White Paper on

“Global Clinical Trials in India – Prospects and Challenges”

Federation of Indian Chambers of Commerce & Industry

White Paper on“Global Clinical Trials in India – Prospects and Challenges”

White Paper on“Global Clinical Trials in India – Prospects and Challenges”

Cygnus Business Consulting & Research
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To begin with. In Part 2. The regulatory framework for conducting Stem Cell. the introduction to clinical trials and its background have been mentioned in the basis of a consensus among the stakeholders has been elaborated. The ways of strengthening Institutional ethics is briefed in part 4. a review and analysis of the opportunities and operational deficiencies evolved on . White Paper on“Global Clinical Trials in India – Prospects and Challenges” part 1. tissue engineering. vaccines. Part 6 & 7 deals with the Capacity building in medical institutions and career options in Clinical research respectively. The regulatory issues for import and export of biological materials are reviewed in part 5. Finally. The future outlook for clinical trials is given in part 8. molecular diagnostic products’ Research in India” is discussed in part 3.PREFACE This White Paper on “Global Clinical Trials in India – Prospects and Challenges” is presented in six parts.

. Regulatory issues for import and export of biological materials.................................. Future Outlook ..................... 2 3........ 6 3............................ Capacity building in clinical research at medical institutions ............. 11 5................ 1 .................................... Introduction ........................... vaccines.............................................. 22 7........................................................... Opportunities and Operational Deficiencies for Clinical Trial in India ............. Career options in Clinical trials .............................................................. Strengthening Institutional Ethics at par with Global Benchmark . tissue engineering................................................................ Regulatory framework for conducting Stem Cell................................. 17 6......... molecular diagnostic products’ Research in India ...................Table of Contents 2........................ 29 White Paper on“Global Clinical Trials in India – Prospects and Challenges” 1........................................................................ 25 8.

numerous world-class medical facilities. tissue engineering. and could rise to US$26 billion by 2007. according to an US estimate. Approximately 90.000 clinical trials were performed globally in 2003 and nearly nine million patients participated in them. 3. India also has the advantage of having a large pool of highly trained physicians. The size of the global clinical trials market is nearly US$10 billion today. Strengthening Institutional ethics at par with global benchmark 4. Analysis of clinical trials data is the major step in the drug development and release. vaccines. diverse and therapy-naïve population with vast gene pool and lower cost of technical services resulting into lower per patient trial cost. Opportunities and operational deficiencies in conducting clinical trials in India 2. To speed up the clinical trails and their analysis. biotechnology and bioinformatics in the research and trials activities. nurses.500 drugs are under development at a given time and the number of new dr ug applications are nearly 4. a favourable IPR environment (post signing the WTO agreement) and use of English as the primary business and medical language. Regulatory issues for import and export of biological materials 5. and technical personnel. molecular diagnostic products’ Research in India. The nature of players involved in these clinical trials in India is given in chart 1. The total value of clinical research performed in India in 2004-05 was about US$100 million. It is well documented that the average costs of doing Phase I/II/III drug trials in US are $20/50/100 million respectively whereas in India they are 50-60% of the same and could be up to 75% faster. The major objectives of the summit are discussed in the paper under the following heads: 1. It has been reported that approximately 3.Introduction White Paper on“Global Clinical Trials in India – Prospects and Challenges” India is fast emerging as a favoured destination for clinical trials by global pharmaceutical and biotech companies that are looking for partnerships or setting up new operations. pharmaceutical industry is using the latest technology tools such as Recombinant DNA technology. broadly developed information technology infrastructure.000. Career option in Clinical Research 1 . Two major reasons for its popularity are: easy access and availability of a large. Capacity building in clinical research at medical institutions 6. Regulatory framework for conducting stem cell.

The quality of science and capabilities in drug . increase in research and development activities would lead to a higher demand for clinical trial services which meet global standards. IT applications and data management and herbal heritage. These include contract research.Opportunities and Operational Deficiencies for Clinical Trial in India White Paper on“Global Clinical Trials in India – Prospects and Challenges” Clinical research industry in India is set for a major growth in terms of revenue. India is recognised as one of the leaders in the IT industry. English-speaking investigators. Favorable environment Increasing the expenditure on drug development. genetically distinct groups. changing regulations have become serious problems/bottlenecks in pharmaceutical research for development of new drugs in developed countries for the past decade. patent regime. R&D for neglected diseases. nearly 7 lakh hospital beds and 221 medical colleges. The emerging positive trends in India offer a potential solution to some of these problems. This strength is already being leveraged in the bioinformatics area to support a variety of drug discovery efforts. environmental and seasonal changes. suffering from various diseases on the basis of socio economic. and skilled. large pool of patients. are India’s Key strengths. clinical trials. In addition. thanks to the country’s inherent advantages like lower cost. large base of qualified personnel. There are key broad areas to leverage the advantages that India offers to the established pharma and biotech industries. a number of large pharma companies are leveraging India’s IT strength to support clinical trials and data management. A huge patient population. In particular. The growth of clinical trial industry is directly linked to the growth of health care industry in India as well as world over. R&D alliances. the importance of Asia-Pacific market is growing. 2 Higher growth in Asia Pacific As pharmaceutical and biotechnology companies continue to explore new geographic opportunities to expand their pipelines of products and create business efficiencies. fast patient recruitment. specialty hospitals with state-of the-art facilities. in-licensing of preclinical as well as early clinical drug candidates. etc. This can be easily extended to safety monitoring and postmarketing surveillance. Opportunities India has a vast population with wide range of races. living in different climatic conditions. lengthening time lines for clinical trials.

According to the various estimates. These alliances are giving preclinical candidates or clinical candidates with proof of concept in humans. Japan. royalties. It is conceivable to reduce the cost of failure and eventually overall cost of bringing new medicines to patients. The probability of success increases to about 50-75% once a molecule enters Phase III clinical trials. Alliances India has already established its strength in developing. 3 White Paper on“Global Clinical Trials in India – Prospects and Challenges” discovery vary widely between India. pharma companies from developed countries are already forging R&D alliances with Indian companies. Transition to innovative R&D is naturally the next step for India. There are a number of contract research organisations that offer quality and cost-effective services in medicinal chemistry. the cost of innovation and development can be drastically reduced. . average cost of bringing new molecule to the market. Since the medicines for neglected diseases must be affordable to patients in the poor countries. A well established statutory. Cost Advantage In developed countries.5%. Taiwan and Singapore. Low cost of innovation and development will allow bringing new molecules for the neglected diseases to market at a much reduced cost. is about US$800m including the cost of possible failures. Pharmaceutical R&D expenditure in Asia is growing faster than in US and Europe. failures occur at various stages and cumulative success rate of a given drug discovery programme is about 1. This success is attributed primarily to its strength in the process chemistry. damage exemptions for clinical trials and statutes blocking importation of products. to safeguard intellectual property rights in India is slowly gaining momentum. It is focused on issues like infringement drug discovery. it is essential to develop these drugs in the most cost-effective manner. Early estimates are that drugs could be tested in India at 60% of the price.New Patent Regime The new patent regime will have a potential impact on domestic and foreign companies doing business in India. patents. By conducting R&D on new molecules up to Phase II of clinical trails in India. The protection of intellectual property rights in India which was one of the biggest concerns of global pharmaceutical companies seeking to enter India in the past has changed rapidly to post-TRIPS and WTO scenario. In order to leverage these resources. administrative and judicial framework. manufacturing and marketing generic products for global market. formulation development and manufacturing areas. Within the pharma R& D value chain. and toxicology areas. formulation development. the global contract research market is estimated at US$10 billion in 2004 and about 40 to 50% of it will be outsourced to developing countries by 2010. China. This is one of the unique opportunities in India.

