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How to Open Pharma Company – Step-by-Step Guide
Learn how to open a pharma company in India with this 2025 step-by-step guide—covering licensing, documents, capital, business models, and setup process.

1.Starting a pharmaceutical company
India's pharmaceutical industry is one of the largest and fastest-growing sectors in the world. As of 2025, it ranks third globally by volume and 14th by value, supplying over 50% of the world’s vaccine demands and a significant portion of generic medicine exports. With a rising population, increasing demand for affordable healthcare, and supportive government initiatives, the Indian pharma sector continues to offer immense business opportunities.
Starting a pharmaceutical company can be a rewarding venture—financially and socially. Whether your interest lies in manufacturing, distribution, marketing, or creating a PCD franchise network, the possibilities are broad. However, the process requires a deep understanding of regulatory frameworks, documentation, licensing, and quality control.
This step-by-step guide is designed to help you understand how to open a pharma company in India. Whether you have a medical background or are simply a driven entrepreneur looking to enter the healthcare domain, this guide simplifies the entire journey from planning to licensing and launching your business.
Why is this the right time to enter pharma?
- Demand for medicines is growing across India and emerging markets.
- The Indian government has launched Production Linked Incentives (PLI) for the pharma sector.
- Consumers are more health-aware and willing to spend on reliable, branded generics.
- Technological innovation in manufacturing and digital distribution is lowering entry barriers.
Who can start a pharma company?
- You don’t necessarily need to be a pharmacist or doctor.
- However, you must hire a full-time qualified pharmacist or technical person as per drug licensing norms.
- Entrepreneurs, investors, or existing distributors can enter the market through the marketing model, PCD model, or third-party manufacturing.
This blog will walk you through all the key aspects: the types of pharma companies you can start, the licensing requirements, the legal setup, the documentation process, and everything else you need to build a legally compliant and scalable pharma business in India.
2. Types of Pharma Companies You Can Start
Before you begin your pharma venture, it’s important to decide what type of pharma company you want to establish. Your business model will influence everything — from licensing and capital requirements to staffing, operations, and product strategy.
Here are the most common pharma business models in India:
1. Manufacturing Pharma Company
This is a full-fledged setup where you own and operate a facility that manufactures medicines, either for your own brand or for other companies on a contract basis.
You will need:
- A manufacturing drug licence (Form 25/28)
- GMP-compliant infrastructure
- Qualified technical staff and equipment
- Approvals for each formulation
Manufacturers can make:
- Tablets, capsules, syrups, ointments, creams
- Injectable drugs
- Nutraceuticals or herbal products (requires separate licence)
This model demands high initial investment but offers full control over production and margins.
2. Pharma Marketing Company
Also known as a non-manufacturing pharma company, this is the most accessible entry model.
Here’s how it works:
- You get products manufactured from a third-party manufacturer or under a loan licence
- You sell the products under your own brand name
- Your responsibilities include product selection, branding, pricing, and distribution
Licences required:
- Drug licence (wholesale or retail)
- Company registration
- Trademark registration
This model is ideal for entrepreneurs with strong sales, marketing, or distribution experience.
3. PCD (Propaganda Cum Distribution) Pharma Company
This is a franchise-based model where you appoint distributors or agents to sell your products region-wise.
Your business earns revenue by:
- Supplying goods to franchise partners at net rates
- Offering marketing and promotional support
- Managing a consistent supply chain
Common in tier-2 and tier-3 cities, the PCD model allows fast expansion with relatively low overhead.
4. Pharma Wholesale & Distribution Business
You can start a pharma distribution firm by:
- Procuring medicines from manufacturers
- Supplying to chemists, hospitals, nursing homes, and online platforms
Requirements:
- Wholesale drug licence (Form 20B/21B)
- Pharmacist or person with 1+ years of experience
- Storage infrastructure with temperature control
This model is ideal for those who want to be part of the pharma supply chain without creating their own brand.
