The Hindu Business Line : GEAC approval for anti-hepatitis clinical trials

THE Genetic Engineering Approval Committee (GEAC) has permitted Cadilla Healthcare to conduct phase III clinical trials on recombinant human interferon alpha, which is used for the treatment of Hepatitis B and C.

The company can start its clinical trials subject to clearance by the Drug Controller General of India (DCGI).

"Taking note of the recommendation made by Review Committee on Genetic Manipulation and the observations made by the representative of DCGI, the GEAC accorded approval for conduct of phase-III clinical trials subject to clearance from DCGI," GEAC said.

In its meeting held recently, the committee has sought further clarifications from the DCGI on issuing an ex-post facto approval to Hyderabad-based Virchow Biotech Pvt Ltd for conducting phase III clinical trials and permission to manufacture and market recombinant human platelet-derived growth factor.

The committee has also sought additional data from Bangalore-based Biocon before permitting the company to import a drug from Cuba-based Centre of Molecular Immunology to conduct phase II clinical trials on Indian cancer patients.

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