In India alternative medicine systems are well-established. In addition. Even more serious is the lack of confidentiality. Regulatory uncertainties about time to approval. the institutional policies are not yet geared up to support the investigator in managing clinical trials efficiently. A number of development candidates are out-licensed by Indian companies to the medium size as well as large pharma companies in the developed countries. A large majority of potential investigators lack knowledge of regulations. 4 Government Policies Regulatory approvals in India can take three months or more. India would need about six times its present number of investigators. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Operational Deficiencies The increase in clinical trials is fueled by the recent push for global commerce. drug / sample storage.000 investigators. Some of the major operational deficiencies are as follows: Training for Clinical Trials Most medical schools lack a formal course in training for clinical research. archival. There is a shortage of trained manpower. ethics and GCP. as compared to United States that has 50. The quality of global trials and academic clinical research is not uniform. There are opportunities to apply modern science to elucidate molecular mechanism of action and to identify active ingredients of these medicines.Established Pharma Companies Indian companies are highly capable in research and development particularly in drug discovery. compared to 30 days in the US. This trend is expected to continue. The situation is worse in non-metro cities which have tremendous potential for participation in global trials. India does not yet grant protection for data gleaned from clinical trials. involvement of multiple agencies for approval of biotech products and for processing import/export licenses. which makes it easy for generic drug makers to copy the . With the projections made for the industry in 2010. Perhaps the most important challenge is that of designing elegant clinical trials that will test concepts rather than simply compare products. India has about 500 – 1000 investigators in the country. The process of reverse pharmacology can be applied to discover new drug candidate molecules from these traditional medicines. and several other factors are hurdles in planning a clinical trial. It has already proven its capabilities in discovering and developing drug candidate molecules. Unlike China. However. and investigators have relied on mentors to learn how to conduct clinical trials. the molecular mechanism of action and identity of active ingredient(s) may not be known for most of these traditional medicines. There are also issues of inadequate permanent research staff and lack of adequate infrastructure for communication. and skills for clinical trial management.

only those drugs that have already passed Phase 1 safety trials in the country of their origin can be tested on Indians. only 400-500 investigator sites have taken part in global GCP trials. Ethical committees The field is dogged by complaints that Indian trial investigators recruit patients unethically. Institutional ethics committees can’t help much either. regulators and ethics committees. At the federal level. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Weak Patent Law In India. The efforts of the government and industry to create awareness through GCP workshops and to provide training to the investigators and ECs will go a long way in creating a culture of global GCP quality trials. the journey towards achieving global quality is unlikely to be smooth. the committees are headed by the institutional heads. Good Clinical Practices (GCP) The experience of conducting global GCP trials is limited. and follow their instructions rather than the ethical committee’s recommendations. Drafting patent laws with the help of industry experts and its implementation is highly essential. In a country which boasts of a large medical fraternity.drug under trial. 5 . the central ethics committee at the Indian Council of Medical Research issues guidelines but has no policing powers. Under India’s existing laws. opportunities will become limited unless there is a very strong patent law and mechanism to enforce it. exaggerate claims and downplay the risks of trial drugs. As all stakeholders are still learning. investigators. In most of the cases. GCP is a shared responsibility amongst sponsors.

In coming 5-10 years. brain. muscle. medical research has taken unprecedented turn to address many hard core diseases like kidney failure. skin. Reliance Life Sciences Laboratories. vaccines. It is believed that stem cells can transform eventually into any of human body’s approximately 260 different cell types. two prestigious institutes are recognised by federal governments for stem cell research: 1. roughly 128m people suffer from diseases that could be effectively treated or cured through stem cell research. Intellectual property rights. which can develop into a variety of cells in human body. Research Since isolation of human embryonic stem cells. In India.White Paper on“Global Clinical Trials in India – Prospects and Challenges” Regulatory framework for conducting Stem Cell. bones or into any other body tissue. National and International Guidelines and Policies for stem cell research are . stem cell therapies will be able to treat a number of diseases. Out of these. These cells can also develop into heart. It is estimated that. The distribution of the cell lines for research or for commercialisation purposes will be solely at the discretion of the individual laboratories which created them. National Institute of Health which maintains stem cell registry has registered 64 stem cell lines so far. financial supports and funding. Several medical research institutes around the globe have developed stem cell lines which are accepted for federal funding by the US Government. as many as 58m people suffer from some form of cardiovascular diseases treatable through the new form of medical research. Biotech companies based in the US namely Geron Corp and Curis Inc are already working on the commercial applications of this new medical technology. National Centre for Biological Sciences. Stem cells are blank cells obtained from human embryos of a few weeks old. tissue engineering. Bangalore 2. blood transfusion and ophthalmic problems. Mumbai 6 Issues in Stem Cell Research Several important issues which impinge on the future of stem cell research are: scientific. Scientists are of the view that these diverse cell types would lead to new forms of treatment for many serious diseases that cannot be cured presently. ethical and moral issues on use of human embryo or adult cells. technical. molecular diagnostic products’ Research in India Stem Cells Stem Cell is a cell that has the ability to continuously divide and differentiate into various other kind(s) of cells/tissues is called stem cell.

