Pharmaceutical Sciences Career*
Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs. The scope of pharmacy practice includes more traditional roles such as compounding and dispensing medications, and it also includes more modern services related to health care, including clinical services, reviewing medications for safety and efficacy, and providing drug information. Pharmacists, therefore, are the experts on drug therapy and are the primary health professionals who optimize medication use to provide patients with positive health outcomes. Pharmacists are highly-trained and skilled healthcare professionals who perform various roles to ensure optimal health outcomes for their patients. Many pharmacists are also small-business owners, owning the pharmacy in which they practice.
Pharmacy Profession in India:
Currently there are over a million pharmacists in India with around 55% of them in community, 20% in hospital, 10% in industry and regulatory and 2% in academia. In India, formal pharmacy education leading to a degree began with the introduction of a 4 year industry - oriented Bachelor of Pharmacy course. To meet the varying needs of the profession at different levels the following pharmacy programs are offered in India today : Diploma in Pharmacy (D. Pharm.), Bachelor of Pharmacy (B. Pharm.), Master of Pharmacy (M. Pharm.), practice - based Doctor of Pharmacy (Pharm. D.), and Doctor of Philosophy in Pharmacy (Ph. D).
India has a vast and growing pharmaceutical industry. Increasing number of hospitals, nursing homes and pharmaceuticals companies all over the country is a clear indication of the growing scope in this area. Pharmacy offers reasonably good career opportunities both by way of jobs as well as in terms of starting own business. The job avenues for a pharmacist are with pharmaceutical industry, government departments, universities, teaching hospitals, investigation and research institute etc. Within the pharmaceutical industry you might be involved in activities relating to the development, formulation, production or marketing of new drugs for clinical use. Drug control administration and armed forces also offer a wide range of opportunities to pharmacists. Appointments are also available in sale promotion work as medical representatives. M. Pharm or Ph.D holders are normally absorbed in research work, to develop new useful drugs, in laboratories and in production work in pharmaceutical industry and analyzing them for purity and strength. Pharmacist may also take up teaching as a profession as lectures in pharmacy colleges and universities. Pharmacists are hired within the central and state government departments- the Health Protection Branch of the Department of Health and Welfare, the Pest Control Division of Agriculture, the Department of National Defence, Provincial Research Councils, and the Provincial Departments of Agriculture or the Environment. There is also an employment opportunity within the food and cosmetic industries or within any other industry that requires the assurance that new products are as safe and effective as possible. In government departments, a pharmacist maintains proper records according to various Government acts governing the profession of pharmacy. As a drug inspector or government analyst, he has to make sure that the drugs manufactured and sold, are of standard quality. A diploma or degree holder in Pharmacy, after registering with the State Pharmacy Council, can set up and run their own pharmacy or chemists and druggists shop to stock and sell medicines and dispense them according to doctors’ prescriptions. In a retail Pharmacy he has varied duties, including buying and selling of related items demanded by the public.
Current status of pharmacy profession in India:
The Pharmacy education in our country has witnessed tremendous expansion in last one decade. However, the standards in education have been eroded by rising tides of mediocrity. There is an urgent need to initiate an academic exercise aimed at attaining revamping of curriculum, keeping in pace with current and emerging trends in the field of pharmacy.
We have today 6 lacs pharmacists in the country, of which 5 lacs are in community pharmacy. Diploma holders largely handle the pharmacy profession and the providing of quality pharmaceutical care is still a dream. However, significant developments underway may change the situation-
- Increase in consumer awareness
- Awareness among the pharmacists on the need to provide direct patient care
- Entry of international players in community pharmacy and health insurance
- Increasing foreign direct investment in health industry
- Increase in awareness that quality pharmaceutical care can be delivered only by pharmacists trained in direct patient care.
Careers in Pharmacy:
Pharmacist - Being in the health-related field, the graduate can be Hospital Pharmacist or Community Pharmacist. The graduates can therefore work in hospitals as hospital pharmacist or community pharmacist.
