Starting a bulk drug or Active Pharmaceutical Ingredient manufacturing unit is substantially more complex than establishing an ordinary pharmaceutical formulation plant.

An API project may involve:

• Chemical reactions
• Hazardous raw materials
• Flammable solvents
• High temperature or pressure
• Toxic intermediates
• Solvent recovery
• Controlled crystallization
• Impurity removal
• Drying and milling
• Hazardous effluent
• Air emissions
• Occupational exposure risks

Therefore, the project must combine:

**Drug licensing

• Revised Schedule M compliance
• Chemical-process engineering
• Environmental clearance
• Pollution control
• Factory and fire safety
• Qualified technical staff
• Quality control
• Process validation
• Financial feasibility**

The practical procedure is:

Select the API
→ Confirm regulatory status
→ Develop the manufacturing process
→ Conduct market and financial feasibility
→ Select an industrial location
→ Obtain environmental approvals
→ Design the plant and containment systems
→ Install utilities, machinery and laboratory
→ Recruit qualified technical personnel
→ Establish the pharmaceutical quality system
→ Apply for manufacturing licence and product permission
→ Qualify and validate the facility
→ Manufacture commercial batches only after approval

What Is a Bulk Drug or API?

An Active Pharmaceutical Ingredient is the substance intended to provide pharmacological activity in a finished pharmaceutical product.

Examples include substances used to manufacture:

• Tablets
• Capsules
• Oral liquids
• Injections
• Ointments
• Inhalation products
• Other finished medicines

The revised Schedule M defines API manufacturing broadly. It includes:

• Receipt of materials
• Production
• Packaging
• Repacking
• Labelling
• Relabelling
• Quality control
• Batch release
• Storage
• Distribution

API manufacturing under Part XII covers chemical synthesis, extraction, fermentation, cell culture, recovery from natural sources and combinations of these processes.

API, Intermediate and Starting Material

These terms should not be used interchangeably.

API Starting Material

An API starting material is a raw material, intermediate or API incorporated as a significant structural fragment into the final API.

The manufacturer must define and scientifically justify the stage at which API production begins for GMP purposes.

Intermediate

An intermediate is a material produced during API processing that undergoes further molecular change or purification before becoming the final API.

Active Pharmaceutical Ingredient

The API is the final active substance meeting the approved:

• Identity
• Strength
• Purity
• Impurity profile
• Physical characteristics
• Microbiological requirements, where applicable

Types of API Manufacturing Units

1. Synthetic API Plant

The API is produced through one or more chemical-reaction stages.

Possible operations include:

• Reaction
• Distillation
• Extraction
• Phase separation
• Neutralization
• Filtration
• Crystallization
• Centrifugation
• Drying
• Milling
• Blending

2. Fermentation-Based API Plant

Products may be produced using:

• Microorganisms
• Fermentation media
• Bioreactors
• Cell separation
• Extraction
• Purification

Such facilities require stronger microbiological and biological-process controls.

3. Extraction-Based API Plant

The active substance may be recovered from:

• Plant material
• Animal sources
• Natural substances
• Fermentation broth

4. High-Potency API Facility

High-potency APIs may require:

• Occupational exposure limits
• Closed processing
• Isolators
• Dedicated HVAC
• Negative-pressure containment
• Specialized cleaning validation
• Personnel monitoring

5. Sterile API Facility

Part XII applies to sterile APIs only up to the stage immediately before the API is rendered sterile. Sterilization and aseptic processing must follow the applicable GMP requirements for sterile products.

6. Biological or Biotechnology-Derived API

Certain biological substances fall under different or additional licensing arrangements.

Part XII does not itself cover every biological category, such as vaccines, whole cells, whole blood, plasma derivatives and gene-therapy APIs. The exact central and state approval route must therefore be confirmed product-wise.

First Select the API Products

Do not construct a multipurpose API factory before deciding which products will be manufactured.

For every proposed API, evaluate:

• Domestic demand
• Export demand
• Existing manufacturers
• Patent position
• Raw-material availability
• Number of reaction stages
• Yield
• Solvent requirement
• Waste generation
• Energy consumption
• Impurity risks
• Occupational hazards
• Selling price
• Customer qualification requirements
• Pharmacopoeial status

API Selection Matrix

A practical comparison may include:

Factor	API A	API B	API C
Annual market demand
Expected selling rate
Overall process yield
Number of reaction stages
Raw-material availability
Solvent recovery potential
Waste per kilogram
Patent risk
Required containment
Expected gross contribution

A product with a high selling price may still be commercially weak where:

• Yield is low.
• Raw materials are imported.
• Waste-treatment cost is high.
• Several purification stages are required.
• Competition forces rapid price reductions.

