(a) whether the leading bio-tech units of Andhra Pradesh have submitted a number of applications to the Drugs Controller General of India;
(b) if so, the details thereof alongwith the time since when these are pending; and
(c) the action taken by DCGI for the clearance of these applications?
MINISTER OF HEALTH AND FAMILY WELFARE AND PARLIAMENTARY AFFAIRS (SMT. SUSHMA SWARAJ)
(a) Yes, Sir.
(b) & (c) : Unlike pharmaceuticals, r-DNA based therapeutics
are required to be initially evaluated for by the Review Committee
on Genetic Manipulation Clearance under Deptt. of Bio-technology.
The safety and efficacy data generated with the proposed r-DNA
base products are thereafter evaluated before the expert panel
constituted for r-DNA based therapeutics in the office of Drugs
Controller General of India, and Genetic Engineering Approval
Committee under Ministry of Environment etc., before the final
clearance is accorded.
Details of the proposals filed by Bio-tech units of Hyderabad in
the office of DCG (I) alongwith the status of each application is
given in Annexure.
Annexure referred to in reply to Lok Sabha Unstarred Question No.
3971 for 9.4.2003
Sr.No. Name of the Firm Date of Proposal For Status application
1.M/s Bharat Bio-tech Int.Ltd. 17.05.99 Manufacture and Mar- Under Clinical evaluation Hyderabad keting of Indigenously by the company developed r-Human Streptokinase
2.M/s Shantha Bio-tech pvt.Ltd. 28.11.01 Manufacture and Mar- Under Clinical evaluation keting of Indigenously by the company developed r-Human RCGM Clearance obtained Streptokinase on 10.03.03. Permission 11.2.2003 Manufacture and Mar- given for conducting the keting of Indigenously Clinical trial on 4.4.03 developed r-Human erythropoietin Inj.
3.M/s Dr. Reddy`s Labs, 28.05.01 Manufacturer and Mar- Under Clinical evaluation Hyderabad keting of Indigenously by the company developed r-Human interferon alpha 2b
4.M/s Biological E Ltd. 26.8.02 Manufacturer and Mar- Under Clinical evaluation Hyderabad keting of Indigenously by the company developed r-Hepatitis B vaccine
5.M/s Virchow Bio-tech pvt.Ltd 19.12.02 Manufacturer and Mar- RCGM clearance not yet Hyderabad keting of Indigenously obtained by the firm. In developed r-Human all the proposals, the 19.12.02 Interferon alpha 2b inj.Firm has been advised in 17.12.02 Interleukin inj. Feb/march, 03 to get the Platelets derived facility inspected in growth factor, conformity with GMP norms before the trial batches are produced.
6.M/s Medgene Bio-tech, 28.11.02 Manufacture and Mar- Firm has not submitted Hyderabad keting of indige- application as per nously developed prescribed norm. Firm r-Human growth Hormone was advised on 4.1.03 to make the application in the prescribed Form 40 along with requisite fees as per the rules.