Relaxed drug legislation in China comes as a boon for patients, who will now be able to use generic medicines made in other countries such as India.
Generic medicines unapproved in China were hitherto classified as counterfeit drugs, making their use illegal. Now, however, a session of the national legislature has relaxed this stipulation. Patients will now be permitted to own small quantities of generic medicines for personal use without facing legal penalties. The relaxed legislation will take effect from December 1st.
The announcement comes as good news for individuals in China, carrying the potential to reduce out-of-pocket spending on healthcare by allowing patients to turn to cheaper alternatives to on-brand medicines. For the generics industry in India, this could partially open a new market. However, Chinese officials are keen to emphasise that the relaxed law does not represent an opportunity for the international generics industry, including that of India, to establish a new footprint.
“Article 124 of the newly revised drug administration law stipulates that the import of a small number of drugs that have been legally listed overseas (but) without approval (in China) can be exempted from punishment in minor cases,” said a report published in Chinese newspaper The Global Times. The report goes on to note that the relaxed stipulations doesn’t “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.”
India is one of the two main countries of origin for generic drug producers applying for approval in China along with Switzerland. India is considered a global leader in generic drugs, earning the title ‘pharmacy of the developing world’ for its provision of generic medicines to numerous international markets.
“Under the new definition, a cheaper generic drug made in India can be imported and sold in China,” Yanzhong Huang, a Council on Foreign Relations senior fellow for global health, explained to The New York Times. “Given that these drugs are usually much cheaper than the prohibitively priced Western patented drugs, a significantly larger percentage of Chinese people can now afford those lifesaving drugs.”