Existing API vs New Drug Substance

The first regulatory question is whether the proposed API is:

• An established approved drug substance
• A subsequent new drug
• A new drug substance
• An investigational substance
• An export-only unapproved product
• A controlled or specially regulated substance

CDSCO separately processes approvals concerning new drug substances and drug products. A bulk drug approved within the applicable new-drug period may require central review before the State Licensing Authority can grant or endorse the manufacturing permission.

Do not assume that a State manufacturing licence alone authorizes manufacture of a completely new API.

Manufacturing-Licence Forms

The licence form depends on the drug category.

Ordinary APIs Not Falling Under Schedule C, C(1) or X

The common route is:

• Application in Form 24
• Manufacturing licence in Form 25

Schedule X APIs Not Falling Under Schedule C or C(1)

The common route is:

• Application in Form 24-F
• Manufacturing licence in Form 25-F

Drugs Falling Under Schedule C and C(1)

The applicable route may involve:

• Application in Form 27
• Licence in Form 28

The correct form depends on the product’s schedule, biological status and licence classification. Official State Licensing Authority guidance lists Form 25 under Rule 71 and Form 28 under Rule 76, read with Schedule M.

Who Issues the API Manufacturing Licence?

For many ordinary APIs, the manufacturing licence is granted by the concerned State Licensing Authority under the Drugs and Cosmetics Act and Drugs Rules.

CDSCO or the Central Licensing Authority becomes involved where the project concerns matters such as:

• New drug substances
• Certain biological products
• r-DNA products
• Investigational products
• Import permissions
• Specially controlled products
• Export of unapproved drugs

The final licensing route should be confirmed before preparing the regulatory dossier.

Test and Development Batches

Commercial sale cannot begin under a development or testing permission.

From January 2026, the New Drugs and Clinical Trials Rules introduced a prior-intimation system for manufacturing certain categories of drugs for analytical and non-clinical testing, while specified high-risk categories remain subject to permission requirements.

The manufacturer should identify separately:

• Laboratory-development batches
• Pilot batches
• Validation batches
• Commercial batches
• Export-only batches

Revised Schedule M Requirements

As of 1 January 2026, revised Schedule M applies to manufacturers with turnover up to ₹250 crore as well as larger manufacturers.

A new API plant should therefore be designed directly under:

• Part I: General GMP principles
• Part XII: Specific requirements for APIs
• Other applicable product-specific parts
• Applicable sterile-manufacturing requirements

The revised framework requires systems covering:

• Pharmaceutical quality system
• Quality-risk management
• Qualification
• Validation
• Change control
• CAPA
• Product-quality review
• Supplier qualification
• Data integrity
• Outsourced activities

Environmental Clearance

API and bulk-drug projects may fall under item 5(f)—Synthetic Organic Chemicals Industry, which includes bulk drugs and related synthetic organic chemical operations.

Official environmental-clearance records show API projects being processed under item 5(f) as Category A, B1 or B2 depending on project characteristics, applicable notifications, location and other conditions.

The project should determine whether it requires:

• Prior Environmental Clearance
• Terms of Reference
• Environmental Impact Assessment
• Public consultation
• State-level appraisal
• Central-level appraisal
• Exemption applicable to an approved industrial estate

This assessment should be completed before construction.

Pollution Control Board Consents

An API unit likely to discharge trade effluent or emit air pollutants requires prior consent from the State Pollution Control Board under the Water and Air Acts.

The usual approval sequence is:

1. Consent to Establish
2. Construction and installation
3. Compliance verification
4. Consent to Operate

The national Online Consent Management and Monitoring System explains that an industry likely to discharge trade effluent or operate in an air-pollution-control area cannot be established or operated without the State Board’s prior consent.

