Delay in product registrations is troubling Indian pharma companies that are trying to expand their presence in the Chinese market and the Pharmaceuticals Export Promotion Council (Pharmexcil) has requested the Department of Commerce to take up the issue with the Chinese Food and Drug Administration (CFDA).
Pharmexcil, in a circular issued recently, has asked its members to submit the data regarding the number of applications currently pending with the Chinese regulator, and the reasons cited by the CFDA for the pendency.
According to official figures, more than 250 product registrations are pending as the Chinese regulator takes 3 to 5 years to issue required approvals. The US FDA usually takes not more than three years.
The matter assumes significance as interest of Indian drug makers in the Chinese market is growing, with active pharmaceutical ingredients (APIs) forming the bulk of exports.
Pharma exports to China registered a 37 per cent increase, from $145 million in FY 17 to $200 million in FY 18, according to Pharmexcil data. North America is currently the Indian pharma industry’s largest market, accounting for over 31 per cent of total exports.
After remaining in the negative territory for the first five months of FY 18, pharma exports increased YoY from November despite a slowdown in the US. Though the cumulative data for FY 18 shows a modest 2.91 per cent growth to $17.27 billion from $16.78 billion in FY 17, annualised shipments have gone up 14 per cent since November 2017.
Recently, Beijing has removed import duties on as many as 28 medicines, including all cancer drugs. The new regulations came into force on May 1. It has also relaxed its regulatory guidelines for pharmaceutical sector to boost innovation and growth. As per the new guidelines, China will accept data collected from clinical trials conducted outside the mainland for applications to register drugs and medical equipment.
“The clinical use of new types of drugs will be supported. Local medical authorities are asked to include new medicines in the coverage of basic medical insurance and the scope of centralised procurement by public hospitals,” the regulatory notification stated.
India is a major player in clinical trials and a destination for many pharma majors from the US and Europe. The more than $100 billion China market is dominated by local drug manufacturers and multinationals and India’s pharmaceutical exports of around $160 million are a fraction of the companies’ sales.