The new clinical trial rules in India for the year 2019 have reduced the time for approving applications. The time taken for approval of drugs in India was the main reason why foreign companies restricted themselves from conducting trials in India. Realizing this and working on it, the ISCR has confirmed that the time for approvals have now been reduced to 30 days for drugs discovered in India, or whose research and development has been done in India, and are proposed to be manufactured and marketed in India. But, for drugs that have been developed out of the country, the approval time has been decided upon to be 90 days.
India has the second largest population in the world, and the highest disease burden, but has been conducting a relatively very less percentage of global clinical trials. But, with these New Drugs and Clinical Trials Rules 2019, which were notified by the Ministry of Health and Family Welfare, and made public on March 25, things are set to change. These new guidelines are said to be well-balanced. Also, the ISCR will be further conducting ethical and quality clinical trials in the country that will benefit patients too. This is because the new rules seek to protect the rights, safety, and well-being of patients, while also ensuring a strong scientific base for conducting clinical trials. This is expected to lead to more stability and growth in clinical research being done in India that will ensure patients to have access to faster and more effective treatment.
These new rules will also provide clarity to various applicants and help to smooth the application process. There have been lots of challenges that the Indian clinical trial industry has faced over the years, but with these new rules, the trust and confidence is being built for the same industry such that more and more sponsors now come to India to conduct trials. The ISCR president also added that the validity of clinical trial approval in the country has been determined as two years to initiate a study, which extendable by one year. This will ensure the initiation of approved studies and quicker access to new treatment for patients.
For the first time in India’s history, orphan drugs have been defined as intended to treat conditions that affect not more than five lakh people in India. Furthermore, fee waivers for orphan drug trials are likely to encourage more trials for rare diseases in India.
With such amazing changes and modifications made to the rules of Indian clinical trials, the Indian clinical research industry is all set to boom in the future. You can set up a great career in the field by taking up professional online clinical research courses from a reputed institute like Avigna Clinical Research Institute. You will be able to earn a legitimate certification, and earn a guaranteed job in some of the top CROs, Bio-tech companies, and pharmaceutical companies, both in India and abroad.
