Genetic engineering regulator orders drug manufacture probe
Our Economy Bureau / New Delhi November 28, 2003
The Genetic Engineering Approval Committee (GEAC) has requested the Drug Controller General of India (DCGI) to probe the unauthorised manufacturing of drugs in India.
The GEAC has asked the DCGI to conduct an inquiry into the reports of manufacturing of recombinant Streptokinase by Shanta Biotechnics, a Hyderabad-based company, and the trial of the drug on patients without the panel’s prior approval. The drug controller has also been asked to investigate the reported deaths of some of these patients.
The committee also recommended the import of crude degummed soyabean oil for a period of one year while stipulating that a post-marketing surveillance through Integrated Child Development Services programme managers should be carried out.
Also, results of the monitoring, along with comments from the Indian Council for Medical Research, should be submitted to the GEAC.
Genetic engineering regulator orders drug manufacture probe
Our Economy Bureau / New Delhi Nov 28, 2003, 00:00 IST
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