The Hindu Business Line : Govt wary about allowing Chinese biotech imports

THE threat from the dragon in the biotech sector is real and the Government has decided to be extra-cautious in granting approvals to Indian companies planning to import molecules from China.

Consider the applications placed before the Genetic Engineering Approval Committee (GEAC), the apex body granting approvals to companies wishing to import molecules from abroad, the Mumbai-based V.H. Bhagat Co plans to import a r-human growth hormone manufactured by Shanghai United Cell Biotechnology Co Ltd, Gland Pharma Ltd is seeking approval to import molecules from China to treat deficiency of white blood cells while the Pune-based Emucure Biotech Ltd wants to bring in products for the treatment of skin and kidney cancer from Jiangsu Kingsley Pharmaceuticals Inc.

Sources in the Ministry of Environment and Forests said that the number of applications from China and Korea has been growing and there is need to exercise caution. "We are concerned about this trend and are exercising extra caution while scrutinising applications pertaining to imports from China," said officials.

Companies are therefore being asked to provide details on the number of years of approval of the product in the country of origin and also conduct Phase III clinical trials in ``at least statistically significant Indian population before introduction of the product in India, as the product is not well-experienced in China.''

Industry sources said that the reason for the extra-caution is that there are doubts about the safety standards of products being imported from China. "The biotech industry is growing in China but there are no track records on the approval procedures or safety of the products tested there. Drugs originating in the US have to get approval from the Food & Drug Administration (FDA) and are hence considered to be safe," said industry sources.

Another reason for surge in imports from China or Korea is the huge cost advantage. Pharma industry officials said that it is about five to ten times cheaper to source molecules and drugs from these Asian countries compared to either the European or the US markets.