Clinical trial data rules relaxed, approvals and registration hastened, access eased
HYDERABAD, MARCH 30
Indian pharmaceutical and medical equipment manufacturers are set to gain in the China market, thanks to new regulatory norms notified by the Chinese government.
According to a notification received by the Pharmaceutical Exports Promotion Council (Pharmexcil), China’s General Office of the State Council has released new guidelines that aim at encouraging innovation in drugs and medical equipment.
“Authorities in China will now accept data collected from clinical trials conducted outside the mainland for applications to register drugs and medical equipment,” Uday Bhaskar, Director-General, Pharmexcil, told BusinessLine.
India has been a major player in clinical trials and has been a destination for many pharma majors from the US and Europe.
The data collected from clinical trials must meet Chinese regulations for registration of drugs and medical equipment. “The clinical use of new types of drugs will be supported. Local medical authorities have been asked to include new medicines in the coverage of basic medical insurance and the scope of centralised procurement by public hospitals,’’ the official said.
As per the norms, the review and approval for urgently needed drugs and medical equipment will become 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.
“These new provisions are likely to offer faster drug registration and easier market access for Indian pharmaceuticals and medical equipment in China,’’ Bhaskar said. Generally, registrations take about three years but now the time taken will be brought down “significantly”.
A few Indian majors such as Dr Reddy’s Laboratories and Aurobindo Pharma are already operating in China. “We understand that many others are drawing up plans to enter the Chinese market,’’ he added.
The news is likely to bring relief to the Indian pharma industry even as it comes amid growing concern over higher dependence of Indian bulk drug makers on raw materials imported from China.
According to government data, India’s exports to China stood at $10.17 billion in 2016-17 while imports were at $61.28 billion.
“However, API exports from India to China are now growing. In percentage terms, there has been over 70 per cent growth of late in this segment,’’ Bhaskar said.