Plant setup · Machinery planning
Pharma machinery list: the short answer
In India, the starting point for a section-wise pharma machinery list is not a vendor catalogue. It is Part XIII, “Requirements of Plant and Equipment”, of Revised Schedule M, notified as G.S.R. 922(E) on 28 December 2023.[1] Part XIII names the equipment it recommends for each dosage section and a minimum floor area for each.
A tablet section needs four separate areas: granulation and drying, compression, packaging, and coating where required. Part XIII lists 23 items across them. A hard-gelatin capsule section needs 6 listed items inside an enclosed, air-conditioned, dehumidified room with an airlock. An oral liquid section needs 9 listed items, from mixing tanks to a pilfer-proof cap sealer. Utilities such as HVAC, purified water and dust extraction are not in the Part XIII lists, but Parts I, VIII and IX of the same schedule make them unavoidable.
How the machines line up in a tablet section
The order of the machines follows the order of the process. In a wet-granulation tablet line, each step below maps to at least one item in Part XIII:
- 01Dispensing
- 02Sifting
- 03Wet granulation (RMG)
- 04Drying (tray dryer / FBD)
- 05Sizing (multi mill)
- 06Blending and lubrication
- 07Compression
- 08De-dusting and inspection
- 09Coating
- 10Strip / blister packing
A direct-compression product skips steps 03 to 05. That is the main reason two tablet plants of the same output can have very different machinery bills.
Section-wise pharma machinery list (mapped to Schedule M)
Each row shows where the requirement comes from. The Part XIII rows are the equipment Schedule M recommends by name. The Clause rows come from a binding clause elsewhere in the schedule. The Practice rows are the author’s plant-floor recommendation and are not a regulatory requirement.
Tablet section machinery list
Part XIII, clause 3, says the tablet department “shall be divided into four distinct and separate sections” and that each compression machine shall be isolated in a cubicle connected to a vacuum dust collector or exhaust system.[1]
Scroll the table sideways →
| Machine | Job in the process | Basis | What to specify when buying |
|---|---|---|---|
| (a) Granulation-cum-drying | |||
| Disintegrator and sifter (vibro-sifter) | De-lumps and screens raw materials. All dry ingredients must be sifted before use unless the process says otherwise (Part VIII 1.4). | Part XIII | Mesh range, sieve-integrity check, and dust extraction or a closed system (Part VIII 2.1). |
| Powder mixer (double-cone, octagonal or bin blender) | Dry mixing and final lubrication. | Part XIII | Working volume matched to batch size, fill range, stainless contact parts. |
| Mass mixer, planetary mixer or rapid mixer granulator (RMG) | Wet massing and granulation. | Part XIII | Impeller and chopper speed control. Recording of mixing time, which Part VIII 2.3 requires in the batch record. |
| Granulator (oscillating granulator or multi mill) | Sizes wet and dried granules. Listed “wherever required”. | Part XIII | Screen sizes, speed range, knife and blade options. |
| Tray dryer (thermostatic hot-air oven) or fluid bed dryer (FBD) | Dries granules to target moisture. | Part XIII | Filtered inlet air. A filter-bag policy: bags washed between products, and product-specific bags for potent products (Part VIII 2.4). |
| Weighing machines | Dispensing and in-process weighing. | Part XIII | Range and readability matched to the quantities weighed, calibrated to a fixed schedule (Part I 13.5). |
| (b) Compression | |||
| Tablet compression machine (single, multi-punch or rotary) | Compresses lubricated granules into tablets. | Part XIII | Number of stations, tooling type, maximum compression force, and a dust control or cubicle arrangement (Part VIII 3.1). |
| Punch and die storage cabinets | Controlled storage and inspection of tooling. | Part XIII | Slots per tooling set, plus a tooling issue and inspection log. |
| Tablet de-duster | Removes surface powder. Part VIII 3.5 prefers an automatic device. | Part XIII | Mounted in line at the press outlet. |
