Expert Group Guidelines State Licencing Officer

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My document/minutes/eg guidelines state licencing officer
3-6/2005-CIR.II
Comments of the Pesticide Industries Associations are invited on the issue as under
within a period of 15 days:
Minutes of the meeting of the Expert Group for fixing guidelines for the minimum
pre-manufacturing facilities to be created by the manufacturer of pesticides and
their formulations to meet the requirements for issue of Licence by respective State
Governments (Licencing Authority) held on 13.5.2005
The meeting of the Expert Group (constituted by 251st RC) for evolving
guidelines for the minimum infrastructural facilities to be created by the manufacturer of
pesticides and their formulations to meet the requirements for issue of Licence by
respective State Governments (Licencing Authority) was held under the Chairmanship of
Shri P.N. Maji, Additional Industrial Adviser, Department of Chemicals &
Petrochemicals on 13.5.2005. The list of the participants is annexed (Annexure-I). The
subject matter was discussed in detail with respect to important key areas including
quality assurance, safety, safe packing and safe transport, etc. It was noted that under
Section 13 of the Insecticides Act and Chapter -IV, 9(1) of the Insecticides Rules,
requirements for grant of licence to manufacturers of insecticides has been spelt out. The
application has to be submitted as per format – (Form 3) which include information on
expert staff connected with the manufacture and testing of insecticides as well as safety
facilities spelt out in Chapter – VIII of the Rules.
The minimum requirement of infrastructure with respect to equipment and
manpower is dependent on the nature of pesticide undertaken for manufacture and also
infrastructure shall vary for technical manufacture and formulated products as well as
nature of
formulations DP, WP, EC, SC, etc..
However, prior to obtaining
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manufacturing licence for pesticide, the following documents are generally required to be
kept ready with the manufacturers”
1.
Registration Certificate.
2.
Statement of production capacity with documentary evidence (as per
Industrial Development and Regulation Act).
3.
Affidavit from person responsible for quality of finished product.
4.
Consent from Pollution Control Board towards safety of environment.
5.
Registration with factory inspector of the area regarding Labour Laws
6.
Provision for safety policy as per Chapter-VIII.
7.
Consent from Explosive Department, Nagpur for hazardous chemicals
8.
Provision for storage, handling and transportation of raw materials.
9.
Provision for storage, handling and transportation of finished goods.
10.
Provision for packaging and labeling.
11.
Provision for plant, machinery and equipment to be used for manufacture of
technical insecticides and formulated product.
12.
Provision for skill manpower.
After detailed discussions, the Committee framed the guidelines for minimum
infrastructure facilities to be created by the manufacturers of pesticides and their
formulations to meet the requirements for issue of licence by the respective state
Governments. The guidelines are placed at Annexure-II.
The meeting ended with a vote of thanks to the chair.
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Annexure-1
List of participants who attended the meeting of the Expert Group for fixing
guidelines for the minimum pre-manufacturing facilities to be created by the
manufacturers of pesticides and their formulations to meet the requirements for
issue of licence by respective State Governments (Licencing Authority)
1.
2.
3.
Dr. P.N. Maji, Additional Industrial Adviser, Department of Chemical &
Petrochemicals, Shastri Bhavan, New Delhi.
Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC, Directorate of Plant
Protection, Quarantine & Storage, NH-IV, Faridabad.
Dr. (Mrs.) G. Mukherjee, Joint Director (Chemistry-CIR), Directorate of Plant
Protection, Quarantine & Storage, NH-IV, Faridabad.
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Annexure_II
Guidelines for the minimum infrastructure to be created by the manufacturers of
pesticides and their formulations to meet the requirements for issue of licence by
respective State Governments (Licencing Authority)
These are the general requirements, However, for individual chemicals, specific
requirements are to be installed and additional equipment are to be supplemented to suit
the reactions involved in the manufacturing process. Further, other specifications as per
the Insecticides Rules viz. medical facilities, protective clothing, respiratory devices, first
aid measures, training towards safety precaution and handling safety equipment, safety
disposal, etc. are required to be made.
1.
The minimum infrastructure with respect to manpower shall be as under
Sr.
No.
Manpower
For Technical
plant
For formulation
plant
1
2.
3.
Production Manager
Supervisor
Instrument and process control
personnel
Maintenance Personnel (Plant and
utilities)
Store Keeper (Raw material and
finished products)
Quality Control Chemist
Security personnel
R
R
R
R
R
R*/NR
R
R
R
R
R
R
R
R
4.
5.
6.
7.
* In case of automatic plant
2.
Minimum infrastructure with respect to machinery & equipment
A.
For technical plant
Sr.
No.
Equipment
For Technical plant
1
Control console
R
My document/minutes/EGguidelines state licening officer
2.
Feed tank for raw material
R
3.
Reactors
R
4.
Distillation towers
R
5.
Evaporators
R
6.
Condenser / heat exchanger / boiler/ extinguisher
plant / chilling system / steam plant
R
7.
Crystallizer
R
8.
Centrifuge
R
9.
Drier
R
10.
Phase separator
R
11.
Extractor
R
12
Storage tank
R
13.
Process water tank
R
14.
Pipelines with conventional colour code
R
15.
Gas plant
R
B.
For Formulation plant
S.No.
Equipment
Solid, DP,
WG, SP, etc
WG/G
Liquid (EC,
EW, SL)
1.
Feeding channel /
Chute
R
R
R
2.
Jaw Crusher
R
R
NR
3.
Raw material feed tank
R
R
R
4.
Pulveriser
R
R
NR
5.
Blender
R
R
R
5
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6.
Siever
R
R
R
7.
Bag Filter
R
NR
NR
8.
Homogenizer
R
R
R
9.
Ball mill
R
NR
NR
10.
Weighing machine /
R
R
R
platform balance
11.
Vessel with stirrer
R
R
R
12.
Drier
R
R
NR
13.
Cooling machine
NR
R
R
14.
Sprayer
NR
R
NR
15.
Water tank for liquid
NR
NR
R
16.
Filter
NR
NR
R
3.
Equipment for quality control laboratory
1.
Analytical weighing balance
2.
Hot air over
3.
Refrigerator
4.
pH meter
5.
Spectro-photometer / colourimeter
6.
GLC / HPLC depending on the products analytical process as in the
specification.
7.
Standard glassware, chemical and general requirements for laboratory
8.
Pesticide Repository
9.
Specification / BIS standard of the product to be manufactured / formulated
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My document/minutes/EGguidelines state licening officer
10.
Sieve shaker.
11.
Fume Hood
12.
Distilled water still
13.
Flash point apparatus
14.
Melting point apparaturs
4.
Packaging plant and equipment
1.
Packaging machinery.
2.
Filling machine (automatic / semi automatic).
3.
Weighing machine
4.
Bagging machine
5.
Sealing machine
6.
Labeling equipment.
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