The Drugs Controller General of India released a list of nations covered by Rule 101 of the 2019 New Drugs and Clinical Trial Rules last week.
The US, UK, Japan, Australia, Canada, and the EU have been named by the drug regulator, who is acting in accordance with Rule 101.
Read on to find out all the details about the new update!
DCGI Permits Forgoing Local Clinical Trial Requirements
This ruling permits the consideration of forgoing local clinical trial requirements in order to approve new drugs under Chapter X.
It moreover permits the conduct of clinical trials under Chapter V in the event that the medications are presently licensed in these nations, which are renowned for having strict regulatory environments.
This specification permits new pharmaceuticals licensed in these countries—known for their strict regulatory frameworks—to be approved without the need for local clinical studies.
This waiver is applicable to:
- Orphan drugs for rare diseases
- Gene and cellular therapy products
- New drugs used in pandemic situations
- New drugs used for special defense purposes
- New drugs with significant therapeutic advances over the current standard care
What Does Rule 75 State?
According to Rule 75 of the New Drugs and Clinical Trial Rules, 2019, if a drug is licensed and marketed in one of the designated countries and no significant adverse events have been documented, there may be no need for local clinical trials.
The DCGI’s ruling complies with both Rule 101 and Rule 75 of the New Drugs and Clinical Trial Rules, 2019.
By removing medications from local trials, this decision is anticipated to lower the cost of medications and increase their accessibility and affordability for end users.
The directive mandates that pharmaceuticals be examined by a committee of experts who will assess the available data regarding the drugs; it does not, however, imply their approval in its entirety.
Rule 75 of the New Drugs and Clinical Trial Rules, 2019 states, “the local clinical trial may not be required if the new drug is approved and marketed in countries specified”. The words state in the law is may, and not shall. Thus, the recent DGCI order shall not imply a blanket approval fulfilling the two-test i.e., jurisdiction and application which means that drugs will be scrutinised by the expert committee and will be evaluating evidence related to the drugs.”