grow new blood vessels. heal wounds and new cartilage. that these regulations are finalised without much delay and after adequate consultations with various non-government organisations and independent medical experts. Research It is an emerging field with extraordinary advances in medical technology. issues of extreme concern not only for the US but also for all countries including India. Products currently in the market include simple tissues such as skin. But in USA. In studies conducted on mice. it has been recently shown that the belief that adult cells are incapable of differentiation and hence are not useful is indeed a myth. cartilage and bone. or even stop cancerous cells from a multiplication spree. combining stem cells with animal embryos or even using stem cells to create a human being. under preparation.Regulatory environment As these promising new therapies are going to be based on biological materials derived from human bodies. . It is important. These possible misuses are. hospitals or research labs for stem cells derived for research purpose. Tissue Engineering Tissue engineering is the science of altering. particularly suffering from cardiovascular diseases which cannot be cured with medicines. The significance of these observations is that this technique of using adult cells could be more useful for repairing of tissues damaged by injury or disease. may prohibit payment or other inducement to donors. This technology is available with several types of replacement skin. cartilage. Currently there are no regulations governing the stem cell research in any of the countries which are identified to be having stem cell lines. no doubt. Regenerative Medicine is one of the most rapidly advancing biotechnological areas of development and discovery in the medical field. Repairing/replacing the tissue/organs with the help of advanced technology like stem cell research/tissue engineering can treat many patients. AHA guidelines are also expected to ban creation of embryos for the purpose of harvesting stem cells. some of the social and ethical issues involved in procuring these materials need to be addressed. adult cells from certain parts of the body could transform themselves to other cell types. In addition. it is possible to regenerate dying tissues and organs in a human body. The estimated market for tissue engineering products is expected to be approximately US$5 billion worldwide by 2013. physicians. 7 White Paper on“Global Clinical Trials in India – Prospects and Challenges” in the initial stages of drafting and implementation. The Government of India too has set up a high level committee in a bid to frame an ethics policy for genomic research including stem cell technology. in this context. These guidelines. American Heart Association (AHA) is already developing a set of guidelines to be followed by the laboratories engaged in the stem cell research. Using tissue engineering techniques. regeneration of bone and other connective structural substitutes. the technology could lead to the in vitro construction of human organs. modifying and controlling reproduction and degeneration of biological tissue along with complete tissues outside of the body ready for future transplant use.

Cord blood stem cell is generally used for haemopoietic stem cell transplantation. human cloning is not permitted for the purpose of creating a new individual. clinical or therapeutic trials. EG cells will be permitted only for experimental purposes at present. DNA fingerprinting of the cell line should be preserved and it is advised to keep it in cell repository. Approval from NAC must be sought for carrying out these experiments. Foetal stem cells/tissue: These can be processed from spontaneously aborted foetus or from foetuses obtained from MTP clinics. In vivo studies: Experimental work on stimulation of adult stem cells also has tremendous future. Monitoring Mechanism: A central monitoring committee – a sub committee of the Apex Committee should be constituted to make site visits as and when required. Bone marrow. For any other form of therapy detailed protocol has to be submitted for approval. limbal cells are some of the tissues in use. There is a risk that the neonate donor may need his or her own cord blood later. All centres doing stem cell transplantation should register with this Committee. Proper informed consent procedures are to be followed as given in the ICMR ethical guidelines. At present. Only surplus or spare or supernumery embryos can be used with the permission of the couple from registered ART clinics. he or she may be left without much needed blood. skin. Storage and preservation Standard Operating Procedures (SOPs) should be followed. If the blood has been used for another.Guidelines for Stem cell Research and Tissue engineering Adult Stem Cells: Use of adult stem cells does not pose major ethical problems at present. However. Embryonic stem cells (ES Cells): Embryo should not be generated for the sole purpose of obtaining stem cells. as these are easy to obtain. Cell lines generated should be registered. it must be ensured that no harm should occur to the foetus or the neonate. peripheral blood. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Cord Blood Stem Cells: For using umbilical cord blood from a live foetus or a neonate. tissues or organs. Parents should be informed of the risks of donation and a written consent be obtained from them. the committee will examine on a case-to-case basis. Reproductive cloning will not be permitted on ethical grounds. in cases where cloning is for therapeutic purposes involving cells. Generally. Any therapeutic transplantation will not be permitted at present and this possibility will be examined at an appropriate time later. Annual report should be submitted in appropriate format for further continuation of the project by 10th month of commencement of the project decision and review should be communicated in 8 . At present only research programme relating to in vitro induction of differentiation into various cell lines will be cleared by the Committee (NAC) on case-to-case basis.

This approach enables the vaccinia virus to function as a live vaccine against several diseases once it has received gene splices from the relevant disease-causing micro-organism. Now most of the hardcore diseases have vaccines. India along with other developing countries such as Indonesia. Any violation of guidelines would be strictly dealt with. new vaccines are developed for many life threatening diseases.4-6 weeks. They are able to identify the portion that reacts with the human immune system to build antibodies to defend against the disease or infection. recombinant DNA Technology and advanced equipments supported by computers and electronics. Research Presently. Patent issues need wider discussion and public debates should be held on who should be the beneficiary and what type of patents can be taken. All proposals for therapeutic trial should be cleared by this committee before submitting to DCGI. With the help of latest technologies like tissue culture. Researchers are able to identify certain biochemical components of a disease-causing microorganism that stimulate the immune response to that micro-organism in the body. The potential for these products is immense with the possible market for all types of diarrhea vaccines alone being about $200 million. Vaccines Preventing and controlling diseases with the help of vaccines has become common. producing immune components and combining it into DNA of an entirely different micro-organism. Many developed countries are no longer interested in producing vaccines since production has become uneconomical due to drastic reduction in prices and less access to markets in the developing countries. Vaccinia virus is produced by splicing and isolating the gene. Cuba and Brazil supplies 60% of UNICEF’s global requirement for vaccines. This biochemical component of the pathogen is then produced in a laboratory and given to humans as a vaccine. Another approach being used is the Recombination of DNA technology. Regulation of stem cell lines: All cell lines should be registered with this committee. The domestic vaccine market is currently US$100m and growing at the rate of more than 20% per year. Market Vaccine producers in developing countries are strengthening their manufacturing capacities and are looking forward to development and launch of newer vaccines. different types of vaccines are being developed with the help of advanced research tools. 9 White Paper on“Global Clinical Trials in India – Prospects and Challenges” . The altered virus is then injected into the human and stimulates antibody production both to itself and to the pathogen with the newly incorporated genes. Commercialisation and Patent issues: Established stem cell lines can have considerable commercial value as wide ranging potential benefits for large number of patients is possible.

Vaccine clinical development follows the same general pathway as for drugs and other biologics. The market for molecular diagnostics includes an extensive list of innovative products and testing solutions. including reimbursement issues. all potential adverse events cannot be anticipated. Collaborations between diagnostic and pharmaceutical companies are expected to drive sales of both products. At any stage of the clinical or animal studies. chemists. viral load monitoring and single nucleotide polymorphism detection. lack of standardisation and difficulties in interpreting test data.) with the efficacy and safety information necessary to make a risk/benefit assessment and to recommend or oppose the approval of a vaccine. have led to their emergence as valuable tools for the management of hepatitis C. many vaccines undergo Phase 4 studies . The viral load monitoring and genotyping techniques that have increased the life expectancy of HIV-infected patients.formal studies on a vaccine once it is in the market.Regulatory environment White Paper on“Global Clinical Trials in India – Prospects and Challenges” FDA’s Centre for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines. Successful completion of all three phases of clinical development can be followed by the submission of a Biologics License Application (BLA). management and treatment. Innovative molecular-based diagnostic solutions have provided healthcare professionals with valuable data unobtainable by other means. Until a vaccine is given to the general population. etc. Current trends . However. Thus. Molecular Diagnostic Products Molecular diagnostics is continuing to emerge as one of the dominant testing platforms and represents one of the fastest-growing segments of the In-vitro diagnostic tests (IVD) market. Also. 10 Research Molecular based diagnostics are used in genotyping. New developments such as gene sequencing and nucleic acid amplification have revolutionised the in vitro diagnostics industry. FDA may request additional information or studies. if data raises significant concerns about either safety or effectiveness. the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins. biostatisticians. Market Use of molecular-based diagnostic solutions is expanding. or may halt ongoing clinical studies. Molecular diagnostic products become vital components of disease prevention. the contributions that molecular diagnostics can make to clinical decision making still face significant obstacles. Increasing insight into the ways in which genes influence a pathogen’s response to therapy is ensuring tremendous growth in pharmacogenomics. The license application must provide the multidisciplinary FDA reviewer team (medical officers. microbiologists.

