1. Introduction
A clinical trial is a particular type of research that tests one treatment against another. It may involve either patients or people in good health, or both. Small studies produce less
reliable results so studies often have to be carried out on a largenumber of people before the results are considered reliable. For this purpose the concept of CROs must be understood to ascertain whether the treatments under study are safe, have any side effects, and whether the new treatments are better than available standard treatments. A Contract Research Organization (CRO) is a service organization that provides support to the pharmaceutical industry. CROs offer clients a wide range of “outsourced” pharmaceutical research services to aid in the drug andmedical device research and development process. The Services offered by CROs include: product development, formulation and manufacturing; clinical trial management; clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA); regulatory affairs support; and many other complementary services. The clinical studies take up most of the time spent in the R&D division of a Pharmaceutical firm; the major expenses incurred in the new drug discovery process are mainly limited to the Phase I, II and III of the clinical trials. As drug discovery is a tedious and time consuming process involving exorbitant expenses on part of the research organizations, CROs may help in screening of thousands of compounds over a period of 10–12 years, costing millions of USD, before bringing into realization the successful launch of a product in the market.
The Research paper on Clinical Research Industry Issues
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2. Contract research organizations (CROs) in India
At present, talking in terms of India, the Clinical Trials Industry occupies a very small pie of the global market share but it is estimated to conduct nearly 5% of global clinical trials
by 2012. The global CRO industry valued $18 bn in 2008, showed an increase of 14% over 2007. The CRO market will grow at an annual rate of 14% between 2009 and 13 and it is expected to reach around $35 bn by 2013. And this figure will only increase further, with the broadening of the spectrum of services outsourced to cover the entire value chain. The fragmented structure of the CRO industry has led to an increase in strategic alliances, acquisitions, joint-ventures and other partnership deals as companies attempt to expand their service offerings and geographical presence [6]. This has led to top multinational pharmaceuticals companies like Novartis, Eli Lilly, Pfizer, and GlaxoSmithKline, Aventis etc. to venture into this business, in collaboration with Indian Drug Companies like Nicholas Piramal India Ltd., Advinus Therapeutics, Ranbaxy laboratories, Torrent Pharma, Dr. Reddy’s Laboratories, and Cipla etc. India is fast emerging as a favoured destination for clinical research globally, owing to a large number of contributing factors, like:
(a) Easy availability of a significantly large pool of qualified, well-trained and English speaking biomedical, bioinformatics, biostatistics and chemistry professionals.
(b) Cost effective location for conducting clinical trials, on a large, treatment naïve, genetically diverse population, with high patient-enrolment rates.
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(c) Availability of state-of-art, latest and well-equipped support system encompassing over 20,000 hospitals and laboratories, bio-IT initiatives, intensely well-spread and well-connected networking and other facilities.
(d) India being a country of varying climatic conditions can offer in the study of a host of regionalized diseases.
(e) Major reforms in the area of Jurisprudence ,in respect of, restructuring of both Patents Act, 1970 and the Indian Drugs and Cosmetics Act, 1940 and the adoption of “Product patents” on the lines of Trade Related Intellectual Property Rights (TRIPs) in 2005, guarantee data protection and data exclusivity.
(f) Incentives granted on part of the Govt. of India, like, exemption of import duty and service tax on testing and analysis of new drugs, vaccines and herbal remedies on human participants by a Clinical Reference Group (approved by the Drugs Controller General
of India to conduct clinical trials) encourage more and more foreign investment in the Indian Clinical Research Industry.
Besides, the Govt. has also taken initiatives to ensure that the results generated from these studies live up to the International standards, by bringing into picture the setting
up of National Board for Accredition of Testing and Calibration laboratories (NABL) and Indian Society for Clinical Research (ISCR) to look into the analytical, advisory and
ethical issues associated with clinical trials in India.
A report released by US Govt. Accountability Office, in 2006, says that the annual R&D expenditure by the pharmaceutical industry increased by nearly 147% to about USD
40 billion between 1993 and 2004, while the period witnessed only 38% increase in the new drug applications to the US FDA. Such a financial burdenmay suggest that why the
major pharma players in themarket are heading towards cost effective and “suitably appropriate” locations like India.
John Watson, the President of Strategic Partnering and Integrated Drug Development Group at Covance, “with all the pressure that the larger pharmaceutical companies are
The Research paper on Clinical Trials
... The Clinical Trials Registry- India (CTRI)-2009, Indian Association for Statistics in Clinical Trials (IASCT) 2007, Indian Society for Clinical Research do ... works on developing standards and regulatory measures for drugs, diagnostics and devices; laying down regulatory measures ... major role in Clinical Data Management for pharma giants and CROs. Known for outsourcing, Indian software companies have ...
under, there’s been a shift to more strategic outsourcing” where CROs are no longer mere service providers, but full service collaborators.
According to a recent study by Mckinsey and company, the Indian Clinical Research Industry can attract USD 1.5 billion of revenue fromUS and EU by 2010, thereby creating a demand for more than 10000 investigators, trained in Good Clinical Practice (GCP), supported by nearly 50,000 clinical research professionals. The revenue is expected to reach USD 20 billion in India till 2015. Such an increase in outsourcing
from the western countries has led the global pharma companies and Indian entrepreneurs to set up Contract Research Organizations (CROs) in India.
Consequently a number of international companies, specializing in IT and production, are entering the Indian healthcare sector and forging alliances with the local companies to niche out their own identity, in order to empower themselves to rise above the rest e.g. Eli Lilly and Co. is now working in collaboration with Nicholas Piramal India Ltd. since January 2007, for the development and specialization of certain Lilly preclinical drug products. Likewise Lilly has also turned into alliance with Tata Consultancy Services, in November 2006, for the statistical analysis and management of clinical data.
Some of the leading Indian CROs are Apothecaries Clinical Research, GVK Bio Sciences Pvt. Ltd., Lotus labs, Reliance Clinical Research, SIRO Clinpharm Pvt. Ltd., Vimta Labs, Synchron Research Services.
3. Challenges for CROs in India
(a) Financial challenges: due to financial constraints arising out of lack of funds, and inadequately trained personnel, the drug approval process in India is extremely slow
when compared to countries like U.K.
(b) Regulatory challenges: the office of the Drug Controller General of India (DGCI) is largely working with a staff that is considerably insufficient, in terms of numbers as
well as expertise required for the job, raising eyebrows on the quality of work being regulated and approved by the Agency.
(c) Lack of ICH-GCP compliant research sites: a dearth of hospital sites following ICH-GCP guidelines is one of the prime challenges faced, as out of around 14000 general hospitals only about 150 meet the required standards.
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(d) Emergence of non-accredited CROs: mushrooming of uncertified CROs needs to be curtailed with an iron fist by the Government as any untoward mishap might tarnish the global image of the Indian CRO Industry.
(e) Lack of awareness among patients: patients need to have a proper insight into what goes into in these trials, to avoid their misuse as “guinea pigs”.
4. Conclusions
In spite of the many issues to be addressed and taken care of, there is absolutely no doubt in the potential of India as an imminent global power in the Clinical Research and Contract Research Industry, in the nearby future. Easy availability of one of the most diversified genetic pools, well-trained and qualified professionals, most modern technological advancements, alongside reforms and amendments in the Indian Laws, and a diligentwatchdog in the formof the Government, working most efficiently to ensure transparency, efficacious, safe and cost-effective procedures to the end-user, would
help Indian Clinical Research Industry to attain a global stand, that is respected and looked upon by all.
