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STAKE HOLDERS IN HEALTH CARE SECTOR

1.

Write Notes on any two

A)

Health Insurance contracts:

Health insurance policies cover the cost of medical treatments. Dental insurance, like medical insurance protects policyholders for dental costs. In the US and Canada, dental insurance is often part of an employer's benefits package, along with health insurance.

A health insurance policy is: 1) a contract between an insurance provider (e.g. an insurance company or a government) and an individual or his sponsor (e.g. an employer or a community organization). The contract can be renewable (e.g. annually, monthly) or lifelong in the case of private insurance, or be mandatory for all citizens in the case of national plans. The type and amount of health care costs that will be covered by the health insurance provider are specified in writing, in a member contract or "Evidence of Coverage" booklet for private insurance, or in a national health policy for public insurance. 2) Insurance coverage is provided by an employer-sponsored self-funded ERISA plan. The company generally advertises that they have one of the big insurance companies. However, in an ERISA case, that insurance company "doesn't engage in the act of insurance", they just administer it. Therefore ERISA plans are not subject to state laws. ERISA plans are governed by federal law under the jurisdiction of the US Department of Labor (USDOL). The specific benefits or coverage details are found in the Summary Plan Description (SPD). An appeal must go through the insurance company, then to the Employer's Plan Fiduciary. If still required, the Fiduciary s decision can be brought to the USDOL to review for ERISA compliance, and then file a lawsuit in federal court. The individual insured person's obligations may take several forms: Premium: The amount the policy-holder or his sponsor (e.g. an employer) pays to the health plan to purchase health coverage. Deductible: The amount that the insured must pay out-of-pocket before the health insurer pays its share. For example, policy-holders might have to pay a $500 deductible per year, before any of their health care is covered by the health insurer. It may take several doctor's visits or prescription refills before the insured person reaches the deductible and the insurance company starts to pay for care.

Co-payment: The amount that the insured person must pay out of pocket before the health insurer pays for a particular visit or service. For example, an insured person might pay a $45 co-payment for a doctor's visit, or to obtain a prescription. A co-payment must be paid each time a particular service is obtained. Coinsurance: Instead of, or in addition to, paying a fixed amount up front (a co-payment), the co-insurance is a percentage of the total cost that insured person may also pay. For example, the member might have to pay 20% of the cost of a surgery over and above a co-payment, while the insurance company pays the other 80%. If there is an upper limit on coinsurance, the policy-holder could end up owing very little, or a great deal, depending on the actual costs of the services they obtain. Exclusions: Not all services are covered. The insured are generally expected to pay the full cost of non-covered services out of their own pockets. Coverage limits: Some health insurance policies only pay for health care up to a certain dollar amount. The insured person may be expected to pay any charges in excess of the health plan's maximum payment for a specific service. In addition, some insurance company schemes have annual or lifetime coverage maximums. In these cases, the health plan will stop payment when they reach the benefit maximum, and the policy-holder must pay all remaining costs. Out-of-pocket maximums: Similar to coverage limits, except that in this case, the insured person's payment obligation ends when they reach the out-of-pocket maximum, and health insurance pays all further covered costs. Out-of-pocket maximums can be limited to a specific benefit category (such as prescription drugs) or can apply to all coverage provided during a specific benefit year. Capitation: An amount paid by an insurer to a health care provider, for which the provider agrees to treat all members of the insurer. In-Network Provider: (U.S. term) A health care provider on a list of providers preselected by the insurer. The insurer will offer discounted coinsurance or co-payments, or additional benefits, to a plan member to see an in-network provider. Generally, providers in network are providers who have a contract with the insurer to accept rates further discounted from the "usual and customary" charges the insurer pays to out-of-network providers. Prior Authorization: A certification or authorization that an insurer provides prior to medical service occurring. Obtaining an authorization means that the insurer is obligated to pay for the service, assuming it matches what was authorized. Many smaller, routine services do not require authorization.[3] Explanation of Benefits: A document that may be sent by an insurer to a patient explaining what was covered for a medical service, and how payment amount and patient responsibility amount were determined. Prescription drug plans are a form of insurance offered through some health insurance plans. In the U.S., the patient usually pays a copayment and the prescription drug insurance part or all of the

balance for drugs covered in the formulary of the plan. Such plans are routinely part of national health insurance programs. For example in the province of Quebec, Canada, prescription drug insurance is universally required as part of the public health insurance plan, but may be purchased and administered either through private or group plans, or through the public plan.[4] Some, if not most, health care providers in the United States will agree to bill the insurance company if patients are willing to sign an agreement that they will be responsible for the amount that the insurance company doesn't pay. The insurance company pays out of network providers according to "reasonable and customary" charges, which may be less than the provider's usual fee. The provider may also have a separate contract with the insurer to accept what amounts to a discounted rate or capitation to the provider's standard charges. It generally costs the patient less to use an in-network provider.

