Value Of Life Only Rs 2.2 lakh In India: Report

New Delhi, Sept 10, IRNA -- The value of life is only Rs 2.2 lakh in India if the average compensation paid for deaths during clinical trials of drugs is any yardstick. And the value is only getting cheaper going by the compensation amount paid in 2011 as against average compensation of Rs 3.2 lakhs for clinical trial-related deaths paid in 2010, according to an analysis of data provided in Parliament by the Union Health Ministry. The alarmingly low-level of compensation for lives lost during clinical trials in India can be credited to the fact that government is yet to frame rules for compensation in such cases under the existing drug regulation laws in the country. By its own admission, the government said there were no such rules in place and it was in the process of finalizing them. Health Minister Ghulam Nabi Azad said the government is in the process of finalizing such guidelines and expects to do so soon. 'The government expects to finalize these guidelines soon keeping in view the rights and well-being of trial subjects,' Azad has said in a written reply to a question in Lok Sabha. The Minister said draft guidelines for determining the quantum of financial compensation to be paid in cases of clinical trial-related injury or death have been prepared and comments from public have been sought. Though the total number of deaths in the country in 2010 and 2011 during clinical trials were 668 and 438 respectively, the Serious Adverse Events (SAEs) of death attributed only to clinical trials of drugs were found to be in 22 and 16 cases in these respective years. In 2012, there have been 211 deaths till June during clinical trials, but the reasons of their deaths are being assessed. A perusal of financial compensation in cases of clinical trial-related deaths in 2011 indicate that a total of Rs 35.21 lakh has been paid in 16 cases by drug firms. They ranged from a paltry Rs 50,000 to a maximum of Rs 5 lakh (still under process of payment). In 2010, a total financial compensation of Rs 70.33 lakh was paid in 22 cases with the maximum amount being Rs 20 lakh by and a minimum amount being Rs 1.08 lakh. Meanwhile, In spite of the recent bad press the clinical trial market has received, a research report says a positive change is taking place with the country being viewed as a drug discovery destination, and the market likely to cross USD 1 billion by 2016. The domestic Clinical Research Organization (CRO) market was worth USD 485 million in 2011, but is set to cross USD 1-billion-mark by the turn of 2016, PTI news agency cited a recent Frost and Sullivan report. The report says that the large, easy-to-access, treatment-naive population, high degree of available cost arbitrage of up to 30-50 percent over the US, and an improved regulatory environment is driving the domestic CRO market, which is growing at 11-13 percent. The domestic CRO market is dominated by multinational pharma companies. While the MNCs are into global trials, domestic drug companies usually look at conducting local trials. 'Therapeutic areas in which research can be conducted here are varied, and this is likely to result in more number of studies in the country,' says report, adding 'emerging areas, such as diagnostic research, are also expected to drive the domestic CRO market.' However, increasing competition, quality concerns and lack of quality infrastructure in smaller cities are some factors that impede the growth rate of the CRO market. 'Consumer confidence in the clinical trials data is lacking, greatly impacting the CRO market. This is due to the fact that a number of small-scale CROs having compromised on the standard of their studies in their bid to compete,' report said. 'Developing a single-window clearance for clinical trials as well as clear guidelines on the types of international/global trials that can be performed on Indians will shore up the market growth,' notes the report. India is the ideal destination for clinical trials. Pharma giants are also magnetized by India due to the fact that the country offers nearly 700,000 specialty hospital beds, 221 medical colleges and skilled English-speaking medical personnel. The Indian pharmaceutical industry, consisting over 10,000 firms, is estimated as a Rs 1 lakh crore industry, of which about Rs 60,000 crore is from the domestic market. Clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases. Good Clinical Practices (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Compliance with this standard provides assurance to public that the rights, safety and well being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki and ensures that clinical trial data are credible./end