nut, an indispensable component of gutka, causes oral
submucous fibrosis and is a precursor to oral cancer. Unlike smoking with gutka use, oral submucous
fibrosis develops within a very short period of time
National tobacco control program
There is no doubt that from view of public health point, this highly toxic industrial product
needs strict control measures. The Government of India enacted ‘Cigarettes and Other Tobacco
Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply
and Distribution) Act, 2003 (COTPA) to prohibit the consumption of cigarettes and other tobacco
products, which are injurious to health. To strengthen the implementation of the tobacco control
provisions under COTPA and policies of tobacco control mandated under the WHO FCTC, the
Government of the India piloted National Tobacco Control Programme (NTCP) in 2007–2008.
The main components of the NTCP were:
National level
i. Public awareness/mass media campaigns against tobacco; ii. Establishment of tobacco product
testing laboratories iii. Mainstreaming the program components as part of the health care delivery
mechanism under the National Rural Health Mission framework; iv. Mainstream Research and
Training on alternate crops and livelihoods in collaboration with other nodal Ministries; v. Monitoring and Evaluation including surveillance e.g. GATS India
State level
i. Tobacco control cells with dedicated manpower for effective implementation and monitoring of anti tobacco laws and initiatives
District level
i. Training of health and social workers, SHGs, NGOs, school teachers etc; ii. Local IEC activities;
iii. Setting up tobacco cessation facilities; iv. School Programme; v. Monitoring tobacco control laws
The Ministry of Health and Family Welfare, Government of India under the proposed National
Tobacco Control Programme currently has 19 Tobacco Cessation Centres (TCCs) in diverse settings
across India. These centres function under the District Tobacco Control Cell and comprise cancer
treatment centres, psychiatric centres, medical colleges and NGOs .
Other tobacco control strategies initiated by the government:
The other prime initiatives that have been taken by Government of India for tobacco control include –(i)A national level interministerial task force has been set up with stakeholder ministries and representatives from other states and civil society; (ii) A Steering Committee has been
formed under the chairmanship of Secretary (Health) to look into specific instances of violation of
Section 5 at national level. Monitoring Committees have also been formed at state level; (iii) In 2008,
the Ministry of Health and Family Welfare initiated a pilot project for developing alternative cropping systems to replace bidi and chewing tobacco with Central Tobacco Research Institute (CTRI), Rajamundhry; (iv) The Ministry of Labour has launched a pilot programme for skillbased vocational training of bidi workers especially women and minors; (v) Tobacco control initiatives are being integrated with other national health programs.e.g National Mental Helath Program(NMHP), National Cancer Control Program(NCCP) etc .
Recommendations for tobacco control in future
The National Action Plan and Monitoring Framework for Prevention and Control of Non
Communicable Diseases in India developed by Ministry of Health and Family Welfare aims to
achieve a 20% reduction in current tobacco use by 2020 and 30% by 2025. A comprehensive study on the economic burden of tobacco related diseases was supported by the Ministry of Health & Family Welfare, Government of India, WHO Country Office for India and was developed by the Public Health Foundation of India (PHFI) in 2014. According to the report the total economic costs
attributable to tobacco use from all diseases in India in the year 2011 amounted to Rs. 1,04,500 crores.

The massive direct medical costs of tobacco attributable diseases amounted to Rs.16,800 crore and
associated indirect morbidity cost was of Rs. 14,700 crore. The cost from premature mortality is Rs.
73,000 crores, indicating a substantial productive loss to the nation. Therefore in order to reduce the
tremendous economic burden and the concurrent losses of the nation the following tobacco control
efforts has been recommended by the report(i) Comprehensive tobacco control policy; (ii) Tobacco taxation policy; (iii) Treatment for tobacco dependence; (iv) Prohibition of sale and manufacture of all forms of smokeless tobacco products/chewing tobacco; (v) Enhancing public awareness; (vi) Implementation of the WHO framework convention on tobacco control and tobacco control laws.
Conclusion
The tobacco problem in India is complex due to the varied nature of tobacco use. Cessation
in Indian settings needs a multi disciplinary approach which should include preventive, curative and
rehabilitative care. Mass awareness activities in India should address adult and youth smokers as well
as chewers. Educational interventions are very necessary in schools and colleges due to the large
number of tobacco addicted children and teenagers. Effective tobacco control in India is dependent on balanced implementation of demand and supply reduction strategies by the Government and
stakeholder departments as well as on synergism of government policies and tobacco control
initiatives by non government organisations.
March 11 is observed as Anti Smoking Day
*Prof. (Dr.) Jaydip Biswas is Director, Chittaranjan National Cancer Institute, M/o Health & Family
Welfare, Govt of India, Kolkata
﴾Copied from pib.nic.in)

Vector-borne disease research in India

Ailing research

PAYYALORE KRISHNAIER RAJAGOPALAN

Vector-borne disease research in India has remained stagnant for decades owing to administrative apathy and lack of proper policies. By PAYYALORE KRISHNAIER RAJAGOPALAN

     THERE are many vector-borne diseases (VBD) prevalent in India apart from malaria and filariasis, such as Kyasanur forest disease, Japanese encephalitis, scrub typhus, dengue and chikungunya. The control of all of them depends on an understanding of the natural cycles and epidemiology of their vectors. Malaria, for example, is ideal for explaining VBDs because a lot of fieldwork was done on it by scientists all over the world, particularly British scientists in pre-Independence India. Their endeavours had led to a clear understanding of the ecology and behaviour of the vectors involved, which helped in devising appropriate control measures.

