The Drugs Controller General of India (DCGI) has cleared 139 import registration applications for bulk drugs during February - April 2004. The authority has also accorded sanctions for the import of 20 formulations during the period.
In bulk drug imports, Chinese products continue to dominate Indian market. 63 of the total approvals are to import bulk actives from China. 19 approvals have been given to Japanese companies.
The import approvals for formulations were given to Daunorubicin 20mg Injection USP (Zhejiang Hisun Pharmaceuticals Co. Ltd., China), Bionect Cream (15mg Tabs. Hyalluromic Acid Sodium Salt) (Fida Farmaceutici Spa, Italy), Cupripen 250mg (D-Penicillamine) Capsules (Laboratorios SA, C/Industria, Spian), Resincalcio 400gm (Calcium Polystrene Sulphonate) Powder (Laboratorios SA, C/Industria, Spian), Resinsodio 400gm (Sodium Polystrene Sulphonate) Powder (Laboratorios SA, C/Industria, Spian), Miocrin 10mg/ 25mg/ 50mg (Sodium Aurothiomalate) 1ml/ampoules (Laboratorios SA, C/Industria, Spian), Royen 500mg / 2.5gm (Calcium Acetate) Capsules (Laboratorios SA, C/Industria, Spian) and Injection Nitromycin (Nitilmium Sulphate) (Boryung Pharm Co. Ltd., Korea).
Other medicines include Disodium Pamidrone Inj. (Mayne Pharma Pty Ltd., Australia), Imatinib Mesilate 100mg / 40mg (Novartis Pharma Stein AG, Switzerland), Fluvastatin Sodium Prolonged Release Tab 80mg (Novartis Pharma Stein AG, Switzerland), Virkon S-Disinfectant (Duporit (UK) Ltd., UK), Imuran Tablets (Azothioprime 50mg)( Heumann Pharma GmbH, Germany), Human Recombinant Interleukin-2 (Aldesleukin) (Chiron BV Netherland having factory at Chiron BV, Calefornia, USA), Cardioxane Inj. 500mg (Dexrazonane) (Chiron BV Netherland having factory at Laboratories Thissen SA, Belgium), r-hu-Insulin & its formulations (Lilly Egypt Ltd., Egypt), Estradiol 0.1% gel (Divigel) (Orion Corporation, Finland), r-hu-Growth Hormone (Biotechnology General Israel Ltd., Israel) and Caniverm Tab AD. US. Vet (Bioveta AS, Czech Republic) were also given import approvals.
In addition to this, the office of the DCGI cleared import applications for Hybrid Capture II HBV DNA Test and blood grouping sera manufactured by Digene Corporation, USA and Serologicals Ltd., UK respectively.
Approvals have also been given to Shree Krishna Keshav Laboratories Ltd, Ahmedabad to import Human Albumin and Human Tetanus Immunoglobulin from Instituto Grifils, SA, Spain.