Indian Clinical Trial Rules Modified To Bring In More Sponsors - ACRI India

1. Indian Clinical Trial Rules Modified To Bring In More Sponsors The World Health Organization had written to the Indian government that stringent rules of the clinical research industry would push away pharmaceutical companies from conducting clinical trials in India, while also hampering WHO’s work. Taking this into consideration, the BJP-led NDA government is all set to remove a clause from the final version of the clinical trial rules that authorizes compensation in case of death or injury during a clinical trial. The clinical trials rules that were released in February 2018 included a provision stating that if a clinical trial participant died or suffered permanent disability during the course of the trial, the sponsor will pay an interim compensation upfront, amounting to 60% of the compensation, payable within 15 days of the opinion of an Ethics Committee. The remaining 40% was to be paid within 30 days of the order. It was stated that any organization intending to conduct biomedical and health research should have an Ethics Committee in place to oversee the conduct of the research, which would consist of 7 members including medical scientists, non- medical scientists, legal experts, non-scientific experts, one lay member, and a woman member. The purpose of this committee was to ensure that the medical research and experiments being done were carried out in compliance with ethical concerns and requirements, which would be reviewed and approved to a clinical trial protocol by the committee.

2. But, on June 19, the deputy director general of the World Health Organization, Mr. Sowmya Swami Nathan wrote to the Union health secretary to have the Indian government reconsider the compensation clause as it would drive away drug companies and would also hamper the WHO’s work with India. He wrote that if the draft becomes final, sponsors may not consider conducting clinical trials in India. He added that as a part of WHO, he himself would not act as a sponsor as it is a public health priority to conduct clinical trials on a particular condition in India. The Indian Council of Medical Research also agreed with these objections, as the director general, Mr. Bal ram Bhargava wrote to the Healthy Ministry that some provisions in the draft rules would negatively affect the future of clinical trials in India. Looking at all of this, it was decided to eliminate this clause from the clinical trials rules list, as it could prove to be too difficult for companies and sponsors to run clinical trials in India, while being bound by this provision. With this modification, it can be confirmed that India is definitely going to see a huge expansion of the clinical research industry in the near future, which will in turn make clinical research careers one of the most sought after ones soon. If you are interested in such a career, and want to be able to stand upright in this field and achieve success, you need to get the best possible education about the field. Avigna Clinical Research Institute is who you can approach them to provide you with the finest quality online clinical research courses in Bangalore. Here, you can learn from experienced professionals right from the comfort of your home, and earn a legitimate certification to help you get the best jobs across the globe!