5. Retail Pharmacy / Chemist Shop
If you’re planning to open a brick-and-mortar medical store, this falls under the retail category.
You’ll need:
- Retail drug licence (Form 20/21)
- Registered pharmacist on payroll
- Proper documentation and rent/ownership proof
You can also explore online pharmacy partnerships or telemedicine collaborations.
6. Online Pharma Business / eCommerce
This is an emerging segment where businesses:
- Launch their own website/app for medicine delivery
- Tie up with licensed wholesalers and retailers
- Use third-party logistics for fulfillment
Note:
- You still need to comply with drug sale regulations
- A retail or wholesale licence is mandatory
- Inventory sourcing must be from licensed entities
Choosing the right model depends on:
- Your investment capacity
- Regulatory readiness
- Product knowledge
- Access to a sales/distribution network
- Long-term business goals
3. Legal Requirements to Start a Pharma Company in India
Setting up a pharma company in India is a regulated process governed primarily by the Drugs and Cosmetics Act, 1940, and its associated Rules. These laws ensure that all pharmaceutical businesses operate responsibly, safely, and with adherence to health standards.
To begin operations, your pharma company must fulfill specific legal obligations depending on your business model (manufacturer, marketer, distributor, etc.).
Key Regulatory Bodies
- Central Drugs Standard Control Organization (CDSCO):
This is India’s national regulatory authority for pharmaceuticals and medical devices. It oversees:
- Drug approvals
- Import/export permissions
- Clinical trials
- Schedule H/X drug control
- Drug approvals
- State Drug Licensing Authority (SLA):
Every state in India has its own FDA or Drug Control Department that issues:
- Manufacturing licences
- Wholesale/retail drug licences
- Inspection and enforcement of premises compliance
- Manufacturing licences
Types of Drug Licences Required
- Manufacturing Drug Licence (Form 25/28):
Needed to produce allopathic or Ayurvedic medicines. Issued only after GMP compliance, staff qualification, and premises approval.
- Wholesale Drug Licence (Form 20B & 21B):
Required if you want to distribute or supply medicines in bulk to chemists, hospitals, and franchises.
- Retail Drug Licence (Form 20 & 21):
Required for running a pharmacy or selling directly to consumers.
- Loan Licence:
Applicable if you outsource manufacturing to a third-party unit that already holds a manufacturing licence.
- FSSAI Registration:
Needed if your company deals with nutraceuticals, health supplements, or any product regulated under the Food Safety and Standards Act.
- Trade and Business Licences:
Includes GST registration, Shops and Establishment Licence, and company incorporation under MCA.
Who Can Apply for a Drug Licence?
- Only a registered company/entity can apply
- You must have a qualified pharmacist or a person with at least 1 year of experience in pharma sales/operations
- Premises must fulfill storage, hygiene, and safety norms
Important Considerations
- All licences are issued state-wise, but you can apply for central approvals (for new drug approvals, imports, exports)
- A company can hold multiple licences if engaged in more than one type of pharma activity
- Renewal, product registration, and post-licence audits are periodic obligations
Understanding these legalities is crucial before moving to the operational phase. It ensures your business is built on a foundation of compliance and credibility.
4. Step-by-Step Process to Open a Pharma Company
Once you understand the legal framework, you can follow this practical 8-step process to start your pharma company.
Step 1: Finalize Your Business Model
Decide whether you’ll:
- Manufacture medicines
- Launch your own brand (marketing model)
- Operate as a distributor (wholesale)
- Sell via retail or eCommerce
Your model will determine the licences, staff, capital, and documentation needed.
Step 2: Register Your Company
Choose a business structure:
- Proprietorship (for small setups)
- Partnership / LLP
- Private Limited Company (recommended for branding, funding, scaling)
Register with the Ministry of Corporate Affairs (MCA) and get:
- Certificate of Incorporation
- PAN and TAN
- GST registration
Step 3: Arrange Your Premises
You must have a physical location that meets state norms for:
- Size (minimum 100–150 sq. ft. for wholesale/retail, 1200+ sq. ft. for manufacturing)
- Storage (cold storage, racks, fire safety)
- Cleanliness and proper ventilation
Lease or own the space and get the rent agreement or ownership deed.