Types of Health Insurance Contract The most common types of health insurance contract are: Temporary Disability Insurance

Temporary disability insurance protects you in the event that you are unable to work, and you will receive an agreed sum for every day that you are unable to work. This benefit is paid for a maximum of 364 days within a three-year period from taking out the insurance policy. Hospital Daily Benefit Insurance

A hospital daily benefit allowance provides for the payment of a predetermined sum for every day that you spend in hospital. The level of benefit is thus independent of, and not related to, the actual expense of hospitalization. Care Allowance Insurance

Private provision can be made for the potential costs of care. This can be in the form of care insurance (Pflegeversicherung), care provision (Pflegevorsorge), or supplementary care annuity insurance (Pflegerentenzusatzversicherung). Insurance companies offer a number of products suited to the needs and requirements of the individual; varying benefits are also offered for different levels of care. It is recommended to seek advice in individual cases. Travel Health Insurance Hospital Expense Insurance :

Hospital expense insurance covers you against all the costs arising from hospitalization. The cost of accommodation and treatment in the hospital, all incidental expenses, transport costs to and from hospital, as well as the cost of being accommodated in any special facility, are all covered by any such policy. Outpatient Treatment Insurance : This covers all costs arising from treatment as an outpatient, including doctors fees, medication and therapeutic aids (such as elastic bandages, orthopedic supports etc.). Dental Treatment and Prosthodontics Insurance :

This insurance covers the cost of dental treatment and dentures; such policies usually define an excess, by way of which the patient is obliged to pay a predetermined amount (deductible portion) of the actual cost of any such treatment.

B)

Classification of Health Insurance :

Health insurance is insurance against the risk of incurring medical expenses among individuals. By estimating the overall risk of health care expenses among a targeted group, an insurer can develop a routine finance structure, such as a monthly premium or payroll tax, to ensure that money is available to pay for the health care benefits specified in the insurance agreement. The benefit is administered by a central organization such as a government agency, private business, or not-for-profit entity. There are many insurance companies that offer different types of health insurance. The difference lies on the amount recoverable, the risks insured against, the length of the insurance, or the amount of premium to be paid by the party insured. Although there are many differences, one should thoroughly examine the contract in order to guard him from undesirable terms and conditions. Also, one should only purchase a scheme that best suits him, and should not sacrifice the services of the insurance company just because it is cheap. As such, here are the general classifications of a health insurance that one may look into in selecting the right one.

1. Comprehensive - this kind only pays a certain percentage of the hospitalization cost, physician's professional fee, and other medical expenses. When the plan is comprehensive, there is more money payout. This is because the payment of the premium is much higher than scheduled plan. 2. Scheduled - as compared with comprehensive scheme, the cash payout is relatively smaller and the coverage is very limited. Generally, scheduled plan covers day-today health care such as visiting a doctor for a regular check up. Although this kind of plan also covers surgeries and hospitalization, the amount to be received from the insurance company is very limited. The importance of knowing whether the health insurance plan is comprehensive or scheduled is because of the amount of money to be received by the party insured. If one knows the amount to be recovered, he can intelligently choose which among the insurance offers he would choose.

Health insurance coverage could be categorized into 2 chief categories:

Your plan should be to insure yourself and your family against the most dangerous and the money-wise terrible losses, which could result from an illness or any accident. If you are provided with health benefits at work, carefully assess the health insurance plans' writing to make sure that one you choose is apt for your needs. If you buy individual coverage policy, purchase a policy, which would cover key expenses and one would pay them to the uppermost maximum level. Save money on policy premiums, if essential, by taking large deductibles and paying lesser value out-of-pocket.

Indemnity plans

An indemnity plan repays you for your medical expenses, in spite of of who offers the service. In certain situations / kinds of coverage, this amount might as well be restricted. The coverage provided by most of the insurers would be in the form of an indemnity plan.

Different plans use diverse techniques for shaping how much you would be reimbursed for your own medical expenses. Below are some universal methods of reimbursement:

Reimbursement - Percentage of actual charges

Under this plan policy, the insurer pays a percentage of the actual charges for insurance covered process and services, in spite of how much they cost. A universal reimbursement percentage comes about 80%. This has the same result as a 20% co-payment.