Other Approvals

Depending on the chemistry and location, the project may also need:

• Factory-plan approval
• Factory licence
• Fire NOC
• Hazardous-waste authorization
• Boiler approval
• Pressure-vessel approval
• Solvent-storage permission
• Petroleum or explosive-storage approval
• Groundwater permission
• Electrical approval
• Building approval
• Local industrial-development approval
• Public-liability insurance
• Import Export Code

Applicability must be determined from the process, solvent inventory, pressure systems and state requirements.

Select the Correct Industrial Location

An API unit should normally be established in an approved chemical or pharmaceutical industrial area.

Before purchasing land, verify:

• Permitted industrial use
• Environmental-clearance status of the estate
• Distance from residential areas
• Water availability
• Electricity and fuel
• CETP availability
• Hazardous-waste disposal facilities
• Solvent and tanker access
• Fire-station access
• Future expansion
• Local groundwater restrictions
• Flood risk
• Availability of technical staff

Do not select a low-cost plot before confirming that the proposed chemical processes are allowed there.

Prepare a Detailed Project Report

The project report should contain:

• Proposed APIs
• Manufacturing routes
• Reaction chemistry
• Batch sizes
• Annual production capacity
• Material balance
• Solvent balance
• Water balance
• Energy balance
• Waste generation
• Equipment capacity
• Utility requirements
• Environmental-control systems
• Staffing
• Capital investment
• Working capital
• Sales projection
• Break-even analysis
• Project risks

Process Development

The process-development package should identify:

• Starting materials
• Reagents
• Catalysts
• Solvents
• Reaction conditions
• Critical parameters
• Intermediates
• Work-up steps
• Purification
• Crystallization
• Drying
• Milling
• Packaging
• Expected yield
• Impurity profile
• Waste streams

Material Balance

For every batch, prepare a material balance:

Inputs

=

Starting materials

+ Reagents

+ Solvents

+ Process water

Outputs

=

API

+ Recovered solvent

+ By-products

+ Effluent

+ Solid waste

+ Process loss

An economically attractive laboratory process may become commercially unsuitable when scaled up because of:

• Low recovery
• Excess solvent use
• Difficult filtration
• Long drying time
• High effluent load
• Unstable intermediates

Process-Safety Review

Before scale-up, evaluate:

• Exothermic reactions
• Runaway-reaction risk
• Gas evolution
• Pressure generation
• Toxic releases
• Flammability
• Static electricity
• Dust explosion
• Incompatible chemicals
• Thermal decomposition
• Emergency quenching

The project may require:

• Reaction calorimetry
• Hazard and Operability Study
• Process Hazard Analysis
• Safety-integrity review
• Explosion-protection study
• Emergency-response planning

Factory Layout

A multipurpose synthetic API facility may include:

1. Raw-material receiving
2. Raw-material quarantine
3. Approved-material storage
4. Solvent tank farm
5. Hazardous-material storage
6. Dispensing
7. Reaction blocks
8. Centrifuge areas
9. Drying rooms
10. Milling and sifting
11. Blending
12. API packing
13. Intermediate storage
14. Finished-API quarantine
15. Released API store
16. Rejected-material area
17. Quality-control laboratory
18. Stability section
19. Utility block
20. Solvent-recovery plant
21. Effluent-treatment plant
22. Hazardous-waste storage
23. Engineering workshop
24. Change rooms and decontamination areas

Personnel and Material Flow

The layout should control the movement of:

• Employees
• Contractors
• Raw materials
• Solvents
• Intermediates
• Finished APIs
• Recovered solvents
• Waste
• Returned materials

Crossing between clean product movement and waste movement should be minimized.

Utilities

Critical utilities may include:

• Steam
• Thermic fluid
• Chilled water
• Cooling water
• Brine
• Vacuum
• Compressed air
• Nitrogen
• Purified water
• Process water
• HVAC
• Dust extraction
• Scrubbers
• Power backup

Schedule M requires utilities capable of affecting product quality to be qualified, appropriately monitored and supported by available drawings.

Water Requirements

Water quality depends on its intended use.

Part XII requires water used in API manufacture to be demonstrated as suitable for its intended purpose. Unless otherwise justified, process water should at least meet potable-water quality; tighter chemical, microbiological or endotoxin controls may be necessary for particular operations.

