Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil), which falls under India’s trade ministry, said 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,” Dua said.
Many Indian drug makers are already selling to the EU. 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.
Swift regulatory approvals in China, the world’s second-largest drug market, would allow Indian companies to boost revenue at a time when pricing scrutiny and regulatory troubles have hurt US sales.
Some of India’s largest drug makers, Sun Pharmaceutical Industries 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 US.
Details of Chinese moves to open up its heavily regulated pharmaceuticals sector have not been previously reported.
The China Food and Drug Administration (CFDA) did not respond to a request for comment.
But Chinese foreign ministry spokesperson 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,” Hua told a regular news conference on Monday.
“The relevant departments have formulated specific measures on promoting China-India pharmaceutical trade co-operation 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.
About 250 product applications from Indian drug firms are pending before the CFDA, some of them for years, an Indian trade ministry official said.
Bilateral trade between the two Asian nations touched $89.6 billion in 2017-18 with the trade deficit widening to $62.9 billion in China’s favour, an over nine-fold increase over the last decade.
The two sides are discussing ways to increase Indian sales of farm products, including sugar and some varieties of rice, to China.
India is also trying to persuade China to give access to its cost-competitive software service firms that have dominated global markets. Some of these firms are pitching for “smart” manufacturing projects in the central city of Wuhan and two other provinces in the healthcare and automotive sector.
But it is in the drugs sector that India is hoping to make the first dent, according to officials and a government document.
China has agreed to train Indian pharmaceutical executives to help them gain a swifter entry into the Chinese market, a government document seen by Reuters on efforts to improve trade with China showed. The training is planned for August.
India’s Pharmexcil and the China Chamber of Commerce for Import and Export of Medicines and Health Products will shortly sign an agreement to ease clearance processes and help Indian companies find Chinese partners, according to the document.
Dua and the Indian trade ministry official said China will soon open a desk at its embassy in New Delhi to facilitate Indian drug makers.