Since they have a good knowledge of therapeutic effects of drugs and that of drug-drug interaction, they are more suitable for a job in clinical research. They can opt for the post of clinical pharmacist or clinical research associate in a clinical research laboratory.
Teaching - While in teaching profession they can do research in pharmaceutical field and strive to become a well-known Research Scientist.
Clinical Research- The human testing phase is called the clinical trial. A pharmacist can work as clinical research associate or clinical pharmacist and can rise to the position of project manager. The clinical research associate plays an important role of monitoring and overseeing the conducts of clinical trials, which are conducted on healthy human volunteers. They have to see that the trials meet the international guidelines and the national regulatory requirements.
Pharmaceutical industry - The pharmaceutical industry is a complex, multi-factorial environment, but with the overall aim of discovering, developing and marketing safe and efficacious medicines, and it demands high standards and quality from its employees. With the rich skill mix developed and applicable from the Pharmacy undergraduate degree, the industry provides an ideal environment for a career rich in variety, diversity and challenges.
Scientists - Pharma graduates can absorb as scientist in R&D and F&D. It is field of innovation where talented people in pharmacy working as scientist. Numerous researches are going on in India though compare to less than US and other British industries. Very less candidate from B.Pharm is selected because lack of knowledge but those who have all ideas of subject are greeted in this field.
Quality Assurance Health Manager- The Pharmacy graduate can play an important role in the development of clinical care plans, can investigate adverse medication events and in some cases can suggest preventive measures. He can play a key role in spreading awareness amongst the people about AIDS and the preventive measures to be taken.
Medical Transcription - The graduate can work with medical practitioners to maintain the patient treatment history, the drug to which he/she is allergic etc.
Analytical Chemist of Quality Control Manager – The pharmacy graduate can play a crucial role in controlling product quality. The drug and the Cosmetics Act (1945), Rules 71(1) and 76(1) say that the manufacturing activity should be taken up under the supervision of a technical man whose qualification should be pharmacy graduate.
Sales and Marketing - Ambitious achievers with pleasant personality and good communication skills can opt for the job of Medical Sales Representative. The companies prefer pharmacy graduates for this job, as they have a good knowledge about the drug molecules, their therapeutic effects and the drug - drug interactions.
Data Manager- A pharmacist can seek employment as “Data Manager” to store the data in the computer and process it using software developed for the purpose.
Regulatory Manager - A pharmacy graduate can work as “Regulatory Manager” (RM) in companies and contract research organization. As an RM he has to oversee regulatory documentation such as Clinical trial approval permission, marketing approval permission etc.
Career in Regulatory bodies - A Pharmacist can be absorbed in the Regulatory bodies like Food and Drug Administration. Pharmacist having experience in clinical trial centres can also work as an inspector to inspect the clinical trial process.
Biotechnology – Biotechnology is a fast growing branch and the graduates can opt for post graduate diploma programme in Bioinformatics. They can handle the job of monitoring the conduct of clinical trials that are conducted on human volunteers. It is their responsibility to see that the clinical trials are carried out as per the international guidelines.
Higher studies - After a B.Pharm in pharmacy there are various opportunities for students, they can either go for higher studies like M.Pharm, MBA or Ph.D degrees for improving their skills and up gradation of their degree or they can go for jobs in the chemical companies, research institutes ,Pharma companies ,even universities and colleges.
Pharm.D - is brand new option for graduates in India. It is total 3 years course out of which 2 years of academics and 1 year of training in hospital. Then, appear for NAPLEX and one can register as pharmacist in most of the countries. It involves all the aspects of clinical pharmacology and drug administration covering chiefly drug interactions and adverse effects. It will go to prove more ascents to pharmacist.
Overseas career- Some of the B.Pharm graduates are choosing to fly overseas and make their career bright. By scoring well in GRE, TOEFL, IELTS etc entrances they can pursue M.S, MBA and other pharmacy related courses in US, UK, Australia etc.