Step 4: Hire Qualified Personnel
As per licensing norms, you must appoint:
- A registered pharmacist (for retail or wholesale licence)
- A technical staff member with B.Pharm/M.Pharm/B.Sc for manufacturing
Their credentials must be attached during the licence application.
Step 5: Apply for Drug Licences
Submit your licence application to the State Drug Licensing Authority. Based on your business type, apply for:
- Form 20/21 – Retail Licence
- Form 20B/21B – Wholesale Licence
- Form 25/28 – Manufacturing Licence
- Loan Licence – for outsourced manufacturing
Upload all required documents and pay the prescribed fees.
Step 6: Trademark and Brand Registration
If you’re launching your own products:
- Choose a unique brand name
- Register the trademark under the Trade Marks Act, 1999
- Check that the name isn’t similar to any existing medicine to avoid legal issues
This protects your product identity in the market.
Step 7: Develop Product Portfolio
For marketers and manufacturers:
- Choose dosage forms: tablets, capsules, syrups, injections, ointments
- Ensure compositions are DCGI approved (if required)
- Work with a formulation consultant or contract manufacturer to finalise products
For retailers/distributors:
- Decide which companies and SKUs to stock
- Set up supplier and payment agreements
Step 8: Launch Your Business
Once licences are approved:
- Begin procurement or production
- Create packaging and promotional materials
- Set MRP, schemes, and distribution terms
- Hire a sales team or set up franchise/PCD partners (if applicable)
Keep records of all operations to stay compliant with audits and inspections.
5. Pharma Company Licensing in Detail
Obtaining the right licence is the most critical step in starting a pharma company. The type of licence you need depends on your business model—whether you plan to manufacture medicines, distribute them, market your own brand, or run a pharmacy.
Let’s break down the key types of licences required, their application process, cost, and validity.
A. Types of Drug Licences
1.
Retail Drug Licence (Form 20 & 21)
Issued to pharmacy stores or outlets that sell medicines directly to consumers.
Key Requirements:
- A full-time registered pharmacist
- Premises: minimum 100 sq. ft.
- Refrigerator and storage facilities
- Shop & Establishment Registration
- GST Registration
Used by: Chemist shops, medical stores, online pharmacies
2.
Wholesale Drug Licence (Form 20B & 21B)
Required for businesses that intend to distribute medicines in bulk to retailers, hospitals, or other wholesalers.
Key Requirements:
- Qualified person with B.Pharm degree or 1+ year of experience in drug sales
- Premises: minimum 150 sq. ft.
- Storage & record-keeping facility
- Drug purchase and sale records
- Invoices with batch number, MRP, etc.
Used by: Distributors, PCD companies, pharma logistics providers
3.
Manufacturing Drug Licence (Form 25/28)
This is required for full-scale pharma manufacturing units.
Key Requirements:
- GMP-compliant infrastructure
- Site plan approval from drug inspector
- Qualified production and quality control staff
- Valid company incorporation and rent agreement
- Machinery, sanitation, and batch documentation
Used by: Pharma production units, contract manufacturers, R&D labs
4.
Loan Licence (Form 25A/28A)
If you want to market your own pharma brand but get the product manufactured from an existing licensed unit, this is the way to go.
Key Requirements:
- Agreement with licensed manufacturer
- Product dossier and label samples
- List of intended products with composition
- Company registration and trademark (optional)
Used by: Pharma marketing companies, startups, D2C health brands
5.
FSSAI Licence (for Nutraceuticals)
If your portfolio includes:
- Protein powders
- Herbal supplements
- Immunity boosters
- Food-based health products
…then you need an FSSAI licence under the Food Safety and Standards Authority of India.
