Quick answer : Quick answerTo start a pharma manufacturing company in India, choose your products and business model, run a feasibility study, form a legal entity, secure a site, design a plant that meets revised Schedule M, install and qualify equipment, hire competent technical staff, and apply to the State Licensing Authority for a manufacturing licence.
Many first-time founders mix up four different businesses: a pharma marketing company, a franchise, a company that uses a contract manufacturer, and a company that owns a licensed plant. Only the last one needs its own factory and its own manufacturing licence. This guide is about that last path, and it also shows where the cheaper routes fit.
Choose the right business model first
| Model | Who holds the manufacturing licence? | Best for | Main catch |
|---|---|---|---|
| Own manufacturing plant | You | Control, scale, own brands, contract work | Highest capital and longest setup |
| Loan licence | You hold a loan licence; the host plant holds the main licence | Brand owners who want to start faster without building a plant | You stay responsible for product quality and labelling |
| Third-party / contract manufacturing | The contract manufacturer | Marketers and PCD or franchise businesses | You depend on the manufacturer’s compliance |
| Marketing / franchise company | No manufacturing licence needed for the marketing itself | Low-capital distribution businesses | Not a manufacturing company |
The setup roadmap
The order matters. Money spent on land or machines before the product list and design are fixed is the most common source of rework.
- Product selection. Pick dosage forms and therapeutic segments. This drives everything below.
- Feasibility study. Test the technical, regulatory and financial case before committing capital.
- Entity and registrations. Form a company or LLP and complete PAN, GST and other business registrations.
- Site selection. Check zoning, water, power, effluent options and room for expansion.
- Design and layout. Prepare a layout that follows revised Schedule M and your dosage forms.
- Construction and utilities. Build the premises, HVAC, water systems and power backup.
- Equipment. Prepare a user requirement specification, buy, install and qualify.
- People and quality system. Appoint competent technical staff. Write SOPs and the quality manual.
- Licence application. Apply through the state process and answer queries.
- Inspection. Host the regulatory inspection with records ready.
- Validation and first batches. Complete process validation and start commercial production.
- Ongoing compliance. Run change control, CAPA, training, self-inspection and renewals.
Do a pharma project feasibility study first
A useful study covers: product mix and competition; realistic capacity; site and utilities; the regulatory path for each dosage form; capital expenditure; operating cost; working capital; revenue assumptions with a low, base and high case; and the main risks. Lenders also expect it. Since revised Schedule M raised infrastructure expectations, a study that ignores those design costs will understate your budget.
Licences and approvals: who grants what
| Item | What it covers | Who is involved |
|---|---|---|
| Forms 24 → 25 | Application and licence for drugs other than Schedules C and C(1) | State Licensing Authority |
| Forms 27 → 28 | Application and licence for Schedule C and C(1) drugs (excluding Schedule X) | State Licensing Authority |
| Forms 24A/25A and 27A/28A | Loan licences, with a licensed host manufacturer | State Licensing Authority |
| Product permissions | Needed for some products, such as new drugs | CDSCO (Central Licensing Authority) |
| Other approvals | Company registration, GST, factory licence, building, fire and pollution consents where applicable | Central, state and local bodies |
Read Also: CDSCO Compliance Challenges in India
GMP and the revised Schedule M
The revised Schedule M was notified on 28 December 2023 and published in the Gazette on 5 January 2024. Large manufacturers (turnover above ₹250 crore) had six months to comply. Smaller units had 12 months, and MSMEs with turnover of ₹250 crore or less could apply through Form A for time until 31 December 2025 under G.S.R. 127(E) of 12 February 2025. That window has now closed. A new plant should be designed for the revised standard from day one. Inspection activity has also been reported as more active. Always read the Gazette text itself, and confirm the latest position with your State Drugs Control office.
In practice, GMP means being able to show, on paper and on the floor, that each batch is made the same controlled way. The main building blocks are:
- Pharmaceutical quality system (PQS) and quality risk management. Decisions are documented and risk-based.
- Personnel and training. Named responsibilities, trained staff, hygiene rules.
- Premises and equipment. Fit for the dosage form, cleanable, qualified and maintained.
- Documentation and data integrity. Specifications, SOPs, batch records and computerised system controls.
- Production and quality control. In-process checks, tested materials, approved release.
- Change control, CAPA, complaints, recalls, product quality review and self-inspection.
Plant layout and facility planning
Layout is where compliance becomes physical. A good design separates people, materials and waste, limits contamination, and lets the plant be cleaned easily. A poor design is expensive to fix after construction. A well-drawn layout supports your application, but it does not by itself guarantee approval.
Most plants need these areas, sized to the dosage form: material receiving and quarantine; sampling; raw material and packaging storage; production; in-process areas; primary and secondary packaging; finished goods storage; a QC laboratory; personnel change rooms; utilities; and waste handling. Depending on the product, add HVAC with pressure zones, purified water, compressed air and dust control. Sterile products need a far higher level of environmental control than oral solids, and they are a different project altogether.
Equipment depends on the dosage form
| Dosage form | Typical equipment examples | Key design concern |
|---|---|---|
| Tablets | Sifter, granulator, dryer, blender, compression machine, coating machine, blister or strip packing | Dust control, cross-contamination |
| Capsules | Blender, capsule filler, polisher, packing line | Dust and humidity control |
| Oral liquids | Manufacturing vessel, mixer, filter, filling and capping line | Water quality, microbial control |
| Ointments and creams | Heated vessel, homogeniser, tube filling and sealing | Cleaning, temperature control |
| Dry powders | Blender, powder filling line | Moisture and dust |
| Injectables (sterile) | Washing, depyrogenation, filling, sterilisation, isolators or cleanroom systems | Sterility assurance, high-grade cleanrooms |
Every listed machine still needs installation, operational and performance qualification, plus a QC laboratory sized to the products. Write a user requirement specification before you buy. Buying first and checking compliance later is a common and costly mistake.
