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ControllingManaging Quality of Pesticides
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Title: ControllingManaging Quality of Pesticides
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Controlling/Managing Quality of Pesticides
- Salil Singhal
- Chairman Managing Director
- PI INDUSTRIES LTD.
- On behalf of Crop Care Federation of India
Crop Life India
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Pesticide Quality Problems The Legal the
practical interpretation.
MISBRANDED Pesticides SUB-STANDARD
Pesticides SPURIOUS Pesticides
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Misbranded Products
- In common parlance, this should be understood to
mean that the product is off specs in a small
way. - Primarily, these are minor variations and need to
be tackled differently. - Section 31(1) of the Insecticides Act, 1968,
requires that no prosecution for an offence is to
be launched without the approval of the State
Govt.
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Misbranded Products
- Certain states take a practical view and do not
grant permission for prosecution every time, but
instead, seek the removal of such misbranded
products from the State and issue suitable
warning to the manufacturer this, of course, if
the producer has a good quality track record.
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Sub Standard Products
- The variation in quality parameters is high, say
more than 10. - In such cases, not only there is a need to
prosecute the manufacturer, but also investigate
why such failure has occurred including past
performance, manufacturing system etc.
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Spurious Products
- Copies of genuine products.
- Manufactured by fly-by-night operators who
imitate labels of leading brands and supply the
product. - These are the real culprits who are really
harming the farmers. - For such persons, not only the entire stocks must
be seized but by an application to the
Magistrate, police raid should be conducted and
the offenders should be booked under IPC.
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Factors Relating to Sub-standard/Spurious Products
- Grant of manufacturing licenses to the units by
the State Licensing Authorities. - Drawing of market samples by the Insecticides
Inspectors. - Analysis of samples by the State Pesticides
Testing Labs (SPTLs).
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What can be done?
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Grant of Manufacturing Licenses
- The States are advised to appoint a Standing
Committee consisting of - Representatives of the Director of Medical Health
- One or two representatives from the Engineering
Colleges who understand manufacturing processes - Representatives of the Director of Agriculture.
- The Committee should
- inspect the units before granting manufacturing
licenses. - carry out surprise visits to the manufacturing
units to ensure complying with the quality and
safety requirements and other licensing
conditions.
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Grant of Manufacturing Licenses
- The licensing officer must vigorously implement
the provisions of Chapter 4 Chapter 8 of the
Insecticides Rules, 1971. - He must also visit the manufacturing unit at
least twice a year as per Rule 28 of the
Insecticides Rules to ensure compliance of
licensing conditions. - A detailed check list must be given to the
Licensing Officer to enable appropriate
performance. - Under Rule 12, the Licensing Officer has to be
satisfied that the premises are adequate and
equipped with proper storage in respect of which
the license is granted.
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Grant of Manufacturing Licenses
- Under Rule 9 (4-A) the Licensing Officer must
ensure that necessary plant machinery safety
devices and first aid facilities etc. exists in
the premises. . . . - Recently the Registration Committee has approved
guidelines for the requirement of minimum
infrastructure (Copy available). - Industry can provide a detailed proposal of
minimum requirement for Good Manufacturing
Practices (GMP).
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Grant of Manufacturing Licenses
- States could direct producers to implement GMP
within fixed time-frame or lose their
manufacturing licenses under Rule 9 (4-A). - Conduct GMP Training programmes - industry is
willing to fully support these programmes.
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Sampling Case StudyRAJASTHAN
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- Rajasthan State has the unique distinction of a
very effective method for market drawing of
samples. - Emphasis on effective and qualitative sampling,
analysis and appropriate legal action against
poor quality manufacturers rather than just
numbers of samples. - The system adopted in Rajasthan needs to be
pursued vigorously, across the country.
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Key Features
- Prepare list of all manufacturers selling
pesticides in the sate. - Analyse past 4 years record of sample analyses.
- Work out company-wise quality performance.
- Grade manufacturers into A, B, C D categories
- New manufacturer to be included in category D.
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Key Features
- Calculate total sample analysis capacity of the
state. - Allocate 63 sampling of D category, 20 C, 15 B
2 of A Category, district-wise. - State Agriculture Dept authorities invariably
visit manufacturing units in their jurisdiction
and draw sample. - Analyze the quality performance of state mfg.
units separately .
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Key Features
- Identify poor quality producers, and take
exemplary action. - Every inspector send form no. XX within 5 days of
sample drawl. - At least one sample of every registered company
is drawn under each PD/JD/DDA jurisdiction.
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Sampling
- The objectives should be
- To ensure that samples of all manufacturers are
drawn. - To focus on greater sampling of poor quality
track record manufacturers.
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Sampling
- The Inspectors must be directed to ensure to send
every testing report received from the SPTLs
(whether passing or failure) to the concerned
manufacturer. - The test reports must enclose the chromatograms
generated due to the test protocol. - The above would ensure transparency, and prevent
manipulation of results by unscrupulous lab staff.
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Analysis of Samples at SPTLs
- Each Pesticides Testing Lab must urgently strive
to get ISO 17025 accreditation i.e. accreditation
from the National Accreditation Board, New Delhi.
- This will ensure that the laboratory complies
with requirements of Good Laboratory Practices
including systematic record keeping, analytical
systems, instrumentation calibrations etc.
SYSTEMS APPROACH GREATLY PREVENTS POSSIBLE
MANIPULATIONS
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Analysis of Samples at SPTLs
- Regular training and updating for the
Analysts/Chemists is a must. - One or two day annual training programme must be
conducted for pesticides analysts esp. for newer
molecules. - The Industry would help to conduct these.
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Analysis of Samples at SPTLs
- A Standing Committee be constituted with
knowledgeable persons in chemical analyses,
industry and independent quality lab
representatives who should carry surprise visits
to the SPTLs for ensuring quality performance by
their staff.
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General
- Provision to reward Inspectors, or for that
matter anyone who can expose spurious and
sub-standard pesticides supplies in the State. - Section 31 of the I. Act needs to be properly
implemented by the state authorities. - Rather than give mechanical approval for
prosecution, the concerned authority must
investigate the genuineness/seriousness of the
offence, as also the past record, and only then
accord permission for prosecution.
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Thanks
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