Fast-Tracked Registration Process for Indian Generic Drugs in Singapore

During a bilateral India-Singapore Comprehensive Economic Cooperation
Agreement (CECA) review meeting on May 11, 2010, representatives
of both parties signed an agreement to allow easier access for
Indian generic (off-patent) drugs in Singapore.

The Indian commerce and industry minister Anand Sharma and Lim
Hng Kiang of Singapore signed the “Special Scheme For Registration
Of Generic Medicinal Products From India.” The purpose of
the agreement is to speed up the registration and approval process
for Indian generic drugs.

Previous to this agreement, Indian drug manufacturers could not
export generic drugs to Singapore without undergoing clearances.
However, under this new agreement, if the US, EU, Canada, or Australia
has approved the Indian drug, then it will not need any more clearances
to enter the Singaporean market.

India is currently the fourth largest producer of generic drugs
in the world. It is a $25 billion industry. Its presence in the
global market has cut down the cost of life-saving drugs. The
hope is that this agreement will not only speed up the registration
process for generic drugs, but also will promote further harmonization
in generic drug certification.