Reimbursement--actual charges

Under this kind of health insurance plan, the insurer would reimburse you for the actual cost of particular procedures or services, in spite of how much that cost might be.

Indemnity

Under this kind of plan, the insurer pays a particular amount each day for a specific maximum number of days. Although your repayment amount does not really depend on the actual cost of your care, your reimbursement would actually never go beyond your expenses.

If you purchase a hospital indemnity policy, do every so often assess it if you require increasing your every day benefits to keep lick with rising health insurance policy costs. Medicare supplement insurance plan policy, at times called Medigap or Meds up, is personal insurance policy, which assists cover some of the gaps in Medicare coverage. Medicare is the national plan policy of hospital and other medical insurance first and foremost for people age 65 and over who are not covered by any employer's insurance plan. But Medicare does not cover all medical expenses.

2.

Write notes on any two

a.

Evolution of NGOs in India :

A non-governmental organization (NGO) is a legally constituted organization created by natural or legal persons that operates independently from any government. The term originated from the United Nations (UN), and is normally used to refer to organizations that do not form part of the government and are not conventional for-profit business. In the cases in which NGOs are funded totally or partially by governments, the NGO maintains its non-governmental status by excluding government representatives from membership in the organization. The term is usually applied only to organizations that pursue some wider social aim that has political aspects, but that are not overtly political organizations such as political parties. Unlike the term "intergovernmental organization", the term "nongovernmental organization" has no generally agreed legal definition. In many jurisdictions, these types of organization are called "civil society organizations" or referred to by other names.

The term NGO became popular in India only in the 1980s, the voluntary sector has an older tradition. Since independence from the British in 1947, the voluntary sector had a lot of respect in the minds of people - first, because the father of the nation Mahatma Gandhi was an active participant; and second because India has always had the tradition of honouring those who have made some sacrifice to help others. In independent India, the initial role played by the voluntary organizations started by Gandhi and his disciples was to fill in the gaps left by the government in the development process. The volunteers organized handloom weavers in villages to form cooperatives through which they could market their products directly in the cities, and thus get a better price. Similar cooperatives were later set up in areas like marketing of dairy products and fish. In almost all these cases, the volunteers helped in other areas of development - running literacy classes for adults at night, for example. In the 1980s, however, the groups who were now known as NGOs became more specialized, and the voluntary movement was, in a way, fragmented into three major groups. There were those considered the traditional development NGOs, who went into a village or a group of villages and ran literacy programmes, crches for children and

clinics, encouraged farmers to experiment with new crops and livestock breeds that would bring more money, helped the weavers and other village artisans market their products and so on - in short became almost a part of the community in their chosen area (usually in rural India) and tried to fill all the gaps left in the development process by the government. There are many examples of voluntary organizations of this kind running very successfully in India for the last five decades. Perhaps the most celebrated example would be the treatment centre for leprosy patients run by Baba Amte in central India. The second group of NGOs were those who researched a particular subject in depth, and then lobbied with the government or with industry or petitioned the courts for improvements in the lives of the citizens, as far as that particular subject was concerned. A well-known example of an NGO of this type is the Centre for Science and Environment. It was a CSE who picked up that sample of well water and then submitted the results of the chemical analysis to a court because the organization had not been able to get the factory to change its polluting practices in any other way. In the third group were those volunteers who saw themselves more as activists than other NGOs did. Of course, all NGOs undertook a certain amount of activism to get their points across - they petitioned the bureaucrats, they alerted the media whenever they found something wrong and so on. But this third group of NGOs saw activism as their primary means of reaching their goals, because they did not believe they could get the authorities to move in any other way. Perhaps the best-known example of an NGO in this category is the Narmada Bachao Andolan (Save Narmada Campaign), an organisation that opposed the construction of a series of large dams in a large river valley of central India. The members of this NGO believe that large dams worsen water scarcity for the majority of the people in the long run rather than solve the problem,

