New Delhi, March 26, 2019: A call for expression of interest from Indian pharma companies desirous of supplying medicines to a Chinese province has met with lukewarm response, something which is bound to turn the spotlight on the regulatory approval process in China.
There has not been one response thus far, Pharmaceuticals Export Promotion Council of India Director General Ravi Udaya Bhaskar said late on Friday, when a deadline for the companies to respond to the Yunnan province’s call ended. A few companies had, however, sought to know the list of products the province wanted to source, he said. Pharmexcil, a body under the Commerce Ministry, had recently sounded out member-firms about the opportunity, in the wake of the Director General of Yunnan Provincial Foreign Affairs informing the Consulate General of India in Guangzhou about the province’s interest to introduce Indian drugs to the city and the provincial health system.
Indian pharma firms were asked to submit a list of products they can supply to Yunnan, along with certifications such as those from the U.S. Food and Drug Administration (USFDA), if any.
The response may have been better had the companies been provided with a list of products Yunnan planned to source, Mr. Bhaskar said. Lack of information as well as the regulatory process in China, especially the time taken for product registration, were issues behind the level of response, he added.
Three to five years is the norm for getting a product registration from China’s National Medical Products Administration (NMPA) and this comes to about $58,000 per drug. Also, this is not the first instance of such a tepid response from pharma firms — they did not evince much interest when opportunities in Guiyang City were highlighted according to the reports published by N.Ravi Kumar published in thehindu.
The report further adds that, pharmexcil is keen on stepping up its efforts to pursue the Chinese government to fast track the registration and medicines procurement process from India. The Council is also working with the China Chamber of Commerce of Import and Export of Medicines and Health Products.
Such an emphasis comes in the backdrop of the potential to grow pharma exports to China. In 2017-18, pharma exports to China rose 37% to $200 million, an increase of over 37% from the $145 million of the previous fiscal. Aurobindo Pharma, Dr.Reddy’s Laboratories, Lupin, Hetero are some of the companies already doing business in China. The exports are set to grow this fiscal too, with the $185 million mark crossed in January, but at the pace could be faster, he said.
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