more than half of the diagnostic kits are imported at higher cost and are often ineffective as they are not designed for variant Indian strains of microbes. logistics. with an emphasis on practical applications. competition. These vary from state to state. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Regulatory environment At present. licensing. isothermal amplification technology for rapid generation of single DNA or RNA templates are becoming easy with the help of molecular diagnostics. government laboratories and non-profit organisations for PCRrelated research. and work synergistically in the treatment of disease. High import duty and custom clearance procedures. has direct benefits to healthcare. pneumonia. Development of polymerase chain reaction (PCR) technology. The implementation of nucleic acid testing reduces the time lag between infection and detection to half of that taken by traditional immunoassays. HIV and Hepatitis C Virus (HCV) immunodiagnostic tests became popular through molecular diagnostics and critical care blood gas analyzers. energy transfer detection method. Instruments like Turgene HIV-1 genotyping assay. There are no standard guidelines to grant license for manufacturing diagnostic products and for the approval of all ranges of products (for either imported or products manufactured in India). The number of cheaper and efficient technology transfers in the area of diagnostics is limited. homogenous amplification and real time detection technology. There is also no special package and exemption in taxes from the government for establishing diagnostic manufacturing units. strep throad. and fungal infections have become routine. This was possible with the commitment in the form of grants to academic institutions. lack of national laboratory network for evaluation and approval of new products are some of the factors slowing down the pace of indigenization. Molecular diagnostics test for tuberculosis. 11 .merge the benefits of assays and drugs. slow pace of approvals from statutory authorities. real time DNA amplification assay. lack of knowledge.

and 3. and requires that people with diminished autonomy be provided special protection. there is an increasing 12 . The principle of Beneficence: It requires protecting individuals by maximizing benefits and minimizing possible harms. children. unless there are scientifically or ethically valid reasons for doing so. In addition. for the drafting and review of hospital policy. The human potential vulnerability. Identifying alternative ways of obtaining the benefits sought from the research. and for clinical ethics case consultation. 2. These include live human fetuses. The principle of Justice: It requires treating subjects fairly. ethical concerns have been raised throughout the globe. New drug development for the treatment of many diseases and its clinical trials on human population by many countries are drawing the attention of many ethical groups. patients in hospitals or volunteers for clinical trials. In hospitals throughout US. certain subject populations are provided with additional protections. 2. These three provide a comprehensive framework for ethical decision-making in research involving human subjects. and difficult ethical dilemmas arise when they conflict. Principle of Respect: Persons acknowledges the dignity and autonomy of individuals. A careful and thoughtful application of the principles will not always achieve clear resolution of ethical problems. Global Ethical Principles and Guidelines for Biomedical Research using Human Subjects: Three fundamental ethical principles that are relevant to all research involving human subjects are globally accepted: 1. Subjects should be carefully and equitably chosen to insure that certain individuals such as prisoners. Beneficence. and people with severe illnesses. prisoners.White Paper on“Global Clinical Trials in India – Prospects and Challenges” Strengthening Institutional Ethics at par with Global Benchmark Since the research activities in biomedical sciences have increased and many live biological organisms are used for the purpose of research. However. 1. be it laboratory animals. Justice. elderly people. Each of these principles carries strong moral force. or financially impoverished people are not systematically selected or excluded. Institutional Ethics Committees (IECs) have become a standard vehicle for the education of health professionals about biomedical ethics. to assure that people who agree to be experimental subjects will be treated in a respectful and ethical manner. the mentally disabled. It is necessary to examine carefully the design of the study and its risks and benefits. 3. Respect for Persons. it is important to understand and apply the principles. All the developed countries who are actively involved in biomedical research are following institutional guidelines of the ethical committee for conducting research.

Composition: Institutional Ethical Committees should be multidisciplinary and multi-sectoral in composition. Improved communication. included in the patient’s medical record. and performance incentives on the care of patients. clarification 7. in most cases. One legal expert or retired judge Academy supports the view that the recommendations from an ethics consultation are advisory only. situation. integrated systems. of an ethics consultant and an IEC. One lay person from the community of differences and available options. with all 5. and. The number of persons in an ethical committee is fairly small. moral. moral. One or two basic medical scientists. One philosopher / ethicist / theologian their own actions.interest in the role for the IEC in organizational ethics. One social scientist / rep. and careful 8. The Chairperson of the Committee should preferably be from outside the Institution and not head of the same Institution to maintain the autonomy of the Committee. Ethics consultations should be documented in the committee records. of NGO parties to a disagreement taking full responsibility for 6. Member Secretary documentation of the decisional process may well reduce the potential for future legal action. The form and extent of chart documentation of ethical consultations may vary depending on local hospital regulations and requirements. Organisational ethics in the purview of the IEC raises specific questions about its structure. The authority. and legal issues surrounding a difficult 2. function. a summary of the consultation should be briefly. IEC Members The quality of an ethical consultation rests on the IEC’s ability to provide a forum for open discussion of the 1. Independence and competence are the two hallmarks of an IEC. Recommendations are made for the membership and structure of an IEC. whether institutional. scientific and non-scientific persons including lay public to reflect varied viewpoints. Other members should be a mix of medical /non-medical. yet completely. The Member Secretary who generally belongs to the same Institution should conduct the business of the Committee. Chairperson medical. and member qualifications. It is generally accepted that a minimum of five persons is required to compose a quorum. and guidelines are provided for those serving on an ethics committee. One or two clinicians from various Institutes legal. is limited. Around 12-15 is the maximum number recommended. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Role of Research Body . or 3. There is no specific recommendation for a widely acceptable maximum number of persons but it should be kept in mind that too large a Committee will make it difficult in reaching consensus of opinion. 13 Role of IEC in Organisational Ethics Recent trends in the financing and provision of health care have raised concerns about the impact of institutional commitments such as managed-care contracts. The 4.