       A review of the research work that led to malaria control demonstrates how science had progressed over the period. Some of the important landmarks in the control of the disease were achieved by biologists and naturalists with a deep understanding of the environment. The first and foremost among them was Sir Ronald Ross, who in 1897 discovered that mosquitoes transmitted malaria. The relationship between the mosquito and the malarial parasite and their adaptation to their environmental ecology had been studied by many. These studies revealed that the transmission was very significantly influenced by many factors, including human activity.

The relationships between vector control and transmission among the mosquito vector, the parasite, the environment, and the behaviour of human carriers have been extensively studied by many. The researches also laid emphasis on the environment and how it contributed to malaria. The environmental studies covered local vectors, ecology, demography, agriculture, and so on. They found that local environmental conditions contributed to the disease, especially in specified zones. The link between parasite transmission and vector control predicated a need to understand other factors that led to malarial transmission. Dr Paul F. Russell was one of the stalwarts who studied malarial transmission. Nicolaas Swellengrebel coined the term “species sanitation” to link the carrier anophelines species with specific habitats, which explained the connection between ecology and malaria. It was found that factors such as availability of local vectors, ecology, demography, race and culture played a significant role in the transmission of the disease.

According to Ross, what was required was not the complete elimination of mosquitoes but a reduction in their numbers to below a certain level, now known as “critical density”. Ross also identified the human factor in the transmission. Malcom Watson in Malaysia and Russell and T. Ramachandra Rao in India demonstrated for the first time the validity of the concept of “critical density” of the vector. In pre-independent India, most of the notable contributions were made by scientists such as Muirhead Thomson in Assam, R. Senior-White and colleagues in Orissa (now Odisha), M.O.T. Iyengar and Sen in Bengal, Russell and Ramachandra Rao in south India, D.K. Viswanathan and Ramachandra Rao in the old Bombay State, and B.A. Rao in Mysore State. They contributed a lot to our understanding of the bionomics and ecology of such vectors as A. culicifacies, A. stephensi, A. minimus, A. fluviatilis, A. philippinensis, and A. sundaicus. In India, the period between 1930 and 1945 could be regarded as the golden era of studies on the bionomics and ecology of malaria vectors. The work by the Malaria Institute of India under the leadership of Sir Gordon Covell needs to be remembered in this respect.

On vector control, pioneering work was done in India by Russell and Ramachandra Rao in the late 1930s; they used pyrethrum as a space spray against anophelines in the malaria-affected areas of Pattukottai (Thanjavur district, Tamil Nadu) where irrigation practices were defective. It was used inside houses against the adult A. culicifacies. Spraying of pyrethrum extracts in the form of mist inside human dwellings during daytime killed the adult mosquitoes resting inside.

They extended their work to North Kanara district of the old Bombay State, which was one of the most malaria-prone areas in the country. Sprays were ineffective here because the vector, A. fluviatilis, rested outdoors. Then DDT appeared on the scene and revolutionised the entire project of malaria control. It was sprayed on the walls and ceilings of human dwellings because the vector mosquito rested there after taking an infected blood meal. This method was successfully used to protect civilian populations by Viswanathan and Ramachandra Rao in North Kanara in 1945 and by Senior-White in Orissa. Almost simultaneously, B.A. Rao and others tested it successfully in other parts of the country. In 1946, Viswanathan and Ramachandra Rao launched one of the largest malaria control projects in the rural tropics—seeking to protect over one million people, in the districts of North Kanara and Dharwar in Bombay State—and it proved to be a remarkable success. Mahatma Gandhi himself praised their efforts.

During the initial years, the control programme was a tremendous success, and was hailed all over the world. All other methods of mosquito larval control, such as the use of the Gambusia fish, larvicides like Paris green, and environmental control, were given up as they did not seem necessary. But in the mid-1960s, malaria came back with a bang. Owing to the euphoria created by the success of vector control in the early 1960s, malaria research, which should have continued, had practically come to a standstill. The Indian Journal of Malariology, which had apparently lost its relevance, had stopped publication.

A.P. Ray, the architect of India’s successful malaria control programme, could be compared to Fred Soper, who organised a successful malaria control programme in the Panama Canal Zone in the pre-DDT era. But Ray failed us in one important aspect. He depended too much on the efficacy of DDT and could not foresee vector adaptation to chemical pressure. Insect resistance to chemicals was not well known at the time. The initial success of DDT made him think that there would be no further need for entomologists in mosquito control work. Many were diverted to family planning operations or had their services terminated. Only the junior supporting field staff were retained to continue with the DDT spraying programme. For this policy choice, India paid a heavy price. There were no trained scientists left to quantify the extent of damage done by DDT-resistant vectors and put in place a policy to minimise the damage.