| Tablet inspection unit or belt | Removes visual defects and foreign material. | Part XIII | Lighting, belt speed, reject collection. |
| In-process testers: single-pan electronic balance, hardness tester, friability and disintegration apparatus | In-process checks at intervals of not more than 30 minutes (Part VIII 3.8). | Part XIII | Placed in the compression area and calibrated. |
| Dissolution test apparatus | Listed “wherever required”. | Part XIII | Number of vessels, apparatus type per your product monographs. |
| Air-conditioning and dehumidification | Listed “wherever necessary” for compression. | Part XIII | RH set-point driven by your most moisture-sensitive product. |
| Metal detector | Supports the Part VIII 3.5 duty to monitor tablets for foreign material. | Practice | Sensitivity for ferrous, non-ferrous and stainless test pieces, with an auto-reject. |
| (c) Packaging | |||
| Strip or blister packing machine | Primary packing. | Part XIII | Inspection for misprints, foil cuts, missing tablets and improper sealing (Part VIII 7.3). |
| Leak test apparatus (vacuum system) | Periodic vacuum test of strips and blisters (Part VIII 7.4). | Part XIII | Vacuum range and a calibrated gauge. |
| Tablet counters | Bottle packs. Listed “wherever applicable”. | Part XIII | Count accuracy, and line clearance of “rogue” tablets (Part VIII 7.1). |
| Air-conditioning and dehumidification | Listed “wherever applicable” for packing. | Part XIII | As for compression. |
| (d) Coating (wherever required) | |||
| Jacketed kettle (steam, gas or electric heated) | Prepares the coating suspension. | Part XIII | Stainless steel or other appropriate material. Suspensions made fresh and their use recorded (Part VIII 4.2). |
| Coating pan (stainless steel) | Film or sugar coating. A perforated auto-coater is the modern form. | Part XIII | Filtered drying air of suitable quality (Part VIII 4.1), spray system, batch capacity. |
| Polishing pan | Listed “where applicable”. | Part XIII | Capacity matched to the coating pan. |
| Exhaust system with vacuum dust collector | Removes powder and solvent fumes (Part XIII 3.2). | Part XIII | Interlocked with the air-handling unit (Part VIII 1.22). |
| Air-conditioning and dehumidification, plus a weighing machine | Two separate Part XIII items for the coating room. | Part XIII | Temperature and RH control (Part VIII 4.1). |
Capsule section machinery list (hard gelatin)
Part XIII, clause 5, requires a “separate enclosed area suitably air-conditioned and dehumidified with an airlock arrangement”, and separate equipment and filling and packaging areas for penicillin and non-penicillin sections.[1]
Scroll the table sideways →
| Machine | Job in the process | Basis | What to specify when buying |
|---|---|---|---|
| Mixing and blending equipment (electrically or power driven) | Prepares the fill blend. It can be shared with the tablet section if cleaning is validated (Part I 13.12). | Part XIII | Working volume, dust extraction, cleanability. |
| Capsule filling units | Fills empty shells: manual, semi-automatic or automatic. | Part XIII | Capsule sizes covered, output per hour, fill-weight control, change-part cost. |
| Capsule counters | Listed “wherever applicable”. | Part XIII | Count accuracy. |
| Weighing machine | Fill-weight checks. | Part XIII | Readability suited to the individual fill weight. |
| Disintegration test apparatus | In-process check. | Part XIII | Calibrated, with a basket suited to capsules. |
| Capsule polishing equipment | Removes surface powder after filling. | Part XIII | Inline with the filler, with dust extraction. |
| Exhaust system | Required where fine powder floats during operations. | Clause | Part XIII 5 text. |
| Strip or blister packing machine | Primary packing, with the same line-clearance and leak-test duties as tablets (Part VIII 7). | Clause | As for tablets. |
| Capsule sorter or inspection unit, and metal detector | Removes empty, split or dented capsules and metal contamination. | Practice | Reject verification, size change-parts. |
Empty capsule shells count as a “drug component” and must be stored away from excessive heat and moisture (Part VIII 5). Budget for a conditioned store, not only the filling room.
