The office of the Drugs Controller General of India (DCGI) has given import approvals for 69 bulk drugs and 31 formulations during October 15-December 31 period in 2003. While 28 bulk drug approvals have been given to Chinese firms and their Indian marketing agents, majority of the formulation approvals are for Korean drugs. The DCGI has also permitted the import of 10 vaccines and a couple of diagnostic products during the period.
The DCGI has cleared nine bulk drug import applications from Italy, eight from Switzerland and six from Korea apart from nine other countries.
The authorities have permitted the import and marketing of Urokinase injections from Korea. Marketing permission has been given to two companies for Urokinase Inj. 250000, 500000, 750000 & 100000 IU (M/s Rushi Corporation, Mumbai) and Urokinase Inj. (M/s Ruskin Chemipharm, Mumbai) respectively. Other Korean formulations that have received import clearances from DCGI are Prazequentel 60mcg Tab, Inj. Dactino (Dactinomycin) 0.5g, Inj. Newtain (Protamine Sulphate), Inj. Lovir (Acyclovir) 250MG / 500mg (all to be marketed by M/s Chandra Bhagat Pharma Pvt. Ltd, Mumbai), Propofol 1 per cent Inj. (M/s Nicholas Piramal, Mumbai), Dobutamine Hydrochloride (M/s Medicine House, New Delhi), Tab. Dxyridostigmine (M/s V.H. Bhagat & Co., Mumbai) and Baclofen 10mg Tablet (M/s. Medi Globe, New Delhi). The drugs that have been approved for import from Germany are Hmg Img 75 IU & 150 IU, Fsh Inj. 75 IU & 150 IU (M/s. Chandra Bhagat Pharma Pvt. Ltd., Mumbai), Lyosypt Collegn Harmostatic, Histoaeceyl Issue Adhesive (N. Butyl-2-Cyonoacelate (M/s B. Braun (I) Pvt. Ltd. Mumbai) and Somaosatin 3mg Inj. (M/s German Remedies Ltd., Mumbai). The formulations approved for import from China during the period are Mitomycin Inj. 2mg & 4mg, Daunorubicin Inj. 20g (M/s Cadila Pharmaceutical Ltd., Ahemedabad), R-HU-EPO 2000/4000 IU (M/s Claris Life Sciences Ltd, Ahmedabad) and L-Asparaginase Inj. (M/s Chandra Bhagat Pharma Pvt. Ltd., Mumbai).
On the vaccine import clearance front, Ranabaxy Laboratories received approval to import five veterinary products from Hungary while Serum Institute has been given marketing approval for three vaccines manufactured in China. Approvals for import of two diagnostic kits and one blood product and medical device each were given by DCGI during the period.