The domestic drug and medical device manufacturers looking at expanding presence in the Chinese market have reasons to cheer as Beijing has decided to relax its regulatory guidelines for pharmaceutical sector to boost innovation and growth.

The General Office of the State Council in Beijing has released a new set of guidelines that states that it will accept data collected from clinical trials conducted outside the mainland for applications to register drugs and medical equipment.

India is a major player in clinical trials and a destination for many pharma majors from the US and Europe.

According to a notification issued by the Pharmaceutical Exports Promotion Council (Pharmexcil), the data collected from clinical trials must meet Chinese regulations for registration of drugs and medical equipment.

The guidelines state that the review and approval for urgently needed drugs and medical equipment should be made faster, including those that can be used to treat life-threatening diseases lacking effective treatment or are urgently needed for public health.

Measures will be introduced to promote drug innovation, including setting up of a catalogue of marketed drugs, building a system linking the review and approval of drugs with their patents, and improving the protection of drug trial data.

“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 norms added.

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.

Indian pharma majors such as Dr Reddy’s Laboratories and Aurobindo Pharma have operations in China. The new provisions are expected to offer faster drug registration and easier market access for Indian pharmaceuticals and medical equipment to China. According to industry sources, drug manufacturers such as Cipla and Lupin are also exploring opportunities there.

Official figures showed that India’s exports to China stood at $10.17 billion in 2016-17 while imports were at $61.28 billion.