Haryana act 9 of 2006 : The Ease Of Doing Business

PROFORMA CHECK LIST FOR VERIFYING BONAFIDES OF THE APPLICANT SEEKING REGISTRATION UNDER SECTION 9(4) FOR MANUFACTURE OF TECHNICAL GRADE PESTICIDES/FORMULATIONS. I. Name of the Applicant 2. Detailed Address 3. Is the proposed factory located in industrial area ? a) Size of the proposed industrial plot : b) Covered area for proposed manufacturing unit c) Covered area for proposed storage 4. Address of the immediate neighbouring : Industrial unit 5. Proposed number of personnel being employed by the applicant (detail in following format) (attach extra sheet, if required) Number Name of the person Designation Qualification Mgiiggsince 6. Proposed laboratory facilities (List of Laboratory equipments and instruments Available for in house quality control) 7. Proposed manufacturing facilities (giving information on manufacturing/ formulation equipments/machineries as well as equipments for packaging of pesticides) 8. Proposed effluent treatment method 9. Proposed medical facilities 10. Proposed arrangements of First Aid Measures RECOMMENDATION Place: Name and Designation Dated: With Seal NOTE: Manufacturing Licence shall be issued only after verification of the actual facilities by the concerned State Department of Agriculture.

FORM III (See Rule 9) Application for the grant of license of manufacture of Insecticides Name, address and status of the applicant Address of the premises where the manufacturing activity will be done: Name of the insecticides with Name of the Registration No Date Their registration number and Insecticides Date for which manufacturing 1. License is applied (enclose copies 2. of certificate of registration duly 3. Signed by the applicant) Whether any registration is Provisional, if so give particulars. Details of full time expert staff Name Qualification Experience Connected with the manufacture 1 and testing of he insecticides in 2 The above unit 3 Whether all the facilities required Under Chapter VIII of the Rules have Been provided, Give full details In a separate sheet Particulars of the fee deposited. Signature of the applicant VERIHCATION I s/o . do hereby solemnly verify that to the best of my knowledge and belief the information given in the application and the annexure and statements accompanying it, is correct and complete. I further declare that I am making this application in my capacity as and that I am competent to make this application and verify it by Virtue of,____wm ______________ , a photo/attested copy of which is enclosed herewith. Date: Signature with seal Place:

P I FORM IV [See Rule 9 (1)] Application for renewal of iicense to manufacture insecticides I/We as of -. hereby apply for the renewal of the license to manufacture insecticides on the premises situated (License No. and date to be given). . The other details regarding the manufacture of the insecticide continue to remain the same. Particulars of the fee deposited. . The license is enclosed herewith. Date: _ Signature VERIFICATEON S/o ; do hereby solemnly verify that what is stated above is true and correct to the best of my knowledge and belief. I further declare that I am making this application in my capacity as (designation) and that I am competent to make this application and verify it, by virtue of ; A photo / attested copy of which is enclosed. Date: Signature with Seal Place: Note: If there is any change in details of manufacture or conditions of license subject to which the license is required to be renewed, the same may be indicated here.

10. DOCUMENT REQUIRED FOR THE INSTALLATION OF MANUFACTURING UNIT FOR FORMULATION/TECHNICAL OF PESTICIDES. ......................... 0 Proof of Ownership in favour of the firm either owned or rented site/plot/land where the Manufacturing unit of pesticides is to be proposed for establishment. Originat/Attested copies of the insecticide/ Insecticides registered by Central Insecticides Board and Registration Committee, Govt. of India, Ministry of Agriculture, (Department of Agriculture & Co- operation) Directorate of Plant Protection, Quarantine & Storage, N.H.iV, Faridabad (Haryana) of the products desired to be formulated in the Unit/Factory. Detail of minimum infrastructure facilities to be created/made-as per the guidelines issued by Ministry of Agriculture, (Department of Agriculture & Co— operation) Directorate of Plant Protection, Quarantine & Storage, N.H.IV, Faridabad (Haryana) for the minimum infrastructure to be created by the manufactures of pesticides and their formulations to meet the requirement for the issue of licence by respective State Government ( Liceneing Authority ) ‘ Application for the grant or renewal of a licence to manufacturing any insecticide/ insecticides shall be made in form ~III or form—IV as the case may be to the licensing officer. Fee of Rs 50/ for the grant Irenewai of licence for every insecticide/ insecticides subject to maximum of Rs 500/ No Objection Certificate/ consent for Air, water & HWM from Poiiution angle issued by competent authority/ Board/ Department. List of members of the board with proof of complete address and identification. Copy of resolution passed by the board of directors to authorizing a person for submitting papers in the office under his signature. Proof of registration ofthe unit with the small scale industries department. Affidavit from Director/Proprietor to undertake the responsibiiity of Chemist Responsibie for quality 'control and person responsible for conduct of business under section 33 of the insecticides Act,i968 in case leave /retires /lei°t over the firm or terminated from the firm ,and authorized or nominate other person and also take responsibility to appear in the court. .Affidavit from responsible person to maintains quality of products under section 33 of the insecticides Act, 1968. With copy of resolution passed by the board of directors along with proof of address & identification. . List of Plant / Machineries. . List of laboratory equipments, . Consent of Medical Doctor required under Rules 37 of Insecticides Rule, 1971. . List of first-aid measures required under Rules 38 of Insecticides Rules, 1971.