Suggestions for B.Pharm graduates to excel in their profession:
For getting good job opportunities pharmacy graduates should not be satisfied with B.Pharm course alone since there is a need for higher knowledge. Today pharmacy sector is looking for professionals who can develop strategies for their organizations, and to guide them for submitting documents to the regulatory authorities. So it is necessary to add post-graduate qualification and research qualifications also. A person with good knowledge and will power will have excellent job opportunities in India and abroad.
Suggestions for young pharmacy students to become successful leaders:
1. Self confidence and believe in own capabilities.
2. Think high and have only positive thoughts and can automatically go high.
3. Have interaction with staffs that excel in their carriers.
4. Make a network of innovators and a network of users.
5. Attend international conferences.
6. Utilise libraries and laboratories.
7. Attend seminars, refresher programs, work shop and training programs continuously in collaboration with industries.
8. Development of writing skills as well as communication skills.
9. Work hard and have a dream for the future. From the dream have a good vision and the vision comes to a reality.
By this way, one can improve and update the knowledge to face global challenges.
The current era of globalization has witnessed evolution in the professions of the health sector, especially in pharmacy. Whereas previously the pharmacist worldwide was seen as responsible primarily for manufacturing and supplying medicines, today the pharmacist's role has evolved towards a clinical orientation. The profession is still under continuous transition. With change in the health demands, pharmacists have a further role to play in patient care.
The precise role of a pharmacist in the health setting is altering and varies significantly from country to country. In contrast to the developed world, pharmacists in developing countries are not fully executing their potential role. They are still struggling for the recognition of their role that can help improve the health care system. Changes in quality pharmaceutical education meet the challenges and needs of the nation in the 21st century.
Pharmaceutical industry in India
The Pharmaceutical industry in India is the world's third-largest in terms of volume. According to Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the total turnover of India's pharmaceuticals industry between 2008 and September 2009 was US$21.04 billion. While the domestic market was worth US$12.26 billion.
According to Brand India Equity Foundation, the Indian pharmaceutical market is likely to grow at a compound annual growth rate (CAGR) of 14-17 per cent in between 2012- 16 India is now among the top five pharmaceutical emerging markets of the world
Exports of pharmaceuticals products from India increased from US$6.23 billion in 2006-07 to US$8.7 billion in 2008-09 a combined annual growth rate of 21.25%. According to Price waterhouse Coopers (PWC) in 2010, India joined among the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with value reaching US$50 billion.
The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970. However, economic liberalisation in 90s by the former Prime Minister P.V. Narasimha Rao and the then Finance Minister, Dr. Manmohan Singh enabled the industry to become what it is today. This patent act removed composition patents from food and drugs, and though it kept process patents, these were shortened to a period of five to seven years.
The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market, and while they streamed out. Indian companies carved a niche in both the Indian and world markets with their expertise in reverse-engineering new processes for manufacturing drugs at low costs. Although some of the larger companies have taken baby steps towards drug innovation, the industry as a whole has been following this business model until the present.
India's biopharmaceutical industry clocked a 17 percent growth with revenues of Rs. 137 billion ($3 billion) in the 2009-10 financial year over the previous fiscal. Bio-Pharma was the biggest contributor generating 60 percent of the industry's growth at Rs. 88.29 billion followed by bio-services at Rs. 26.39 billion and bio-agri at Rs. 19.36 billion.
In 2013, there were 4,655 pharmaceutical manufacturing plants in all of India, employing over 345 thousand workers.
Pharmaceutical industry today
The number of purely Indian pharma companies is fairly low. Indian pharma industry is mainly operated as well as controlled by dominant foreign companies having subsidiaries in India due to availability of cheap labor in India at lowest cost. In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and Russia. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market. Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago.
Most pharma companies operating in India, even the multinationals, employ Indians almost exclusively from the lowest ranks to high level management. Homegrown pharmaceuticals, like many other businesses in India, are often a mix of public and private enterprise.
