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

1.     INTRODUCTION

1.1    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. 

1.2    As per the CLCSS Scheme of the MSME, 15% Capital Subsidy would be provided on capital investment of upto 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.

 

1.3    The scheme will involve collaboration with the following:

               I.     Development Commissioner, Micro Small, Medium Enterprises, Ministry of  Micro Small, Medium Enterprises

             II.     Certification agencies (CDSCO / SRA)

          III.     Banks and Financial institutions like SIDBI

          IV.     State government officials in Departments of Health and Industry

1.4    Implementation Methodology:    The implementation of the Credit Linked Capital Subsidy Scheme (hereinafter referred to as ‘Scheme’) comprises interalia the following stages:

i.                Awareness Building

ii.               Organizational arrangements

iii.             Implementation processes

iv.             Involvement of all stakeholders

v.              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:

Sl.No.

Venue

Date

Nodal Industry

1.

Goa

05.10.09 (Thursday)

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 (Thursday)

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 (Thursday)

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 Organisagtions:

·       NIPERs:     Ahemdabad, 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:

                i.     Cluster survey of the status of the implementation of Schedule M

               ii.     Status Report on the standards implementation status

             iii.     Gap identification

             iv.     Plan to implement for compliance

              v.     Capacity building of the potential beneficiary

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 Upgradation 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:

(iv) (a)

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.

 

S. No.

Activity

Technology Need

Approx. Cost

(Rs. Lakh)

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--

51.

Disintegration

Disintegration Tester

0.4-0.6

--do--

52.

Capsules polishing

Polishing equipment

2-3

--do--

         Surgical Dressing

53.

Rolling

Roller Machine

2-2.5

--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--

        Ophthalmic Preparations

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.

Laminar flow

Laminar air flow unit

1-1.5

Sterility

         Peccaries and Suppositories

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--

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

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 titratator, 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

32

Microbiological Lab in Quality Control Department.

1)             B.O.D. Incubators.

2)              Incubators.

3)              Laminar Air Flow.

4)              AHU

5)              Oven

6)              Ozone reader

7)              Auto Clave

8)              Microscopes

10

These machines are required to improve the quality of the finished products by way of testing.

33

Stability  chambers

Two stability chambers at 40ź & 25ź 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

(vii) Plastic Moulded/Extruded Products and parts

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

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.