These are major threats to the international companies to conduct clinical trials in India. As per the guidelines. there is an ‘uneasy alliance’ between such bodies and the industry. Strengthening Control ICMR lacks the authority to take action against unethical IECs. The problem is likely to be worse in India. and Requirement of the Joint Commission on Accreditation of Healthcare Organisations White Paper on“Global Clinical Trials in India – Prospects and Challenges” Institutional ethical committees . working with laboratory animals. All the life science researchers. particularly biomedical researchers. and is putting together a database on IECs in the country. supported by fees from the pharmaceutical industry. In the West. 14 ICMR Role In addition to developing general research guidelines. at any stage. It has constituted a ‘Bioethics Cell’ under senior staff trained in bioethics. There is no comprehensive database on either IECs or research participants.Indian Scenario In India. The institute was given authority to monitor the implementation of ethical guidelines in biomedical research. ethical guidelines were drafted by Indian Council of Medical Research (ICMR) for conducting biomedical research in laboratory animals and clinical trials for new drugs on human population. There exists no mechanism for accreditation of IECs and quality control of ethics review is practically impossible. Proposals to establish an IEC as an alternative to judicial review. volunteers in clinical trials has to follow the guidelines strictly. Each institute has its own ethical committee for monitoring the guidelines. It has supported the formation of a forum for ethics review committees in India. Law suggests that IEC deliberations may serve as evidence in court. any deviation in ethics. socioeconomic status. Health care organisations have an established mechanism to address conflicts. a requirement most often met by establishing an IEC. protecting the confidentiality of the volunteers will be awarded severe punishments. Institutional mechanisms for ethical reviewing of research involving human participants in India are weak and vulnerable.Role of IEC in clinical ethics The potential importance of the IEC’s consultative role has been recognised in numerous ways. India is also witnessing the birth of unaffiliated Ethics Committees to review protocols for institutions with no IECs. To enhance ethics capacity. The ICMR and its allied research institutes in India are having the ethical guidelines and IECs for observing the guidelines in its biological research activities. It is preparing standard operating procedures for IECs and standard formats for ethics review across IECs. it has started preparing guidelines for specific areas of research. on the basis of religion. human patients. the ICMR identifies mid-career professionals to be trained in . A concerted effort is required to strengthen them to fulfil their stated missions. is working with similar bodies in the Asia-Pacific region.

USA. It is apparently difficult to get external members to volunteer. education of professional. regardless of whether these functions are delegated to other subcommittees. along with persons committed to developing the requisite knowledge and skills in business ethics. IEC should conduct education and training programs which ensure that members are qualified to perform specific duties. 3. such as an infant care review committee. Department of Health Policy. 6. Douglas K Martin: Assistant Professor. especially from among trained ** V Mohanan Nair: Civil Surgeon. “Despite these guidelines. academicians. 5. 2. IEC should owe responsibility within an institution for clinical ethical consultation. With the help of National Institute of Health. policy development. and self-improvement specific to organisational ethics issues and to the organisational structure of its home institution. IEC members and students within India. Thiruvananthapuram. and success in meeting institutional expectations. general community. 15 Areas for strengthening Effectiveness of IEC’s: According to a study by V Mohanan Nair and K Martin (*). Canada. White Paper on“Global Clinical Trials in India – Prospects and Challenges” . IECs within a general hospital setting should ensure an adequate degree of multidisciplinary expertise for addressing ethical issues specific to pediatrics. General Hospital. 4. bioethics through fellowships. Processes the organisational ethics teams commonly use to carry out their mission mirror Those of clinical ethics: education. University of Toronto. Establish an organizational ethics subcommittee of the IEC that includes additional representatives from administration and finance. Guidelines for Institutional Ethics: The IEC should establish standards of membership. initiatives were taken to strengthen the capacity of bioethics in India to meet the global standards of World Health Organisation and UNESCO. India. process. and support staff about ethical issues. IEC should diverse and reflect different perspectives within hospital. review of policies.Recommendations by ICMR 1. Management and Evaluation and the Joint Centre for Bioethics. Kerala 695011. administrative. and case consultation. IEC should establish procedures for the evaluation and quality improvement of committee functions. training sessions for researchers. should be dissolved or restructured to report to the larger IEC. IEC engaged in clinical ethical consultations should have policies and procedures that conform to ethical principles of fairness and confidentiality. Independent ethics committees. more than 50% of institutions conducting clinical research in India lack formal IECs”. process.

White Paper on“Global Clinical Trials in India – Prospects and Challenges” Infrastructure and processes : Many Institutional Ethical Committees do not have sufficient office space. Institutions’ need for resources may also put subtle pressure on IECs to approve research. Typically. There are no post-approval monitoring systems in place. Institutional members in the IEC may be junior to these researchers. The IEC secretary can be a middle or lower level staff or faculty member for whom this responsibility is in addition to a full workload. 16 . wellknown people are nominated as IEC members. Finally. the IECs may follow different methods for submission. Monitoring: Monitoring of Institutional Ethical Committee is weak.legal scholars and ethicists.a vehicle for career advancement. Most of researchers are middle. carrying out research on a part-time basis. and IECs’ responsibilities tend to end with approval. Drug companies hire practicing doctors as researchers for their prescribing potentials. approval and follow up of research.aged people who are physicians employed by educational institutions. ‘lay persons’ can be intimidated in the presence of more powerful scientific members. Without standard operating procedures. in the Indian context. There have been instances of protocols disappearing after the project’s approval. Many investigators who conduct clinical trials are beneficiaries of largesse from the pharmaceutical manufacturers. The main aim of research professionals is publishing research articles in international reputed journals . researchers may be under pressure to cut corners. Since no overt conflict of interest is apparent to IECs. the indirect benefits and mutual1 arrangements between companies and doctors often go unnoticed. Most medical schools do not offer bioethics courses.

Presently there are three regulatory authorities for the rDNA research. ‘Rules 1989’ also define that the regulatory authorities are responsible for according various approvals. by far. It is also empowered under Rules 1989 to lay down procedures restricting or prohibiting production. Brief description and responsibilities of these regulatory authorities are as follows: (i) Institutional Biosafety Committee (IBSC) It is mandatory that the institutions intending to carry out research activities involving genetic manipulation of organisms constitute the IBSC. the most research intensive among major industries. import and use of genetically engineered organisms or cells as per the Schedule of Rules 1989. sale. These measures will in turn help to capitalize on the inherent cost effectiveness of the Indian Clinical Research enterprises. The RCGM is also responsible to bring out manuals or guidelines specifying the procedure for regulatory process with respect to activities involving genetically modified organisms in research. Use. Its mandate is to monitor the safety related aspects in respect of ongoing research projects and activities involving genetically engineered organisms/hazardous micro-organisms. fiscal incentives and tax benefits are therefore critical to this sector. 17 . White Paper on“Global Clinical Trials in India – Prospects and Challenges” Overview of the Current Regulatory Framework The Ministry of Environment & Forests has notified the Rules for the Manufacture. (ii) Review Committee on Genetic Manipulation (RCGM) The RCGM is serviced by the Department of Biotechnology. utilization and their application including in industry with a view to ensure environmental safety. Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 (Rules 1989) under the Environment (Protection) Act. The biological materials are regulated under these Rules from the research and product development stage up to its release into the environment. The activities of IBSC include training of personnel on bio safety and instituting health monitoring programme for laboratory personnel. The IBSC is the nodal point for interaction within the institution for implementation of the rDNA Biosafety Guidelines. 1986.Regulatory issues for import and export of biological materials Clinical research firms are. Government support. product development and commercialization in the sector. Import. All on-going projects involving rDNA technology and controlled field experiments are reviewed by RCGM to ensure that adequate precautions and containment conditions are followed as per the guidelines. The Rules mandate the inclusion of nominee of DBT in the constitution of the IBSC.