and they oppose the displacement it entails upstream of the dam. When the NBA found that it could not persuade the planners in India to agree to its point of view, the NBA members put up pickets, held demonstrations and tried every other way they could think of to oppose the construction of the first of the big dams. Most of the NBA member went to jail a number of times as a result. Right now, some of them - including celebrated novelist Arundhati Roy - face the prospect of being jailed again, because they criticized the Supreme Court of India when the court's decision on dam construction did not go in their favour. There is no strict boundary between these three groups of NGOs - in fact, Baba Amte is now an important member of the Narmada Bachao Andolan. And whatever be the category a particular NGO falls into, all of them play an important role in modern India they hold the politicians accountable to the people. India is a representative rather than a participatory democracy. Once the elections are over, the politicians who run the federal and state governments do not really need to go back to the electorate for every major decision - there is no tradition of referendums in India, as there is in Switzerland or Denmark. So, in the five years between on election and another, the NGOs - and parts of the media, to some extent - are often the only means available to the citizens to voice their opinions on any decision taken by a government. In a large developing country like India, there are numerous gaps left by the government in the development process - sometimes by intention, sometimes due to lack of funds, sometimes due to lack of awareness. These are the gaps that many NGOs try to fill in modern India. Some of them may work in areas that the government does not want to get into - like fighting discrimination on the basis of caste. Most Indian politicians do not really want to upset the existing caste hierarchy in his or her

constituency, because the politician is dependent for votes on the dominant castes of that particular constituency. In the process, laws prohibiting discrimination on the basis of caste are often ignored unless there is an NGO working in the area that is willing to take up the cause of those being discriminated against.

b.

Types of NGOs :

NGO means non - government organisation. Any organisation who is doing non profit activity is called NGO . The aim to make NGO is to do social activities . These organisations do not involve in commercial activities . The source of fund may be private or govt. NGO collects fund through donation . Now , NGO are also known as private voluntary organisation .

The NGOs can be classified into various types on the basis of different factors like orientation or level of cooperation. NGO type by orientation can be grouped into Charitable orientation; Service orientation; Participatory orientation; and Empowering orientation. NGO type by level of co-operation can be grouped into Community- Based Organisation; City Wide Organisation; National NGOs; and International NGOs; The Non-governmental organizations forms a heterogeneous group and it has a long list of organization working in different areas with varied scope of work. The alternative terms used in addition to NGO include private voluntary organizations, civil society, independent sector, self-help organizations, grassroots organizations, volunteer sector, transnational social movement organizations, and non-state actors (NSA s). Some of the Famous terms used for NGO are mentioned below. BINGO It is a short term used for business-friendly international NGO CITS It is a type of NGO that basically devoted in helping the scientific community by motivating the young talent towards R & D. CSO It is short term for civil society organization DONGO It refers to the Donor Organized NGO

ENGO It is an abbreviated form of environmental NGO like Global 2000; GONGO It refers to the government-operated NGOs INGO It is an abbreviated form of international NGO like Oxfam QUANGO It refers to the quasi-autonomous NGO like an ISO non-governmental organizations, such as the International Organization for Standardization (ISO) TANGO It refers to the technical assistance NGO GSO it stands for the Grassroots Support Organization MANGO It refers to the market advocacy NGO CHARDS It is a short form for Community Health and Rural Development Society As per the World Bank Typology, the NGOs can be classified into Operational and Advocacy NGOs. Operational NGO The main purpose of operational NGO is to design and implement the developmentrelated projects. The scope of the Operational NGOs can be national, international or even communitybased. Advocacy NGO The main purpose of an Advocacy NGO is to promote a specific cause. It makes efforts to raise awareness and knowledge by doing various activities like lobbying, press work and activist events.

It is estimated that 40000 NGO are working internationally and more than 1 million NGO are only in India . Main objectives for making NGO are to reduce poverty , increase employment and support to poor children.

3.

Write notes on any two

a.

Medical equipment manufacturing industry in India

The booming healthcare market, global medical equipment manufacturers are now setting up plants in India. While companies such as Aloka Science and Humanity of Japan and Starkey of the US have recently set up their units, others like Philips Medical Equipment are scouting for partners.

Japanese ultrasound manufacturer Aloka has entered into a 60:40 joint venture with Chennai-based Trivitron. The joint venture will invest Rs 50 crore and manufacture 1,000 ultrasound equipment annually. Trivitron said it would soon form similar joint ventures with 3-4 more foreign companies to manufacture various medical equipment with an investment of Rs 250 crore in a medical equipment manufacturing park in Chennai.

In the past six months, Japanese opthalmist company Hoya, Nova India of Brazil and Chinese company Mind Ray have set up assembly units in India. Niche player Starkey, the No 1 hearing aid maker in the US, has also set up a manufacturing unit in India As there is a good demand, companies can now break even in 2-3 years, compared with 8-10 years some years ago. It is now much more viable for companies to set up units in India, said Starkey India managing director Rohit Misra. However, all these units will mostly manufacture low or middle level segment products and require relatively small investments.

