4.2
Guidelines for Endorsement of Additional Manufacturing Site
(Approved in 325th meeting of RC held on 4th Jan., 2012)
1. The Committee decided that Toll Manufacturing and Additional Manufacturing Site
are two different issues. The Committee recommends that as far Toll manufacturing
is concerned, it should be regulated by the decision taken by the RC in its 296th
meeting. However, endorsement of Additional manufacturing Site may be
considered;
2. The Committee preliminarily recommends the following criteria/guidelines for
accepting the requests for Additional Manufacturing Sites:(i)
The site, proposed to be additional manufacturing site, should belong to
the same registrant (it is not allowed on anyone else’s premises,
whatsoever);
(ii)
the registrant should have registration for manufacture of the same
insecticide/product in the country where the additional site is located;
(iii)
Letter of consent from already approved source and from new
manufacturing site duly certified by the Designated National Authority
(DNA), which shall be verifiable by the DNA of India;
(iv)
Additional declaration from already approved source/principals as well as
from new manufacturing site with respect to the formulation being made
by using technical same raw material & process from the source which is
already approved by the RC in India;
(v)
all operations involved in the manufacturing of the insecticide for which
the additional site is being considered should be fully operated by the
same registrant and have the proof of manufacturing there by submitting
an undertaking to this effect, duly certified by the DNA of that country;
(vi)
the registrant shall be responsible for manufacturing the product having
identical chemical composition and specifications as that of the original
registered source of the product;
(vii)
five batch analytical test report shall be submitted along with the
application for the five batches manufactured at the source originally
registered and the five batches manufactured at the proposed additional
source;
(viii) samples of all the five batch manufactured at the source originally
registered and all the five batches manufactured at the proposed additional
source shall be submitted along with the respective reference standards to
the Sectt of CIB & RC for testing at CIL for verification;
(ix)
the samples and the reference standards should be valid at least for a
period of six month from the date of delivery to the Sectt of CIB & RC;
(x)
documents supporting the claim of the registrant about the additional
manufacturing site, duly certified by the Designated National Authority
(like, ICAMA for China), shall be submitted along with the application,
which shall in turn be verified by the DNA of India before considering the
endorsement;
(xi)
intimation about the import of every consignment, proposed to be
imported from the additional manufacturing site, shall be given to the
Sectt of CIB along with the name of the port of entry into India and
expected date of arrival as soon as the consignment is dispatched from the
additional manufacturing site for arranging the testing of sample(s), if so
considered necessary;
(xii)
Justification for approval of additional manufacturing site; and
(xiii) failure to meeting any of the above mentioned criteria shall
unconditionally empower the Registration Committee to reject application
for such endorsement; or endorsement, if already granted.
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