The Drugs and Cosmetics Act 1940 and the Rules 1945 also regulate the biological materials. The Recombinant Drugs Advisory Committee (RDAC) constituted by Ministry of Health and Family Welfare supports the DCGI. as amended from time to time. 1990: These guidelines include procedure for largescale production and deliberate release of GMOs and products thereof into the environment and shipment and import of GMOs for laboratory research. The current practice of according approval for phase III clinical trials. diagnostics and other biologicals. The State Biotechnology Coordination Committee (SBCC) and District Level Committee (DLC) under Rules 1989 have the responsibility for post-release monitoring of genetically modified organisms/hazardous micro organisms and products thereof. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Guidelines for Safety in Biotechnology aspects Department of Biotechnology has evolved various guidelines. These guidelines include: a) Recombinant DNA Safety Guidelines. GEAC to evaluate the environmental impact caused by handling and . b) Guidelines for generating pre-clinical and clinical data for r-DNA based vaccines. The GEAC is also responsible for approval of proposals relating to release of genetically modified/hazardous micro organisms and products into the environment including experimental field trials. 1999. Since this scenario pertains to import of LMOs.(iii) Genetic Engineering Approval Committee (GEAC) The Genetic Engineering Approval Committee (GEAC) serviced by the Ministry of Environment and Forests is responsible for approval of activities involving large-scale use of genetically modified/hazardous micro organisms and products thereof in research and industrial production from the environment angle. which have been adopted by RCGM and GEAC for the regulation of various biological products in the country. The Authority to regulate the biological products is the Drugs Controller General of India (DCGI) and the State Drugs Controller. in the absence of any product development within the country the probability of environmental risk would be less than that of indigenously manufactured products involving the use of LMOs. The product being a LMO. Accordingly. the only activity envisaged within the country prior to issue of market authorization is the conduct of phase-III clinical trials. both by the GEAC and the DCGI is based on the procedure outlined in the 1999 guidelines. the procedure outlined therein from the clinical trial stage would be applicable in this case. 18 Import and marketing of biological materials in finished formulation In case of import of LMOs per se as products.

definition of working of an invention not to include imports of the patented article. industry associations as well as the developments 19 White Paper on“Global Clinical Trials in India – Prospects and Challenges” large-scale use of LMOs. obtaining environmental and pollution control approvals would be simplified and streamlined within shorter time frame lines through consultations with various central and state government departments. They are related to lack of patentability of biological materials and various life forms including microorganisms. liberal interpretation of the scope for issue of Compulsory Licenses. insistence on transfer of technology along with license to use the invention etc. Life Saving Drugs imported and sold in India are exempted from paying customs duty. provision for parallel imports under the exhaustion of rights principle. authority of the Controller and the Government to grant Compulsory Licenses for the domestic and export markets or even revocation or forced forfeiture of patent rights under a variety of conditions including high and unaffordable prices of drugs. Fiscal and trade policy initiatives Exemption of import duties on key R&D. Simplification and streamlining of procedures for import. based on the data available from the country of origin and other countries where the product has been tested. land acquisition. contract manufacturing/clinical trial equipment and duty credit for R&D consumer goods to enable small and medium entrepreneurs to reduce the high capital cost of conducting research. raw materials imported by Indian manufacturers should be eligible for Duty Drawback. clearance and storage of biologicals. whereas raw materials for diagnostics and other pharmaceutical biotech products manufactured in India have been levied customs duty. To promote the indigenous manufacturing industry and make it competitive globally. other experts. Based on the assessment GEAC to accord ‘in principle’ approval for import and recommend to DCGI the safety of the product from environmental angle for conduct of phase –III clinical trials. Remove customs duty on raw materials imported into India. Analysis of the Current Regulatory Framework An analysis of the current regulatory framework was carried out in the context of regulatory objectives of various Authorities. Rationalization of import and export of biological material which is critical for clinical research and business process outsourcing. . where the finished product is imported duty free.Product Patents Regime Biological material or traditional knowledge and any other subject matter of strategic importance that may be notified by the Government from time to time cannot be a subject for patent applications as per the new Amendment.

Frequencies of meetings of regulatory authorities are irregular and inadequate. bio-safety and risk categories as per WHO or other international standards/guidelines are not fully implemented.in the international scenario. There is no mechanism for Post Marketing surveillance of biological products and feedback on product efficacy and environmental safety. Regulatory Committees lack expertise in some important aspects. vaccines/ biologicals. The feasibility of establishing a single central regulatory body to address regulatory related issues in drugs. The regulatory authorities also lack professional staffs to support the decision-making Committees. The sequential approval procedure under Rules 1989 off EPA and Drugs & Cosmetics Act and Rules are ambiguous. Documents/information required by the regulatory authorities for review of the proposal is not clearly articulated. Environmental impacts of the GMOs / LMOs per se and the products thereof per se have not been clearly identified. hampering the R&D. Opportunity to an applicant to present proposal to the regulator is not a common practice. food and food products to overcome the constraints and bottlenecks in implementing the projects has not been seriously examined. diagnostics. 20 Stakeholder’s views Several views are expressed by stakeholders in favour of an independent National Biotechnology Regulatory Authority/Commission for providing a professionally managed single window mechanism for giving various clearances including biosafety issues. Imports off GMOs/LMOs as well as the non-GM micro organisms for R&D work has been made cumbersome with the new Plant Quarantine Order. quality control and manufacturing activities. The problems identified in import and exports of biologicals in the country are: Multiple approval system has led to cumbersome and lengthy approval process. Information sought tends to be sometimes duplicated and in piecemeal. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Regulatory objectives of the different agencies in the regulatory chain are sometimes overlapping leading to duplication in the approval process. The risk assessment and management of micro organisms. issued by the Ministry of Agriculture. It was recognized that evolving such an institutional mechanism would involve a lengthy evolutionary process requiring extensive . industrial products.