Currently, India s medical equipment market, including small devices, is estimated to be Rs 2,500 crore. It is growing at 10% but is expected to increase to 15-20% in the next couple of years. About 80-90% of the medical equipment used in the country are imported. Industry officials said once global companies started full-scale manufacturing in India, prices of medical products could fall 15-50%. Hospitals spend a large chunk of their investment in procuring equipment. In the case of top speciality hospitals, medical equipment account for as much as 35% of their total capital investment.

GE has a tie-up with Wipro, which manufactures diagnostic equipment in India. Philips Medical Equipment has said it is looking for suitable partner to start manufacturing in India. The country has never seen such kind of growth. Companies, which want to cash in on the boom, would like to be close to the centre of action than just depend on imports. The country s healthcare industry could see a boom similar to the one it is witnessing in the auto sector today, said Philips Medical Equipment senior director (Indian Sub-continent) Anjan Bose.

US-based healthcare IT and technology provider PekinElmer Inc is also looking for partners to develop its products in India. Besides the cost advantage, the Indian healthcare industry is a large market and has the right skill set. We plan to make India the centre of our exports to unregulated markets such as the Middle East, Asia and Africa, said the company s chairman and CEO, Gregory L Summe. However, he

added that the company would develop its sophisticated equipment for regulated markets such as the US and the UK from its global centres.

The global medical devices market is estimated to be USD196.65 billion in 2006 which has grown at a CAGR of 4.5% during the five year period 2001-05. Indian medical devices and equipment market was estimated for USD1318m in 2005 with a growth of 4.6% over previous year. The medical devices and equipments are used for diagnosis, therapy and patient monitoring. Market for medical supplies and disposables is dominated by the domestic manufacturers, whereas importers dominate the costly and high end medical equipments. Cygnus estimates the market to become US$2028m by 2010 with an annual growth rate of 9%. Some of the growth factors like booming economy with an average growth of 5.97% during 2000-05, increasing healthcare expenditure (personal healthcare expenditure by individual has grown by 16.04% during 2000-05) have been driving the industry. Changing demographic profile with increasing old age population, increasing incidences of life style diseases like cancer, CNS and diabetics, etc are some of the other relevant factors. This Industry Insight on Medical Devices and Equipments in India gives an overview of the industry and its segments in terms of size and growth over the last five years. This report discusses in detail each segment while giving information on their products, exports and imports. Recent trends and developments in the industry are also covered. This report analyses the factors that drive the growth of the industry, issues and challenges faced by the industry and the critical factors that will determine the success of companies in the future. Fifteen major companies have been profiled with informations on their business and products, manufacturing facilities and R&D. Regulations governing the medical devices and equipments have been covered and information on the key developments in the regulatory environment are also provided. The report ends with the outlook for the medical devices

and equipments industry in India for coming years. The report will be useful to the medical device and equipment companies (Indian and overseas) in understanding the industry in a better way. It will also be useful to the government medical departments and agencies working in the field to get an insight of the industry. The educational institutes may also use this information for their academic purpose to have in-depth industry knowledge. Other research bodies, industry experts, associations & consortia of the industry and consulting organizations may also benefit through the information given in the report.

b.

Public Private Partnership (PPP):

The most significant criteria for a continued growth rate of an economy is rests on the provision of a quality infrastructure. According to the Planning Commission, an approximation of 8 percent of the Gross Domestic Product or GDP needs to be invested. This would help in acquiring a prospective economy as stated in the 11th Five Year Plan. Fund investment of over US $ 494 billion has been conceived of according to the 11th Five Year Plan with effective from 2007 to 2012. The investment sectors under consideration are inclusive of telecommunications, electric power, water transport, road, rail, air, water supply as well as irrigation amounts to about Rs. 20,27,169 crore according to 2006-07 prices.

In order to meet such demands, various Public Private Partnerships or PPPs are being promoted for implementation of infrastructure projects. PPP is often described as a private business investment where 2 parties comprising government as well as a private sector undertaking form a partnership. The deficit can be overcome by ensuring much more private capital investment. Expert guidance is the only way out for enabling efficiency through subsequent reduction in cost.

Promotion of PPP is therefore necessary since its the most preferred mode. Despite of its benefits, there are some constraints too which can be summarized as: Sufficient instruments as well as the ability to undertake long-term equity cannot be provided by the market in the present financial scenario. Also financial liability required by infrastructure projects would not be sufficed.