In terms of the global market, India currently holds a modest 1-2% share, but it has been growing at approximately 10% per year. India gained its foothold on the global scene with its innovatively engineered generic drugs and active pharmaceutical ingredients (API), and it is now seeking to become a major player in outsourced clinical research as well as contract manufacturing and research. There are 74 US FDA-approved manufacturing facilities in India, more than in any other country outside the U.S, and in 2005, almost 20% of all Abbreviated New Drug Applications (ANDA) to the FDA are expected to be filed by Indian companies. Growth in other fields notwithstanding, generics is still a large part of the picture. London research company “Global Insight estimates” that India’s share of the global generics market will have raised from 4% to 33% by 2007. The Indian pharmaceutical industry has become the third largest producer in the world and is poised to grow into an industry of $20 billion in 2015 from the current turnover of $12 billion.
As it expands its core business, the industry is being forced to adapt its business model to recent changes in the operating environment. The first and most significant change was the 1 January 2005 enactment of an amendment to India’s patent law that reinstated product patents for the first time since 1972. The legislation took effect on the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognise not only new patents but also any patents filed after 1 January 1995.t13l Indian companies achieved their status in the domestic market by breaking these product patents, and it is estimated that within the next few years, they will lose $650 million of the local generics market to patent-holders.
In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals narrowed their focus onto high-end patients who make up only 12% of the market, taking advantage of their newly bestowed patent protection. Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations
Indian companies are also starting to adapt their product development processes to the new environment. For years, firms have made their ways into the global market by researching generic competitors to patented drugs and following up with litigation to challenge the patent. This approach remains untouched by the new patent regime and looks to increase in the future. However, those that can afford it have set their sights on an even higher goal: new molecule discovery. Although the initial investment is huge, a company is lured by the promise of hefty profit margins and has a legitimate competitor in the global industry. Local firms have slowly been investing more money into their R&D programs or have formed alliances to tap into these opportunities.
Small and medium enterprises
As promising as the future is for a whole, the outlook for small and medium enterprises (SME) is not as bright. The excise structure changed so that companies now have to pay a 16% tax on the maximum retail price (MRP) of their products, as opposed to on the ex-factory price. Consequently, larger companies are cutting back on outsourcing and what business is left is shifting to companies with facilities in the four tax-free states - Himachal Pradesh, Jammu & Kashmir, Uttaranchal and Jharkhand. Consequently a large number of pharmaceutical manufacturers shifted their plant to these states, as it became almost impossible to continue operating in non-tax free zones. But in a matter of a couple of years the excise duty was revised on two occasions, first it was reduced to 8% and then to 4%. As a result the benefits of shifting to a tax free zone were negated. This resulted in, factories in the tax free zones, to start up third party manufacturing. Under this these factories produced goods under the brand names of other parties on job work basis.
As SMEs wrestled with the tax structure, they were also scrambling to meet the 1 July deadline for compliance with the revised Schedule M Good Manufacturing Practices (GMP). While this should be beneficial to consumers and the industry at large, SMEs have been finding it difficult to find the funds to upgrade their manufacturing plants, resulting in the closure of many facilities. Others invested the money to bring their facilities to compliance, but these operations were located in non-tax-free states, making it difficult to compete in the wake of the new excise tax.
Relationship between pharmaceuticals and biotechnology
Unlike in other countries, the difference between biotechnology and pharmaceuticals remains fairly defined in India. Bio-tech there still plays the role of pharma’s little sister, but many outsiders have high expectations for the future. India accounted for 2% of the $41 billion global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region and 11th in the world in number of biotech. In 2004-5, the Indian biotech industry saw its revenues grow 37% to $1.1 billion. The Indian biotech market is dominated by bio pharmaceuticals; 75% of 2004 -5, revenues came from bio-pharmaceuticals, which saw 30% growth last year. Of the revenues from bio-pharmaceuticals, vaccines led the way, comprising 47% of sales. Biologies and large-molecule drugs tend to be more expensive than small-molecule drugs, and India hopes to sweep the market in bio-generics and contract manufacturing as drugs go off patent and Indian companies upgrade their manufacturing capabilities.