Proforma for'inspection of insecticides manufacturing units in Haryana state. rIii Name of the manufacturing unit 2. Location/Address of the unit 3. Purpose a) New Licence b) Renewal of Licence i. i d) Annual/ Surprise Inspection 2__c) Addition of new products/ items ,, i e) Any other L Commerce ? L 6. :qurastructural Facilities: If so, the Number and Year of Registration 5. ls the Unit certified by the Authority under Factories Act ? 4. ls the Unit registered with DGT/Department of Industries & p ,,,,,,,,, i l i Weedicides etc separately. . (a) i (i) Whether sufficient provisions have been made for storage of raw material and finished products of EC, WP, DP, (ii) T Has the Unit separate sheds and machinery required for the formulation of EC, WP, DP, Weedicides etc ? (iii) Is the machinery in working order ‘? (b) Details of Machinery (List to be attached) 110”“ For EC formulation. (11) FflorADl3 formulation. i (iii) T ForWWP formulation. 5 (iv)m_Fi‘or Weedicides. i if!) L For any other. l 7. Laboratory Is the Laboratory equipped as per 181 requirements (List of equipments to be given) 8, Internal analysis of pesticides carried out: ‘ Year Name(s) of product(s) Standard Misbranded “Va, 1.. .,4. M. .r_-v. , a frequency of analysis of different chemicals and their results. # - iWhether—gathroom/Toilet facilitiesiha‘ye-been provided at the site.

' 10. Has the Unit made adequate arrangements for fire-fighting devices 7 If yes, details of systems provided. ll. fDetails of arrangements made for discharge of dust particles, fumes, effluents etc. If yes details of systems provided. 12. Expert staff connected with the manufacturing: i9) Name W, .................. 1#b) Qualification H 77777777 fl . c) Experience J H d) Residential Address e) Other staff l3. . Responsible Person nominated: » M - 'Ma) 1 Name , ._. M b) Father’s Name 7 K c) Qualification d) Experience e) Residential Address l4. Are they doing any contract formulation ? If yes, for whom and for which items. address thereof 15. ; Are the products manufactured by the Unit marketed by any other agency? lf so, nameg 16. source of procurement of TGM (Technical Grade Material) Quality assurance for TGM (Technical Grade Material) , i) Testing facilities f01 TGM _ NMW . ii) No. of tests carried out for TGM , w iii) Frequency of tests. 17. Quantity of pesticid L. ..... .............. to es (product- -wise) formulated (attach list) during the periodfi 18. . Has the Unit adequate & proper facilities like: a) Sufficient area for formulation & storage. W b) Separate sections for liquid/ power/ granules/ herbicides. 'W M _ A, g‘ c) Vessels fitted with stirrers, filter, storage W i tanks for solvents for liquid formulation. - l d) Filling & packing lines for powder, WP formulation, grinding mill Pulverizer, jet mill L etc with blenders.

e) Filling & sealing line for formulation and granules, granulated plant with accessories. _. ,4 t) Sufficient technical manpower (Details). flow are the used containers/ packing and washing disposed oft? ls drinking water facility sufficient for the workers at the factory premises ? F Are the workers being trained in safety measures and handling of savoury equipments etc? l r ‘ respiratory devices being used. Has the Unit provided protective clothing to the workers? Detail of protective clothing & 23. Has the Unit made arrangements for adequate power supply (Electricity). 24. Has the firm valid Air/Water consents from Pollution Control Board, Haryana? If so, the dates of their validity. 1- Air ' l 55,; i 2: .1 Water _- , Has the Unit applied for _____ 7 . 1.. .. _,_.. a) Registration of new products No. & date of application. to the Registration Committee, Ministry of Agriculture, Govt. of India. It so, X b) Securing a licence to manufacture and sale to the Licensing Officer notified/appointed by the State other than Haryana. lf so, name of the State. (1) Manufacturing State(s) (2) Selling State(s) a. Are the medical facilities available in the factory premises? b. Has the Unit 181 standard book on symptoms of poisoning lfind treatment? c. Are the workers being examined medically periodically? If yes, at what intervals? d. Is the Unit maintaining sickness record of its employees? e. Number of persons affected by the pesticides within three years. f. Is the medical expert of the Unit familiar with pesticide poisoning? g. Name of Medical Officer with qualification. h How far his clinic is situated. i. What are the arrangements to take the patient to the doctor, if doctor is part-time? ”a 3'. Are the antidotes readily available and facilities for first aid measures including artificial respiration?

