After completing the first round of overseas inspections, two teams of the Central Drugs Standard Control Organisation (CDSCO) will now be dispatched to China and Italy next month to carry out the second leg of auditing of manufacturing facilities.

Sources said the teams have been finalised and will leave sometime next month to hold the on-site inspections. The CDSCO team, which went to China last month, has already submitted its report and necessary action was taken accordingly, sources said. The Drug Controller General of India (DCGI) had shortlisted 11 manufacturers of China for inspection and the team held inspection of five sites.

Now the second team will inspect three diagnostic tool manufacturers in Zhejiang, Fujian and Guangho districts. On the basis of complaints and doubts on authenticity of GMP certificate, the Health Ministry had cancelled registration of 10 registration certificates and import licences of companies based in these three districts last year. So the next team would be visiting these areas.

The DCGI office shortlisted the diagnostic manufacturers as there were complaints about the quality of imported kits of HIV from China. Similarly, another team will go to Italy to hold inspections of two bulk drug manufacturers in Italy, sources said.

There were several cases where imported products were found to be not of standard quality by the government laboratory which originated from outside. Hence the DCGI office had pressed for carrying out foreign site inspections in line with other regulatory agencies of the world.

Based on the report of the first team, the authorities are planning to cancel the licences of Chongiqing Daxin Pharmaceutical Company which did not allow the Indian drug regulators to inspect its premises and manufacturing facility. Located in China's Beibei district, Chongiqing Daxin Pharmaceutical Company is a bulk drug exporter to India.

India is the largest importer of Chinese bulk drugs. More than 45 per cent of bulk drug exporters registered in India are from China. The number of registered Chinese bulk drug manufacturers in India is 272, and altogether 417 different drugs from the Asian giant are registered. In comparison, Italy, the second biggest supplier after China, has 55 registered BD and overall 97 drugs registered, respectively.