Hyderabad, Nov 29: Shanta Biotechnics has denied the charge by environment ministry`s Genetic Engineering Approval Committee (GEAC) that it has manufactured recombinant Streptokinase unauthorisedly.
Addressing reporters here Shanta Biotechnics (SB), managing director, Varaparasad Reddy, said the report by GEAC at Delhi is "mischievous and misleading".
He asserted that SB has followed full regulatory procedures as specified by the department of biotechnology in getting its recombinant clot-buster drug Shankinase approved for clinical trials and subsequent clearance for manufacturing.
Reddy said according to department of biotechnology protocol, GEAC has no role to play in granting approvals for clinical trials.
All clinical trials are approved by drug controller general of India (DCG) advisory committee, after it has been duly approved by Institutional Biosafety Committee (IBSC) and Review Committee on Genetic Manipulation (RCGN).
Bureau Report