For a non-sterile API intended for further manufacture of sterile finished products, water used in final isolation and purification may require control for:

• Total microbial count
• Objectionable organisms
• Endotoxins

Containment

Dedicated facilities or equipment may be required for highly sensitizing substances such as:

• Penicillins
• Certain cytotoxic drugs
• Sex hormones
• Highly potent substances

The revised API requirements call for dedicated areas where appropriate and controls against cross-contamination between dedicated and non-dedicated operations.

Major Manufacturing Equipment

There is no universal API machinery list.

Equipment must be selected according to:

• Reaction chemistry
• Corrosiveness
• Temperature
• Pressure
• Solvent
• Batch size
• Containment
• Product purity
• Cleaning requirements

Possible equipment includes:

Reaction Equipment

• Stainless-steel reactors
• Glass-lined reactors
• Hastelloy or special-alloy reactors
• Pressure reactors
• Hydrogenators
• Fermenters
• Extraction vessels

Separation Equipment

• Centrifuges
• Nutsche filters
• Filter presses
• Sparkler filters
• Decanters
• Phase separators

Drying Equipment

• Vacuum tray dryers
• Rotary cone vacuum dryers
• Agitated Nutsche filter dryers
• Fluid-bed dryers
• Tray dryers
• Freeze dryers, where required

Size-Reduction Equipment

• Multi mill
• Cone mill
• Pin mill
• Air-jet mill
• Pulverizer
• Sifter

Solvent-Recovery Equipment

• Distillation columns
• Condensers
• Receivers
• Fractionation units
• Vacuum systems
• Solvent-storage tanks

Packing Equipment

• Controlled dispensing booth
• Weighing balances
• Liner-sealing equipment
• Drum-closing equipment
• Label and QR-code printing or verification system

Material of Construction

The correct material may include:

• SS 316L
• Glass-lined steel
• Hastelloy
• PTFE-lined equipment
• Rubber-lined equipment
• Other compatible materials

SS 304 or SS 316 cannot be prescribed universally.

Compatibility must be demonstrated against:

• Acids
• Alkalis
• Halogenated solvents
• Oxidizing agents
• Temperature
• Pressure
• Cleaning chemicals

Quality-Control Laboratory

The laboratory should be designed around the specifications of the proposed APIs.

Possible sections include:

• Wet chemistry
• Instrumental analysis
• Stability
• Microbiology
• Reference standards
• Retention samples
• Controlled substances
• Glassware washing
• Laboratory reagents

Possible Laboratory Instruments

Depending on the product, the laboratory may require:

• HPLC
• Gas chromatograph
• FTIR
• UV-visible spectrophotometer
• Karl Fischer apparatus
• Polarimeter
• Melting-point apparatus
• pH meter
• Analytical balances
• Particle-size analyser
• X-ray diffraction
• ICP-MS or atomic-absorption equipment
• LC-MS
• GC-MS
• Total organic carbon analyser
• Stability chambers
• Microbiological equipment
• Endotoxin-testing equipment

Not every API laboratory needs every instrument.

The equipment should follow the approved:

• Specification
• Pharmacopoeial monograph
• Impurity method
• Residual-solvent method
• Customer requirement
• Regulatory dossier

Outsourced Testing

Specialized testing may be outsourced to an approved testing laboratory where permitted.

Possible outsourced tests include:

• Genotoxic impurities
• Nitrosamines
• Elemental impurities
• X-ray diffraction
• Mass spectrometry
• Specialized microbiology

The API manufacturer remains responsible for:

• Qualifying the laboratory
• Approving the method
• Reviewing results
• Investigating failures
• Releasing the batch

Technical Personnel

An API plant requires separate competent personnel for:

• Production
• Quality assurance
• Quality control
• Engineering
• Safety and environment
• Warehouse
• Regulatory affairs

The manufacturing and testing technical staff must possess qualifications and experience accepted by the State Licensing Authority under the applicable rules.

Depending on the licence category, recognized backgrounds may include:

• Pharmacy
• Pharmaceutical chemistry
• Chemistry
• Microbiology
• Chemical engineering
• Other approved equivalent qualifications

The qualification list should be checked with:

• Current consolidated Drugs Rules
• Proposed licence form
• Product category
• State Licensing Authority checklist
• Exact post-qualification experience

Official licensing guidance requires submission of qualification, experience, biodata, appointment and full-time employment records for manufacturing and testing personnel.

