Union government is expected to finalise the Bill which will monitor unethical clinical trials in the country. The bill will police individuals and organizations engaged in the unscrupulous practices during conduct of clinical trials. The Bill is expected to be cleared by August this year.
Although Ethical Guidelines for Biomedical Research on human subjects drafted by the Indian Council of Medical Research (ICMR) has been lying with the Health Ministry for a few years, scores of poor patients and youngsters were being enticed and subjected to unethical practices. This is primarily because of the absence of an effective law to monitor the activities of CROs and pharma companies.
The Association of Clinical Research Organizations along with the clinical research industry has been lobbying with the government to bring in a stringent rule to take the violators to task and encourage responsible conduct of human studies, said Dr Anand Bidarkar, vice president, SIRO Clinpharm Pvt Ltd.
There have been serious concerns on the part of the global companies when the clinical trials are conducted in India. These include lack of compliance to patient management, design and reporting of clinical trials. It was high time for the Indian Clinical Research Organizations to evaluate their current business development models to get an acceptance in the US and UK markets. Now this bill will bring in much self-assurance to the Indian clinical industry, he added.
The Bill will call for a punishment of 10 years and it will also include the judiciary and legal framework to strengthen the verdict.
The clinical research and data management sector in India is at significant deflection point. Almost all major pharma biotech and a slew of small and mid-sized companies now include India in their clinical trial plans. The sector has witnessed significant growth rates even in the recessionary scenario. The US$300 million industry is however a far cry from McKinsey projection of US$1.8 - 2 billion by 2010. A number of unresolved issues are constraining from achieving its full potential. An inclusive approach could fast rack the growth. The proposed Bill will now track down the illegal players, pointed out Bidarkar.
On June 15, the health ministry mandated the registration of all clinical trials in the Indian Council of Medical Research Trial Registry in order to streamline sector. The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the ICMR. It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office.
Another issue is that people in India refer to clinical trials as "guinea pig syndrome". This attitude can change only if the government brings in a regulatory framework to reprimand those indulging in unethical practices. These efforts along with other regulatory steps need to be in place for the growth of the industry to the US$1 billion mark, he added.