Why in news
The Indian government has announced a new policy affecting drug approvals.
Drugs approved in major markets (U.S., U.K., Japan, Australia, Canada, EU) will not need additional clinical trials in India.
This change is expected to make foreign-manufactured drugs more accessible and affordable in India.
The government has specified a set of five categories for new drugs that will be considered for the Indian market.
The government has specified a set of five categories for new drugs that will be considered for the Indian market.
Drugs for rare diseases,
gene and cellular therapy products,
new drugs used in pandemic situations,
new drugs used for special defence purposes,
new drugs having significant therapeutic advances over the current standard care
As per Rule 101 of the New Drugs and Clinical Trial Rules, 2019, the Central licensing authority, can specify countries for waiving local clinical trials.
The Central licensing authority needs approval from the Union government for this specification.
COMMENTS