Independent Quality Unit

The quality unit should remain independent of production for decisions involving:

• Raw-material release
• Intermediate release
• API release
• Rejection
• Deviations
• OOS investigations
• CAPA
• Change control
• Validation
• Complaints
• Recalls

Pharmaceutical Quality System

The plant should prepare controlled systems for:

• Document control
• Training
• Vendor qualification
• Material receipt and sampling
• Manufacturing
• In-process controls
• Cleaning
• Calibration
• Maintenance
• Qualification
• Process validation
• Analytical-method validation
• Cleaning validation
• Change control
• Deviations
• OOS and OOT results
• CAPA
• Stability
• Complaints
• Recall
• Self-inspection
• Data integrity

API Specifications

The finished API specification may include:

• Description
• Identification
• Assay
• Related substances
• Individual impurities
• Total impurities
• Residual solvents
• Water or loss on drying
• Residue on ignition
• Elemental impurities
• Particle size
• Polymorphic form
• Bulk density
• Microbial limits
• Endotoxins, where applicable

Impurity Control

Impurity management is central to API manufacturing.

The company should evaluate:

• Process impurities
• Degradation impurities
• Residual starting materials
• Residual reagents
• Residual solvents
• Elemental impurities
• Genotoxic impurities
• Nitrosamine risks
• Isomeric impurities

Changes to:

• Supplier
• Starting material
• Solvent
• Catalyst
• Reaction conditions
• Purification
• Drying

may alter the impurity profile and should pass through change control.

Qualification and Validation

The plant should establish a Validation Master Plan covering:

• Design qualification
• Installation qualification
• Operational qualification
• Performance qualification
• Utility qualification
• Process validation
• Cleaning validation
• Analytical-method validation
• Computerized-system validation
• Transport validation
• Revalidation

Process Validation

Commercial API processes should demonstrate reproducibility in:

• Reaction completion
• Yield
• Impurity removal
• Crystallization
• Drying
• Milling
• Blending
• Final quality

Critical process parameters may include:

• Temperature
• Pressure
• pH
• Addition rate
• Mixing speed
• Reaction time
• Moisture
• Cooling rate
• Seeding
• Drying endpoint

Cleaning Validation

Cleaning validation should consider:

• Potency
• Toxicity
• Solubility
• Batch size
• Equipment surface area
• Occupational exposure
• Cross-contamination risk
• Cleaning-agent residues
• Swab recovery
• Rinse recovery

Recovered Solvents and Materials

Recovered solvents may be reused only under controlled and justified conditions.

Controls should address:

• Identity
• Purity
• Water content
• Cross-contamination
• Number of recovery cycles
• Approved use
• Traceability
• Testing

Stability and Retest Period

APIs commonly use a justified:

• Retest date, or
• Expiry date where appropriate

The company should establish the period through a documented stability programme covering:

• Packaging
• Storage condition
• Analytical methods
• Stability-indicating parameters
• Ongoing batches
• Adverse trends

API Packaging and QR Code

Every API or bulk drug manufactured or imported in India must carry a QR code on its label at each level of packaging to facilitate tracking and tracing.

The stored data must include prescribed information such as:

• Unique product identification code
• Batch number
• Manufacturing date
• Expiry date
• Other required particulars

Manufacturing Application Documents

A typical application may require:

Legal Documents

• Covering letter
• Form 24, 24-F or 27 as applicable
• Fee receipt
• Entity constitution documents
• Board resolution
• Authorized-signatory documents
• Identity proofs
• Non-conviction declarations

Premises Documents

• Ownership document
• Lease or rent agreement
• Owner’s NOC
• Site plan
• Key plan
• Plant layout
• Industrial-use permission
• Building approval

Technical Documents

• Technical-staff qualifications
• Experience certificates
• Appointment letters
• Biodata
• Full-time employment declarations
• Departmental responsibilities

Plant Documents

• Site Master File
• Machinery list
• Laboratory-equipment list
• Process-flow diagrams
• HVAC and ventilation drawings
• Water-system drawings
• Utility diagrams
• Solvent-storage details
• Effluent-treatment details
• Validation Master Plan

Product Documents

• API list
• Regulatory status
• Process summary
• Master formula
• Specifications
• Analytical methods
• Impurity profile
• Stability data
• Packing details
• Proposed labels
• Central approval where applicable

Supporting Approvals

• Environmental Clearance
• Consent to Establish
• Factory approval
• Fire NOC
• Hazardous-waste authorization
• Water-analysis report
• Safety approvals

Official State Licensing Authority guidance lists the site and key plans, machinery, testing equipment, technical staff and product information among the principal manufacturing-licence documents.

