India and China have been identified by pharmaceutical companies as the future markets that would support drug research and development in a cost efficient manner. This has become necessary as resources to conduct clinical studies dwindle, coupled with the fact that pharmaceutical industries are under pressure to deliver quality medicine, on time, to the public. Exploring and examining India and China’s potential in a stepwise fashion provides the opportunity to dissect the good, the bad and the ugly of globalization in a comparative approach. This paper will cover areas like ethics in the conduct of studies, good clinical practice (GCP), economic realities, ICH influence, intellectual property security and the role of government in global clinical trial.
The Comparative Impact of Globalization of Clinical Trials in India and China
Increasingly, resources for conducting clinical trials continue to dwindle following pressure from other economic competing priorities. To this end, pharmaceutical industries look for more innovative ways of delivering medicinal products to the door steps of end users who are in need of quality medicines for their health. In addition, pharmaceutical industries are also faced with the challenge of a more cost efficient way of doing business which culminates to balancing quality, time and cost (Phillips, 2005). The outcome of this development is the exploration of off-shore drug research and development. This is also referred to as outsourcing of clinical trials, as well as globalization of clinical studies.
India and China have been identified as potential hubs and are currently being explored by large and medium scale pharmaceutical/biotechnology companies as future markets. These two countries hold great potentials, considering the abundance of humans in need of quality medicine, the labor workforce with Western education to support clinical studies at a reduced cost, upcoming infrastructures that are of internationally recognized standards, a mixture of relaxed and complex regulatory pathways and drug naïve subjects that are ready to enroll in trials. These two emerging markets are also in the process of aligning their regulatory guidelines and laws with that of the Western world. As rosy as this appears, there are still hurdles to overcome in these countries being explored by pharmaceutical industries.
Some large pharma industries, in trying to make the best of these opportunities, have entered into strategic alliances, collaboration and partnership with local industries and other multi-national CROs with the ability to navigate complex drug regulatory pathway to fast track business development and to conduct research (EMERGING MARKETS). However, this also comes with its attendant challenging risk of losing intellectual property, quality standard compromise and recruiting patients without consent (EMERGING MARKETS).
The speeds at which pharmaceutical industries are exploring these offshore terrains vary because of the competitive advantage of one region over the other or rather the way these countries are repositioning themselves to attract the capital market of the industry. This paper will explore and examine the good, the bad and the ugly in a comparative manner that has resulted following globalization of clinical trials. As the paper examines the impact of globalization, it will compare a broad range of globalization impacts on regulatory climates; ethics in the conduct of clinical trials; ICH influences (good clinical practice (GCP) and global acceptance including adaptation; intellectual property security; and the role of government in global clinical trials; economic realities.
Indian drug regulatory body versus the Chinese system
The increasing outsourcing of clinical trials to India stems from the fact that large pharmaceutical companies are pressured to deliver quality medicines to meet unmet needs in the society. In addition, dwindling research funds calls for more effective ways of doing business across the globe.
Not only that, companies are also interested in repositioning themselves to capture emerging markets as projection have shown that these markets hold great potentials for global clinical trials. The Indian pharmaceutical market capitalization was projected to grow to 2 billion US dollars as of 2010 (Chatterjee, 2008). India is now one of the emerging hubs for clinical trials as it boasts of technically competent and young workforce (More than 500,000 trained in the US and in the UK), low cost of drug development, availability of treatment naïve population, concentration of large population in urban cities, presence of major diseases, use of English as a means of communication, supportive infrastructure, population diversity, highest number of FDA-approved labs as well as friendly drug control systems (Chatterjee, 2008; Mukesh, 2009; Jankosky, Jiang,& Farwell, 2007 and China).
As companies try to take advantage of the potential gains presented by the outsourcing of clinical trials to emerging markets, their actions and inactions have impacted both positively and negatively in the evolutions of drug regulatory system, including uncovering gaps that have exposed patients to harm during trial conducts. Before now, India has demonstrated expertise in conducting research in generic medicines while hosting only 1% of US sponsored investigational new drug research (Mukesh, 2009). However, with increased outsourcing of clinical trials, and expected rise of FDA regulated drug research, India conducted 10% of FDA regulated studies back in 2010 and 15% in 2011 respectively (Jankosky,Jiang,& Farwell, 2007; Deepakmb, 2011 ). The Indian regulatory framework is repositioning itself and as well aligning its practices and organization to measure up to that of the West in order to make it competitive among emerging markets.
The Drug Controller General India (DCGI) has being restructured to serves as the Indian equivalent of Food and Drug Administration of the US and European Medicine agency in Europe. It is the Federal body regulating all pharmaceutical related issues in India as described in the drug and cosmetic rule of 2005 (Mukesh, 2009). The DCGI is equivalent to the FDA commissioner, while clinical trial is regulated per schedule Y of the drug and cosmetic rule, synonymous with the investigational new drug regulation described in 21 CFR 312 of the United States (Mukesh, 2009). This resemblance on the surface is attractive to Western countries as it makes India a favorable hub for clinical trials. The FDA is subdivided into various offices that address issues regarding new chemical entities, biologics and medical devices with designate leads. This is not the case with the DCGI, making regulatory approval cumbersome and complex. Drug approval in India could take as long as six months. Trial documents with queries may stay longer including trials considered as sensitive. Indian drug regulatory system was realigned to capture lead drug markets in 2006 by categorizing application in A&B. Category A are trials that have received approval in major markets (US, UK, Germany, South Africa, Canada, Australia and New Zealand including Europe) following the rigor and expertise of regulatory system in these countries. Proposal and protocol documents submitted under category A are given preference and reviewed within 2 - 4 weeks. The category B research is reviewed within 5 - 6 months (Mukesh, 2009). Before 2005, retesting of foreign drugs is required and in addition, the Indian regulatory system requires all research to be conducted in India to lag by one phase from the country outsourcing the trials (Deepakmb, 2011). However this has changed as parallel studies are now allowed making Indian suitable to participate in multinational trials.
As good and appealing as these prospects to clinical trial conduct, continual outsourcing of clinical studies to India has revealed that the gains of global clinical trial is that of a slow yet consistent improvement. The human resource for health needs of DCGI is yet to be addressed as the DCGI is only one person supported by a deputy that reviews research proposal documents submitted for research conduct. This has further lengthened research approval process to 6 - 8 weeks. There are still gaps in the tracking system for submitted files making it difficult for sponsor companies to accurately predict the position of submitted files and their status. In additions, global outsourcing to India is yet to address formal meetings with regulatory bodies before submission of files making it challenging in putting documents together to meet regulatory requirements (Mukesh, 2009).
China as an emerging market in Asia Pacific and as well a potential hub for the conduct of clinical trial across the globe features some unique advantages that make it attractive to lead markets in the pharmaceutical industries. Some of the potential it shares with India and beyond include; having the largest urban treatment naïve population, supportive and motivated workforce (18,000 hospitals, 1.5 million physicians, 2 million physician assistance, and 1.6 million nurses), significantly reduced cost of research conduct, abound and unique disease resources, a huge market, GCP compliant database and certified GCP public hospitals for research conduct. (Jankosky, Jiang, & Farwell, 2007; How to conduct clinical trials in china). To this end, it is expected that china will be the 3rd largest pharmaceutical market by 2020. Global clinical trials have impacted positively on the Chinese drug regulatory process to support clinical trials in this region.