B. Application Process
- Visit the State Drug Control portal (varies by state)
- Create login and fill the application form
- Upload all required documents in PDF format
- Pay the government fee online
- Drug inspector visits for physical verification
- If satisfied, licence is granted (within 30–60 days)
C. Licence Validity and Renewal
Licence Type |
Validity |
Renewal Timeline |
Retail/Wholesale |
5 years |
Apply 90 days before expiry |
Manufacturing |
5 years |
Subject to periodic GMP audit |
Loan Licence |
5 years |
Revalidated upon formulation changes |
Late renewal may incur a penalty or even cancellation.
D. Estimated Licence Fees (2025)
Licence Type |
Govt. Fee (Approx.) |
Retail/Wholesale |
₹3,000 – ₹10,000 |
Manufacturing |
₹10,000 – ₹25,000 |
Loan Licence |
₹5,000 – ₹15,000 |
FSSAI Registration |
₹2,000 – ₹7,500 |
Note: Consultant and document notarization charges may add ₹5,000–₹15,000 depending on your state.
Pro Tip:
For product approvals (especially proprietary or fixed-dose combinations), you may need to submit dossiers or apply to the CDSCO for central approval.
6. Investment and Capital Required
Starting a pharma company in India doesn’t always require crores of rupees — but your capital requirement will vary greatly depending on your business model. For example, launching a marketing company or PCD brand requires significantly less investment compared to setting up a manufacturing plant.
Let’s break down the costs for different models.
A. Pharma Marketing or PCD Company (Low to Moderate Investment)
This model is ideal for startups and entrepreneurs who want to sell under their own brand name while outsourcing manufacturing.
Estimated Capital Requirement: ₹3–10 lakhs
Breakdown:
- Company registration & legal fees: ₹20,000 – ₹50,000
- Loan licence or contract manufacturing tie-up: ₹50,000 – ₹1,00,000
- First batch product manufacturing: ₹1,50,000 – ₹3,00,000
- Packing, branding & design: ₹50,000 – ₹1,00,000
- Marketing materials (visual aids, samples): ₹50,000 – ₹2,00,000
- Working capital: ₹1,00,000+
This model allows for flexible scaling as you grow your customer base and distributor network.
B. Pharma Manufacturing Company (High Investment)
If you are building your own production facility, be prepared for a higher setup cost.
Estimated Capital Requirement: ₹50 lakhs – ₹2 crores+
Breakdown:
- Land and building (own or rented): ₹10–30 lakhs+
- Equipment & machinery: ₹20–40 lakhs
- Staff salaries and recruitment: ₹3–5 lakhs
- Regulatory compliance & GMP setup: ₹3–10 lakhs
- Product R&D and batch testing: ₹2–5 lakhs
- Inventory and raw materials: ₹5–10 lakhs
- Marketing & distribution: ₹5+ lakhs
Additionally, you’ll need funds for maintenance, audits, and licence renewals.
C. Wholesale or Distribution Business (Moderate Investment)
If your plan is to start as a licensed distributor:
Estimated Capital Requirement: ₹5–15 lakhs
- Drug licence and registration: ₹50,000
- Storage infrastructure (refrigeration, racking): ₹1–2 lakhs
- Initial inventory: ₹3–10 lakhs
- Logistics and local delivery setup: ₹1–2 lakhs
- Working capital: ₹1–2 lakhs
This model requires deep relationships with retail chains, hospitals, and clinics for steady growth.
Key Tips to Manage Capital Wisely
- Start with a focused product range to reduce costs
- Use third-party manufacturers initially
- Avoid overstocking inventory without confirmed demand
- Negotiate credit terms with vendors and distributors
- Invest in digital tools to reduce manual overhead
7. Documents Required to Start a Pharma Company
Proper documentation is the backbone of a compliant pharma company setup. Whether you’re applying for a drug licence, registering your brand, or finalizing a manufacturing partnership, keeping your paperwork in order is non-negotiable.
