For many years, India’s clinical trials have been under international scrutiny. India’s global clinical trials have had many problems, such as unethical treatment of subjects, failure to compensate patients for serious adverse events, and lack of adherence to India’s clinical trial regulations by companies. Many Western countries have stopped accepting clinical trial data from India and require some companies to redo their trials in another country.
As more countries began questioning the credibility of India’s clinical research and relocating elsewhere to conduct clinical trials, India’s medical sector fell behind other developed markets. The Central Drugs Standard Control Organization (CDSCO) began implementing policies in 2012 to improve the system, including increasing participant compensation and mandating Ethics Committee registration to oversee clinical trials. Despite these new policies, other countries are still hesitant to trust India’s data.
Since 2012, the various regulations that have been implemented have been confusing and complicated, and have discouraged companies from conducting clinical trials in India. To increase the number of clinical trials conducted, India has relaxed the video audio consent requirement, permitted facilities to have more than 50 beds, and allowed people to participate in more than one trial at once if ethics committees allow them to do so. India hopes to gain international trust and increase global clinical trials in order to test drugs to combat the diseases rampant in India.