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Implementation of Scheme for Schedule M Compliance for SSI Pharma Units

Implementation of ‘Scheme for Schedule ‘M’ Compliance for SSI Pharma Units to be implemented by dove-tailing with CLCSS Scheme of MSME

  1. INTRODUCTION

    1. As per the second supplement of the Revised Guidelines issued by MSME on the Credit Linked Capital Subsidy Scheme (CLCSS) for Technology Up-gradation of Micro, Small and Medium Enterprises by the Ministry of MSME on 13th July, 2009 the pharma SSI units will now be able to avail the benefits of CLCS Scheme for financial assistance for an expanded list of products from 32 to 179.
    2. As per the CLCSS Scheme of the MSME, 15% Capital Subsidy would be provided on capital investment of up to Rs One Crore. The scheme is available for 179 machinery and equipment as per Annex-I. It will be implemented in the same manner as the CLCSS scheme. SIDBI and other nominated banks would be implementing the scheme as in the case of CLCSS. List of banks is at Annex-II.
    3. The scheme will involve collaboration with the following:


      1. Development Commissioner, Micro Small, Medium Enterprises, Ministry of Micro Small, Medium Enterprises
      2. Certification agencies (CDSCO / SRA)
      3. Banks and Financial institutions like SIDBI
      4. State government officials in Departments of Health and Industry
    4. 1.4 Implementation Methodology: The implementation of the Credit Linked Capital Subsidy Scheme (hereinafter referred to as ‘Scheme’) comprises interalia the following stages:


      1. Awareness Building
      2. Organizational arrangements
      3. Implementation processes
      4. Involvement of all stakeholders
      5. Periodic Review and Monitoring
  2. AWARENESS BUILDING

    For this a three fold strategy is proposed to be adopted:
    • Awareness Building Workshops
    • Dissemination of Scheme brochures and related material
    • Media support
    2.1 Awareness Building Workshops (ABW):
    2.1.1 Workshop Location:
    Workshops at 10 SSI Cluster locations as per following schedule would be organized:
    Workshops at 10 SSI Cluster locations as per following schedule would be organized
    Sl.No. Venue Date Nodal Industry
    1. Goa 05.10.09 (tdursday) SPIC
    2. Mumbai 06.10.09 (Tuesday) IDMA & SPIC
    3. Baddi (H.P) 13.10.09 (Tuesday) FOPE/NIPER, Mohali
    4. Ahmedabad 16.10.09 (Friday) NIPER (PERD)/IDMA
    5. Bengaluru 22.10.09 (tdursday) KAPL/SPIC
    6. Chennai (T.N.) 23.10.09 (Friday) CPI/IDPL
    7. Hyderabad (A.P.) 27.10.09 (Tuesday) NIPER/Pharmexcil
    8. Indore (M.P.) 30.10.09 (Friday) SPIC
    9. Dehradun 12.11.09 (tdursday) FOPE

    The aim of the ABWs would be to spread awareness and deepen the understanding of Pharma SSI manufacturers/entrepreneurs about the implementation of the scheme involving interalia, substantially expanded list of 179 machineries/Equipments required for Schedule ‘M’ Compliance. The choice of these locations takes into account the concentration of SSI pharma units in these locations.

    2.1.2 Workshop Personnel:

    DDG Shri Ashok Vishan Dass and DIA (Shri Mathur) together would co-ordinate these ABWs. JS (Pharma), Shri Devendra Chaudhry would be present in the important workshops, preferably at larger clusters, as an ’Observer’.

    2.1.3 Workshop assisting Organizations:

    • NIPERs: Ahmedabad, Mohali, Hyderabad
    • KAPL: Bangalore
    • NPC: all through
    • Banks including SIDBI
    • IDMA, SPIC, FOPE, CIPI, and other Industry associations will be required to assist in getting in organizing and convening the industry at every location.
    • SMPIC - Small, Medium Pharma Industry Centre at NIPER Mohali may also render technical advise to assist pharma SSIs units. This would also go a long way in capacity building.
    2.1.4 Scheme Brochure:

    A detailed Scheme Brochure will be made available to the potential beneficiaries to understand the various facets of the scheme and its implementation methodology.