Technical staff
Under Rule 71, manufacturing must be under the active direction and personal supervision of a whole-time competent person. The base qualification is a graduate in pharmacy or pharmaceutical chemistry, with prescribed experience; other qualifications are listed in the rule. Rule 76 sets separate criteria for the testing staff. Because the exact criteria vary by licence category, check the rule text and your state’s checklist before you make offers. Production and Quality Control heads should be independent of each other, and QA should have authority to reject or release. Add regulatory affairs, engineering and maintenance, and warehouse roles as scale grows.
Investment and plant cost
| Cost block | What drives it |
|---|---|
| Land and building | Location, area, construction standard |
| Design and engineering | Complexity, number of dosage forms |
| HVAC, cleanrooms, water and utilities | Product risk, room classification, capacity |
| Manufacturing and packaging equipment | Batch size, automation, brand and make |
| QC laboratory and warehouse | Test scope, storage conditions |
| Qualification, validation, documentation | Number of systems and products |
| Licensing and regulatory costs | Fees, consultancy, approvals |
| People, materials, working capital | Salaries, raw and packing materials, credit cycle |
| Maintenance and compliance | Calibration, audits, training, renewals |
How long does setup take?
As one indicative reference, TRACC Global’s planning pages estimate greenfield plants at roughly 12–24 months and list construction at 6–18 months, with licensing review after submission taking longer or shorter by state and case. These are consultant planning estimates, not government commitments. The most common delays are incomplete design, late equipment, weak documentation and unresolved inspection observations.
How a pharmaceutical consultant helps
A consultant helps you plan and prepare. The State Licensing Authority decides whether to grant the licence. On its website, TRACC Global describes support for the stages above, including:
- Project planning and feasibility and detailed project report preparation
- Facility design and engineering, including plant layout and HVAC design
- Equipment selection and process setup, qualification and documentation
- Loan licence support for brand owners who choose that route
- Schedule M compliance, drug manufacturing licence application support and turnkey project management, listed on its pharma products and services page
Before you hire anyone, ask what is included, who will be on your project, and how they handle state-specific queries. Avoid anyone who guarantees approval or a date.
How TraccGlobal Helps with CDSCO Compliance
TraccGlobal is a Gurugram-based regulatory consultancy that works with manufacturers, importers, and global companies on CDSCO compliance in India. Its regulatory services cover medical device registration under Class A to D, CDSCO import licensing, CDSCO manufacturing licensing, IVD kit registration, and SUGAM portal submissions, including preparation of Form MD-14/MD-15 documentation and management of regulatory queries.
Beyond registration, TraccGlobal supports the quality and documentation side of compliance: building and implementing a quality management system aligned with ISO 13485 and MDR requirements, preparing design and development documentation, and compiling the Design History File (DHF) that CDSCO reviewers expect to see in a technical file.
This combination — regulatory strategy, classification support, documentation preparation, and query management — is what a CDSCO consultant is meant to provide. As with any consultant, TraccGlobal prepares and manages the application; the approval decision itself always rests with CDSCO.
Frequently Asked Questions
How do I start a pharmaceutical manufacturing company in India?
Pick your products and business model, complete a feasibility study, register the entity, secure a site, design a plant to revised Schedule M, install and qualify equipment, appoint competent staff, and apply to the State Licensing Authority. Then pass inspection and validate your process before commercial batches.
What licences are required?
The core requirement is a drug manufacturing licence from the State Licensing Authority, such as Form 25 or Form 28 depending on the drug category. You also typically need company and GST registration and factory, local and pollution approvals. Some products need separate CDSCO permission. Requirements vary.
How much investment is required?
It varies too widely for one figure. A simple oral solid plant costs far less than a sterile plant. Land, building, HVAC, utilities, equipment, QC, validation, staff and working capital all count. A feasibility study or detailed project report gives a project-specific estimate.
What are the GMP requirements?
Schedule M, revised through G.S.R. 922(E), requires a pharmaceutical quality system, quality risk management, trained personnel, suitable premises and equipment, documentation, validation, hygiene, storage controls, change control, CAPA, complaints and recalls, and self-inspection.
How long does setup take?
Timelines are project-specific and cannot be guaranteed. Design, construction, equipment supply, qualification, documentation and regulatory queries all affect them. Greenfield projects are often planned over one to two years. Treat that as indicative only.
What type of facility is required?
A facility built for your dosage form, with separated storage, production, packaging and QC areas, controlled personnel and material flow, and suitable utilities. Sterile products need cleanrooms and much tighter environmental control than oral solids.
What equipment is required?
It depends on the dosage form and scale. Tablets may need granulation, blending, compression, coating and packing machines. Liquids need manufacturing vessels and filling lines. All plants need QC equipment, utilities and qualified systems.
Do I need a feasibility study first?
It is not a legal requirement, but it is strongly advisable. It checks demand, capacity, site, regulations, capital and running costs before major spending. It lowers risk but does not guarantee returns.
What technical staff is required?
Competent technical staff for manufacturing (Rule 71) and testing (Rule 76), plus QA, engineering and warehouse personnel. Qualification and experience rules vary by licence category, so verify them against the rule text and your state checklist.
Can a consultant help with design, licensing and setup?
Yes. A consultant can support feasibility, layout, documentation, application preparation, GMP readiness and project execution. It cannot grant a licence or guarantee approval; that decision rests with the government authority.
Company credentials
ISO 9001, ISO 27001 & ISO 45001 certified consultancy
Contact
info@traccglobal.com
