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.