Most sectors face a lot of hindrance in enabling a regulatory framework as well as a consolidated policy. So its important to convert such policies into PPP friendly. To achieve the desires results, active participation of various state projects are essential. Lack of ability of private sectors to fit into the risk of investing in diversified projects also needs to be overcome. Modernization of new airports, transmission systems and building power generating plants are some of the avenues which required skilled manpower. Ability of public institutions to manage the PPP process should also be subdued. Maximizing the return of the stakeholders needs to be managed due to the involvement of long term deals including the life cycle of the asset infrastructure. Lack of credibility of bankable infrastructure projects used for financing the private sector should also be overcome. Inconsistency is still visible in the limitations of PPP projects, despite of continued initiatives by States and Central ministries.

Inadequate support to enable greater acceptance of PPPs by the stakeholders forms another source of constraint. Several initiatives have been undertaken by Government of India to enable a greater PPP framework in order to eradicate the above mentioned constraints. Various foreign as well as private investments by waving off charges are encouraged. Framing of standardized contractual documents for laying down the terminologies related to risks, liabilities and performance standards have been devised. Approval schemes for PPPs in the central sector has been streamlined through Public Private Partnership Appraisal Committee or PPPAC. A website has been launched for the purpose of virtual PPP market serves as an online database for PPP projects.

PPPs can only be mainstreamed by continuous response to the varying goal of people and economy in general. The boundary domains of PPPs should be increased in order to prosper the infrastructure development of India.

Database

The database lists information on all PPP projects in India. The database on a particular PPP project will essentially provide data on

i. ii. iii. iv. v.

Project information, Bidding information, Project benefits and costs, Legal instruments and Financial information

Development and use of PPPs for delivering infrastructure services has now at least 11 years of precedence in India, with the majority of projects coming in line in the last 5 to 7 years. Policies in favor of attracting private participation as well as innovation with different structures have met with varying degrees of success. Some sectors like telecommunications, power, and ports and roads, have done very good progress compared to limited success in other sectors. Some states have undertaken far more PPPs than others, and there has been a much heavier use of PPPs in some sectors. As far as current status of projects is concerned, as per our database, there have been 758 PPP projects in our main sectors of focus where a contract has been awarded and projects are underway in the sense that they are either operational, have reached construction stage, or at least construction/implementation is imminent. The total project cost is estimated to be about Rs. 383,332.06 Crore.

Central Sector Projects

Public Private Partnership Approval Committee (PPPAC)

The Cabinet Committee on Economic Affairs (CCEA) in its meeting of 27th October, 2005 approved the procedure for approval of public private partnership (PPP) projects. Pursuant to this decision, a Public Private Partnership Approval Committee (PPPAC) has been set up comprising of the following: a. b. c. d. e. Secretary, Department of Economic Affairs (in the Chair) Secretary, Planning Commission Secretary, Department of Expenditure; Secretary, Department of Legal Affairs; and Secretary of the Department sponsoring a project

The committee would be serviced by the Department of Economic Affairs, who will set up a special cell for servicing such proposals. The Committee may co-opt experts as necessary.

4.

Write notes on any two :

c.

Indian pharmaceutical industry

India currently represents just U.S. $6 billion of the $550 billion global pharmaceutical industry but its share is increasing at 10 percent a year, compared to 7 percent annual growth for the world market overall.1 Also, while the Indian sector represents just 8 percent of the global industry total by volume, putting it in fourth place worldwide, it accounts for 13 percent by value,2 and its drug exports have been growing 30 percent annually.3 The organized sector of India's pharmaceutical industry consists of 250 to 300 companies, which account for 70 percent of products on the market, with the top 10 firms representing 30 percent. However, the total sector is estimated at nearly 20,000 businesses, some of which are extremely small. Approximately 75 percent of India's demand for medicines is met by local manufacturing.4 According to the German Chemicals Association, in 2005, India's top 10 pharmaceutical companies were Ranbaxy, Cipla, Dr. Reddy's Laboratories, Lupin, Nicolas Piramal, Aurobindo Pharma, Cadila Pharmaceuticals, Sun Pharma, Wockhardt Ltd. and Aventis Pharma.5 Indian-owned firms currently account for 70 percent of the domestic market, up from less than 20 percent in 1970. In 2005, nine of the top 10 companies in India were domestically owned, compared with just four in 1994.6 India's potential to further boost its already-leading role in global generics production, as well as an offshore location of choice for multinational drug manufacturers seeking to curb