As Ray himself pointed out, all major malaria vectors in the country became resistant to the two commonly used and comparatively inexpensive insecticides, namely DDT and benzene hexachloride (BHC). When the incidence of the disease was at its lowest between 1964 and 1966 there was slackness in the allocation of funds and procurement of insecticides, leading to inadequate and untimely spraying in many parts of the country. India, like many other developing countries, almost always followed the advice of the World Health Organisation. The WHO recommended organochlorine insecticides (DDT, BHC, etc.) first, then organophosphorous insecticides (such as malathion), then carbamates, followed by synthetic derivatives, and so on. Newer methods of application were then suggested with the existing insecticides. Use of insecticide-impregnated nets (IIN) or variations of it were recommended by the WHO. These were supplied by multinational companies, which helped them make huge profits. They also financed research projects in India through the WHO. Many foreign universities sought collaboration with Indian institutions. There were also field trials with different kinds of prophylactic drugs. Present-day malarial mosquito research has been going on for the last two or three decades, with scarcely anything coming out of it.

Vaccine for malaria

How do we vaccinate our rural populations, about 300 million of whom live in areas where they are exposed to infection? How long will it take for the best of vaccines to provide even partial immunity to our vulnerable population? Why do we find mixed infections with two or three species of parasites in the blood of the same individual? Immunity from the malarial parasite is incomplete, so the vaccine has to be very good. Even the most severe case of naturally acquired malaria does not protect most people from a second round of infection.

In 1980, Dr Adetokunbo O. Lucas, Director of the WHO Tropical Diseases Programme, in an informal discussion with the WHO Expert Committee on Vector Biology and Control in Geneva, predicted that a “malaria vaccine was just round the corner, and the committee will be able to concentrate on the problems of the other vector-borne diseases within a foreseeable future or the committee can wind up their effort and simply go home.” Dr Lucas was well aware how much money was being invested on this research worldwide, especially in the United States, which had an abundance of expertise and resources. More than 30 years later, we are no nearer a breakthrough, despite many of the world’s leading institutions working on a viable vaccine. It is possible that the microbiologists and immunologists will ultimately be able to produce such a vaccine but we may have to wait for many more years. Undoubtedly, research on this subject has to be greatly accelerated and financially supported.

There is certainly a lack of trained manpower to do malaria research. The work culture almost everywhere in India, including in research institutions specially created for malaria research, has lost its momentum owing to neglect, ignorance or poor planning. Medical entomology in early days was pioneered by trained people who had an instinctive knowledge about developing tools to prevent the spread of the disease. Their expertise was critical in guiding vector control efforts. The scientists toiled in the field, in rain and slush, to obtain essential information on mosquito behaviour, which anti-mosquito tools to use, and so on. Among the Indian entomologists, the late Ramachandra Rao wrote an excellent book, Anophelines of

India.

There is a lack of proper measures to control many of our endemic diseases because of the ineffective application of known procedures and an unwillingness to address the real causes of failure. Our control efforts need more operational research. Prompt diagnosis, immediate hospitalisation, and supportive treatment are necessary. The WHO has to take the major blame for the failure. There was a Vector Biology and Control (VBC) division in the WHO which had done excellent work in the past. This was renamed the Division of Molecular Entomology, presumably with vaccine development in mind. Unfortunately, the emphasis shifted from the field to the laboratory. Universities in India which had departments of zoology and entomology now have departments of life sciences and biotechnology instead. In many medical research institutions, the entomology division was progressively downgraded.

The National Vector Borne Disease Control Programme in India has been facing a staff crunch— many positions of entomologists remain vacant. In 1985, one research institute started a two-year master’s course in Medical Entomology, initially supported by the WHO. The course produced many well-trained entomologists. But it was discontinued in the late 1990s because the graduates could not find jobs in India. Another master’s course, in Public Health Entomology, was started a few years ago in the same institute. This course may also be abandoned soon as the degree has not yet been recognised by

the employing institutions.

The epidemiology of any vector-borne disease is quite complex. The parasite or pathogen (be it a virus, a bacteria, a protozoan or a helminth), the mosquito, the human victim and the environment are all intimately interwoven. In the case of malaria, four (now five) species of human plasmodia with differing biology are involved, and so are numerous vector anophelines, each with its own peculiar bionomics and ecology. Human susceptibility to the disease also varies with the environment and society. And finally, the environment has an infinite variety of features. Most of the arbovirus diseases are of zoonotic origin. The latter do not feature in today’s research priorities in India. In the case of two common diseases, dengue and chikungunya, though there is evidence of a zoonotic cycle, no meaningful work has been done. The Kyasanur forest disease, transmitted by ticks, and scrub typhus, transmitted by mites, are re-emerging in India. Birds and animals, both small and large and wild and domestic, are also involved in the transmission. The forest is one environment with many vectors.

We can only aim at controlling VBDs as it is not possible to eradicate them. The vector population should be kept below the critical level. To do this, we must know all aspects of the vector populations and their build-up, their drivers, the environment and human ecology. The role of medical/field entomologists is therefore crucial in the control of VBDs.

Dr Payyalore Krishnaier Rajagopalan is a former Director of the Vector Control Research Centre in Puducherry.

(Published in Businessworld.in)

HEALTH RISK PREPAREDNESS IN INDIA

RISK PREPAREDNESS

Wake-up call- India’s Preparedness to Disease Breakouts

The Ebola disease outbreak draws attention to the need for preparedness and for more government

spending on public health infrastructure. By T.K. RAJALAKSHMI

    The outbreak of the Ebola virus disease (EVD) in some West African nations and the subsequent possibility of the virus spreading to countries in South Asia, including India, have raised legitimate concerns not only about the state of preparedness but also about the general state of public health infrastructure in the country. While it is true that the government took the threat of the epidemic seriously following the global panic when an American doctor and an aid worker got infected, the thrust of the effort and governmental intervention seem to be symptomatic rather than systemic.