Oral liquid section machinery list (syrups, elixirs, emulsions, suspensions)
Part XIII, clause 2, lists nine items. Part IX adds the binding design rules: stainless steel or other appropriate material for product-contact parts, minimal glassware, a double-door airlock entry, and closed transfer systems recommended.[1]
Scroll the table sideways →
| Machine | Job in the process | Basis | What to specify when buying |
|---|---|---|---|
| Mixing and storage tanks | Stainless steel preferred, or another appropriate material. | Part XIII | Easily cleaned and sanitised, with no dead legs where microbes can collect (Part IX 2.6). |
| Jacketed kettle or stainless steel tank (steam, gas or electric heated) | Sugar syrup preparation and hot dissolution. | Part XIII | Heating medium, temperature indication and recording. |
| Portable stirrer (electrically operated) | Mixing. Suspensions also need stirring during filling (Part IX 4.3). | Part XIII | Speed control, stainless shaft. |
| Colloid mill or suitable emulsifier | Emulsions and suspensions. | Part XIII | Gap setting, throughput. |
| Suitable filtration equipment | Clarifies syrups and solutions. | Part XIII | Filter type and rating, housing material. |
| Semi-automatic or automatic bottle filling machine | Fills bulk into bottles. | Part XIII | Fill-volume accuracy, number of heads, homogeneity at start-up and after stoppages (Part IX 4.3). |
| Pilfer-proof cap sealing machine | Seals ROPP or screw caps. | Part XIII | Cap sizes covered, seal-integrity check. |
| Water distillation unit or deionizer | The Part XIII wording. In practice the purified water system below replaces it. | Part XIII | See purified water. |
| Clarity testing inspection units | Visual inspection of filled bottles. | Part XIII | Black-and-white background, lighting level. |
| Bottle, closure and dropper washing machine | Cleaning “with the help of suitable machines or devices equipped with high pressure air, water and steam jets” (Part IX 2.8). | Clause | Final rinse with purified water where bottles are not dried (Part I 14.26.1). |
| Purified water generation, storage and distribution | Microbial limit not more than 100 cfu per ml with absence of pathogens. Recirculation, UV, heat or chemical sanitisation (Part IX 3.1 to 3.2). | Clause | A validated system producing water to pharmacopoeial specification (Part I 14.6). |
| Sanitary transfer pumps and labelled pipework | Moves bulk from vessel to filler. Pipework labelled with contents and flow direction (Part I 13.3). | Clause | Correct-destination controls (Part IX 2.10). |
| Labelling machine and batch coder | Secondary operations. | Practice | Label reconciliation, code verification. |
For the primary packing area, Part IX 4.4 specifies filtered air (for example EN779 G4 + F8 + EN1822 H13 on a recirculated system) and a temperature not above 30 °C.
Utilities and support equipment common to all sections
Part XIII lists none of these as items, but an inspection will fail without them.
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| System | Why you need it | Basis | What to specify when buying |
|---|---|---|---|
| HVAC: air-handling units with a pressure cascade | Directional airflow and pressure differentials between rooms (Part VIII 1.8 to 1.14). Corridors are kept at a higher pressure than cubicles (Part VIII 1.9). | Clause | Non-overlapping differential ranges, for example 5–15 Pa in one room and 15–30 Pa next door (Part VIII 1.14). Temperature and RH alert and action limits. |
| Central dust extraction | Must be interlocked with the air-handling systems so that both run together (Part VIII 1.22). | Clause | No shared ducting between cubicles with different pressures (Part VIII 1.23). |
| Purified water system | Purified water is used for every operation except washing and cleaning (Part I 14.6). | Clause | Pretreatment, RO with EDI or equivalent, a storage tank, and a recirculating loop with sanitisation. |
| Calibrated balances and measuring equipment | Production and QC balances calibrated to a fixed schedule (Part I 13.5). | Clause | Calibration certificates traceable to national standards. |
| Compressed air | Drives fillers, coaters and packing lines. | Practice | Oil-free and filtered at points where it touches product or contact surfaces. |
| Steam or thermal heating | Jacketed vessels, coating suspension, cleaning. | Practice | Boiler or electric heating sized to the simultaneous load. |
| Power backup (DG set) | Keeps the HVAC and water loop running, so area and water qualification is not lost in an outage. | Practice | Capacity for the HVAC, purified water and critical lines, not only lighting. |
Build your machinery checklist
Pick a section, a product family and a line scale. The builder returns the Part XIII baseline, the clause-driven extras, the minimum area and the segregation rule that applies. Copy the list into your project file or vendor enquiry.
1. Dosage section
2. Product family
3. Line scale
Pick a dosage section to start your list
The list, the minimum area and the segregation rule will appear here.
Three rules that change the machinery list
1. Part XIII is a baseline. Parts I, VIII and IX decide whether you pass.
Every Part XIII list is introduced with “the following equipment is recommended”, and every area figure “is recommended”. The binding duties sit in the rest of the schedule: equipment that is non-reactive with the product (Part I 13.9), qualification through DQ, IQ, OQ and PQ (Part I 5.3), validated cleaning of shared equipment (Part I 13.12), dust control on every press (Part VIII 3.1), and purified water within microbial limits (Part IX 3.1). A plant can own every listed machine and still fail on these.[1] Our Schedule M area requirements by dosage form guide makes the same point about floor area.
