The Central Drugs Standard Control Organisation (CDSCO) has given import approvals for 10 bulk drugs from China during February 15 to March 15. The authority has also issued import registration certificates for 14 formulations and 3 vaccines during the period.

According to CDSCO sources, the import registration applications are being cleared promptly without any backlog. Considering the severe shortage of expert staff in the organisation, the industry should appreciate the sincere efforts of the department, officials said. The information on the import clearances has been updated on the CDSCO website also. "We have introduced a system where the information would be updated once in two months. We have been very successful in carrying out this system. Today there are no pending applications," they claimed.

Following are the details of the bulk drugs, the foreign manufacturers and the Indian agents: D-Calcium Panthothenate USP (Huzhou Lionking Fine Chemicals Co. Ltd., China - S. P. Pharma, Mumbai), Azithromycin Dihyclate (Hangzhou Aida Pharmaceuticals Co. Ltd., China - R.S. Pharma, Delhi), Ciprofluxacin Hydrochloride / Base (Hangzhou Aida Pharmaceuticals Co. Ltd., China - R.S. Pharma, Delhi ),Poxitromycin (Hangzhou Aida Pharmaceuticals Co. Ltd., China - R.S. Pharma, Delhi), Cimetidine (Jiangsu Juarmei Pharma Co., China - Uni Chemie International), Febendazole (Shanghai Vaozong Pharmaceutical Co. Ltd, China - Anzen Exports, Kolkata), Methylprednisolone ( Tianjin Tianyao Pharmaceutical Co., Ltd, China - Rumit International, Mumbai), Methyl Predinisolone Accete BP/USP/EP ( Tianjin Tianyao Pharmaceutical Co., Ltd, China - Rumit International, Mumbai), Methyl Prednisolone Hydrogen Succinate EP/USP/BP ( Tianjin Tianyao Pharmaceutical Co., Ltd, China - Rumit International, Mumbai),
Calcium Polycarbophil USP (Danchem Technologies Inc, USA - Noveon Diamalt Pvt. Ltd., CHENNAI), Acetylesteine BP/USP/EP (Zambon Group S. p. A, Italy - Zambon (India) Pvt. Ltd., Gurgaon) Dexamethasone BP/USP (Tianjin Jinjin Pharmaceutical Factory China - Anant & Co Mumbai) and Bulk Recombinant Human Crystal (Bioton Co Ltd, Poland - Shreya Life Sciences, Mumbai).

The formulations that have been approved for import during the period are Mesna 400 mg/600 mg tab, Leuprolide Acetate Depot Injection (Each vial contains: Leuprolide 3.75mg), Certican (everolimus) Tablets 0.25MG/ 0.5MG/ .75MG/ 100 MG and Dispensible Tab, Leuprolide Acetate Depot Inj (Each vial contains: Leuprolide 3.75mg), Tirofiban Hcl Inj. 0.25mg, Imipenant Cilastatin Sodium USP Inj, Enoxaparin Sodium prefilled Syringes 20mg/40mg/60mg/80mg, Ethisorb Bura Patch, Ethisorb Burr Hole Plug , Duraform-Dural Graft Implant, Somatistin 3mg INJ.and Actilyse 20mg & 50mg Inj.

The vaccines that received import approvals are HBsAg Dipstick, HBsAg Dipstick (HEP-Check-1 Dipstick) Rapid Test, anti-HIV 1+2 EIA Avicenna, Anti-HCV-EIA-Avicenna, Versant HIV-1 RNA 3.0 RNA (bDNA), Trugene HIV-1 Genotyping Kit, Versant HCV Genotyping Assay, Versant HCV RNA Qualitative Assay, Versant HCV RNA 3.0 Assay (bDNA) and Versant HBV DNA 3.0 Assay (SDNA).