The high mortality rate of the disease, at 90 per cent, is attributed to the underdeveloped immune response to the virus. And with pharmaceutical companies reluctant to invest in producing vaccines for the disease as Ebola cases have affected mostly the poorest countries of the world, the need to step up public expenditure on health is of utmost importance. However, the National Democratic Alliance (NDA) government, despite its promises of bringing a new health policy with stepped-up

public expenditure on health and universal access to health services, is relying on the public-private partnership (PPP) model to deliver services. If the experience of the Ebola disease outbreak is anything to go by, there is a crying need for more government spending and research on health.

Resurgence of communicable diseases

It is widely acknowledged that there has been a resurgence of communicable diseases in the past decade, with their outbreak and spread confined not just to developing countries. Following the Ebola disease outbreak, on May 2, the National Institute of Communicable Diseases (NICD) issued an advisory to all health-care providers, including State surveillance officers, to keep a constant vigil and to raise their level of awareness and knowledge of standard precautions to be taken during the care and treatment of suspected Ebola patients. The advisory includes instructions on sample collection techniques and packaging conditions. It also cautions that samples from patients are an “extreme biological risk and that testing should be conducted under maximum biological containment conditions”. The World Health Organisation’s (WHO)

Twelfth General Programme of Work has stated the reduction of “mortality, morbidity and societal disruption resulting from epidemics... through prevention, preparedness, response and recovery activities” as one its five strategic imperatives.

In the editorial titled “Are we prepared?” in Journal of the Association of Physicians of India (September 2014, Volume 62), its authors, Falguni Parekh and Shweta Shah, state that India needs to walk an extra mile as far as “preparedness, response and recovery activities” are concerned. According to them, an estimated 47,000 Indians in Ebola-affected countries were being

contacted by diplomatic missions and supplied with educational material about the disease. And from August 9 onwards, passengers coming from these countries have been asked to fill in a form detailing the places visited and symptoms, if any, before landing. This is essentially a screening procedure for the standard symptoms of the virus. These steps, though welcome, are not adequate, given the potential of the virus to spread. “It is impossible to screen everyone having some symptoms. Given the overcrowding at our airports, by the time the affected person is identified and quarantined, hundreds of people would have been infected,” said a health specialist with expertise

in dealing with epidemics. The government has restricted flights coming from Ebola-affected areas to two international airports, Delhi and Mumbai. The guidelines of the Ministry of Health & Family Welfare state that samples should be collected from any person who has or has had fever with acute clinical symptoms and signs of haemorrhage, such as bleeding of gums, nose bleeds, conjunctival infection, and red spots on the body. But experts say the isolation of such cases coming into the country, given the sheer numbers, will be difficult unless those symptoms are reported by people

themselves.

High cost of PPE and therapy

Dr K.P. Kushwaha, head of BRD Medical College at Gorakhpur, Uttar Pradesh, has dealt with all kinds of diseases caused by deadly viruses, including the scourge of Japanese encephalitis that affects the district and surrounding areas each year. He told Frontline that the Ebola virus, which is an RNA (ribonucleic acid) virus, was a deadly one. The guidelines issued by the Centres for Disease Control and Prevention (CDC) were not followed by the United States government. The personal protection equipment (PPE) comprising gowns that covered the entire body, he said, was manufactured by private companies and was too expensive. “The health worker who has been in contact with an infected person has to be cleaned thoroughly; even while removing the glove, care has to be taken that it does not touch any body part. The guidelines by the WHO and other agencies are very strict about precautionary measures. To what extent they are followed or violated is a big question as the risks are great,” he explained.

   There was no PPE at the airports, Dr Kushwaha said, and expressed doubts about the manpower and resources for the isolation and screening of people, even at the airports. The personnel deployed were only filling in forms and checking whether individuals had any fever or cough. Quarantining was the biggest challenge, but all that had been happening was in the nature of formalities getting fulfilled, he said. There is no cure for Ebola, and persons infected with the virus have to be put on oxygen and antibiotics. In the absence of a vaccine, only an experimental medicine or therapy such as ZMapp, which consists of monoclonal antibodies prepared from the plasma of the person infected, can be given. “Conservative treatment and the isolation of the patient are the only possible ways out,” he said. People returning from Liberia, Sierra Leone or Guinea had to be isolated and screened for

symptoms, he said. “All persons returning from the affected countries should disembark at one airport,” he suggested. In fact, the costs itself of PPE and the experimental therapy have come under question. Each set of PPE costs as much as $100, and the affected countries are finding it very difficult to pay for the PPE. Dr Kushwaha said that barring surgery involving HIV patients, PPE was not provided anywhere in government hospitals.

    The medicine, too, he said, was very costly, at $4,000 a patient a day. The combination had to be taken until the patient was fully cured, he said. Dr Kushwaha also stressed the need for laboratories, biosafety laboratories in particular, in adequate numbers. Given the nature of the virus, special containment facilities were required, which at present were available only at the NICD in Delhi and the National Institute of Virology (NIV) in Pune. Experts are of the opinion that normal pathological

laboratories are not suitable for the testing of suspected Ebola samples.