    2.1.5 Media:

    Two advertisements, one each in vernacular and English languages would be made in the prominent newspapers of the states wherever the ABWs will be held. These advertisements will be released through DAVP.

  3. ORGANISATIONAL ARRANGMENTS

    Scheme Implementation Committee (SIC)

    The Scheme Implementation Committee would be set up to be guided by JS DC. DDG AVD will be Member Convenor with other members from SIDBI, NPC and selected industry nominees. SIC would lay down monitoring and evaluation formats developed with support from NIC for effective reporting on the progress of the Scheme. The Committee would meet every month to ensure proper implementation of the Scheme.

  4. IMPLEMENTATION PROCESS

    4.1 Technical and Certification Support:

    As a number of Pharma SSI units are not well conversant with the technical requirements of the compliance regulators in terms of physical implementation processes, capacity building with the help of NIPER will be done. This will sensitise the SSI units of the implementation issues and increase their commitment to the project. The ABW would be one day event.

    4.2 Other Activities planned:

    1. Cluster survey of the status of the implementation of Schedule M
    2. Status Report on the standards implementation status
    3. Gap identification
    4. Plan to implement for compliance
    5. Capacity building of the potential beneficiary
    6. The requirements of Schedule ‘M’ compliance include documentation - a very essential part. Accordingly, these units will be provided technical advice by NIPERs to secure the necessary certification from the concerned state Regulatory Authority.

    4.3 Project Approval Support

    Each unit would be required to prepare Detailed Project Plan (DPP) for application to the Bank for financial assistance including loan and subsidy. For SIDBI would coordinate and monitor all the applications made seeking assistance under the Scheme.

    There will be weekly monitoring of applications filed and sanctioned as well as disbursals of loan and adjustment of subsidy in the loan amount. A close team led by DDG will have to coordinate with the Bank and beneficiary as well as MSME.

  5. MONITORING & EVALUATION

    Scheme Oversight Committee (SOC)

    A Scheme Oversight Committee would be set up in the Chairmanship of the Secretary Pharma with DC MSME, JS DC, DDG AVD, Senior Officer of NPC and concerned GM of SIDBI, Heads of IDMA, CIPI, FOPE as members. SIDBI would be Member-Convenor. Based on the monthly Scheme Implementation Committee (SIC), the Oversight Committee would provide periodic guidance for successful implementation of the scheme including policy issues. The SOC would meet every two months.

    Annexure-I

    Second Supplement of the Revised Guidelines on the Credit linked Capital Subsidy Scheme (CLCSS) for Technology Up gradation of Micro and Small Enterprises approved by the Technical Sub-Committee on the CLCSS (TSC) in its 7th meeting held on the 13th day of July, 2009 under the chairmanship of the Additional Secretary & Development Commissioner (MSME)

    Office of the Development Commissioner (MSME),
    Ministry of Micro, Small and Medium, Enterprises
    Government of India,
    Nirman Bhawan,
    New Delhi.

    iv: Drugs & Pharmaceuticals:

    1. List of Machineries/ Equipments Recommended for Drug and Pharmaceutical Products, Sub-Sector-wise (including the Existing Technologies in the CLCSS) Required for Schedule ‘M’ Compliance and Indian/International Standards for inclusion at S. No. IV in the Credit Linked Capital Subsidy Scheme for Technology Upgradation.

