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Regulatory Challenges in Global Clinical Trials

In the new patent era pharmaceutical companies have changed their strategy to market their products. They are launching products in multiple markets with a single shot to capture their share. In order to get an approval for marketing of their product, regulatory bodies are insisting on clinical trials of land for the safety concerns of the people of their region and suspecting and questioning the efficacy of the product.

In this scenario, the pharmaceutical companies are bound to go for global clinical trials. In contrast to routine trials, there are multiple technical, procedural, and legal hurdles in conducting global clinical trials varying from site selection to regulatory clearances to precede a trial.

Let’s discuss some of the important issues. In this situation one has to go with global thinking with local regulatory process awareness.

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Focus on skilled talent pipeline in Indian Pharma sector

In recent years, several domestic pharmaceutical companies from India has addressed their recruitment needs to flourish their footprint extensively in international pharmaceutical arena and to improve quality of output.

Simultaneously various multinational companies are planing for job cuts, the enticed international market, is making companies in India and other Asian parts strengthen the quality of their human resource base. Now the evolution of human capital is one of the most vital factor for the companies growth, re-structuring of management training programs to built a highly motivated, innovative, and ethically committed team(s) to play a key role in ensuring the future pharma industry progress. The various schemes such as fortifying quality manpower is now an integrated part of the agenda of Asian pharmaceutical companies, as the aim is the evolution of new and innovative drugs.

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Future trends of Indian Pharma Industry

Conventionally, the Indian pharmaceutical industry has been depended on a core competency in generics, manufacturing and comparatively unripened potentialities in Research & Development. This prospect has overhauled considerably since the 1990s and Indian companies have been making investments towards nourishing drug discovery and development activities.

The adoption of patent laws and the surge of contract manufacturing have preceded to the diversification of revenue streams, altering Indian pharma industry to go across high market growth.

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Few tips for Medical Practice Promotion Strategy

400 Plus medical colleges in India, a largest number of medical colleges in the world, where qualifications are recognised by the Medical Council of India (MCI). These medical colleges have a combined capacity to provide medical education for 54,145 students and churning out close to 19,000 medical specialists per year. The MCI motto is to provide quality healthcare to all citizens through promotion and sustenance of excellence in medical education.

Setting up a new healthcare facility is the ultimate goal for doctors in India. The challenge of pulling patients starts right at the beginning of the medical profession. Market competition and standard of living demands that the so called "waiting period" be kept down to a minimum. As a result, calls for effective and highly focused promotions for new medical care establishments. 

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Hiring trends for Medical, Bio and Pharma sector

Medical, bio and pharma : Hiring trends:

From past few years, the healthcare, bio, and pharmaceutical sector has been determined and delineated by ever increasing scientific, industrial progress, invention and developing patient sentience. Market has been perky for players those who are willing to change to newer suits. In spite of, economic precariousness and the general convulsion of an industry in discharge stage; however employment aspects in these segments are continued in a positive wave. We bringing with medical, bio and pharma hiring trends that will be with these sectors ahead:

Patient engagement:

Indian healthcare sector yet to leverage the do good of data repelled patient relationships. Industry anticipated seeing a more active move towards to patient engagement, with more scope for software technologies and data management.

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The multiplicity of players in the Healthcare Industry

Success Review on Specialty Hospitals:

The continuing boom in the healthcare industry, despite slowdown has invited many players into the healthcare industry and forced many older ones for strategic change, to invest more and standout with specific USP edge over the competitor.

Despite competition and prevailing pessimism on the success of a new hospitals, a group of young doctors turned entrepreneurs have come across with new concept of exclusive specialty hospitals or rather healthcare centers in their respective specialty across India and even trying their luck across the borders, the promoters of many such healthcare centers in the country and elsewhere are relishing great success. All of these successful new generation entrepreneurs have adopted different business strategies to justify high investments, reaping benefits for themselves and their investors.

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Sustainable growth of Indian Healthcare Industry

Indian healthcare industry is on a robust growth curve with enormous scope for investing in new specialty/ multi specialty hospitals (or) expansion of existing facilities in recent days and installation of advanced equipments/ technology up gradation. According to industry experts, definitely these factors will enable healthcare players to serve the increasing patient population to access qualitative diagnosis and treatment at affordable price models.

Industry Snapshot:

According to a report by an industry body, The Indian health care sector is reckoned to be the engine of the economy in the coming years.

Health care industry in India is predicted to reach US $150 billion by 2017 and approx. US $ 250 billion by 2020, contributing an expected Gross Domestic Product spend of 8 % by 2012 from 5.5 % in 2009. The segment from dedicated pharmacies to medical colleges, gives up bigger investment avenues and competitive advantages, modern facilities with highly technology oriented and good

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Challenges and Prospects of Healthcare in India

The healthcare sector in India is projected to grow about 30 % per arum in coming years, Fastest growing industry in India, accounting roughly 6% of GDP and becoming a lucrative career space in India. Reasonably Recession Proof due to growing domestic demand.

A fast developing economy, increased Monthly Household Income and raised urbanization have been instrumental in spreading the affordability net of average Indian. In present environment patients are demanding for value and quality healthcare services for their money.

Economy, demography and Industry:

Indian economy - average annual growth rate over the past half century

  • during the 50s, 60s and 70s - 3.5%
  • during the 80s - 5.7%
  • during 1990-2005 - 6.0%
  • during 2005-06 (9.4%), 2006-07 (9.6%) and 2007-08 (9.0%), averaging 9.3%

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Why do we need a prescription from physicians?

Why do we need a prescription...?

Why do we need a prescription from a physician for some medicament and not for others? It is a fact that comes a point in everybody's life when who needs a medical help. At that situations it turns vital to take prescription medicines in order to recover from the health problems. Often while buying drugs, a thought comes up that, why we should prefer medications that are prescribed by the medical practitioners.

The answer here for this question (?) is that, certain drugs that are listed under schedules, can be consumed only when you have a doctors consultation and their prescription.

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs and cosmetics. The FD&C Act and later amendments, established the current system of drug regulation. It set up classes of drugs and th

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Drug Industry vs. Quality assurance unit

QA is a good practice in the manufacture of bio, pharmaceutical products, as it is the process of ensuring for integrity of products to meet the regulatory standards for the proposed indication or proposed use. It is a responsibility that guarantees manufacturers meet the requirements of patients in terms of safety, quality, efficacy, strength, stability and reliability.

Drug Industry vs. Quality assurance department The spate of counterfeit, inferior /adulterated medicines is a serious concern in the industry. The biopharma segment interpreted an increase in regulations after the thalidomide disaster in 1957. The rigorous, in-depth, scientific, systematic and sustainable move towards to commercial pharmaceutical manufacturing ensures protection of public health.

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