Here’s a comprehensive list of documents typically required at different stages:
A. Company Registration Documents
These apply whether you’re registering as a proprietorship, partnership, or private limited company:
- Certificate of Incorporation
- PAN and GST registration
- Memorandum and Articles of Association (MOA/AOA)
- Board resolution (for Pvt Ltd) authorizing drug licence application
- Rent agreement or ownership proof of premises
B. Premises-Related Documents
- Site plan/layout of your premises
- NOC from landlord (if rented)
- Address proof with utility bill
- Photos of premises (external and internal)
C. Personnel Documents
For drug licence applications, submit details of your technical/qualified person:
- Degree certificates (B.Pharm, M.Pharm, etc.)
- Experience certificate (1+ year in drug sales for wholesale)
- Pharmacist registration proof (for retail)
- Appointment letter and ID proof
- Passport-size photos
D. Drug Licence Application Documents
- Duly filled application form (Form 20/21/25/28 etc.)
- Covering letter on company letterhead
- Product list with composition and dosage
- Label mock-ups (with mandatory details)
- Affidavit and declaration forms
- Equipment list (for manufacturing units)
- Storage arrangement declaration (for distributors)
E. Product-Related Documents
- Composition and therapeutic category
- Reference from pharmacopoeia or classical text (if applicable)
- Stability data (if exporting or for proprietary formulations)
- Copy of product approval (if applicable)
F. Optional Documents (For Online/Export)
- Trademark registration certificate
- Website declaration (for eCommerce pharma sales)
- Free Sale Certificate (for exports)
- COPP or WHO-GMP certificate (if applying abroad)
Pro Tip:
All documents must be self-attested, clear, and often notarized. Submitting incomplete or incorrect documentation is the top reason for licence rejection or delay.
8. Pharma Product Development or Sourcing
After your company is registered and licensing is underway, the next major step is to decide your product lineup. Whether you plan to manufacture your own formulations or market third-party products, this phase shapes your business identity.
There are two main routes you can take:
1. Develop your own products (manufacturing model)
2. Source existing formulations from third-party manufacturers (marketing or PCD model)
Let’s break down both.
A. Developing Your Own Pharma Products (Manufacturing Model)
If you own a manufacturing unit or plan to set one up, you can develop original or classical formulations under approved dosage forms. The process involves:
1.
Product Formulation
- Work with pharmacists, chemists, and R&D staff
- Choose drug combinations based on therapeutic needs
- Ensure each product follows Indian Pharmacopoeia (IP) or other accepted standards
2.
Stability Testing & Batch Trials
- Conduct pilot batches to validate shelf life, uniformity, and compliance
- Keep testing records and samples for licensing audits
3.
DCGI Approval (if needed)
- For new drug combinations or Schedule X drugs, central approval from CDSCO may be required
4.
Packaging Development
- Select container types (blister packs, bottles, vials)
- Design compliant labels with all mandatory details
This approach gives you full control over formulation quality and IP — but comes with higher costs and timelines.
B. Third-Party Manufacturing (Marketing Model)
This is the most popular model for pharma startups in India. Here’s how it works:
1.
Find a Manufacturer
- Choose a GMP-certified third-party manufacturer
- Check their product list and existing DCGI approvals
- Sign a manufacturing agreement with MoQs (Minimum Order Quantities)
2.
Product Selection
- Select products based on:
- Market demand
- Competition
- Margins
- Therapeutic segment (e.g., dermatology, anti-infectives, pediatric, etc.)
- Market demand
3.
Label Customization
- Share your brand name, logo, and packaging preferences
- Ensure the labels include:
- Drug licence number
- Batch number, MRP, expiry, usage, etc.
- Manufacturer details
- Drug licence number
4.
Sample Approvals
- Approve samples for packaging, print quality, and dosage
- Request batch test reports for each product lot
Third-party manufacturing reduces upfront investment while allowing you to focus on marketing, sales, and brand growth.
