While the global pharmaceutical industry is weighing the pros and cons of testing their drugs in the huge drug naïve patient population in India, the domestic clinical trials industry and the government are mooting the methods to improve the authenticity of human studies in the country.
The country, which is expected to host a large number of clinical trials from the pharmaceutical companies world-wide in near future, has recorded almost five-fold growth in the number of clinical trials approved by the drug control authority in a minimum of three years.
"In 2005, around 100 clinical trials had been approved in the country by the Drugs Controller of India (DCI). In 2006, it increased to around 150 and to 240 in 2007. In the current year, around 450 have already been approved," A B Ramteke, joint drugs controller of India. The government is currently examining the measures to increase the authenticity of clinical trails conducted in India, he added in the sidelines of a clinical trials conference conducted by the Confederation of Indian Industry (CII) in Mumbai.
The clinical trial industry has recorded a growth of 60 per cent in the past few years, and is expected to reach a size of USD400 million in 2010, informed industry experts in the conference. The growth of Information Technology Enabled Services (ITES) and its outsourcing in the country also supports the Indian clinical trial industry to become an eligible partner for global pharmaceutical and clinical trial industry majors for their projects, they added.
The clinical research organisations (CROs) in India should focalise on even the minute details of regulatory aspects including the documentation standards and standard operating procedure to build up confidence in the overseas partner, comments S P Vasireddi, chairman, Association of Contract Research Organisation (ACRO) and chairman and managing director, Vimta Labs Ltd.
High confidentiality, quality assurance and business continuity plans from the Indian CROs would enable the companies to build up successful partnership with global CROs and pharmaceutical companies. However, the availability of skilled manpower in the clinical research field will be a major challenge for the Indian CROs in the near future. With more multi national companies entering into the domestic market for clinical research, the scarcity of human resources will be a crucial problem to be solved, said Reddi.
Taking cue from this remark, S K Gupta, dean an director general, Institute of Clinical Research (India), averred that the clinical trial industry will meet a huge gap in demand supply of CRO professionals in 2010. By the time, the country will have a demand of 2000 investigators whereas the available number of professionals in the field would be very less. The growth of global biotech industry and the Indian potential in the field will also boost the growth of the clinical trial sector in the country,he added.
However, India has to consider a couple of questions raised on the ethics and safety of clinical trials conducted in the country to become a preferred destination for clinical trials, said Dr Arun Bhatt, president, ClinInvent Research Pvt Ltd. With a wide spectrum of responsibilities taken by the CROs, including the role of sponsor and contractor, can result in conflict of ethics and interest between the CRO and the sponsor. The operation procedures and accountability should be improved to meet the demands of the client, he added.