Doctor-patient ratio

Dr Kushwaha also laments the poor doctor-patient ratio in the country. “The number of doctors and health workers has not kept pace with the growth in population. The 40,000-odd doctors and 284 medical colleges are hardly enough to meet this challenge,” he said, adding that every State should ideally have an epidemiological institution. He recommends an epidemiological control authority on the lines of the National Disaster Management Authority to tackle an epidemic situation. The Integrated Disease Surveillance Unit was not working well, he said, as there was no monitoring. He recalled how at the time of the swine flu epidemic, each hospital was sanctioned up to Rs.4 crore to establish swine flu laboratories. None of those laboratories were functional, he said.

      The chapter on health in the 12th Plan document notes that the total health infrastructure in the country is much below the stated requirement. While the number of skilled professionals has increased, they are concentrated in urban areas. In rural areas, the numbers of accredited social health activists (ASHAs) has gone up but only half of the additional numbers got advanced or 5th module training. In any case, ASHAs, who draw incentive-based emoluments, are deployed for the purpose

of reducing maternal and infant mortality. Moreover, their regularisation and working conditions still remain unaddressed. The chapter further notes that very few of the facilities at the sub-centre, community health centre (CHC) and primary health centre (PHC) levels meet the requirements laid down in the Indian Public Health Standards. The shortfall in each category is huge: laboratory technicians 80 per cent, specialists 88 per cent, doctors 76 per cent, health workers (male) 75 per cent, nurses 53 per cent, and auxiliary nurses and midwives (ANMs) 52 per cent.

       Over-reliance on contractual appointments as the means of increasing service providers is another matter mentioned in the chapter. The difference in pay and perks for the same work between contractual and regular staff is irrational. More seriously, the health chapter in the 12th Plan, while arguing for a comprehensive approach for health care, observes that public expenditure on health, both Plan and non-Plan and State and Central, was less than 1 per cent of the gross domestic product (GDP) in 2007-08. This went up marginally to 1.05 per cent in 2010-11, which the chapter says, “needed to increase much more”. But it does not appear that the present government’s thinking on public expenditure is very much different from that of the previous government. Reports of a targeted National Health Assurance Mission with some promises of health insurance and provision of generic variants of essential medicines at affordable rates have appeared, but the government plans to deliver

health care through the PPP mode as well.

For a maximalist approach

While the scare of Ebola should legitimately make the authorities focus attention on India’s public health system, some experts say there is no need to go into panic mode as far as mortality and infectivity are concerned. Agreeing that public health systems needed to be strengthened immeasurably, T. Sundararaman, Visiting Professor at Jawaharlal Nehru University, New Delhi, and former director of the National Health Systems Resource Centre, told Frontline that while mortality and infectivity were high, it was not impossible to control them. Liberia faced the brunt of structural adjustment policies under the dictates of the World Bank and thereby its public health system could not withstand the onslaught of the virus. The problem, he said, was that most public systems, facing the kind of pressure that Liberia did, opted for a minimalist package of health care. This was a highly selective package of health care. “Whenever there is an emergency, there is a maximalist response,” he said, but the approach continued to be minimalist. He advised that at all times, there should be a certain degree of redundant capacity. “This is to say that large hospitals should not target 80 per cent occupancy. We cannot expect a private hospital to keep beds vacant. There should be enough

and more number of beds to respond to situations of emergency,” he said, emphasising that most hospitals in India were overcrowded. “The government has responded in terms of identifying places where the infected can be isolated and in creating awareness, but the overall preparedness is not there,” he said.

     One of the foremost requirements, Sundararaman said, was an efficient system of notifying diseases. The symptoms of Ebola are similar to that of dengue hemorrhagic fever. “One cannot prepare for an epidemic like Ebola without having prepared for tackling epidemics on an ongoing basis. The integration between clinical care and the city health office is an example of such coordination and, to my knowledge, Kolkata and Chennai are two cities that have such a system in place,” he said.

      There could be a guarantee that the virus could be restricted in the airport areas. However, most cities, he said, including second- and third-tier ones, did not have a robust public health system in place. “There has been much talk of a health policy since the 12th Plan, but nothing seems to have taken off. Public expenditure on health has remained stagnant,” he said.

That seems to be the fundamental point. Writing in Journal of the Association of Physicians of India, Falguni Parekh and Shweta Shah say that the WHO has identified some basic principles in dealing with public health emergencies of national and international concern. Assuming that Ebola is one such emergency, a strong and efficient response should include— after considering the socio-economic, demographic, environmental and ecological factors that facilitate the occurrence and

spread of the disease in India—infrastructure for transport, triage and isolation of patients; provision for treatment to the patients and the implementation of infection-prevention practices, including environmental cleaning procedures according to national and international guidelines of the National Centre for Disease Control (NCDC), India, the WHO and the CDC; use of unlicensed drugs and vaccines according to the WHO recommendations; laboratory facilities for diagnosis and sample

collection; an efficient surveillance and reporting system; and provision of information and training to public health officials and the community through mass communication systems.