Popular Dosage Forms to Consider
- Tablets and Capsules
- Oral Liquids (Syrups, Suspensions)
- Injectables (Dry powder and liquid)
- Topicals (Ointments, Creams, Gels)
- Herbal/Nutraceuticals (with FSSAI licence)
Tip:
Start with 8–12 core products in your chosen therapeutic area. Once your sales stabilize, expand the portfolio based on doctor feedback and regional demand.
9. Marketing & Distribution Strategy
In a competitive pharma landscape, your marketing and distribution plan is what will differentiate your business. Regardless of how good your product is, it needs an effective network to reach chemists, hospitals, and consumers.
Here’s how you can build a solid go-to-market strategy:
A. Building Your Sales Force
- Medical Representatives (MRs):
- Hire field staff who will meet doctors, distribute samples, and generate prescriptions
- Train them in product knowledge and objection handling
- Offer incentives, travel allowance, and target-based bonuses
- Hire field staff who will meet doctors, distribute samples, and generate prescriptions
- Zonal Managers or Franchise Partners:
- For larger scale businesses or PCD models, appoint regional heads who manage distribution networks
- For larger scale businesses or PCD models, appoint regional heads who manage distribution networks
B. Promotional Material Development
Create branded promotional kits, such as:
- Visual Aids (detailing sheets for doctors)
- Product cards and leaflets
- Doctor samples
- Branded pens, pads, and bags
- Patient education brochures
Strong branding and doctor engagement boost product recall and prescription conversion.
C. Distribution Channels
You can choose from the following:
- Own sales force + direct chemist contact (field-heavy model)
- Appointing regional stockists/distributors
- PCD Franchise Network (franchise model with monopoly rights)
- Online B2B platforms like Indiamart, TradeIndia, and PharmaHopers
D. Pricing and Schemes
Decide your MRP based on:
- Competitor pricing
- Margin for distributors (10–20%) and retailers (20–30%)
- Schemes (e.g., 10+1 free, cash discounts)
Ensure your pricing strategy balances profitability and competitiveness.
E. Export Strategy (Optional)
For companies planning to export:
- Apply for COPP, Free Sale Certificate, and WHO-GMP
- List on platforms like Alibaba, PharmaBiz, or ExportersIndia
- Attend pharma expos like CPhI or Pharmexcil trade shows
F. Digital Marketing (Emerging Channel)
Even in pharma, digital marketing is growing. Consider:
- Creating a company website with product catalogues
- SEO for B2B pharma keywords
- LinkedIn outreach to doctors, dealers, and importers
- WhatsApp-based order systems for PCD or stockists
Pro Tip:
Your first year should focus on building trust with prescribers and partners. Overdeliver on service and maintain consistent supply to retain your network.
10. Challenges and Regulations to Watch
While the pharma industry offers significant potential, it also comes with its own set of challenges — especially for first-time entrepreneurs. Understanding these upfront helps you prepare and operate your company in a compliant, risk-free way.
A. Regulatory Compliance
India’s drug regulatory framework is one of the strictest in the world. As a pharma company, you must adhere to:
- Drugs and Cosmetics Act, 1940
- Pharmacy Act, 1948
- Drug Price Control Order (DPCO), 2013
- GST regulations
- Schedule M (for GMP compliance)
Failure to comply can result in:
- Licence suspension or cancellation
- Product recalls
- Legal action or penalties
B. Price Control Regulations
The National Pharmaceutical Pricing Authority (NPPA) regulates the maximum retail prices (MRPs) of essential drugs listed under the DPCO. This limits your ability to set high margins on certain medicines.
Solution: Balance your portfolio between price-controlled drugs and open-market products like nutraceuticals, cosmetics, or wellness supplements.
C. Quality Assurance and Batch Recalls
Every batch of drug manufactured or marketed must meet stringent quality parameters. Even one failed sample can:
- Tarnish your brand’s reputation
- Trigger product recalls
- Lead to fines or import bans (in case of exports)
Tip: Always ask for COA (Certificate of Analysis) and third-party lab test reports before dispatching batches.