Inspection Process

The regulatory inspection may review:

• Approved layout
• Building construction
• Reaction areas
• Containment
• Utilities
• Solvent storage
• Quality-control laboratory
• Technical staff
• Documentation
• Material controls
• Validation status
• Environmental permissions
• Safety systems
• Product dossiers

The company should respond to observations using:

• Root-cause analysis
• Corrective action
• Preventive action
• Documentary evidence
• Completion dates
• Effectiveness checks

Step-by-Step Procedure

Step 1: Select APIs

Prepare a commercial and technical shortlist.

Step 2: Confirm Regulatory Status

Determine whether each substance is:

• Established
• New
• Controlled
• Biological
• Export-only
• Patent-protected

Step 3: Develop the Process

Complete laboratory development, scale-up studies and preliminary impurity characterization.

Step 4: Conduct Feasibility

Calculate:

• Raw-material cost
• Yield
• Utility cost
• Solvent recovery
• Waste treatment
• Labour
• Selling price
• Working capital

Step 5: Select the Site

Confirm industrial, environmental and safety acceptability.

Step 6: Obtain Environmental Approvals

Determine EC, Consent to Establish and hazardous-waste requirements before construction.

Step 7: Prepare Detailed Engineering

Finalize:

• Process flow
• Equipment
• Piping
• Instrumentation
• Utilities
• Containment
• ETP
• Safety systems

Step 8: Construct and Install

Build according to the approved design and licensing layout.

Step 9: Recruit Technical Staff

Appoint genuine full-time production, QA, QC, engineering and safety personnel.

Step 10: Establish the Quality System

Prepare the Site Master File, quality manual, SOPs, master records and validation plans.

Step 11: Qualify the Plant

Qualify:

• Equipment
• Utilities
• Laboratory instruments
• HVAC
• Water
• Computerized systems

Step 12: Submit the Licence Application

Apply to the concerned State Licensing Authority and obtain central permission where applicable.

Step 13: Complete Inspection

Close regulatory and environmental observations.

Step 14: Validate the Process

Manufacture approved validation batches and establish consistency.

Step 15: Obtain Commercial Approval

Begin commercial manufacture only after the licence and API endorsement are granted.

Step 16: Operate Under Continued Verification

Monitor:

• Yield
• Impurities
• Deviations
• Stability
• Complaints
• Environmental performance
• Product-quality review

Investment Required

There is no fixed statutory investment amount.

API project cost depends on:

• Chemistry
• Capacity
• Land
• Number of products
• Reaction stages
• Materials of construction
• Containment
• Solvent recovery
• Effluent treatment
• Laboratory
• Safety systems
• Working capital

The following are only broad internal planning estimates:

Project type	Illustrative project range
Small brownfield or specialized API addition	₹25–75 crore
Greenfield multipurpose synthetic API plant	₹75–250 crore or more
High-potency, sterile or fermentation project	₹150 crore to several hundred crores
Large integrated bulk-drug complex	Project-specific; potentially several hundred crores

Land, imported technology, product-development cost and working capital may be additional.

Main Investment Heads

Fixed Capital

• Land
• Civil construction
• Reactors
• Separation equipment
• Dryers
• Solvent-recovery plant
• Utilities
• ETP
• QC laboratory
• Warehouses
• Tank farm
• Fire and safety
• Automation

Pre-Operating Expenses

• Process development
• Environmental studies
• Engineering
• Consultancy
• Licensing
• Validation
• Trial batches
• Stability
• Recruitment
• Training

Working Capital

• Starting materials
• Solvents
• Catalysts
• Packaging
• Salaries
• Utilities
• Waste treatment
• Inventory
• Customer credit

Break-Even Formula

Break-Even Sales

=

Annual Fixed Cost

÷ Contribution Margin Percentage

The calculation should use realistic:

• Process yield
• Batch rejection
• Solvent loss
• ETP cost
• Financing cost
• Customer credit
• Capacity utilization

Export Requirements

Export-oriented API manufacturers may require:

• Importing-country registration
• Drug Master File
• Certificate of Suitability, where applicable
• Written Confirmation for EU exports
• GMP inspection
• Stability data
• Customer audits
• Elemental and genotoxic impurity controls
• Supply-chain traceability
• Change-notification procedures

A domestic manufacturing licence does not automatically authorize market entry in another country.