       The Ebola disease outbreak is a wake-up call for the government to spend more public health. According to the Jan Swasthya Abhiyaan (people’s health movement), even though public health care systems account for only 29 per cent of the total health expenditure and employ less than 20 per cent of the medical workforce, they provide about 33 per cent of all outpatient care as provided by a qualified provider and 40 to 50 per cent of all inpatient care and 100 per cent of all preventive and promotive care. If anything, health care requires a maximalist approach in terms of everything beginning with public expenditure.

(Published in Frontline.in)

Antenatal and Postnatal care initiatives

Caring for the mother and child: Health Ministry makes innovative use of technology to provide antenatal and postnatal care

The Ministry of Health & Family Welfare has been making innovative use of technology to reach out to the mother and child for effective delivery of health services under the National Health Mission.
Mother and Child Tracking System (MCTS)
The Health Ministry has introduced web based name based tracking system called Mother & Child
Tracking System (MCTS) across all the States and UTs in 2010 to facilitate timely delivery of
antenatal and postnatal care services to all the pregnant women and immunization to all the children.
The system captures personal details such as name, address, mobile number etc., of every pregnant
woman and child up to five years of age. A total of over 14 crore pregnant women and children,
besides 2.24 lakh Auxiliary Nurse Midwives (ANMs) and 9.31 Accredited Social Health Activists
(ASHAs) have been registered in MCTS till now. The MCTS aims to ensure that every pregnant
woman gets complete and quality antenatal and postnatal care, and every child receives the full range
of immunization services. Under MCTS, appropriate health promotion messages to beneficiaries that
are relevant according to the month of pregnancy or date of birth of the child are being sent on
mobiles of beneficiaries.      
Unstructured Supplementary Services Data (USSD) based solution has been introduced for real time
updation of MCTS database by ANMs using their existing mobile phones. Efforts are being made to
develop tablet based applications which will allow health workers to register and update service
delivery information from tablets, resulting in timely registration and updation of information and
better microplanning. Integration with Aadhaar is being planned for unique identification and generation of records. A self registration web portal is also expected to enable the beneficiaries to maintain and see the details of ANC, PNC, etc., related to them.
Mother and Child Tracking Facilitation Centre (MCTFC):
In addition, the Health Ministry has set up the Mother and Child Tracking Facilitation Centre
(MCTFC) at the National Institute of Health and Family Welfare (NHFW). It is major step taken by
Government of India under the National Health Mission in improving the maternal and child health
care services.
The MCTFC has 86 seats and it is designed to:
I. Provide a supporting framework to MCTS and help in validating the date entered in MCTS by

making phone calls to pregnant women and parents of children and health workers;
II. Be a powerful tool in preceding relevant information and guidance directly to the pregnant
women, parents of children and to community health workers, thus creating awareness among
them about health services and promoting right health practices and behaviour;
III. Contact the service providers and recipients of mother and child care services to get their
feedback on various mother and child care services, programmes and initiatives like JSSK,
JSY, RBSK, National Iron Plus Initiative (NIPI), contraceptive distribution by ASHAs etc.
This feedback would help the Government of India and the state governments to easily and
quickly evaluate the programme interventions, and plan appropriate corrective measures to
improve the health service delivery;
IV. Check with ASHAs and ANMs regarding availability of essential drugs and supplies like ORS
packets and contraceptives.
Kilkari
The IVRS based application called Kilkari is being piloted under which audio messages on maternal
and child health care are being sent to pregnant women and parents of children. A series of 18 health
promotion and awareness generation messages for pregnant women and parents of infants which have
been specially customised for each stage of pregnancy and the age of infant have been professionally
recorded in simple Hindi dialect and would be disseminated as audio messages through mobiles to
lakhs of pregnant women and parents of infants particularly those residing in high priority districts of
high focus States. Another IVRS based application called Mobile Academy had been tested for
training of ASHAs and ANMs. These applications are proposed to be nationally rolled out by 15th
August, 2015 to increase awareness and improve the healthseeking behavior of pregnant women, parents of infants and to provide training to the health workers.
******
*Dr. Manisha Verma, Director (Media), M/O Health & Family Welfare, Govt. of India.
Featured in pib.nic.in

DPCO and NPPA

We Are Governed By DPCO, & We Go By It’  The NPPA chairman is betting on its online database to help track fraudulent activities, including drug pricing

Recently, there was talk that the Narendra Modi government had “arm twisted” the National Pharmaceutical Pricing Authority (NPPA), the drug price regulator, into withdrawing an internal guideline for operationalising a public interest clause in the Drugs Price Control Order (DPCO) 2013.The timing of the withdrawal — a few days before Modi’s US visit — lent credence to this view as the global pharmaceutical industry is the biggest anti-India lobby in the US. In an interview to BW| Business world, Injeti Srinivas, chairman, NPPA, dismisses such talk, asserting that the agency’s powers to keep medicine prices under check remain intact. Excerpts:

The NPPA has moved out of a time-tested price fixing mechanism that was linked to actual production cost of the drug to a market price-based system after the introduction of DPCO 2013. Has it changed the NPPA’s role as an independent drug price watchdog?