    Surgical Dressing Ophthalmic Preparations Peccaries and Suppositories

    Surgical Dressing Ophthalmic Preparations Peccaries and Suppositories
    S.No. Activity Approx. Cost (Rs. Lakh) Technology Need Advantages

    External Preparations

    1. Mixing and Storage Reactor 3-4.0 WHO-GMP Compliance Better Quality
    2. Reaction Reactor 2-2.5 --do--
    3. Mixing Vessel 3-3.5 --do--
    4. Planetary Mixing Mixture 3-3.5 --do--
    5. Colloidal Milling Emulsifier 0.6-0.9 --do--
    6. Milling Ointment Mill 1-1.5 --do--
    7. Liquid filling Filling Machine 2-2.5 --do--
    8. Filling Jar Filling Equipment 1.5-2.0 --do--

    In Oral Liquid Preparation

    9. Stirring Agitator 0.3-0.5 --do--
    10. Colloidal Milling Colloidal Mill 0.3-0.5 --do--
    11. Filtration Filter 0.3-0.5 --do--
    12. Pill Proof capping Capping machine 1-1.2 --do--
    13. Clarity testing Inspection unit 0.2-0.3 --do--
    14. Mixing Reactor 4-8 --do--
    15. Reaction Reactor 2-3 --do--
    16. Bottle Filling 4 head filling machine 2-3 --do--
    17. Distillation Distillation unit 4-5 --do--

    Tablets

    18. Dispensing Reverse laminar flow equipment 1.5-2.0 Safety of personnel
    19. Storing Storage Cabinet 0.5-0.8 Storage
    20. De-Dusting of Tablet On-line de-duster 0.4-0.6 GMP
    21. Dissolution test Lab testing apparatus 1-1.2 Quality testing
    22. Sifter 24 Dia Sifter 0.8-1.0 WHO-GMP Compliance
    23. Powder Mixing Blender 2-2.5 --do--
    24. Mass Mixing RMG 3-5 --do--
    25. Granulation Roller Compactor 1.5-3 --do--
    26. Weighing Balance 0.8-1 --do--
    27. Thermostatically controlled hot air TD 2-3 --do--
    28. Tablet compression 16 station rotary tablet machine, 27 station rotary tablet machine 2.0-3.0, 3.25-4.0 Increased Productivity
    --do--
    29. Tablet Inspection Inspection Table 1-1.2 --do--
    30. In Process testing Lab instruments 2-2.5 --do--
    31. AHU AHU 15-17 GMP
    32. Strip/blister packing Strip/blister packing machine 6-9 Production
    33. Leak testing Vacuum leak tester 1-1.2 Analysis
    34. Table Counter Counter 0.3-0.5 Packing
    35. AHU Dehumidifier 8-10 GMP
    36. Reaction Reactor 2-3 WHO-GMP compliance
    37. Coating Coating Pan 1.5-3 --do--
    38. Exhaust System Dust Extractor 0.3-0.5 --do--
    39. AHU Dehumidifier 8-10 GMP
    40. Weighing Balance 0.8-1 GMP
    41. Disintegration Multi mill 1-1.5 Production
    42. Powder Mixing Blender 2-2.5 --do--
    43. Sifter 24” Dia Sifter 0.8-1.0 --do--
    44. Vessels SS vessels & scoops 0.2-0.9 --do--
    45. Filling Filling machine 4-6 --do--
    46. Weighing Balance 0.8-1 --do--

