China’s revised drug law, which removes drugs that are legal in foreign countries but not approved in China from the category of fake medicines, may allow entry of Indian generic medicines in the country, media reports stated.
China’s top legislature, the Standing Committee of National People’s Congress, passed the revised law recently to enhance management and supervision of the pharmaceutical market following numerous fake drugs and vaccine cases that had triggered a call for stronger measures to ensure drug safety.
India has been demanding that China open its pharmaceutical market to Indian drugs as part of the efforts to lower the USD 57 billion trade deficit in about USD 95.5 billion total trade last year.
No major Indian pharma company managed to establish itself in China in view of the rigid regulations and the costs involved.
Legal foreign drugs, including generic drugs from India, will not be treated as fake medicine in China based on a revised drug administration law that will take effect on December 1, state-run Global Times reported.
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.
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 the revision did not mean that China was 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, the report said.