Drugs and changes in clinical trial rules
The government is going to make the rules related to medicines and research easier. The Ministry of Health has proposed a change in New Drugs and Clinical Trials Rules, 2019. Its notification has been released on 28 August 2025 in the Gazette of India and suggestions have been sought from the common people.
This draft Rules have been released for further strengthening the current rules of 2019. However, this draft will be finalized after the response of the people. The government has said that objections and suggestions on this can be sent within the next 30 days. Under this proposal, permission for testing of new drug has now been very important.
What changes will be made?
- Now there will be no need to get separate license for most medicines. It will be enough to give only information. At the same time, license will be required only on high-risk category medicines.
- The time of the test license process will be reduced from 90 days to 45 days.
- License will no longer have to be taken for some category biovelism/bioqueline (BA/B) study. The study can be started only after giving information.
Why are these changes beneficial?
This proposal is considered important in many ways. This will reduce the license files by about 50%. Research and trials on new drugs will start quickly. Also, the process of drug approval will be accelerated. CDSCO (Central Drugs Standard Control Organization) will be able to use its resources better. The government says that with these reforms, India will become a big center of medicines and clinical research in the world and the Indian pharma industry will get strengthened.
30 days for suggestion
Suggestions have been sought from the pharmaceutical company, researcher or common citizen on this proposal. He has been given 30 days to give suggestions. In these 30 days, he can give his opinion on this proposal. Its flaws and features, what and changes can be made can tell. This initiative shows that the government wants to create an easy and systematic process by taking the opinion of experts and common people associated with the industry.