The new DPCO 2013, which replaced the DPCO 1995, has three major departures. The first is its market-based pricing approach, in place of the cost-based pricing approach. The second departure is over the identification of the “scheduled” drugs that should come under price control. While the earlier DPCO identified certain bulk drugs and controlled the prices of all formulations that had any of these bulk drugs as ingredients, the new order follows a principle of essentiality. It treats all medicines included in the National List of Essential Medicines (NLEM) of the health ministry as “essential” for inclusion in the “scheduled drug” list for the purpose of price control. The third important departure is the exclusion of bulk drugs from price control. Unlike the DPCO 1995, today you only control the formulation prices; that too, formulations of specific strength and dosage form as specified in the NLEM. However, that doesn’t mean the overall mandate of the NPPA has changed. The NPPA continues to strive to ensure that all essential drugs are made available to people at an affordable price. Most importantly, the “essentiality” factor became the underlying criteria for price control after a Supreme Court directive to the government to ensure that “essential” medicines are not left out of price control. The SC directive carries the force of law, and overrides anything to the contrary.

The NPPA has been accused of going beyond the NLEM list and bringing many drugs/versions of drugs under price control. Should an extended release (ER) or a sustained release (SR) form of a scheduled medicine also come under price control?

A new or novel drug delivery system (NDDS) does not automatically exempt a scheduled drug from price control. As far as the delivery system is concerned, we have a separate provision in the DPCO (paragraph 32 of the Order). If any medicine qualifies for exemption under para 32 by virtue of having a novel delivery system developed through indigenous research and development, it has to get a certification to that effect from the DCGI (Drugs Controller General of India), and we will honour it instantly. Even if a scheduled drug does not qualify for price exemption, it may qualify for differential pricing if it meets the criteria of “new drug” as defined in the DPCO. Second, in case there is a well-acknowledged therapeutic gain associated with the NDDS in question, then the health ministry will have to make a separate entry for that advanced version in the NLEM list as an ER category, or as a SR category, etc. Then we will compare similar versions of the medicine. Ordinary tablets will have one price, and sustained release will have another price. We are governed by the DPCO, and we go by it alone.

Going by the number of litigations involving drug firms and the NPPA, each price notification seems to be resulting in a fresh set of complaint. Why so?

 Sometimes, there will be bona fide mistakes that the NPPA may have committed. We do issue corrigendum in such cases. But then, there is the larger issue of poor database. How are we monitoring overcharging today? We are purchasing random samples from the market (to see if the pack price matches the ceiling price fixed by the NPPA). This is always subjective. Companies can always say why you have picked us, not others. Errors will always be there as long as we do not have a comprehensive data (collection and management) system. The problem will persist until we make this exercise totally non-discretionary and until every case of breach of the ceiling price gets a show cause notice.

How to move towards this system?

Especially when the NPPA does not have its own data collection mechanism, and depends on private databases such as IMS, Pharmatrac, medical bulletins, etc Technology has gone very far, and we have developed, with the help of NIC, IPDMS (integrated pharmaceutical database management system), a multi-purpose tool for this purpose. It is an online platform that allows companies to provide essential information about the products they are manufacturing, procuring through import or third-party arrangement, the quantities they sell, the prices of those products, the price revision status, etc. The current NLEM list, prepared by the health ministry in 2011, is undergoing a revision now. What will be the NPPA’s recommendations to the NLEM revision committee? The NLEM needs certain modifications in order to fully meet this requirement from a strictly price control angle. We are making an independent assessment to see how far the NLEM has served as an effective tool for price control and an affordable access to essential drugs, what has been the impact of the medicines already included in the list and what more needs to be included. The NPPA is part of this exercise.

Why should the NPPA get into a separate exercise to assess this? Why cannot it be a combined evaluation with the health ministry committee, especially since the NPPA representative is also a member of the NLEM revision committee?

The reason is simple. It is not a separate exercise, but a specific input from the price control angle. The NLEM is primarily meant to promote scientific and rational use of medicines, which is what the health ministry committee will look into. They will look at the disease burden of the country, prevalence of diseases, and then map drugs across therapeutic groups. In each therapeutic group, they will look at the molecules, and the cost-effective options for public health procurement. This may not exactly match our mass consumption and affordability parameters.

The NLEM does not reflect the prescription pattern. So, what does one do if despite having a set of price-controlled medicines, people continue to buy high-priced ones that are commonly prescribed? How do you intend to address this problem?

Well, those medicines, the ones that are consumed most but are not part of the NLEM, should be closely scrutinised as very important candidates for inclusion in the revised list. We are looking at the top 300 molecules volume wise, and then distributing it as per therapeutic groups and sub-groups to study the situation. We have found out that 92 of the top 300 molecules are already in the NLEM list. Then, we need to do two exercises. One is to see which are those 208 molecules that are left out, understand whether there are any equivalent NLEM medicines (molecules). We need to see the sale volumes of each of these brands. So if the NLEM volumes are very low, and those of the equivalent, close substitutes or analogs are very high, we will have to add that (in NLEM) to capture the prescription behaviour. Also, we need to see the coverage (in terms of volume across dosage forms) for the balance 92 molecules. Even within the 92, one would tend to seek the inclusion of the most consumed form of medicine.

Companies have approached courts against price fixation for 108 drugs under Para 19 of the DPCO, a public interest clause that allows the NPPA to control the prices of non-scheduled drugs. The withdrawal of the “internal guideline” was also seen as an attempt to bring all medicines under the ambit of Para 19. Your comments.

The matter is sub judice. I would not like to comment on this. Though, one thing must be stated upfront — the withdrawal of internal guidelines had nothing to do with the PM’s US visit. It was done (related to 108 drugs) to strengthen price notification orders, which are speaking orders. Each price notification order itself is a DPCO. They are very much standing and much of it has already been implemented to the consumer’s benefit.