Common Mistakes

Avoid:

• Using the obsolete Part 1F reference
• Purchasing land before environmental assessment
• Assuming Form 25 covers every API category
• Manufacturing a new API without central approval
• Buying machinery before finalizing chemistry
• Underestimating effluent-treatment cost
• Ignoring solvent recovery
• Using SS 316 for every chemical process without compatibility review
• Depending on a generic machinery list
• Treating QC and QA as one function
• Maintaining no impurity-control strategy
• Ignoring occupational exposure
• Reusing recovered solvent without control
• Starting commercial production under a test permission
• Omitting QR codes from API packaging
• Underestimating working capital
• Selecting products only from selling price

Frequently Asked Questions

1. Which licence is required for API manufacturing?

For many ordinary APIs, an application is made in Form 24 and the licence is issued in Form 25. Other categories may require Forms 24-F/25-F or Forms 27/28.

2. Who grants the licence?

The State Licensing Authority generally grants routine manufacturing licences. CDSCO approval may also be required for new drug substances and specified categories.

3. Which part of Schedule M applies to APIs?

Part XII of revised Schedule M contains the specific requirements for manufacture of Active Pharmaceutical Ingredients.

4. Is Part 1F still applicable?

The old Part 1F reference should not be used as the current framework. Revised Schedule M now contains the API requirements in Part XII.

5. Is environmental clearance compulsory?

Applicability depends on the project, location and current environmental notifications. Many API and bulk-drug projects are processed under item 5(f) for synthetic organic chemicals.

6. Is Consent to Establish required?

An industry likely to discharge trade effluent or emit air pollutants must obtain the applicable prior consent from the State Pollution Control Board.

7. Can one plant manufacture several APIs?

Yes, where the facility, equipment, environmental approvals, containment, validation and licence endorsement support the proposed products.

8. Is a general pharmaceutical plant suitable for API production?

Not automatically. API plants require chemical-process equipment, solvent handling, environmental controls and process-safety systems.

9. Is every API manufactured in stainless-steel reactors?

No. The material of construction depends on chemical compatibility, pressure, temperature and product-quality requirements.

10. Is a QR code required?

Yes. APIs manufactured or imported in India must bear QR codes at each level of packaging with prescribed traceability information.

11. Is a wholesale drug licence compulsory?

A separate wholesale licence may be required for a separately operated depot or wholesale premises. The exact distribution structure should be confirmed with the State Licensing Authority.

12. How much investment is required?

A compliant API project generally requires investment in several tens of crores or more, depending on chemistry, capacity, utilities, environment and containment.

Final Conclusion

Starting an API manufacturing unit requires the integration of:

**Commercially viable API selection

• Valid manufacturing process
• Regulatory approval
• Revised Schedule M Part XII
• Environmental clearance
• Pollution-control consents
• Safe chemical engineering
• Qualified personnel
• Impurity control
• Validation
• Adequate capital**

The safest sequence is:

Select the API
→ Confirm its regulatory status
→ Develop and evaluate the process
→ Complete environmental feasibility
→ Design the plant
→ Obtain approvals
→ Install and qualify systems
→ Apply for licensing
→ Validate the process
→ Begin commercial production

A promoter should not begin an API project using only a generic machinery quotation or an old Schedule M checklist.

The project should be supported by qualified professionals in:

• API process chemistry
• Pharmaceutical quality assurance
• Chemical engineering
• Environmental engineering
• Process safety
• Drug regulatory affairs
• Project finance

Looking for Ayurvedic Franchise or Distribution Opportunities?

Looking to start an Ayurvedic franchise, become a distributor, or launch your own herbal product range?

Elzac Herbal India offers:

• Ayurvedic & Herbal Product Range
• Franchise & Distribution Opportunities
• Third-Party Manufacturing Services
• Product Development Support
• Marketing Guidance
• PAN India Business Opportunities

Whether you are an entrepreneur, retailer, distributor, or healthcare professional, our team can help you explore the right business opportunity in the growing Ayurvedic sector.

Contact us today to discuss ayurvedic franchise, distribution, or third-party manufacturing opportunities.