    Capsules

    47. Mixing Blender 2-2.5 Production
    48. Filling Capsules filling machine 8-15 --do--
    49. Counter Capsules counter 1-1.2 --do--
    50. Weighing Balance 0.8-1 --do--
    50. Weighing Balance 0.8-1 --do--
    51. Disintegration Disintegration Tester 0.4-0.6 --do--
    52. Capsules polishing Polishing equipment 2-3 --do--
    52. Rolling Roller Machine 2-2.5 --do--
    53. Trimming Trimming Machine 1-2 --do--
    54. Trimming Trimming Machine 1-2 --do--
    55. Cutting Cutting equipment 1-2 --do--
    56. Folding & Pressing Folding & pressing machine 2-3 --do--
    57. Mixing Medicating processing tanks 2-3 --do--
    58. Heating Dry steam sterilizer 10-15 --do--
    59. Air heating Oven 1-2 --do--
    60. Working place Tables 1-2 --do--
    61. Steam Sterilization DHS 10-18 --do--
    62. Heating Temp. controlled oven 4-5 WHO-GMP compliance
    63. Reaction Reactor 2-3 --do--
    64. Mixing Reactor 4-8 --do--
    65. Colloidal milling Ointment mill 1-1.2 --do--
    66. Tube filling Crimping Equipment 1-4 --do--
    67. Cleaning Tune cleaning 0.8-1 WHO-GMP Compliance
    68. Automatic washing Tube washing machine 1-3 --do--
    69. Drying Oven 2-4 --do--
    70. Automatic vial washing Vial washing machine 1-3 --do--
    71. Washing Rubber bungs washing 2-3 --do--
    72. Filter Cartridge candle filter 1.5-3 --do--
    73. Liquid filling Liquid filling machine 2-5 --do--
    74. Sterilization Ventilator autoclave 2-6 --do--
    75. AHU Dehumidifier 8-10 GMP
    76. AHU Laminar air flow unit 1-1.5 Sterility
    77. Mixing Reactor 1-1.5 --do--
    78. Moulding Moulding equipment 1-1.2 --do--
    79. Weighing Balance 1-1.5 --do--
    80. Mixing Reactor 1-2 --do--
    81. Measuring Graduated measuring equipment 1-2 --do--
    82. Sealing Sealing machine 1-1.2 --do--

    Repacking of Drugs & Pharmaceutical Chemicals

    83. Powder disintegration Powder disintegrator 1-1.2 --do--
    84. Sieving Sifter 1.5-2 --do--
    85. Scoops Scoop 0.2-0.3 --do--
    86. Weighing Balance 1-1.5 --do--
    87. Filling Filling Machine 2-2.5 --do--
    88. Pill proof capping Capping machine 1-1.2 --do--
    89. Sealing Sealing machine 0.3-0.5 --do--
    90. Water lines SS pipes 3-5 --do--

    Parental preparation

    91. De-ionization Ion exchange unit 12-15 --do--
    92. Distillation Triple effect evaporators 4-5 Sterility
    93. Water storage Thermal controlled reactor 3-5 --do--
    94. Pumping Pump 2-3 --do--
    95. Piping SS lines for water 4-6 --do--

    Container & closer preparation

    96. Automated Rotary Ampoule washing machine 5-7 --do--
    97. Washing Closure washing machine 2-3 --do--
    98. Storage Storage cabinet 2-3 --do--
    99. Storages benches SS benches 2-3 --do--
    100. Automatic vial washing Vial washing machine 4-5 --do--
    101. Rubber bung washing Rubber bung washing machine 1-3 --do--

    Solution preparation

    102. Stirring Agitator 0.3-0.5 --do--
    103. Filtration Filter 2-3 --do--
    104. Pumping Pump 2-3 --do--
    105. Benches SS benches 1-2 --do--
    106. Preparation Tank Reactor 2-4 --do--

    Filling capping

    107. Ampoule filling Ampoule/vial filling machine 3-5 --do--
    108. Gas lining SS pipes 2-4 --do--
    109. Benches SS benches 1-2 --do--
    110. Pressure leak testing Pressure leak test equip 1-1.2 --do--
    111. Steam Sterilizer Autoclave 10-12 --do--
    112. Dry heat sterilizer DHS 14-18 --do--
    113. Quarantine area Room storage 4-7 --do--
    114. Platforms SS Platforms 2-4 --do--
    115. Visual inspection Belt type inspection table 1-3 --do--
    116. Benches SS benches 1-1.5 --do--

    Parental preparations in Plastic containers

    117. DM water Ion exchange unit 12-15 --do--
    118. Distillation Triple effect evaporators 4-5 --do--
    119. Water Storage Thermal controlled reactor 3-5 --do--
    120. Pumping Pump 2-3 --do--
    121. Water transportation SS lines for water 4-6 --do--
    121. Water transportation SS lines for water 4-6 --do--