2. Penicillins need their own facility, not only their own machines
Part I 12.6.1 requires “dedicated and self-contained facilities” for highly sensitising materials such as penicillins. Part XIII adds separate areas and equipment for penicillin tablets (3.2) and for penicillin capsules (5). For a beta-lactam line, budget a second set of machines and a separate HVAC zone.[1]
3. Oral liquids: the DEG/EG lesson is now an inspection item
On 7 October 2025, after child deaths in Madhya Pradesh and Rajasthan linked to contaminated cough syrup, the DCGI asked state drug controllers to make sure manufacturers test every batch of raw material, including excipients, and every batch of finished product before release. The advisory cited rules 74(c) and 78(c)(ii) of the Drugs Rules and called for a robust vendor-qualification system.[5] US FDA guidance (2023) recommends testing high-risk components such as glycerin, propylene glycol and sorbitol solution for diethylene glycol (DEG) and ethylene glycol (EG).[6]
The machinery consequence: a syrup plant’s budget must include QC capacity for DEG/EG testing (usually gas chromatography) or a contract with an approved testing laboratory. This is not optional in 2026.
How to buy pharma machinery that passes inspection
Before the purchase order
- Write a user requirement specification for each machine: capacity, batch size, product range.
- Get a design qualification (DQ) from the vendor: drawings, contact-part materials, and a list of every surface that touches product.
- Ask for material-of-construction certificates for contact parts. Schedule M asks for stainless steel or another appropriate material that is not reactive, additive or absorptive (Part I 13.9; Part IX 2.7).
- Check spares availability and service response near your site.
At delivery and installation
- Factory and site acceptance tests against the specification.
- Installation qualification (IQ) and operational qualification (OQ), then performance qualification or process validation (PQ/PV) on your product (Part I 5.3).
- Calibration of every gauge, sensor and balance that gives a GMP reading (Part I 13.5).
- Cleaning procedure written and validated for shared equipment (Part I 13.12).
Second-hand machinery
- Acceptable if it is qualified like new equipment. Any significant equipment change must be qualified and validated (Part I 5.4).
- Inspect contact surfaces for pitting, welds and earlier product residues.
- Get the original manuals and drawings. Without them, DQ and IQ have to be rebuilt.
- Confirm that spares for the model are still made.
Examples of Indian machinery makers by equipment family
Each product range below was checked on the maker’s own website on 12 Oct 2026. These are examples, not endorsements: Laafon does not certify vendors, and you should collect at least three quotations.
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| Maker (location) | Relevant range listed on its website | Section | Website |
|---|---|---|---|
| Cadmach (Ahmedabad, Gujarat) | Tablet presses (small to high scale), roll compactors, comminuting mills, tablet tooling | Tablets | cadmach.com |
| Gansons (Thane, Maharashtra) | Fluid bed dryers and processors, high-shear mixer granulators, tablet coaters | Tablets, capsules | gansons.com |
| Lodha International LLP (Ahmedabad, Gujarat) | Liquid filling, cap sealing (screw and ROPP), bottle washing, sticker labelling machines | Oral liquids | lodhapharma.com |
Turn this machinery list into a project cost
Machinery is only one part of the capex. The section-wise package also includes the air-handling unit, the classified area, qualification and licensing. The calculator prices all of it for your sections and capacity, at Revised Schedule M, WHO-GMP, EU-GMP or US-oriented standard.
Estimate your plant setup cost
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Rent or contract
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Pharma machinery list: frequently asked questions
Revised Schedule M Part XIII lists equipment for four tablet sub-sections. Granulation and drying: disintegrator and sifter, powder mixer, mass, planetary or rapid mixer granulator, granulator where required, tray dryer or fluid bed dryer, and weighing machines. Compression: compression machine, punch and die cabinets, de-duster, inspection unit or belt, dissolution apparatus where required, in-process testers, and air-conditioning with dehumidification. Packaging: strip or blister machine, vacuum leak tester, counters, and air-conditioning. Coating: jacketed kettle, stainless steel coating pan, polishing pan, exhaust with dust collector, air-conditioning and a weighing machine.
Part XIII recommends 60 m² basic plus 20 m² ancillary for uncoated tablets, with an additional 30 m² plus 10 m² for a coating section. Hard gelatin capsules need 25 m² plus 10 m² for each of the penicillin and non-penicillin sections. Oral liquids need 30 m² plus 10 m². These figures cover the production section only. Warehouse, QC laboratory, change rooms and utilities are additional.