Industry fears that too much reduction in prices in the home market can impact export revenues. For instance, the US Congress asked 14 companies, including three Indian firms, to give details of the lowest price of their drug internationally. Do you see merit in this argument?

You see, reference prices are seen in relation to comparable countries in terms of purchasing power. Every country has a reference basket. And in the reference basket they have similar countries. India cannot be in the reference basket for the US. India has a per capita income of $1,500($5,400 on the purchasing power parity scale), whereas the US per capita income is $53,000. Even after adjusting it to purchasing power parity, the difference will remain so large that you cannot compare the two. So, it is not a valid argument at all.But they say drug prices in India are already lowest…No. When you factor in the per capita income and purchasing power parity, many drugs in the generic drug category (99 per cent of India’s drug market is generic) are cheaper in the US than in India.

The price of medical devices is another concern. Industry says the NPPA is trying to fix the prices of medical devices by using the parameters meant for chemical drugs. What is your view?

See, there are 22 medical devices that have been notified as drugs under the Drugs and Cosmetics Act and Rules. Therefore, they are drugs. Nobody can dispute that. When a separate statute will come for medical devices, it will apply. But until that happens, they would be governed under the Drugs and Cosmetics Act. So, if they are drugs, they are well within the ambit of price control. That much is clear. Already two of those are under price control (Copper T and condom). The rest are not. We have got inputs from some state drug controllers that orthopaedic implants and cardiac stents need to be brought under price control. These are important recommendations because many of these are imported goods. The landing price and cost to patient are often three to four times higher. A cardiac stent comes at Rs 40,000, but it ends up being sold at Rs 1,30,000, which is exploitative. And something has to be done.The problem, which we are facing and needs to be solved, is that these are not identical across brands like chemical compositions. So making the simple average is a problem. I agree that will have to be addressed. But that is more of a formula problem.(This story was published in BW | Businessworld Issue Dated 29-12-2014)

Drug Resistant Antibiotics and Superbugs

Incredibly Unwell India must follow up quick delivery of tourist visas with efforts to tackle the emergent threat of super bugs by nayan Chanda

India has recently launched an online visa program- me in the hope of doubling the inflow of tourist dollars, which has been well below the country’s potential. Quick delivery of visas is, however, only the first and easiest step. It is much harder to provide the facilities for a safe and enjoyable visit for millions wishing to taste what the country’s tourist promotion has billed as ‘Incredible India.’ It is high time the country redoubled its efforts to tackle the emergent threat of superbugs that has increasingly come to be associated with India. In recent years, the so-called superbugs — the catch-all for pathogens resistant to known antibiotics — have caused thousands of deaths around the world. Even developed countries like the US and those in Western Europe see nearly 50,000 deaths each year from infections caused by antibiotic-resistant bacteria. In 2010, a British scientist named a superbug NDM-1 — after New Delhi where it was found, — and it caused an uproar. Some even spoke of a plot to harm India’s rising medical tourism. Now, a research paper published by the US National Institute of Health has named India as the likely home of superbugs. The paper warned that health care providers should be aware of the increased risk of superbug infection “among returned travelers, especially those from India”. Shortly thereafter, in September, President Obama concluded that superbugs pose a serious public health risk and appointed a commission to prepare a five-year plan to confront the potential spread of the disease. The seriousness and international nature of the problem was highlighted by the fact that in addition to the relevant health authorities the commission included the state and defence departments. In a way, those afflicted with the superbug are victims of India’s success. The rise of the country’s $12.4 billion pharmaceutical industry, producer of nearly one-third of the world’s antibiotics, has seen the proliferation of powerful generic drugs to every corner of India. Until recently, local chemists in any small town would hand strips of antibiotics, without a prescription, to customers complaining of common ailments like diarrhoea, fever or cough. The indiscriminate use of such magic drugs has provoked an inevitable response: these ‘bugs’ have gradually developed a resistance to antibiotics. According to Yale University’s Manisha Juthani-Mehta, a specialist in infectious diseases, between 70 to 90 per cent of Indians have drug resistant variety residing harmlessly in their intestines. The problem is that open-air defecation and poor public hygiene have allowed the superbug to contaminate the river, waterways and even drinking water. If such bacteria infects other organs or enters the blood stream it can be lethal.  There have been incidences in India’s private hospitals where international patients after undergoing routine bypass surgery have died of an infection from superbug. Global concern led India to set up a taskforce in 2011 to address the issue of the superbug. After initially blaming unnamed foreigners for plotting to damage India’s medical tourism industry (which brought in $872 million in revenues in 2010) the government has taken some long overdue measures. A decision earlier this year requiring chemists to insist on a doctor’s prescription before selling common antibiotics should help in reducing the overuse of antibiotics. However, the efficacy of the rule will depend on its enforcement. The Modi government’s cleanliness campaign and the drive to build toilets in the countryside, where millions relieve themselves in the open, is a good start. Along with measures to provide toilets, clean drinking water and build sanitation infrastructure, India needs to launch mass education campaigns about public hygiene and preventive healthcare. The country certainly needs more international visitors, but the easy availability of tourist visas should not merely open the door to an incredibly unwell India.