"27:1 Any other item which is not covered above. 28. Recommendation of the inspecting officers. Date: Signatures of Inspecting Officers with Seal

(Elli Guidelines for minimum infrastructure facilities to be created by the manufacturers of microbial biopesticides (Antagonistic fungi, Entomopathogenic fungi, Antagonistic bacteria, Entomotoxic bacteria). (as approved in 297th meeting of RC held on 29—01-2009) SLNO. MANPOWER REQUIREMENT J L Quality Control Biologist 2. Sufficient personnel to supervise production, maintenance, stores etc. GENERAL REQUIREMENT 1. 7 Production, Mixing & Drying Room and Formulation Unit A for Antagonistic fungi/ Entomopathogenic fungi 2. Inoculation, Fermentor, & Sterilization Room and Formulation unit for Antagonistic bacteria/ Entomotoxic bacteria. 3, Packaging and storage room 4. Quality Control laboratory #5. Protective clothing 6. 7 Respiratory devices 7 First Aid Measure 8. Waste disposal arrangement in compliance with Pollution 1 Control norms PLANT EQUIPMENT REQUIREMENT 1. Plant Fermentor with all accessories / Bioreactor / Shaker Steam Boiler Chilling plant M ”M Air compressor RO/ Softener (water treatment plant) Distillation Unit Micro centrifuge Magnetic stirrer 300 u and 160 u Sieves Electronic Weighing Balance l l. Blender/Homogenizer 12. Vortex 13. Vibro-screen 14. ‘Autoclavable bag 15. Large air tight container 16. Pouch sealing machine

17. Box strapping machine 18. Racks and cabinet LABORATORY EQUIPMENT/ INSTRUMENT REQUIREMENT 1. Autoclave 2. Water bath 3. Shaking incubator 4. Refrigerator 5. Thermo hygrometer 6. U. V. light 7. BOD Incubator 8. Hot Air oven 9. Laminar Flow 10. pH meter 1 1. Balance (2-3 decimal places) 12. Vacuum pump _ 13. Hot plate 14. Deep freezer 15. Spirit 16. Microscope and all accessories 17. Glassware viz. Conical Flasks, Test tubes, Beaker etc. 18. Petri dishes 19. Titanium inoculating needles 20. Pipette fillers 2 21 Pipettes (0.1 ml to 20 ml) 22. Haemocytometer 23. Colony counter Note: These are the general requirements of minimum infrastr the manufacturers. However, for specific microbial biopesticides formul and their quantum of production, requirement of manpower, space, equipment/ instrument may be needed. ucture to be created by ation(s)

1C22.2 Guidelines for minimum infrastructure facilities to be created by the manufacturers of Baculoviruses (NPV, GV). (as approved in 297th meeting of RC held on 29-01-2009) SLNO. MANPOWER REQUIREMENT Quality Control Biologist Sufficient personnel to supervise production, maintenance, stores etc, GENERAL REQUIREMENT Post culture production room with temperature and humidity control Moth ovi—position room with temperature and humidity control Production room with temperature and humidity control Diet preparation room Virus processing lab. Quality control lab. Formulation unit Cold storage l’ Washing and sterilization facility Stores room Protective clothing Respiratory devices First aid measures. Waste disposal arrangement in compliance with Pollution Control normsfi - I EQUIPMENT/INSTRUMENT REQUIREMENT r Diet preparation machine (mixer) Diet dispenser. r Multi channel pipette 4 Vacuum pump with an aspirator Blenders Multipurpose centrifuges B.O.D. incubator or an incubator room or an environmental chamber 1 Scale balance piomflev‘ewwr l 1 rd ._‘ Digital balance Haemocytometer shallow depth Counting chamber Hot air oven. 5" Compound research microscope. .._.l DJ 1 Zoom microscope. F M...‘ Lit-5% Vortex mixers T Tally counters

F k 16. Electric stove. l7. Autoclave w 18. i Shaker. 19. Water distillation unit. 20. Air conditioners 21. Humidifiers j 22. Oviposition iron cage 23. T Washing machine 24. Racks and cabinet 25. Refrigerators Note: These are the general the manufacturers. However, for speci of production, requirement of manpower, spac requirements of minimum infrastructure to be created by fic baculovirus formulation(s) and their quantum e, equipment/ instrument may be needed.

