THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI A. RAJA)
(a) & (b) : Before approving indigenously manufactured
Bio-tech products, the proposal is required to be gone
through various stages like Clearance of Recombinant
Committee for Genetic Manipulation (under Department of Bio-
Technology), Validation of test report by CDL,
Kasauli/Kolkata, Conduction of Clinical Trial, Clearance of
Expert Committee constituted by Ministry of Health for r-DNA
based Therapeutics, Clearance of Genetic Engineering
Approval Committee (GEAC) under Ministry of Environment,
verification of manufacturing facility as per GMP norms etc.
The details indicating the number of applications filed
by the leading Bio-Tech units in the State of Andhra Pradesh
and the corresponding year by which the approval accorded by
the office of DCG (I) in respect of Recombinant products
proposed to be indigenously manufactured during the last
three years and current year are at Annexure.
(c),(d) &(e): Shri B.P.Achraya, Secretary to Government
A.P. through a copy of letter from Hon`ble Chief Minister of
Andhra Pradesh addressed to the Hon`ble Union Minister for
Health and Family Welfare dated 03.08.2001, requested that
suitable instruction be issued to DCG(I) for an early
disposal of the pending proposal pertaining to leading
biotech units in the States and not to take credence of
certain allegations and counter allegations by certain
prominent Bio-Tech companies in the State of Andhra Pradesh.
The office of DCG(I) approved the three proposals
pertaining to biotech products for units existing in the
State of Andhra Pradesh, after completion of statutory
requirements. Permission for conducting clinical trial have
been accorded in respect of remaining three applications
i.e. (i) r-streptokinase of M/s Shantha Biotech Pvt. Ltd.,
Hyderabad, (ii) r-streptokinase of M/s Bharat Biotech (I)
Limited, Hyderabad and (iii) Interferon alpha 2b of M/s Dr.
Reddy`s Lab, Hyderabad.
ANNEXURE
Year No.of Year in which required Year in which Applications formalities completed the proposal Received cleared by the DCG(I) office
1999 1 Dec.2001 Feb.2002
2000 4. One proposal in the One proposal year April 2001 and cleared in second proposal in the the year June year March 2002. In the 2001 and third proposal the second clinical trial is being proposal undertaken by the cleared in applicant. In the the year fourth proposal, the March 2002. report of clinical trial received on 30.6.2002 and GEAC approval is awaited.
2001 2. In both the proposals the clinical trial is being undertaken by the applicant.