However. the feasibility of setting up such an institutional mechanism should be explored.To clearly define the roles of each regulatory authority and enumerate decision making criteria under Rules 1989 of EPA to remove ambiguity in the existing regulatory process To clearly enumerate the stepwise procedure involved in the bio safety regulations of LMOs and the products thereof for indigenous development as well as imported products. To specify the timelines for decision making by each regulatory authority To evolve the documentation system to be submitted by the applicant to the regulatory authorities for obtaining clearances. Recommendations Exemption of customs duty for materials and samples shall be a great boost to the CROs in bringing samples for trials. Income tax holiday for companies venturing into R&D extended by one-year up to 2004 shall encourage newer players in the R&D field. Customs duty exemptions for specified pharma and biotech units approved by DSIR for importing equipment for R&D activities will include CROs as these are capital intensive and require sophisticated instruments for evaluation of drug substances. 21 White Paper on“Global Clinical Trials in India – Prospects and Challenges” consultations among various stakeholders. Pressure on the industry is also reduced by abolishing the minimum export turnover concept. Streamlining of the existing regulatory procedures for immediate redressal of the issues is required. Speedier customs clearance of clinical trial materials and frozen biological samples shall provide a great opportunity for the clinical trial companies to grow and provide the much needed service to industry. The streamlining of the existing regulatory system under the Rules 1989 of EPA and the Drugs & Cosmetics Act and Rules are required as given below: .

. clinical research takes the huge chunk.g. innovate. good clinical and laboratory practices and standard operating procedures were absent. Unfortunately.White Paper on“Global Clinical Trials in India – Prospects and Challenges” Capacity building in clinical research at medical institutions The total amount spent on new drug discovery in India is approximately 30%. management of change – and most important. In making research to work. Data collection and recording were not stipulated and lacked appropriate supervision and monitoring. chairs) 22 Clinical Research Advisory Committee Attending to the relationship between stakeholders (e. while the remaining 70% is on development. Major areas Capacity-building requires examination of interventions that develop the abilities. In development. till recently. relationships and values that enable an organization to carry out complex tasks. sustainability. The central most are notions of time. Research capacity building is an approach that starts with people and their needs. and adapt technology to our own needs in order to better address the burden of neglected tropical diseases. behaviour. a vital ingredient is to have local research capacity available. medical school and clinical system) Honestly examine current infrastructure & metrics. it is necessary to have the research capacity to identify. while adverse reaction detection and reporting mechanisms and ethical issues too were not addressed properly during planning and conducting of the trial. human resources. While it is not very expensive to develop cutting-edge innovative research programs. clinical research has not received the attention that it deserves in our country. Focus areas Formation of Ethics Committees or institutional Review Boards: it is vital for these committees to be constituted and follow the procedures of ICH GCP guidelines Members should be trained in ICH GCP guidelines . to address the health needs of the poorest populations. most of the clinical trials were conducted without a properly designed and reviewed protocol. Some of the critical components include: Understanding institutional priorities Initiating faculty discussions (dept.

Standard Operating Procedures (SOPs). the Indian Council of Medical Research (ICMR) has launched a first-of-its-kind national survey of over 1. There are reputed institutions for training such as the Academy for Clinical Excellence and Institute of Clinical Research India. which will be soon rolled out to other cities. it’s hardly surprising that it is fast becoming the global outsourcing hub for hosting clinical trials. and regulators .Principal Investigators: Should be encouraged by the institutions to actively participate in early phase drug development studies for Indian as well as MNC companies. Thus. The Council not only plans and promotes medical research in the current and emerging health problems of the country but is also expected to build a strong cadre of skilled biomedical scientists. White Paper on“Global Clinical Trials in India – Prospects and Challenges” The medical institutions should identify clinical research as an important area to attract funding by the pharmaceutical industry. Requirements for individual stakeholders may vary based on his responsibility but some of the training elements remain common for all the stakeholders. ethics and consent process and responsibilities of the investigators and the sponsors. whether they function properly so as to accredit them. promotion and conduct of biomedical research in India.sponsors. GCP and applicable regulatory guidelines. Specialized training requirements include training on clinical trial process. With India becoming the largest pool of diabetics and cancer patients. If one doesn’t comply.industry training efforts. The survey will also throw light on the status of the ethics committees on these institutions.has been enthusiastic. These programmes cover foundations of GCP. they will not be doing 23 . To carry out these functions effectively. The response to pilot programmes in Mumbai for all four stake holders . concerned over the rights and safety of volunteers. there is a need of training at the level of medical institutions. One of the major mandates of the Council is to augment capacity strengthening of the institutions involved in both basic and clinical sciences. Compliance to these is a standard requirement. investigators. Training need for Clinical trials Since clinical research is a highly specialized job function it requires specific skill-sets to carry out various operations. provides the much needed government boost to the academia. WHO-CDSCO (Central Drugs Standard Control Organization) has launched GCP training programmes. amended Schedule Y. ICMR leading medical institutions The Indian Council of Medical Research (ICMR) is the premier national agency for the formulation. ethics committees. All of us are aware of the importance of good laboratory practices and good clinical practices. The mandate and policies of the ICMR coincide with the national health policies.000 scientific institutions and medical colleges to assess their “ethics committees”. This programme.

While Sagar Apollo hospital has a tie-up with Clinigene. Lotus Labs has signed an MoU with St John’s Medical College for multiple phase clinical studies and has also set up a clinical research facility in the medical college campus. is based in Mumbai. industry associations and other stakeholders are initiating various programmes for drawing attention to GCP and GLP awareness and compliance by CROs. set up by Asian Clinical Trials. The Government of India. Collaborative work Many big hospitals are also contributing plenty of patients to the clinical trials done by these companies. a group company of Hyderabad-based Suven Lifesciences and Pfizer. By having a partnership with the Bombay College of Pharmacy.White Paper on“Global Clinical Trials in India – Prospects and Challenges” business. 24 . The Academy for Clinical Excellence (ACE). Lotus Labs has an association with around 20 hospitals in the country for these studies and so do other CROs. ACE aims to provide a one-stop-shop for all the training needs of the clinical research professionals in the country. It offers various course options to pursue in clinical research. These programmes are proving fruitful. It depends on all the stakeholders to see that only quality service providers exist. Even online programmes are available through various service providers.

India has become an attractive destination for contract research businesses because of the huge talent pool of investigators and clinical research (CR) professionals. biotech and laboratory aspects of the business. This gives a plethora of opportunities to professionals from science. project manager. But the profession of clinical research is entirely new to India and requires certain specific cognitive and communication skills. India has today approximately 6 lakh physicians. 4 lakh pharmacists. Today India has produced 300 GCP trained investigators and approximately 600 trained CR (clinical research) professionals. The career prospects in CR business continue to look positive from the growing number of studies being carried out and this conforms to the market estimates of several top analysts. quality assurance manager. chemistry. data entry operator and head of clinical operations. and 3 lakh bioscience graduates and postgraduates. The growing industry scenario always demands good quality professionals to lead the business. This new profession demands roles such as a clinical research associate.Career options in Clinical trials White Paper on“Global Clinical Trials in India – Prospects and Challenges” Most recently. data manager.5 billion in value by 2010. India already has a talent pool of scientific personnel to handle the pharmaceutical manufacturing. who are successfully handling several global multi-centric studies. McKinsey estimated that the Indian CR (clinical research) market will grow to US$1. clinical team leader. the educational institutions in India generate a further 50–60. discovery. availability of high quality infrastructure. biotechnolog y and medical sciences streams to look for a promising future career. Furthermore. manager–clinical trial supplies. There are five distinct career segments that have emerged as a result of the growth of the vibrant CR business. The emerging career The CR business in India has created several career models for graduates and postgraduates. phar macy.000 graduates and postgraduates in different streams of science every year. facilitating regulatory support and increased outsourcing opportunities. medical and regulatory affairs manager. in addition to other key enablers such as the lower cost of operations. Each of these segments depicts the career pathways in a succinct manner for the CR career aspirants to assess his capability and choose one 25 .

