China's Drug Law for India

China’s Drug Law an advantage for India’s Generic Drug Manufacturers. Until now, all different generic drugs not approved in China were clubbed under the counterfeit category and were illegal.

India has been demanding that China should open its pharmaceutical market to Indian generic drugs as part of the efforts to lower the $57 billion trade deficit in about $95.5 billion total trade last year.

China’s changed drug law, which removes drugs that are legal in foreign countries but not approved in China from the category of ‘fake medicines,’ could open up the possibility of Indian generic drug manufacturers entering the Chinese market.

Patients can use these drugs in small quantities from December 1, the newly revised drug administration law of the country said. The revision was approved at the end of the session of the National People’s Congress (NPC), the country’s top legislature, on Monday. The change in drug law is good news for Chinese patients suffering from serious diseases such as cancer.

None of the major Indian pharmaceutical company managed to establish itself in China given the rigid regulations and the costs involved.

Legal foreign drugs, including generic medicin

es from India, will not be treated as fake medicine in China. This is based on a revised drug administration law that will come into effect from December 1, state-run Global Times reported. The latest drug law revision removes drugs that are legal in foreign countries but not approved in China from the category of fake medicines. It also stated that citizens of China who take these drugs without official approval into China could be granted leniency if the amount of the drug is small.

In June, India had asked for a “clear roadmap” from Chinese Government to meet its long-standing demand to open up Chinese pharmaceuticals market for Indian generic drug exports as the drug regulators of both the nations held their first-ever meeting in Shanghai.

India has, for long, been pushing China to open its pharmaceutical market, where the prices for cancer and generic drugs are relatively high. The opening up of the Chinese market- China’s Drug Law for India- pharma exports was seen as a means to address the yawning trade deficit. This trade deficit crossed $57 billion according to the official figure released by the Chinese Government.

Author: Rahul Mishra


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