GEAC SEEKS A PROBE INTO UNAUTHORISED
MANUFACTURING OF DRUGS
The Genetic Engineering
Approval Committee (GEAC) under the aegis of the Ministry of Environment
& Forests has viewed with concern reports of manufacturing
of recombinant Streptokinase by M/s. Shanta Biotechnics Pvt. Ltd.,
Hyderabad and the trial of the same on patients in Hyderabad without
the prior approval of the GEAC. GEAC requested Drug Controller
General of India (DCGI) to conduct a full inquiry into the incident
and into the report of deaths of some patients. A final view on
what action needs to be initiated against the erring company will
be decided after getting all reports.
There was also a
request from CARE to waive the condition of post marketing surveillance,
which was imposed by GEAC in its 34th meeting held
on November 7, 2002. While recommending the import of crude Degummed
Soyabean Oil for a period of one year, GEAC had stipulated that
a post marketing surveillance through ICDS programme managers
should be carried out and results of the monitoring should be
submitted for consideration of the GEAC after obtaining the views
of Indian Council for Medical Research. At today’s meeting GEAC
deferred a decision on the issue and decided to seek more information
from CARE and the concerned government departments.
1. The GEAC which
met under the Chairmanship of Ms. Meena Gupta, Additional Secretary
in the Ministry of Environment & Forests, gave environmental
clearance for import of several pharmaceutical products by various
firms. The clearance is subject to other regulatory requirements
existing in the country.
The GEAC deferred
a decision on the application of M/s. Rasi Seeds Pvt. Ltd., Attur,
Tamil Nadu, a sub licensee of the same Bt.cotton technology which
was acquired by MAHYCO from Monsanto, USA, for seed production
of transgenic cotton hybrids, namely, RCH-134 and RCH-138 in an
area of 200 hectres for Kharif 2003 in the Northern region because
of non-availability of basic data. Similarly, GEAC deferred any
decision to undertake seed production of 7 transgenic cotton hybrid
seed in 127 hectres by MAHYCO, Mumbai. The hybrids are Bt.MRC-6301,
Bt.MRC-6160, Bt.MRC-6304, Bt.MRC-6703, Bt.MRC-6322, Bt.MRC-6918,
and Bt.MRC-6928.
The GEAC also deferred
a decision on the proposal for import and marketing of Recombinant
Bovine Somatrotropin from L.G. Chemicals, Korea pending further
information from the Department of Animal Husbandry and IVRI.