the increasing costs of their manufacturing, R&D and other support services, presents an opportunity worth an estimated $48 billion in 2007.7 Over-the-Counter Medicines The Indian market for over-the-counter medicines (OTCs) is worth about $940 million and is growing 20 percent a year, or double the rate for prescription medicines.8 The government is keen to widen the availability of OTCs to outlets other than pharmacies, and the Organisation of Pharmaceutical Producers of India (OPPI) has called for them to be sold in post offices. Developing an innovative new drug, from discovery to worldwide marketing, now involves investments of around $1 billion,9 and the global industry's profitability is under constant attack as costs continue to rise and prices come under pressure. Pharmaceutical production costs are almost 50 percent lower in India than in Western nations, while overall R&D costs are about one-eighth and clinical trial expenses around one-tenth of Western levels. India's long-established manufacturing base also offers a large, well-educated, English-speaking workforce, with 700,000 scientists and engineers graduating every year, including 122,000 chemists and chemical engineers, with 1,500 PhDs.10 The industry provides the highest intellectual capital per dollar worldwide. The Indian Pharmaceutical Industry The industry's exports were worth more than $3.75 billion in 2004-05 and they have been growing at a compound annual rate of 22.7 percent over the last few years, according to the government's draft National Pharmaceuticals Policy for 2006, published in January 2006. The Policy estimates that, by the year 2010, the industry has the potential to achieve $22.40 billion in formulations, with bulk drug production going up from $1.79 billion to $5.60 billion: India's rich human capital is believed to be the strongest asset for this

knowledge-led industry. Various studies show that the scientific talent pool of 4 million Indians is the second-largest English-speaking group worldwide, after the USA. 11 The Indian Pharmaceutical Industry in 2004 Turnover: $6.02 billion, up 6.4 percent year over year Exports: $3.72 billion Imports: $985.3 million Bulk drug production: $2.10 billion, with over 400 bulk drugs produced. Over 60,000 formulations produced, in 60 therapeutic categories Capital investment: up 14.8 percent to $1.16 billion Employment: 5 million direct, 24 million indirect

A)

Health Care Network

Many large private hospitals in India are slowly turning into large network of healthcare organizations. This network includes 'Treatment for Sickness' and the 'Wellness Industry'. At the heart of all these networks is mostly either a Pharma or a Insurance company, because they are the biggest gainers in the healthcare industry.

These healthcare networks seem to be pushing the single encounter-based medicine to a more holistic patient-based medicine by providing all the services in the network and retaining the patient within the network across the country. Therefore Healthcare Network is a very healthy trend for India.

However the emerging healthcare networks can not achieve their ' Enterprise level Digital Healthcare' dream without an integrated Healthcare-IT policy. But today no existing Healthcare-IT package provides all what is required for running such a massive Healthcare Network.

5.

Write notes on any two

b) Ethics in clinical research

People usually become aware of the opportunity to participate in a clinical study through a variety of means, including: Health care providers Public listings and registries of clinical trials Public notices in print or broadcast media Friends, family, or others who tell them about the clinical research Groups or organizations that conduct or sponsor clinical research

Getting involved in clinical research You don t have to be sick to join a clinical research study Many studies include people who have and who don t have a certain condition. People volunteer to enroll in clinical research. Those who volunteer have the opportunity to have the potential risks, benefits, alternatives, and responsibilities of the clinical research explained to them before they agree to participate, except in rare circumstances involving emergency procedures in immediate life-threatening situations.

A clinical research volunteer may receive some form of compensation for time and expenses, but not all clinical research offers compensation. Clinical research volunteers are sometimes referred to as study or research participants or study subjects.

Giving consent and assent When potential participants decide that they are interested in taking part in a study, they begin discussions with various members of the scientific community who are also involved in the study. Once potential participants understand what it means to be in the study and what the possible risks and benefits are, they indicate their willingness to participate by communicating their agreement and signing a document saying they agree to take part. This process is called giving consent. For children or others who are not legally able to provide consent, a parent or legal guardian provides permission for the person to participate. Even though a person may not be legally able to provide consent, they are still informed about the clinical research to the degree that they are able to understand. They may also have the opportunity to provide their agreement to participate in an alternative way that includes the process of assent.

Protecting participants in clinical research Federally funded clinical research has many safeguards in place to protect those who volunteer to take part. For study participants, especially those with complex illnesses, protected does not mean risk-free all studies carry some risk. Some of the principles that protect study participants include the following: study organizers identify risks, they inform potential study participants of the risks, and they formalize a risk-management plan. Some of the protections for study participants include (but are not limited to): Knowing what will happen during a study Study protocols. A study protocol is a document that describes in detail the plan for conducting a clinical study. o Federal regulations define study protocol contents, particularly if the study involves investigational (not FDA approved) products. o Clinical studies are designed to include a listing of the characteristics that allow a person to participate called the eligibility criteria. o Studies also schedule relevant procedures and evaluations for participants often enough so that potential risks can be detected and addressed in a timely manner.

