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`Shantha Biotech did not get clearance before phase-III trials'

Our Bureau

New Delhi , Feb. 6

THE Genetic Engineering Approval Committee (GEAC) said that there has been a clear lapse on the part of the Hyderabad-based Shantha Biotechnics Pvt Ltd in not obtaining clearance before conducting the Phase-III human clinical trials using Recombinant Streptokinase for treatment of acute myocardial infarction (heart attack).

The Department of Biotechnology (DBT) had directed the company in May 2002 to obtain the permission of the GEAC and the Drug Controller General of India (DCGI) before conducting such trials. The company had said that the procedural necessity of getting a GEAC clearance had been obviated due to a revised clearance procedure evolved by DBT and displayed on their Web site.

Hence, the committee under the chairmanship of Ms Veena Chhotray, Additional Secretary, Ministry of Environment & Forests, has decided to condone the procedural lapse by the company with a strict warning.

However, the GEAC has sought clarifications from the DBT and the DGCI regarding the approval for manufacture and marketing of r-Streptokinase.

Shantha Biotechnics, on its part, has been claiming that that it has followed regulatory procedures as specified by the DBT in getting its recombinant clot-buster drug - Shankinase - approved for clinical trials and also subsequent clearance for manufacturing.

The committee today also gave environmental clearance for import of r- human Lactoferrin (rhlf) Placebo for clinical studies by Reliance Clinical Services, Mumbai from Agennix Inc Houston, US in the field of oncology as an anti-tumour drug along with standard Paclitaxel/Carboplatin in non-small cell lung cancer.

It also revalidated the permission to manufacture and market human insulin by M.J. Pharmaceuticals, Mumbai. GEAC approved the import and marketing of Ovidrel-250 mcg (Recombinant Human Chorionic Gonadotropin/Chorionogonadtopin Alfa) from Industria Farmaceutica Serono S.P.A, Italy by Serum International Ltd, Pune.

Approval was also given for the import of Insulin Detemir (r-DNA origin) for formulation for Phase-III clinical trials from Novo Nordisk A/S Denmark by Novo Nordisk Pvt Ltd, Bangalore for treatment of diabetes.

The proposal for import and marketing of Recombinant Human Growth Hormone (Jintropin) manufactured by Changchun Gene Science Pharmaceuticals of China by Hindustan Bio-Sciences, Hyderabad was rejected by GEAC for non-submission of requisite information sought by DBT. It is claimed that Jintropin stimulates linear growth and increases growth rate in children who lack endogenous growth hormone.

In adults, it is believed to help in reducing fat mass, increasing muscle mass and improving energy.

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