    Solution preparation area

    122. Pumping Pump 2-3 --do--
    123. Water storage Thermal controlled reactor 3-5 --do--
    124. Filteration Membrance filter 1-2 --do--
    125. Sterile filling Sterile filling machine 2-3 --do--
    126. Filling Plastic filling machine 2-3 --do--
    127. Batch Coding Batch coding machine 1-1.2 --do--
    128. Labeling Labeling machine 2-3 --do--
    129. Batch coding Batch coding machine 1-1.2 --do--
    130. Labeling unit Labeling machine 2-3 --do--
    131. Automatic vial washing Vial washing machine 4-5 --do--
    132. Vial drying Oven 2-4 --do--
    133. Autoclave Autoclave 4-5 --do--
    134. Laminar flow Laminar air flow unit 1-1.5 Sterility
    135. AHU HVAC 10-15

    Bulk Drugs

    (vii) Plastic Moulded/Extruded Products and parts

    Sl. No. Activity Technology need Cost (in Rs. Lakh) Advantages
    1. Weighing Automatic electronic balance 300kg.;150kg and 1kg. 0.5-2.0 depending on the model Accurate weighing of raw materials; increased productivity
    2. Reaction MS,SS,MS/GL Lead/RL lined Reaction Vessel 25 Suitable for process
    3. Filtration Centrifuge, Nutch filter, Vacumm filter, filter press, Pressure filter SS, MS/GL 15 Suitable for process
    4. Distillation Unit SS Distillation Unit 15 Solvent Quality Reusable
    5. Dryer TD,VTD, Nauta dryer, Rotatory Vacuum, SS Dryer with modern facilities, spray/ flash 15 Quality upgradation
    6. Storage tanks MS, SS, MS/RL Storage tanks 10 Avoid mixing
    7. Pumps Centrifugal, Totopump 5 Process
    Multistage Handling
    8. Powder Processing Multimill, vibrator, blender coating 10 Quality Requirements
    9. Scrubber Glass/ MS/RL 5 Environmental Improvement
    10. Laboratory Equipments HPLC, FTIR, UV, KF testing, HTTLC 35 Quality Requirements
    11. Mixing Blenders 5 For uniformity of the product
    12. Micronisation Jet mill, Pulverizer 25 For better dissolution rate
    13. Compacting Roll compacter 15 For increasing bulk density of the product
    14. Distillation SS Condensers 10 For improving recovery of solvents and uniform reaction
    15. Raw material and finished product weighing Electronic Weighing machine 0.15
    1. Saving of time
    2. Saving of labour
    3. No loss of material
    4. Increase in the profitability
    16. Quality control Laboratory Equipment of latest technology, spectrophotometer, Gas Chromatograph & others. ITR, 10
    1. To get the best possible precise results.
    2. less time consuming & immediate results display
    17. Pulverisation. Latest technology pulverisers impact 4
    1. Quality of products improves due to finest particles.
    2. Physical loss of material is very less
    18. Heating Boilers 10 For heating
    19. Power DG Set 10-15 For uninterrupted power during process
    20. Chilling Chilling units, cooling towers. WAS systems 25-50 To maintain process parameters
    21. Instrumentation Online PH meters, temperature meters 5 To maintain process parameters
    22. AHU Air conditioning & Rh control 25 Quality up gradation
    23. Chilling Cooling water, chilled water chilled brine, air water VAS System 30-45 To maintain process conditions parameters
    24. Accurate Weighing Digital balances, 1 For accuracy
    25. Non-reactive Storage Tanks Storage Containers Numbers & size to depend on operation 1-8 For handling of pharmaceuticals in-process
    26. Containers Storage Sontainers Number & size to depend on operation 1-5 Material handling
    27. Process Instruments Measuring temperature, pressure 2-5 Process Control
    28. Pumps Centifugure, vacuum 5 Atomization