Part XIII introduces each list as equipment that “is recommended”, so it is a baseline rather than a closed specification. The obligations that inspectors cite sit in Parts I, VIII and IX: qualification of equipment (DQ, IQ, OQ, PQ), validated cleaning, dust control on compression machines, filtered air for dryers and coaters, and purified water within microbial limits. Treat the Part XIII list as the minimum, and the other Parts as the test it has to pass.
Yes, for general products, provided shared equipment is cleaned by validated procedures between products (Part I 13.12) and its capacity suits both batch sizes. The capsule filling operation itself still needs a separate enclosed, air-conditioned, dehumidified area with an airlock (Part XIII 5). Shared equipment is not acceptable for penicillins: these need dedicated, self-contained facilities (Part I 12.6.1).
Part XIII still says “water distillation unit or deionizer”, but the operative rules are stricter. Part I 14.6 requires a validated system producing purified water to pharmacopoeial specification for all operations except washing and cleaning. Part IX 3.1 sets a microbial limit of not more than 100 cfu per ml with absence of pathogens, and Part IX 3.2 requires measures such as recirculation, UV, heat or chemical sanitisation. Most new plants meet this with pretreatment, RO plus EDI, a storage tank and a recirculating loop.
It can be, if it is qualified exactly like new equipment. Revised Schedule M requires significant changes to equipment to be qualified and validated (Part I 5.4), and contact parts must not react with or absorb the product (Part I 13.9). Before buying, inspect contact surfaces, collect manuals and drawings, confirm that spares are still made, and plan a full IQ, OQ and PQ at your site.
Laafon’s own planning estimate, last reviewed in August 2026, puts an integrated oral-solids machinery line at about ₹1.5 to 2.5 crore. That excludes qualification, utilities and installation; utilities (HVAC, water, power) add about ₹0.5 to 1.5 crore. These are indicative bands, not quotations. Capacity, automation and the GMP standard you build to move them a lot, so use the plant setup cost calculator for your own configuration.
On 7 October 2025 the DCGI asked state drug controllers to make sure manufacturers test each batch of raw material, including excipients, and each batch of finished product before release, citing rules 74(c) and 78(c)(ii) of the Drugs Rules. For an oral liquid section, this means planning QC capability or an approved testing laboratory for diethylene glycol and ethylene glycol in glycerin, propylene glycol and sorbitol, together with a qualified-vendor system for those excipients.
References
- Ministry of Health and Family Welfare (India). G.S.R. 922(E): Drugs Rules, 1945 – Schedule M (Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products), Parts I, VIII, IX and XIII. Gazette of India, Extraordinary, Part II, Sec. 3(i). New Delhi; 28 Dec 2023. Available from: CDSCO Gazette Notifications. Accessed Oct 2026.
- Ministry of Health and Family Welfare (India). G.S.R. 666(E): Corrigendum to G.S.R. 922(E) dated 28 December 2023. Gazette of India, Extraordinary. New Delhi; 25 Oct 2024. Available from: CDSCO Gazette Notifications. Accessed Oct 2026.
- Ministry of Health and Family Welfare (India). G.S.R. 127(E): Extension of timeline for implementation of Schedule M. Gazette of India, Extraordinary. New Delhi; 11 Feb 2025. Available from: CDSCO Gazette Notifications. Accessed Oct 2026.
- Business Standard. CDSCO asks state units to start inspections under Schedule M norms. New Delhi: Business Standard; 8 Nov 2025. Available from: business-standard.com. Accessed Oct 2026. (Secondary source; the CDSCO letter was not available online.)
- Press Trust of India. Drug controllers urged to ensure testing of pharma products before releasing them in market. The Week; 8 Oct 2025. Available from: theweek.in. Accessed Oct 2026. (Secondary source reporting the DCGI advisory of 7 Oct 2025.)
- US Food and Drug Administration. Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol; Guidance for Industry; Availability. Federal Register. 2023 May 10;88(90):30139. Available from: regulations.gov. Accessed Oct 2026.
This page is technical and educational information for pharmaceutical professionals, not legal, regulatory or investment advice. Indian statutory instruments, CDSCO advisories and pharmacopoeial texts change often. Confirm the current text with CDSCO and your State Licensing Authority before you place orders or file a licence application. Vendor names are examples only, and cost figures are indicative, not quotations.
