cphi-online.com

China's medicines regulator is introducing a new set of quality standards as the superpower seeks to make its mark on the global pharmaceutical arena. At present, the nation only accounts for around 1.5 per cent of the global drug market, despite being home to a fifth of the world's population.

A number of factors have acted as barriers to China's success on the world stage, including its highly fragmented domestic pharmaceutical market, lack of intellectual property rights and relatively poor grasp of the English language compared to competitors. Another important factor has been China's lack of visible drug approval procedures and pharmaceutical-related regulations - something the nation is now seeking to address.

The ongoing problems with drug manufacturing standards have been highlighted by several recent healthcare scandals, with 22 people being arrested earlier this month in a case involving contamination of medicine capsules with chromium. Thirteen products had to be recalled by the State Food and Drug Administrion (SFDA), which told the state-run Xinhua news agency that the capsules contained up to 90 times the permissible level of chromium.

This latest episode has angered the public and caused embarrassment for the authorities, who have taken steps to boost quality levels in recent months. Just last year, new Good Manufacturing Practice (GMP) guidelines were published, which will require all companies to meet stringent quality standards by 2015.

Another attempt to reduce the likelihood of such incidents came in the form of the 2011-2015 National Drug Safety Plan, which was published by the Chinese government last year. The five-year plan aims to address the country's lack of regulatory oversight by speeding up the revision of laws and strengthening enforcement powers. The SFDA's inspection activities are being cranked up and facilities are being improved for the quality testing of medicines.

This will include traditional Chinese medicines (TCM) - a market that China is keen to capitalise on. Hu Songyu, director of the Guizhou Miao Medicine Pharmaceutical Engineering Centre, recently told Xinhua that western countries are increasingly turning to Chinese herbal medicines. As a result, medicine companies are taking steps to apply intellectual property protection to their products to ensure foreign companies cannot patent traditional remedies.

All of these steps are being noted by the international market, which is now waking up to China's pharma capabilities. But China is not the only country with big ideas and its key competitor is undoubtedly India, whose English-speaking population gives it a key advantage. As a result, China will have to work hard to overcome this barrier, as well as proving its expertise and ability to achieve and maintain high-quality standards in drug production.