    Quality Control Depatment

    29. Dispensing Reverse laminar flow equipment 1.5-2 Safety o personnel
    30. Weighing Automatic electronic balance 300kg.; 150 kg. and 1kg 0.5-2.0 depending on the model Accurate weighing of raw materials; Increased productivity
    31. Drug Assay and testing HPLC, HPTLC, FTIR, automatic titration, PH meter, melting point, karl fisher instrument Gas chromatograph, small rato evaporator system with vacuum pump tablet hardness tester, dissolution test apparatus, disintegration test apparatus, UV spectroscope, laminar flow benches, TLC/FID detector 20-40 Accurate drug analysis
    33. Stability chambers Two stability chambers at 40Ÿ & 25Ÿ with alarm bell and printer 7

    Environment Control Devices

    34. Weighing Automatic electronic balance 300kg. 150kg. & 1kg. 0.5-2.0 depending on the model Accurate weighing of raw materials; increased productivity
    35. Air conditioning and humidity control of all types of areas Air conditioning Humidity control equipment (dehumidifier) 10-30 Improve product stability, enhance personal comfort
    36. Air handling for parenteral (Sterile) area Air handling unit with HEPA filters, Ducting with insulation; chilled water piping; electrical cabling and panels; chilled water pump; chilled water control 15-40 Improve product quality, enhance personal safety
    37. Air handling other for parenteral area Air handling unit with 5 micron filters, 10-15 Improve product quality, enhanced personal safety,
    38. Miscellaneous fittings Ducting with insulation; chilled water piping; electrical cabling and panels; chilled water pump; chilled water control 5-6 Improves product quality, enhanced personal safety
    39. Energy Generation DG 2.0-12.01 For continuous Production
    40. Pollution control Effluent Treatment Pollution Control Machinery 10-15 Biochemical treatment of effluent removes 90 to 95% of soluble organic matter in the waste
    41. Recovery Reverse osmosis plant, scrubbers 10 To improve discharge or waste water
    42. Pollution control Incinerators 20 For solid waste disposal
    43. Cleaning Vacuum cleaner and scrubbers 2 For maintaining cleanness as required Schedule M

    Annexure –II

    Addresses of Nodal Agencies for CLCSS

    Addresses of Nodal Agencies for CLCSS
    S.No. Title
    1. CHIEF Manager, Bank of India, 70/80,M.G.Road, Post Box No. 238, Mumbai-400001.
    2. Chief General Manager, National Bank of Agriculture & Rural Development, Block-C-24, G Block, 5th Floor, B Wing, Bandra Kurla Complex, Bandra East Mumbai-51.
    3. Dy. General Manager, Small Industries Development Bank of India, SIDBI Tower, 15, Ashok Marg, Lucknow -226001. (U.P.)
    4. Chief Manager, State Bank of India, Commercial Branch, Corporate Operation Division, N.G.N.Vaidya Marg, Mumbai.
    5. Chief Manager (SME Division), Punjab National Bank, H.O., Atma Ram House, 1, Tolstoy Marg, New Delhi.
    6. AGM, Canara Bank Corporate Credit Wing, 112, J.C. Road, Head Office, Post Box N. 6648, Bangalore-560002.
    7. GM (SME Banking), Bank of Baroda, Baroda Corporate Centre, Plot No. C- 26, G Block, Bandra Kurla Complex, Bandra (East). Mumbai-400051
    8. Dy. General Manager (IC), The Tamilnadu Industrial Investment Corporation Ltd. 692, Anna Salai, Nandanam, Chennai – 6000035.
    9. AGM, Andhra Bank, Head Office Dr. Pattabhi Bhawan, 5-9-11, Saifabad, Hyderabad – 500004.
    10. Chief Manager (C&I), State Bank koff Bikaner & Jaipur, Head Office, Tilak Marg, Jaipur – 302005.