D. Counterfeit Medicines
The Indian market is vulnerable to fake or duplicate products. If your brand name is misused or your supply chain is not secure, it can affect trust and lead to regulatory issues.
Protect yourself by:
- Registering your trademark
- Securing your packaging (QR codes, holograms)
- Verifying all partners before onboarding
E. Drug Approval Delays
If you plan to manufacture new drug combinations or fixed-dose combinations (FDCs), approvals from CDSCO can take months. This delays go-to-market plans.
Plan early and use consultants familiar with DCGI submission formats and timelines.
F. Cash Flow and Credit Risk
Distributors and stockists often operate on 60–90 day credit cycles, affecting your cash flow. Defaulting partners can cause working capital issues.
Always:
- Vet new partners thoroughly
- Use post-dated cheques or agreements
- Start with smaller credit limits
Running a pharma company isn’t just about making and selling medicines — it’s about managing risks, staying compliant, and earning trust every day.
11. FAQs About Opening a Pharma Company
Here are answers to some of the most commonly asked questions by aspiring pharma entrepreneurs:
Q1. Do I need to be a pharmacist to start a pharma company?
No, you do not need to be a pharmacist or doctor. However, you must:
- Appoint a registered pharmacist (for retail/wholesale)
- Hire a qualified technical staff (for manufacturing)
Q2. How much capital is required to start a pharma company in India?
It depends on the model:
- PCD or marketing company: ₹3–10 lakhs
- Wholesale distributor: ₹5–15 lakhs
- Manufacturing unit: ₹50 lakhs – ₹2 crores+
Q3. How long does it take to get a drug licence?
Typically, it takes:
- Retail/Wholesale licence: 15–30 days
- Loan/Manufacturing licence: 30–90 days
This may vary based on your state and application completeness.
Q4. Can I operate from a residential address?
Usually no. Most state FDAs require a commercial premises or designated business space that meets sanitation and size requirements. Always check local guidelines.
Q5. Do I need separate licences for different drug categories?
Yes. For example:
- Allopathic drugs: Form 20/21 or 25/28
- Ayurvedic or Herbal products: AYUSH licence
- Nutraceuticals: FSSAI licence
Always match your product type to the corresponding authority.
Q6. Can I sell online as a new pharma company?
Yes, but you must have:
- A valid retail/wholesale licence
- Tie-up with licensed courier services
- Compliant labelling and storage
You can build your own D2C website or sell via platforms like Amazon, Flipkart Health+, and 1mg.
Q7. What is the difference between loan licence and third-party manufacturing?
- Loan Licence: You apply for a licence under someone else’s facility
- Third-Party Manufacturing: You use a manufacturer’s licence but do not apply for one yourself
Both allow you to sell products under your own brand.
12. Conclusion and Key Takeaways
Starting a pharmaceutical company in India is one of the most promising business ventures today — thanks to a growing demand for medicines, strong government support, and India’s global leadership in generics and healthcare exports.
However, the industry is also highly regulated, competitive, and operationally complex. Whether you’re starting a marketing company, launching a PCD franchise, becoming a wholesaler, or building your own manufacturing plant, success depends on more than just a good idea — it demands meticulous planning, compliance, and execution.
Here’s a quick recap of the journey to open a pharma company:
✅ Decide your business model — marketing, manufacturing, wholesale, or retail
✅ Register your company with proper legal and tax structures
✅ Secure your premises and hire qualified technical staff
✅ Apply for the correct drug licence(s) based on your operations
✅ Develop or source products with proper testing and documentation
✅ Set up your branding, pricing, and promotional strategy
✅ Build strong distributor and doctor networks
✅ Maintain quality, batch records, and GMP compliance throughout
Final Tips for Pharma Entrepreneurs
- Start small and focus on one therapeutic area before expanding
- Keep your documentation airtight — it protects you legally and helps in audits
- Build strong relationships with reliable manufacturers and stockists
- Be proactive about regulatory updates, especially DPCO and CDSCO guidelines
- Don’t compromise on quality control or ethical marketing