The “New Drugs and Clinical Trials Rules 2019” has been issued by the Union Ministry of Health and Family welfare in March 2019. It has regulations over the import of drugs and approval of new drugs.
The rules have been framed by the Central Drugs Standard Control Organisation (CDSCO), which is the Government’s Central Drug Authority.
The new rules incorporate some changes in the organizational functioning involved in the conduct of clinical trials of medicines and vaccines.
The rules detail conditions for orphan drugs, post-trial access, pre, and post-submission meeting, waiver of clinical trials, time norms for approval of drug drugs, etc.
As per the new rules, the application fee for Clinical trials from Phase 1 to 4 has been increased.
The rules defined the timelines for review and approval of Clinical trial applications. In the case of global clinical trials, the deadline is 90 days while 30 days for national clinical trials. Also, if no response is received from DGCI within the specified limit, an automatic approval provision is there.
Two types of Ethics committee can be formed- for Clinical Trials & BA/BE studies and for Biomedical & Health Research.
The validity of the Ethics committee has also been increased to 5 years from 3 years. Also, DCGI must be informed about the approval of an Ethics committee within 15 days of the approval.
If a clinical trial application is rejected, the applicant may request for the reconsideration of the application within 60 days from the date of rejection.
The rules also provide local clinical trials waiver, if the drug has been approved globally.
The new set of rules is a balanced and comprehensive guideline that is expected to improve the ethical and quality standards of clinical trials in India.
Central Drugs Standard Control Organisation
It is a regulatory body for pharmaceuticals and medical devices in India. It is headquartered in New Delhi. Drugs Controller General of India (DCGI) is a department under CDSCO which provides licences for the specified categories of drugs.
Pfizer India apply for EUA
On the basis of New Drugs and Clinical Trials Rules 2019, Pfizer India submitted an application for Emergency Use Authorization to DGCI as its parent company got similar approval in the UK and Bahrain.