Lack of GMP compliance could cause hepatitis B vaccine shortage in China
Top three producers have failed to obtain government authorisation to manufacture the hepatitis B vaccine
China's top three producers of hepatitis B vaccine have all failed to obtain the government's authorisation to manufacture the products, triggering fears of a shortage in the market.
The China Food and Drug Administration, the country's top food and drug watchdog, did not include Dalian Hissen BioPharm Co, Shenzhen BioKangtai and Beijing Tiantan Biological Products Corporation in its most recent list of companies to have received the Good Manufacturing Practices (GMP) certificate for pharmaceutical products.
Vaccine companies that did not obtain the GMP certificate before the 31 December deadline are banned from manufacturing new products in 2014, although they are still able to sell their existing products. The country's current GMP rules, which were adopted in early 2011, include stricter requirements for pharmaceutical companies in terms of their manufacturing process and the quality of their production facilities.
The failure of the three firms to get the certificate before the deadline should be seen against the backdrop of recent deaths. In early December, more than 10 babies died after hepatitis B vaccine inoculations, prompting the authorities to ban the use of vaccines produced by some drug companies. The three companies have a share of more than 80% of China's hepatitis B vaccine market, with Hissen taking 29%, BioKangtai holding 26.3% and Tiantan owning 25.8% as of October 2013.
Yu Mingde, president of the Chinese Pharmaceutical Enterprises Association, said there is a huge demand for hepatitis B vaccines because the inoculation is required and paid for by the government in China.
Incidentally, only 60.3% of the 1,319 sterile drug producers in China have obtained GMP certification.
