How to Open a Pharma Company in India?

How to Open a Pharma Company in India?

The Indian pharmaceutical industry is changing fast. With more people needing quality healthcare, the country is seeing a strong rise in demand for safe, affordable and effective medicines. India already supplies more than 50% of the vaccines which is used worldwide. It is the third-largest pharmaceutical producer by volume. The pharma sector in India is expected to reach $130 billion by 2025. This makes it the perfect time to start a pharmaceutical company.

Opening a pharma company in India is not only a business move. It’s a step into a system that saves lives every day. Still, the process is not simple. There are rules to follow, documents to file, and approvals to secure. If you're new to this sector, the steps can feel hard to track. But with the right planning, knowledge, and strategy, you can do it smoothly.

This guide will help you understand what you need. From licenses to infrastructure from business setup to compliance we’ll walk you through each step

1. Choose the Type of Pharma Company

Before you apply for licenses you need to decide what kind of pharma business you want. There are several types:

• Pharma Manufacturing Company: You make medicines in your own unit.
• Marketing Company: You sell medicines under your own brand, but a third-party manufacturer produces them.
• Wholesale Distribution Company: You buy medicines in bulk from manufacturers and sell them to retailers or hospitals.
• Retail Pharmacy: You sell medicines directly to patients through a shop or online platform.

Each type comes with different legal needs. So, the first step is to define what you want the company to do.

2. Register Your Business Entity

Once you choose your business type, you need to register it legally. In India, you can set up your pharma company as a:

• Proprietorship (owned by one person)
• Partnership
• Limited Liability Partnership (LLP)
• Private Limited Company (most preferred in pharma)
• One Person Company (OPC)

3. Secure a Drug License

This step is one of the most important. Under the Drugs and Cosmetics Act, 1940, no company in India can sell or distribute drugs without a valid license. The license type depends on your business:

• Manufacturing License: For making drugs. Issued by the State Drug Control Department.
• Wholesale Drug License: For selling drugs in bulk.
• Retail Drug License: For selling directly to customers.

To apply, you’ll need documents like:

• Premises blueprint
• Proof of ownership or rental agreement
• Details of your technical staff (registered pharmacists or experienced persons)
• Company incorporation proof
• Identity and address proof of directors/partners

4. Choose a Suitable Premises

To get the license, your premises must match government rules. The Drug Control Department checks that your space is clean, well-ventilated, and has enough area for storing medicines.

Here are some key premises requirements:

• Minimum 10 square meters for a retail/wholesale unit
• Minimum 120 square meters for a manufacturing unit
• Separate space for storage and office work
• Air conditioners for storing temperature-sensitive drugs
• Refrigerator for vaccines and insulin

5. Hire Qualified Staff

You cannot run a pharma company alone. You’ll need skilled and licensed staff to meet regulatory standards.

• For a Retail Drug License, you need a registered pharmacist with a valid license.
• For a Wholesale Drug License, you need someone with a degree and 1 year of experience, or someone with an SSC certificate and 4 years of experience.
• For Manufacturing, you’ll need technical staff approved by the Drug Control Department.

6. Apply for GST and Other Registrations

Besides the drug license, your business needs tax registrations. These include:

• GST Registration
• Import Export Code (IEC)
• Trademark Registration
• FSSAI License

7. Plan Your Product and Get DPCO Clearance

Before launching your medicines. Decide your product list. If you’re marketing your own brand, choose Formulations or Therapeutic Segments such as:

• Antibiotics
• Pain relief
• Cardiac care
• Diabetes care
• Dermatology

8. Set Up Supply Chain and Vendors

Next, you must build your pharma supply chain. This includes:

• Raw material suppliers (for manufacturers)
• Third-party manufacturers (for marketing firms)
• Packaging vendors
• Transport partners
• Stockists and distributors

9. Build a Marketing Strategy

Marketing is a must, even for a regulated sector like pharma. You need to educate doctors, reach hospitals, and inform chemists.

Your strategies may include:

• MR (Medical Representative) Teams
• Doctor Outreach Programs
• Online Branding
• Trade Advertising
• CME (Continuing Medical Education) Sponsorships

10. Stay Compliant and Audit-Ready

Once you’re up and running, you must stay compliant. This means:

• Renewing your licenses on time
• Keeping batch records
• Following GMP/GDP rules
• Paying taxes
• Submitting price declarations to NPPA if needed
• Reporting adverse drug reactions, if any

Final Thoughts

Opening a pharma company in India in 2025 is a serious but rewarding path. The sector is growing, and the need for ethical, effective medicine is rising fast. Still, this business needs structure, care, and full legal compliance.

If you follow each step—business setup, licensing, premises, hiring, compliance—you can build a strong pharma company. Make sure your goals are clear, and your records are clean. Only then can your company grow.