China's top legislature, the Standing Committee of National People's Congress, passed the revised drug law on Monday to enhance management and supervision of the drug market following numerous fake drug and vaccine cases that had triggered a call for stronger measures to ensure drug safety.
The latest revision removes drugs that are legal in foreign countries but not approved in China from the category of fake medicines. It also states that people who take these drugs without an official approval into China can be granted leniency if the amount of the drug is small. They will be exempt from punishment if the drug does not cause health problems or delays anyone's treatment, thepaper.cn reported.
Some experts take the move as a sign that China is opening its market to cheap generic medicines, especially from India, which caused national concern in 2018 following the release of the Chinese black comedy, Dying to Survive.
The revised clause addresses patients' needs, Liu Changqiu, a health law expert and research fellow at the Shanghai Academy of Social Sciences, told the Global Times on Monday.
Different countries may apply different standards to drugs, but patients should be allowed the right to buy legal foreign drugs as long as they are effective, Liu said.
However, Liu said that the revision does not mean that China is ready to relax management on imported generic medicine. People who want to import generic drugs for profit still have to follow Chinese laws to register and get an approval in advance.
Most generic medicines which applied for registration in China from 2016 to 2018 were reportedly produced in India and Switzerland.
Experts warned legal risks still exist for distributors who buy drugs abroad.
Along with the revised law, China is also mulling a tracking platform for drugs to prevent fake and substandard medicines from getting through legal channels, according to Liu Pei, director of the policies and regulations department of the National Medical Products Administration, thepaper.cn reported Monday.
The revised law provides the strictest standards and toughest measures over the industry chain, including research and development, manufacturing, sales, use and management of drugs, the Xinhua News Agency reported.
It increased the penalty for fake medicine producers from 2-5 times of the production value to 15-30 times, which means the lowest fine will be about 1.5 million yuan ($210,000), the deputy director of the National People's Congress' state law office of the legislative affairs commission told China Central Television on Monday.