• Commerce Ministry in talks with Chinese FDA for speedy approval of Indian pharma products

    • May 19, 2018
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    Indian pharma companies may look forward to speedy product registrations with the Chinese Food and Drug Administration (CFDA).
    The Pharmaceutical Export Promotion Council (Pharmexcil) had requested the Department of Commerce to pursue the issue with CFDA officials.
    “The process is on, and the issue has already been discussed at the highest level,” Pharmexcil Director-General Uday Bhaskar told BusinessLine on Monday.
    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 has taken 3-5 years to approve,” Uday 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 per cent increase, from $145 million in FY17 to $200 million in FY18, according to Pharmexcil data. North America is currently the Indian pharma industry’s largest market, accounting for over 31 per cent 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.
    Pharma exports
    After remaining in the negative territory for the first five months of FY18, pharma exports increased YoY from November despite a slowdown in the US. Though the cumulative data for FY18 shows a modest 2.91 per cent growth to $17.27 billion from $16.78 billion in FY17, annualised shipments have gone up 14 per cent since November 2017.


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