Among the cognitive skill sets. This segment supports the clinical trial management in critical areas such as safety monitoring and management. medical writing. and compliance in clinical trials. who are essentially the field force and revenue earners for most CROs and pharma companies that are required for budgeting. manage finance and provide training to the core teams. This segment is essentially the scientific and medical support arm of any organisation and contributes in an important way for the “make or break” decision making. follow-up. therapeutic training to the clinical operations. the most important ones are the knowledge of human anatomy and physiology. the CR business would not be able to operate. and is called the management arm of the CR business. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Required skills The success of the CR profession is dependent on an individual’s level of knowledge and skill sets. understanding of the drug development process. SEGMENT 1 describes the career pathways for medical graduates and post-graduates. The professionals in great demand in this segment are the CRAs and Project Managers. identify and recruit the right professionals. are the real lifeline of the CR business and they provide tremendous support as the study staff in the hospital—set up for patient care. But nonetheless. SEGMENT 5 the investigators. the science of disease and management. Since it is an emerging business. All these professionals need to be trained in GCP standards and should be interested in spending time and energy to participate in a CR. This arm contributes to the bottom line of the CR business and constitutes 60%–70% of the CR manpower. The professionals involved in this segment have a statistical and programming back ground. and the applicable local and global guidelines. The Indian talent pool has the skill sets necessary to orient and train them quickly to meet the demand of any 26 . There are relatively few senior professionals having work experience in global pharmaceutical companies that include the handling of global clinical trials. regulatory submission and approval. India’s resource pool has had a limited exposure to GCP trials.that best fits the potential. SEGMENT 3 also plays a crucial role and is the analytical arm of the CR career model. and study team. SEGMENT 2 is very crucial. India has a lot of professionals with the desired cognitive and communication skill sets required to manage the business. The country lacks a mature pool of trained CR professionals with more than 10–15 years of CR industry experience to handle complex issues in the CR business. They play a major role in the beginning of trial design and at the end to analyse and statistically interpret the data to derive conclusions. Without their support. SEGMENT 4 is the support arm of the CR model. These individuals bring business. the regulatory framework of the country.

in CR management. Despite this. study managers in CROs. A clinical trial monitor typically earns approximately 10%–15% of his U. Bioinformatics Institute of India. experienced. ACRP. there is a considerable emphasis on the training staff to equip them with knowledge and the necessary skills to handle global projects. A company with good. are also exploring the possibility of expanding their training programs in India to support the growing demand for quality training. Thomson Centerwatch. From 60 students this year. Global organisations like MDS. ayurvedic. such as. and homeopathic streams and work as CRAs. Nerul. Kriger Research Institute. These professionals are graduates in life science.S. Barnett International.growing business. However. class room based and/or online. qualified. The Academy of Clinical Excellence (ACE) Institute of Clinical Research (ICR). Kundnani College of Pharmacy. and other topics. through its support from industry professionals. Another institute in Mumbai. has introduced a full-time module on CR management as a part of their PG Diploma in Pharmaceutical management. study coordinators. a sudden rise in the demand for trained and skilled professionals by many CROs and pharma companies has increased the salary levels and expectations of professionals. Naturally. etc. the cost of skilled professionals in India is still low in comparison to its western counterparts. pharmacy. and Other similar organisations. and trained people demonstrates sufficient credibility and capability to attract projects from sponsors. SIES Institute of Management. medical. and hospitals in India. diploma courses. ACE also hosted ACRP examinations in India in 2004 where many CR professionals were certified. pharma companies. ethics committee members. The senior professionals have utilised the transferable skills of related businesses to understand the needs of the CR industry. This is extremely important for the CR industry too. have started full-time. quality assurance. ACE has trained 700 professionals on short-term programs and awarded 100 professionals with post graduation diplomas. 27 Career attraction The CR business is largely driven and managed by people. White Paper on“Global Clinical Trials in India – Prospects and Challenges” Strengthening CR through training Training is another important parameter for ensuring success in any profession. approximately 15%-20% have chosen to pursue CR careers in CROs and pharma companies. ACE. Many local and global training institutes. conducts certificate and postgraduate diploma courses to train professionals on the foundations of clinical research and GCP. since it is a new industry in India./European . short-term.

including investigators.000 trained persons every year. As many growing number of global companies are setting up their operations in India and as demands for the skilled professionals are also increasing. Only three big players — Institute of Clinical Research India. It is definitely attractive for the sponsors and CROs to increase their headcount in India in order to run more trials in comparison to their set up costs elsewhere. however. the requirement will grow to over 50. 3-4 times higher in Europe. The approximate per patient investigator fees in a complex oncology trial is US$2. This is a promising situation for CR professionals. when compared to alternative job options or compensations available in India.White Paper on“Global Clinical Trials in India – Prospects and Challenges” counterpart. may not be able to make the most of this multi-million dollar opportunity due to the absence of trained manpower. Besides the “fast bucks. infrastructure. 28 . it seems to be a win-win situation for the clinical research associates.000 over the next five years.000 persons are trained and certified annually. India.000 in India. However.” the CR profession encourages professionals by providing them with the opportunity to work in a global environment by providing them global systems. Academy for Clinical Excellence and Bioinformatics Institute of India — train professionals for clinical research. which is again more than 7 times higher in USA. With demand far outstripping supply. many recruiters have started offering bonuses and stock options as added incentives to retain professionals. salary levels will no doubt rise dramatically over the next few years. it is more than double this figure in Russia. Future requirement This growth area of the healthcare industry requires 10. and facilities. As per industry estimates. only 1. Besides the salary and compensations.

With the increasing business opportunities in these ‘future markets’. China. 29 . pharmaceutical companies are devising tailor-made strategies for the developing countries which include exploiting the potential for clinical research. clinical research was predominantly conducted in the West. it is likely to hold a good future world over. Developing countries such as India.Future Outlook White Paper on“Global Clinical Trials in India – Prospects and Challenges” In the past. However. those in Latin America and South East Asia are increasingly becoming capable of catering to the growing needs of the industry.

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