My document/minutes/eg guidelines state licencmg officer 3C) 1. Guidelines for the minimum infrastructure to be created by the manufacturers of pesticides and their formulations to meet the reguirements for issue of licence by respective State Governments gLicencing Authority)— as approved in 261St RC held on 15-02-2006 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 factlities, protective clothing, respiratory devices) first aid measures, training towards safety precaution and handling safety equipment, safety disposal, etc. are required to be made. The minimum infrastructure With respect to manpower shall be as under ....‘ r _S_1_; Manpower For Technical W93 j Ne mam: 91.21111 1 Production Manager TR t R F 2. #Supervisor ] R R 3. instrument and process control R R*/N R personnel J 4. T Maintenance Personnel (Plant and R R utilities) 5. j Store Keeper (Raw material and R R , Lfinished products) _2_ A 6. Quality Control Chemist j R R , i V 7. Security personnel R T R ".1 * In case of automatic plant 2. Minimum infrastructure with respect to machinepy & eguipment A. For technical plant §I; 7 Eguipment For Technical plant _N_0_; 1 Control console R 2. Feed tank for raw material R 3: Reactors R f l

My document/minutes/EGguidelines state licening officer 2 Distillation towers Evaporators i i Condenser / heat exchanger / boiler/ extinguisher plant / chilling system / steam plant 7. Crystallizer — m 8. kCentrifuge 9. T Drier l0. Phase separator l l Extractor — M 12 Storage tank 13. Process water tank 14. Pipelines with conventional colour code M l5 Gas plant B. For Formulation plant S.No. Equipment Solid, DP, WG/G Liquid (EC, WG, SP, etc EW, SL) W- l. Feeding channel / R R R Chute 2. k Jaw Crusher R R NR L 3. Raw material feed tank R R L 4. Pulveriser R 4 NR 75. R i Slender ., R R w 6. Siever R R 7. Bag Filter i R NR LNR

8. Homogenizer R R R 9. L Ball mill R NR NR l0. Weighing machine / R R R 71 platform balance ll. Vessel with stirrer R i R R l2. Drier R R NR 13. Cooling machine NR 4 R i R M 14. Sprayer NR R 4 NR 15. Water tank for liquid NR NR R l6. Filter NR NR l R 2. DJ Eguipment for Quality control laboratory Analytical weighing balance Hot air over Refrigerator pH meter Spectro-photometer / colourimeter GLC / HPLC depending on the products analytical process as in the specification. Standard glassware, chemical and general requirements for laboratory Pesticide Repository Specification / BIS standard of the product to be manufactured / formulated Sieve shaker. Fume Hood

4. 12. l3. 14. l. U.) 4. 5V 6. My document/minuIeS/EGguidelines state licening officer Distilled water still Flash point apparatus Melting point apparaturs Packaging glant and eguipment Packaging machinery. Filling machine (automatic / semi automatic). Weighing machine Bagging machine Sealing machine Labeling equipment. 4

502.3 Guidelines for minimum infrastructure facilities to be created by the manufacturers of botanical biopesticides (Pyrethrum, Azadirachtin, Cymbopogon etc.) (as approved in 297th meeting of RC held on 29—01-2009) Sl.No. MANPOWER REQUIRMENT + Quality Control Biologist Sufficient personnel to supervise production, maintenance, stores etc. GENERAL REQUIREMENT Extraction room Production room Formulation unit Packing and storage room Quality control laboratory Protective clothing Respiratory devices First aid measures pwflewewwr Waste disposal arrangement in compliance with Pollution Control norms PLANT EQUIPMENT/INSTRUMENT REQUIREMENT Phase separation vessels Decanter Mixing vessels with stirrer Centrifuge Soxhlet apparatus Electric oven with thermometer Chemical measuring cylinders Chemical transfer pumps pWFP‘P‘EP’NT‘ 10. Filter pressure pump Measuring cans ll. Electric weighing machine Counter scales l3. Filtration assembly 14. Water distillation unit 15. Wrist action shaker l6. Blender ”i7. Vortex 18. Large air tight containers l9. Material filling trays

20. Storage tank J 21. j Filling machine 22. Sealing machine 23. Packing accessories LABORATORY EQUIPMENT/INSTRUMENT REQUIREMENT 1. HPLC System M w 2. pH meter 3. Spectrophotometer 4. Refrigerator 5. Thermometer 6. l Microscope 7. Autoclave 8. U. V. Lamp M 9. Abel flash point Apparatus 10. Incubator ll. Glassware viz. Conical Flasks, Test tubes, Beaker, Separating funnel, Funnels, Glass tubes, etc. 12. Pipette fillers 13. J Pipette l4. Burette LS; 4 TLC apparatus & accessories "1 _l6. Micro~syringes Note: These are the general requirements of minimum infrastructure to be created by the manufacturers. However, for specific botanical biopesticides formulation(s) and their quantum of production, requirement of manpower, space, equipment /instrument may be needed.