09 June 2011
By Kounteya Sinha
New Delhi, India
Three–Member Indian Team Was Disallowed From Inspecting Its Manufacturing Facility
Located in China’s Beibei district, Chongiqing Daxin Pharmaceutical Company is a bulk drug (BD) exporter to India. A three–member delegation from the Central Drugs Standard Control Organization (CDSCO), led by assistant drugs controller of India Arvind Kukrety, visited the units in China from May 9 to 21. This was CDSCO team’s maiden international trip. Altogether, they inspected manufacturing facilities of five major Chinese BD exporters.
"Chongiqing refused to allow inspection of their manufacturing unit. The registration certificate of the firm will be cancelled," a CDSCO official told TOI.
India is the largest importer of Chinese bulk drugs. More than 45% of BD exporters registered in India are from China.
The number of registered Chinese BD 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. In 2009–10, the value of drugs imported from China stood at Rs 3,094.4 crore against a total import value of Rs 4,953.87 crore.
The decision to audit 11 Chinese drug manufacturing units was taken after several import licences of local agents of such overseas units were cancelled due to poor drug quality and their failure to comply with good manufacturing practices.