Most companies in the biotech sector are extremely small, with only two firms breaking 100 million dollars in revenues. At last count there were 265 firms registered in India, over 75% of which were incorporated in the last five years. The newness of the companies explains the industry's high consolidation in both physical and financial terms. Almost 50% of all biotech are in or around Bangalore, and the top ten companies capture 47% of the market. The top five companies were homegrown; Indian firms account for 62% of the bio-pharma sector and 52% of the industry as a whole.[4,46] The Association of Biotechnology-Led Enterprises (ABLE) is aiming to grow the industry to $5 billion in revenues generated by 1 million employees by 2009, and data from the Confederation of Indian Industry (CM) seem to suggest that it is possible.
Comparison with the US
The Indian biotech sector parallels that of the US in many ways. Both are filled with small start-ups while the majority of the market is controlled by a few powerful companies. Both are dependent upon government grants and venture capitalists for funding because neither will be commercially viable for years. Pharmaceutical companies in both countries have recognised the potential effect that biotechnology could have on their pipelines and have responded by either investing in existing start-ups or venturing into the field themselves. In both India and the US, as well as in much of the globe, biotech is seen as a hot field with a lot of growth potential.
Relationship with IT
Many analysts have observed that the hype around the biotech sector mirrors that of the IT sector. Biotech colleges have been popping up around the country eager to service the pools of students that want to take advantage of a growing industry. The International Finance Corporation, the private investment arm of the World Bank, called India the "centerpiece of IFC’s global biotech strategy." Of the $110 million invested in 14 biotech projects investment globally, the IFC has given $43 million to 4 projects in India. According to Dr. Manju Sharma, former director of the Department of Biotechnology, the biotech industry could become the "single largest sector for employment of skilled human resource in the years to come".
British Prime Minister Tony Blair was similarly impressed, citing the success of India’s biotech industry as the reason for his own country’s own biotech opportunities. Malaysia is also looking to India as an example for growing its own biotech industry.
Indian Government Support
The Indian government has been very supportive. It established the Department of Biotechnology in 1986 under the Ministry of Science and Technology. Since then, there have been a number of dispensations offered by both the central government and various states to encourage the growth of the industry. India’s science minister launched a program that provides tax incentives and grants for biotech start-ups and firms seeking to expand and establishes the Biotechnology Parks Society of India to support ten biotech parks by 2010. Previously limited to rodents, animal testing was expanded to include large animals as part of the minister's initiative. States have started to vie with one another for biotech business, and they are offering such goodies as exemption from VAT and other fees, financial assistance with patents and subsidies on everything ranging from investment to land to utilities.
The government has also taken steps to encourage foreign investment in its biotech sector. An initiative passed earlier this year allowed 100% foreign direct investment without compulsory licensing from the government. In April, a delegation headed by the Kapil Sibal, the minister of science and technology and ocean development, visited five cities in the US to encourage investment in India, with special emphasis on biotech. Just two months later, Sibal returned to the US to unveil India’s biotech growth strategy at the BI02005 conference in Philadelphia.
The biotech sector faces some major challenges in its quest for growth. Chief among them is a lack of funding, particularly for firms that are just starting out. The most likely sources of funds are government grants and venture capital, which is a relatively young industry in India. Government grants are difficult to secure, and due to the expensive and uncertain nature of biotech research, venture capitalists are reluctant to invest in firms that have not yet developed a commercially viable product.
The government has addressed the problem of educated but unqualified candidates in its Draft National Biotech Development Strategy. This plan included a proposal to create a National Task Force that will work with the biotech industry to revise the curriculum for undergraduate and graduate study in life sciences and biotechnology. The government’s strategy also stated intentions to increase the number of PhD Fellowships awarded by the Department of Biotechnology to 200 per year. These human resources will be further leveraged with a "Bio-Edu-Grid" that will knit together the resources of the academic and scientific industrial communities, much as they are in the US.