‘Drugmakers may get Chinese licences within six months’
China is preparing to give swift regulatory approvals to India-manufactured drugs, the head of an Indian export promotion group said, as Beijing looks for new commercial partners ahead of what could be a protracted trade war with the United States.
Indian firms are looking to fill gaps in Chinese demand for generic drugs, software, sugar and some varieties of rice, trade officials in New Delhi said.
“We do feel that China is receptive at this time and it’s all about making prices competitive,” said a government official involved in the effort to promote trade with China. The official declined to be identified since he is not authorised to speak to the media. No concrete deals have been signed but the outlook for pharmaceutical sales from India is positive, according to officials from both nations.
India dominates the world’s generic drugs market, exporting $17.3 billion of drugs in the 2017/18 (April-March) year, including to the U.S. and the EU. But only 1% of that went to China, the world’s second-largest market for pharmaceuticals, industry data shows.
Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil), which falls under India’s trade ministry, told Reuters in an interview that Indian firms could expect to win licences to export to China within six months of application.
“We understand internally that Chinese authorities have issued instructions that EU-approved Indian suppliers should be granted the industrial drug licence in an expeditious manner so they can enter the Chinese market within six months,” Mr. Dua said.
The EU is already one of India’s key export markets for medicines, and accounted for about 15% of overall drug exports in 2016/17, according to Pharmexcil.
U.S. market woes
Swift regulatory approvals in China would allow Indian companies to boost revenue at a time when pricing scrutiny and regulatory troubles have hurt U.S. sales.
Some of India’s largest drugmakers, Sun Pharmaceutical and Lupin as well as Aurobindo Pharma, have been trying for years to expand in the massive Chinese market, which is second only to the U.S.
The China Food and Drug Administration (CFDA) did not respond to a Reuters’ request for comment.
But Chinese Foreign Ministry spokeswoman Hua Chunying said this week that China was moving forward on giving greater market access to Indian drug makers.
“China and India are witnessing a growth in pharmaceutical trade, and the two sides are in sound communication on opening the Chinese market to drugs from India and conducting dialogue and co-operation between the two sides’ pharmaceutical industries,” Ms. Hua told reporters on Monday.
“The relevant departments have formulated specific measures on promoting China-India pharmaceutical trade cooperation and granting greater access to drugs from India. We believe that stronger pharmaceutical trade co-operation will contribute to the well being of the people in our two countries.”
In May, China exempted import tariffs on 28 drugs, including all cancer drugs, a move that would help India reduce its trade imbalance with China, Luo Zhaohui, the Chinese ambassador to India said.
China has been touting greater access to cancer drugs and pushing to lower prices in a bid to soothe a major social issue in the country, where traditionally many patients with serious illness have had to pay out of their pocket for cutting-edge drugs or have had to buy medicines through unapproved grey market channels.
China also lags far behind in terms of drug approvals versus developed markets.
The issue was highlighted in a recent film that went viral in China which echoed the U.S. Dallas Buyers Club about a Chinese cancer patient who had helped others getting unapproved cancer drugs at lower prices shipped in from India.
About 250 product applications from Indian drug firms are pending before the CFDA, some of them for years, an Indian trade ministry official said.
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