Commerce Ministry in Talks with Chinese FDA for Speedy Approval of Indian Pharma

The Pharmaceutical Export Promotion Council (Pharmexcil) has requested the Department of Commerce to pursue the issue of speedy product registrations for Indian pharma product with the Chinese Food and Drug Administration (CFDA).

“The process is on, and the issue has already been discussed at the highest level,” Pharmexcil Director-General, Mr. Uday Bhaskar said.

According to data available with the council, 254 product registrations are pending with the Chinese regulator. “The delay in registration has been a problem, as the CFDA takes 3-5 years to approve,” Mr. Bhaskar said. The US FDA, on the other hand, takes not more than three years.

The matter is significant in view of the growing interest of Indian drugmakers in the Chinese market, with active pharmaceutical ingredients (APIs) forming the bulk of exports. Pharma exports to China registered a 37% increase, from $145-mn in FY17 to $200-mn in FY18, according to Pharmexcil data. North America is currently the Indian pharma industry’s largest market, accounting for over 31% of total exports. In recent years, there has been increasing interest from China too, the Pharmexcil official said, adding, “Some companies prefer Indian APIs. We expect this trend to pick up further.”

The Commerce Ministry has sought various details from Pharmexcil, including the number of product registration applications filed with the CFDA over the past two years, the number of applications currently pending with the Chinese regulator, and the reasons cited by the CFDA for the pendency. The council has asked its members to submit the data.