o Study participants also have specific contact information so that they can get in touch with someone related to the study for any reason at any time. Knowing the possible risks and benefits of participating Study participation consent process. One of the primary safeguards for study participants is that they are informed about the potential risks, benefits, alternatives, and responsibilities of the clinical trial before they agree to participate. When a potential study participant understands the risks, alternatives, and responsibilities, he or she formalizes the decision to participate by communicating with the study investigator or representative and by documenting the agreement in writing. The interactive process of receiving information, asking questions, and indicating agreement is known as the consent process. Reviewing the study before it begins Institutional Review Boards (IRBs). An IRB is an independent body authorized by federal regulations to evaluate a clinical research study to ensure ethics and safety. The IRB reviews the study protocol at length. At the federal level, the Office for Human Research Protection regulates IRBs and ensures that they meet criteria for IRBs as described in federal regulations. o IRBs review study protocols and the documents used to obtain consent from study participants to ensure that potential risks are clearly stated, and that investigators take sufficient and appropriate measures to address risks before the study can proceed. o If a study protocol uses a product regulated by the Food and Drug Administration (FDA), then the FDA may also review the protocol and has the option to request changes before the study can proceed. In some cases the FDA may waive the requirement for an IRB to approve a study (PDF - 35 KB). IRBs that review FDA-regulated research must follow Title 21, Part 50 of the CFR. Monitoring the study while it is underway Data and Safety Monitoring Committee. Some studies rely on an additional independent committee to monitor the study results and its conduct while the trial is underway. Such an independent chartered committee is known as a Data and Safety Monitoring Committee (DSMC) or Data and Safety and Monitoring Board (DSMB) or Data Monitoring Committee (DMC). The functions and oversight of such committees are distinct and independent from IRB activities and approvals. The NICHD has its own Data Safety and Monitoring Policy which outlines the Institute's expectations for this type of clinical research activity. Protecting privacy Certificates of Confidentiality. In general, confidentiality of study participants is covered under the Health Insurance Portability and Accountability Act. In addition, if the release of study data could have negative consequences if linked to a certain participant, due to the nature of the disease or condition, the study can receive a Certificate of Confidentiality. A Certificate of Confidentiality is issued by the NIH, and is a legal document that protects investigators and institutions from being compelled to reveal information that would identify research participants. Ensuring ethical conduct and scientific quality Good Clinical Practices.

o International policies. International ethical and scientific quality documents, such as the Good Clinical Practices (PDF - 380 KB), created by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, provide further protection for those who take part in clinical studies. Such standards are agreed to by regulatory agencies in the United States, Europe, Japan, and other countries to provide general guidance for assuring that participants in clinical research are respected and protected. o FDA Good Clinical Practice Guidelines. The Food and Drug Administration (FDA) has developed guidelines related to good clinical practices.

c) Documentation in clinical research

What is clinical research?

Clinical research is research that either directly involves a particular person or group of people or uses materials from humans, such as their behavior or samples of their tissue, that can be linked to a particular living person. (The process of clinical research, however, protects personal data.) The NIH definition of clinical research is: Patient-oriented research: This type of research involves a particular person or group of people or uses materials from humans. This research can include: o o o o Studies of mechanisms of human disease Studies of therapies or interventions for disease Clinical trials (see About clinical trials for more details) Studies to develop new technology related to disease

Epidemiological and behavioral studies: These types of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions. Outcomes and health services research: These studies seek to identify the most effective and most efficient interventions, treatments, and services. The NICHD is involved with all aspects of clinical research and supports studies without limitations based on age, disease or condition, or technical type of research. What else should I know about clinical research? provides general information about clinical research, from getting involved, to what happens when a clinical research effort ends.

A clinical trial is one type of clinical research. Visit the About clinical trials section of this Web site for more specific information about clinical trials. This Web site provides information about clinical research and the NICHD s role in this research. Select a link below to learn more. General principles of NICHD clinical research Steps involved in clinical research efforts (includes resources for clinical researchers) NICHD clinical research efforts Clinical research references and resources Listings of clinical trials Certificate of Confidentiality Web site The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United States, when a test article is unapproved or not yet cleared by the FDA, or when an approved or cleared test article is used in a way that may significantly increases the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition clinical research may require Institutional Review Board (IRB) or Research Ethics Board (REB) and possibly Other institutional Committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. approval whether or not the research requires prior submission to the FDA. Clinical research review criteria will depend on which Federal regulations the research is subject to (e.g., [(Department of Health and Human Services (DHHS) if Federally funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is

allowed to proceed, by those same FDA regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study.